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510(k) Data Aggregation
(245 days)
The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient's torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
AT-Patch consists of ECG recorder (AT-Patch device), ECG Analysis Software(AT-Report) and Real-time ECG Viewer (AT-Note). ECG Recorder consists of two models, ATP-C130 and ATP-C70, and is a medical device that attaches electrodes to a specific part of the potential difference that occurs when myocardial activity is transmitted to the surface of the body and measures and stores electrocardiogram signals. (ATP-C130: up to 14 days, ATP-C70: up to 7 days) AT-Note is an accessory App for medical device that can confirm the operation of the AT-Patch device using the BLE communication function. AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with diagnosis and can confirm the operation of AT-Patch device using the BLE communication function. AT-Note is intended for quality check purposes only and not intended for real-time patient monitoring. ECG analysis is performed only after data collection is completed.
The provided FDA 510(k) clearance letter introduces the AT-Patch (ATP-C130/ATP-C70), a device for continuous ECG monitoring and analysis. The document details the device's technical characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.
Based on the provided text, primarily section 9. Performance Testing – Nonclinical, and specifically point 12. The performance (Arrhythmia) accuracy, we can extract information regarding the study that proves the device meets acceptance criteria.
However, the document does not explicitly present a "table of acceptance criteria and the reported device performance" with specific numerical thresholds for accuracy metrics (Sensitivity, PPV, FPR). It states that performance was "assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." It implies that these metrics were used to determine accuracy but doesn't provide the acceptance criteria thresholds or the reported performance values.
Therefore, I will construct a table of acceptance criteria based on standard expectations for such devices (as the actual criteria are not specified in the text) and indicate that the reported performance "meets" these implied criteria, as the device received clearance.
Here's the breakdown of the information based on the provided text:
Acceptance Criteria and Device Performance Study
While the document indicates that "The performance (Arrhythmia) accuracy test was evaluated in accordance with ANSI/AAMI EC57:2012," it does not explicitly state the numerical acceptance criteria for Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR). It only states that performance was "assessed based on" these metrics and "validated against reference data." For the purpose of this response, I will list the metrics and assume the device met the implicit or unstated acceptance criteria, as it received 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Specific numerical acceptance criteria and reported performance values for Sensitivity, PPV, and FPR are not provided in the document. The table below represents the types of performance evaluated and the assumed outcome (met criteria for clearance).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| QRS Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
| VEB/SVEB Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
| Atrial Fibrillation (AF) Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
| Couplets Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
| Runs Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
| Tachycardia Detection | High Sensitivity, High PPV, Low FPR (based on ANSI/AAMI EC57:2012) | Met (Implicitly, as cleared) |
The document states: "Performance was assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." The specific numerical thresholds for these metrics that constitute "acceptance criteria" are not disclosed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of patients or ECG recordings. The document mentions "The collected dataset was used to evaluate the accuracy..."
- Data Provenance:
- Country of origin: Not explicitly stated, but the dataset was "designed to closely align with U.S. demographics." This suggests the data was from, or representative of, a U.S. population.
- Retrospective or Prospective: Not explicitly stated. The phrase "ECG data was collected from diverse racial groups..." suggests existing, collected data, which leans towards retrospective.
- Diversity: "ECG data was collected from diverse racial groups (White, Black, Hispanic, Asian), genders (male/female), ages (Young adulthood (18–39 years), Middle adulthood (40–64 years), Old age (Over 65 years)), and BMI categories (normal, overweight, obese), representing the U.S. population. Data was sourced from multiple hospitals..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: "annotated by certified ECG technicians and cardiologists." Specific experience levels (e.g., "10 years of experience") are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The ground truth was "annotated by certified ECG technicians and cardiologists," but the process for reconciling discrepancies (e.g., 2+1, 3+1) is not detailed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: The document describes an "algorithm only" performance evaluation ("The performance (Arrhythmia) accuracy test was evaluated..."). It does not mention a comparative effectiveness study involving human readers with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study or human-in-the-loop comparison is described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the described "Performance (Arrhythmia) accuracy test" is a standalone, algorithm-only evaluation. The analysis software itself performs a "primary analysis" that is then subject to "secondary analysis by a clinician or trained operator." The reported accuracy test appears to be assessing this primary algorithmic analysis.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by human experts: "annotated by certified ECG technicians and cardiologists." This is expert consensus/adjudication. It is validated "against reference data," implying a gold standard or adjudicated truth.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified in the provided text. The document focuses on the performance evaluation of the "AT-Report" software, stating it "utilizes machine learning-based algorithms." However, it does not reveal details about the training data used for these algorithms.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified in the provided text. While the development of "machine learning-based algorithms" implies a training set with ground truth, the document only describes the ground truth process for the test set evaluation.
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(259 days)
The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.
The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.
The provided document is a 510(k) clearance letter from the FDA for a medical device called "ATMOS C 051 Thorax," a powered suction pump for thoracic drainage. While it discusses performance tests and adherence to various standards, it does not contain the detailed clinical study data typically found in a clinical trial report or a comprehensive technical submission.
Therefore, I cannot extract answers for many of your specific questions related to acceptance criteria, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set details from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance bench testing, software validation, biocompatibility testing, human factors validation, and risk management.
However, I can provide information on what is explicitly stated or can be inferred from the document regarding the acceptance criteria and the nature of the study.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Performance tests were carried out to ensure that the subject device functions as intended and meet design specifications." and "Risk analysis was carried out based on acceptance criteria established in accordance with ISO 14971." However, the specific numerical acceptance criteria or the direct reported performance values for each criterion are NOT provided in this summary.
The document lists the following categories of performance tests conducted with "no unexpected results or significant deviations":
| Acceptance Criteria Category (Details Not Provided) | Reported Device Performance (Qualitative) |
|---|---|
| Electrical, Mechanical, and Thermal Safety (in accordance with AAMI/ANSI and IEC 60601 standards) | Successfully tested and complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2. |
| Software Validation (in accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions," June 14, 2023) | Performed, documentation level "enhanced," cybersecurity aspects followed FDA guidance. |
| Biocompatibility Testing (according to ISO 10993-1 and FDA guidance) | Performed (details not explicitly stated). |
| Performance Bench Testing: | "No unexpected results or significant deviations." |
| - Maximum flow rate | (Specific values not provided) |
| - Function and accuracy of flow display | (Specific values not provided) |
| - Minimum to maximum vacuum | (Specific values not provided) |
| - Function, accuracy and control delay of vacuum display | (Specific values not provided) |
| - Battery operation at full power mode | (Specific values not provided) |
| - Battery charge time | (Specific values not provided) |
| - Over suction protection | (Specific values not provided) |
| - Weight | Subject device: 1.16 kg (predicate: 3.27 kg) |
| - Alarm sound and noise level | (Specific values not provided) |
| - Length of hose system | (Specific values not provided) |
| Human Factors Validation (in accordance with IEC 62366-1, IEC 60601-1-6, and FDA guidance) | "Use of the device is safe, especially with regard to the use by lay persons. The residual risks that remain...have been reviewed and determined to be acceptable." |
| Risk Management (in accordance with ISO 14971:2019) | "Overall benefits of using the device outweigh the risks. The device is safe and effective for use in the intended patient population." |
| Reprocessing, Sterility, and Shelf-Life (for certain components) | Cleaning and disinfecting procedures described. Sterile validation performed for secretion canister and hose systems according to ISO 11135. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and validation activities rather than a typical clinical study with a "test set" of patient data. Therefore, the concept of sample size as it applies to patient data is not relevant here. The "tests" refer to engineering and quality assurance activities. No country of origin for data or retrospective/prospective nature is mentioned as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of clinical "ground truth" derived from expert interpretation in this document. The tests performed are technical and engineering-focused (e.g., flow rates, vacuum levels, battery performance), with human factors validation likely involving usability experts or human factors engineers, but their specific qualifications and number are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's relevant for clinical adjudication of medical images or diagnoses, not for the technical bench testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted or mentioned. This device is a powered suction pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (suction pump), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests mentioned are engineering specifications, international standards (IEC, ISO), and regulatory guidance documents (FDA guidance). For example, for flow rate, the "ground truth" would be the measured flow rate compared against the predefined design specification. For human factors, it would be the assessment of safety and effectiveness of use against defined usability goals and risk analysis.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the reason stated above.
In summary, the provided document details a 510(k) submission for a non-AI medical device (powered suction pump). The "studies" proving it meets acceptance criteria are predominantly non-clinical bench tests and validation activities against established engineering specifications, international standards, and regulatory guidelines, rather than clinical trials that generate patient data and require expert ground truth establishment.
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(59 days)
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
- Severe instability, gross deformity and/or bone loss
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection
- Absent or markedly insufficient collateral ligaments
The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.
This document is a 510(k) Premarket Notification from the FDA for the "ATTUNE™ Revision Hinge Knee" device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of an AI/software device.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable to this particular document as it is for a mechanical implant and not an AI/software product. The information provided relates to the non-clinical testing of the physical implant's mechanical and material properties.
However, I can extract the relevant information regarding the tests performed for the determination of substantial equivalence (analogous to proving the device meets certain performance standards for a mechanical device).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria with reported performance values in a direct side-by-side comparison. Instead, it states that "The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices." This implies that the device performed equivalently to the predicate devices in these tests, satisfying the FDA's requirement for substantial equivalence.
| Test Type | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Shear Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Fatigue Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Wear Performance | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Stability Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Contact Pressure Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Biocompatibility | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| MRI Safety Evaluation Testing | Substantially equivalent to predicate devices (if applicable). | Performed in support of substantial equivalence and safety/efficacy. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on specific sample sizes for these tests (e.g., how many specimens were shear-tested or fatigue-tested). It also does not mention data provenance as these are mechanical/materials tests, not human data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a submission for a mechanical medical device, not an AI/Software device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests listed (Shear, Fatigue, Wear, Stability, Contact Pressure, Biocompatibility, MRI Safety Evaluation), the "ground truth" would be established engineering standards, material science specifications, and regulatory requirements relevant to orthopedic implants.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable.
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(90 days)
ATTUNE™ Revision Knee System: Candidates for total knee replacement include patients with A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatod arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: Absence or loss of both cruciate ligaments Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only. The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives. THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM. THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.
S-ROM™ NOILESTM Rotating Hinge Knee: The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: 1. Severe instability, gross deformity and/or bone loss. 2. Failure of a previous knee reconstruction procedure. 3. Trauma or tumor resection. 4. Absent or markedly insufficient collateral ligaments.
DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.
ATTUNE™ Revision Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient.
DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: A Total Knee Prosthesis System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component. The wobble bit is an instrument used to aid implant assembly.
DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: A SIGMA™ Total Knee System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges or augments. The patella component is an all polyethylene design.
S-ROM™ NOILESTM Rotating Hinge Knee System: The S-ROM NOILES Rotating Hinge Knee System is a tricompartmental total knee replacement for both primary and revision cases. The S-ROM NOILES Rotating Hinge Knee System includes the femoral component with hinge pin, the tibial plateau assembly, and the distal femoral augmentation blocks. Replacement bumpers for the femoral component assembly and replacement hinge bearings for the tibial plateau assembly are also available.
DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C.™ SIGMA® Total Knee Prosthesis is a total knee prosthesis composed of individually packaged femoral, tibial base, tibial insert and patellar components designed to replace the natural articular surface of the knee joint or after a failed previous implant. Some femoral and tibial components can be used with modular stems, porous and non-porous coated sleeves and/or modular augments when supplemental fixation is required in the judgement of the surgeon. The natural patella may or may not be resurfaced.
The provided text describes several knee prosthesis systems from DePuy, specifically outlining their intended use, indications for use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The devices in this application (ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, DePuy Sigma PS Femoral Components, DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components, S-ROM™ NOILES™ Rotating Hinge Knee System, DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis, DePuy SIGMA™ Total Knee Prosthesis) are being submitted with a modification to labeling to include updated MRI compatibility information and modernized/standardized language in the Instructions for Use (IFU) and labels. There are no changes in design, manufacturing, principle of operation, indication, or intended use of the devices themselves. Therefore, the "acceptance criteria" and "reported device performance" in this context relate to Magnetic Resonance (MR) Safety standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| ASTM F2503-23: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment | Testing performed to determine MR Safety, including marking devices for the MR environment. |
| ASTM F2182-19E2: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance | Testing performed to determine MR Safety, specifically measuring radio frequency induced heating. |
| ASTM F2052-21: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | Testing performed to determine MR Safety, specifically measuring magnetically induced displacement force. |
| ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | Testing performed to determine MR Safety, specifically measuring magnetically induced torque. |
| ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | Testing performed to determine MR Safety, specifically evaluating MR image artifacts. |
| ANSI/AAMI ST 72:2019: Bacterial endotoxin testing | The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019. |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The "tests" mentioned are non-clinical (bench testing) and refer to compliance with ASTM standards for MR safety and ANSI/AAMI for bacterial endotoxin. The document does not provide specific sample sizes for these non-clinical tests or their data provenance (e.g., country of origin, retrospective/prospective). It merely states that the tests were performed according to the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as "No clinical tests were conducted." The ground truth for this submission is established through compliance with recognized industry standards for MR safety and bacterial endotoxin testing, not through expert-reviewed clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as "No clinical tests were conducted." The assessment is based on the results of non-clinical, standard laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The submission is for knee joint prostheses and concerns MR safety labeling, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The submission does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is the compliance with established international and national standards for medical device safety, specifically:
- ASTM standards for Magnetic Resonance (MR) Environment safety (F2503-23, F2182-19E2, F2052-21, F2213-17, F2119-07).
- ANSI/AAMI ST 72:2019 for bacterial endotoxin testing.
8. The sample size for the training set:
This is not applicable as "No clinical tests were conducted." There is no "training set" in the context of this submission, which relies on non-clinical engineering and biological safety testing against established standards.
9. How the ground truth for the training set was established:
This is not applicable, as explained in point 8.
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(99 days)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Porous coated implants may be used with or without cement. Candidates for total knee replacement include patients with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The FDA document provided is a 510(k) Premarket Notification clearance letter for a medical device: "ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology."
This document does not describe a study involving a medical device using Artificial Intelligence (AI). Instead, it concerns a physical orthopedic implant (a knee replacement component) and its substantial equivalence to previously cleared devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical, material, and chemical properties of the physical implant, and the tests performed to demonstrate their equivalence to a predicate device.
Therefore, I cannot provide information for the following points from your request as they are relevant only to AI/software-based medical devices, which this document does not cover:
- Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
However, I can extract information relevant to the physical device's acceptance criteria and the studies performed to demonstrate its substantial equivalence.
Here's what I can glean from the provided document regarding the physical device:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of explicit numerical acceptance criteria for performance or a direct comparison to specific reported values for the new device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. The primary difference highlighted is the material grade.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Material Composition Equivalence: The new device should have material properties comparable to the predicate device, particularly regarding the Titanium alloy. | The subject device uses Titanium alloy (Ti-6A1-4V) with Grade 5 chemistry (ASTM F-2924). The predicate devices use Titanium alloy with Grade 23 chemistry (ASTM F-3001). The document implies that despite this grade difference, the devices are equivalent based on testing. |
| Manufacturing Process Consistency: The manufacturing process (specifically 3DP technology) should yield consistent and acceptable material properties. | Oxygen Content Study was performed. This suggests an acceptance criterion related to maintaining low oxygen levels in the porous structure, which is critical for material integrity and biocompatibility. (Specific values are not provided in the document). |
| Material Recycling Suitability: If material is recycled in the 3DP process, it must not compromise the final product's quality. | EOS M290 3D Printer Recycling Study was performed. This suggests an acceptance criterion related to the quality and consistency of parts produced using recycled material from the 3D printing process. (Specific findings are not provided in the document). |
| Biocompatibility & Safety: The material and design should be biocompatible and safe for implantation. | The product code "MBH" (Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis) falls under Class II Special Controls, implying that the device must meet recognized standards for biocompatibility, sterility, mechanical performance, fatigue, and wear, among others. The testing performed (Oxygen Content Study, Recycling Study) supports safety and effectiveness. The document states "Clinical testing was not required to demonstrate substantial equivalence," meaning non-clinical (bench) tests were sufficient. |
| Functional Equivalence: The device should perform equivalently to the predicate in its intended function (e.g., stability, fixation). | The subject and predicate devices are stated to be "the same as... in principle of operation, intended use, classification, design, raw material, and fixation." The AFFIXIUM™ 3DP Technology printed titanium porous structure for biological fixation is utilized by both, supporting functional equivalence in bone ingrowth. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of device. The tests mentioned (Oxygen Content Study, Recycling Study) are laboratory-based material and process characterization studies, not clinical trials with human patient data. Sample sizes would refer to the number of test coupons or components manufactured and tested, which is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/clinical interpretation study. "Ground truth" in this context would refer to established material and mechanical standards, and the experts would be material scientists, engineers, and quality control personnel involved in the testing, not clinical "experts" establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for material and manufacturing quality would be established by:
- International standards: Such as ASTM F-2924 and ASTM F-3001 for Titanium alloy chemistry, and other standards for mechanical properties (e.g., fatigue strength, tensile strength).
- Internal specifications and validation methodologies: Defined by the manufacturer based on engineering principles and regulatory requirements.
- Analytical chemistry and material characterization techniques: To determine oxygen content, microstructure, etc.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
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(94 days)
ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
LPS TM Limb Preservation System Indications for Use
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- · malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
- · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
- · severe trauma requiring extensive resection and replacement.
The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.
Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.
Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
This document (K233980) is a 510(k) premarket notification for several DePuy knee systems. It primarily focuses on adding updated MRI compatibility information and standardizing language in the Instructions for Use (IFU) and labels. The core claim for substantial equivalence relies on non-clinical performance data related to MRI safety and bacterial endotoxin testing, rather than a clinical study of device performance in a human-in-the-loop or standalone AI context.
Therefore, the requested information regarding acceptance criteria, study design for device performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from this document as it pertains to a different type of device (knee implants) and regulatory submission (510(k) for labeling changes related to MRI safety, not an AI/software as a medical device performance study).
However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted, and the reported performance as implied by the conclusion of substantial equivalence.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For MRI safety, the acceptance criteria are implicit in meeting the standards listed. The reported "performance" is that the devices meet these standards, thus proving MRI safety.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implied) |
|---|---|
| Conformance to ASTM F2503-23 (Standard practice for marking medical devices for safety in MR environment) | Met |
| Conformance to ASTM F2182-19E2 (Measurement of Radio Frequency Induced Heating On or Near Passive Implants during MR) | Met |
| Conformance to ASTM F2052-21 (Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment) | Met |
| Conformance to ASTM F2213-17 (Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment) | Met |
| Conformance to ASTM F2119-07 (Evaluation of MR Image Artifacts from Passive Implants) | Met |
| Conformance to ANSI/AAMI ST 72:2019 (Bacterial Endotoxin Testing) | Met |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here would refer to the physical devices tested for MRI compatibility and bacterial endotoxin. The document does not specify the number of individual devices subjected to these non-clinical tests.
- Data Provenance: Not applicable for a typical AI/software study. The "data" here are the results from physical and chemical testing of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" established by experts in the context of an AI or diagnostic device study. The ground truth for these tests is defined by the physical properties measured according to established ASTM and ANSI standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as this is not an image-based or diagnostic AI study requiring human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." (pages 6, 9, 12, 15)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a knee implant, not an algorithm or software. The "performance" assessment is of the physical and material properties of the implant itself in relation to MRI safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is established by the physical and chemical properties measured according to the specified ASTM and ANSI international standards for MRI compatibility and bacterial endotoxin levels.
8. The sample size for the training set
- Not applicable. There is no AI model or training set involved in this regulatory submission.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or training set involved in this regulatory submission.
In summary: This FDA 510(k) submission for DePuy knee systems is related to changes in labeling for MRI compatibility, not an AI/software/diagnostic device. The "study" described focuses on non-clinical bench testing to demonstrate MRI safety and bacterial endotoxin compliance, adhering to recognized industry standards, rather than clinical performance or AI algorithm validation.
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(132 days)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacements with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.
The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6Al-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high molecular weight polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cementless or cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.
This document is a 510(k) summary for the ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology. It outlines the device description, intended use, and comparative analysis with predicate devices to demonstrate substantial equivalence, rather than providing a study proving specific performance criteria for the device itself.
Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study (items 1-9) is not applicable to this document. This document pertains to the regulatory clearance of a medical implant, not an AI or diagnostic software.
However, based on the non-clinical tests performed to demonstrate substantial equivalence (as described on page 7), we can infer the types of performance aspects considered for regulatory approval of such a device:
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 7 lists the following tests performed:
- Peg Fatigue Testing for ATTUNE Cementless Patella
- Stryker Peg Fatigue Benchmark Testing for ATTUNE Cementless Patella
- Biocompatibility Evaluation Report (Patella)
- MRI Testing (Tibial Base & Patella)
These tests are designed to assess the safety and efficacy of the implant in terms of its mechanical properties, material compatibility with the human body, and compatibility with MRI imaging. The acceptance criteria for these tests would typically be defined by relevant ASTM or ISO standards for orthopedic implants, and the device would be considered to 'meet' these criteria if its performance falls within the established limits of these standards or is demonstrated to be equivalent to the predicate device.
No information regarding AI performance, human reader studies, or associated metrics like sensitivity, specificity, or effect sizes for AI assistance is present in this product clearance document.
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(90 days)
The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments that are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable and are offered non-sterile to be cleaned and steam sterilized by the end user.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for the "ATEC Posterior Navigated Disc Prep Instruments."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance (Summary of results) |
|---|---|
| Dimensional Analysis: Instruments should meet specified dimensional requirements to ensure compatibility and proper function. | Dimensional analysis of the instruments compared to Medtronic instruments was conducted. |
| Performance with Medtronic StealthStation System: The instruments should perform safely and effectively when used with the Medtronic StealthStation System, ensuring accurate navigation and intended surgical function. | Testing was conducted to confirm performance and safety of the subject instruments when used with the Medtronic StealthStation System. |
| Substantial Equivalence: The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of intended use, indications for use, design, technology, and performance. | Testing results demonstrated the subject ATEC Posterior Navigated Disc Prep Instruments are substantially equivalent when compared to other legally marketed devices cleared by FDA. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample size used for the test set in the performance testing. It generally states that "Dimensional analysis of the instruments compared to Medtronic instruments" and "Testing to confirm performance and safety of the subject instruments when used with Medtronic StealthStation System" were conducted.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing for medical devices, it would generally be prospective testing conducted in a controlled environment to verify design specifications and system compatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For device performance testing, "ground truth" might refer to engineering specifications, established performance benchmarks for predicate devices, or validated measurement techniques. The document does not detail how these "truths" were established or if specific experts were involved in defining them.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" typically refers to how discrepancies in human reader interpretations are resolved, which is relevant for studies involving human assessment (e.g., diagnostic image interpretation). This document describes performance testing of surgical instruments and their compatibility with a navigation system, not human interpretation of medical data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was not done. The device is a set of navigated surgical instruments intended to facilitate discectomy, bony resection, and implant selection, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the typical sense of an algorithm. The device is a set of physical surgical instruments designed to be used with a navigation system. The "performance" being evaluated is the physical and functional interaction of the instruments with the navigation system, not an algorithm's standalone diagnostic capability. The closest analogy might be the performance of the navigation system itself (which the instruments are compatible with), but the document focuses on the instruments' performance and safety when used with that system.
7. The Type of Ground Truth Used
For dimensional analysis, the ground truth would be engineering specifications and drawings for the instruments. For performance and safety with the navigation system, the ground truth would involve defined functional and safety criteria based on the intended use and established performance of the Medtronic StealthStation System. This might include measurements of accuracy, precision, and successful navigation outcomes in a simulated or controlled environment. It is not expert consensus, pathology, or outcomes data in the usual clinical trial sense.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The development and testing of these surgical instruments do not involve a "training set" in the context of machine learning or AI models. Performance testing of physical medical devices relies on engineering principles and validation against specifications, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set." The performance of the instruments is validated against established specifications and functional requirements as described in point 7.
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(28 days)
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.
The provided text describes the ATMOS Scope, a flexible nasopharyngo laryngoscope, and its equivalence to a predicate device (Schoelly CMOS Video Nasopharyngoscope System K143673). However, the document does not contain information typically associated with acceptance criteria and a study design for evaluating the diagnostic performance of a medical device using an AI component.
Instead, the provided text focuses on demonstrating substantial equivalence through comparisons of technical characteristics and various non-clinical performance tests. These tests are primarily related to safety, functionality, and manufacturing compliance, rather than diagnostic accuracy or effectiveness in a clinical context that would require a human-in-the-loop or standalone AI performance study.
Therefore, I cannot directly answer your questions in the requested format as the provided document does not include such a study or information.
Here's what I can extract based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance or reported performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various technical parameters and confirms successful testing against standards.
| Acceptance Criteria Category | Reported Device Performance Summary |
|---|---|
| Indications for Use | "ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor." (Identical to predicate) |
| Design | Flexible and steerable fiberoptic endoscope for diagnostic purposes (Identical to predicate) |
| Material | Handle: aluminum; Insertion tube: PEEK, FKM, TPU, sapphire glass (Identical to predicate) |
| Chip-on-Tip | CMOS image sensor at the tip of the insertion tube (Identical to predicate) |
| Illumination | LED (2 LEDs) (Identical to predicate) |
| Deflection | 2 x 135° (Identical to predicate) |
| Weight | 0.4 kg (Identical to predicate) |
| USB Connection | Yes (Identical to predicate, though direct connection to PC vs. via CCU is a difference) |
| Focus Range | 6 - 60 mm (Identical to predicate) |
| Delivery Status | Non-sterile (Identical to predicate) |
| Image Sensor Resolution | 1280 x 800 pixels (Higher than predicate's 328 x 250 pixels); Justification: provides optimized view, not a negative impact on safety/effectiveness. |
| Field of view | 90° (Larger than predicate's 85°); Justification: provides optimized view, not a negative impact on safety/effectiveness. |
| Stroboscopy | Not supported (Removed feature from predicate due to patient complaints). |
| Sterilization | Validated for Low-Temperature Hydrogen Peroxide Gas Sterilization and SYSTEM 1E® Liquid Chemical Sterilant Processing System (differs from predicate's ethylene oxide); Validation tests performed according to FDA recognized standards. |
| Reprocessing | Manual cleaning with MetriZyme™ or Cidezyme, and manual high-level disinfection with CIDEX® OPA (differs from predicate's listed solutions); Validation performed by AAMI TIR 30: 2011 and ASTM E 1837-96 (2014). |
| Human Factors | Successfully tested regarding dimensions (length, diameter, deflection/angle) and requirements for basic safety and essential performance of endoscopic equipment per IEC 60601-2-18. Ergonmics of patient and user interfaces are equivalent to the predicate device. |
| Optical Performance & Photobiological Safety | Evaluation per IEC 62471:2006, LEDs classified in risk group 2. Measurements prove photobiological safety and no risk/hazard from light source. |
| Biocompatibility | Evaluation performed to comply with ISO 10993-1:2018 and FDA Guidance Documents. Effectiveness confirmed. |
| Electrical Safety & EMC | Tests performed per IEC 60601-1:2005 (Electrical Safety) and IEC 60601-1-2 Edition 4.0 2014-02 (EMC). All risk-based requirements and acceptance criteria were defined and met. |
| Software V&V | Embedded software does not provide support for basic safety or essential performance. Failure does not lead to risk. All firmware functions validated; requirements traceability matrix documented. USB connection checked for configuration, device name, and live image broadcast. All firmware tests passed successfully. |
| Labeling | In compliance with ANSI ISO 15223-1 3rd edition 2016-11-01. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical performance and safety testing. There is no mention of a test set for diagnostic performance or data provenance for such a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set for diagnostic performance or experts establishing ground truth. The device provides "visualization via a monitor" for "visual diagnostics by the user," implying human interpretation, but no study is detailed to quantify this diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The ATMOS Scope is a visualization device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a direct visualization tool. There is no AI algorithm component described for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study requiring ground truth is described.
8. The sample size for the training set
Not applicable. There is no mention of an AI component or a training set for machine learning.
9. How the ground truth for the training set was established
Not applicable. No AI component or training set is mentioned.
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(254 days)
ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
ATTO Mobility Scooter is an electrical battery powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The ATTO is a collapsible electric scooter which has a front-wheel brushless DC hub motor. The scooter can be collapsed in 12 seconds and can also be disassembled with ease. The scooter controlled through a thumb throttle and protected by an electronic-release brake system, has a driving range up to 20 km between charges. It is capable of carrying a driver weighing up to 136 (for ATTO MAX) kg. It moves both directions and handles a 6° slope. It can come to a full stop within 1.1m when on a horizontal plane and within 2.2 m when on a 6° slope.
This document is a 510(k) summary for the ATTO Mobility Scooter and its variations (ATTO SPORT, ATTO SPORT MAX). It describes the device, its intended use, a comparison to a legally marketed predicate device, and the testing performed to demonstrate substantial equivalence.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "ATTO performance and safety testing is conducted according to EN 12184:2014. All Performance testing met the predetermined acceptance values." However, specific acceptance criteria values and the device's reported performance for each criterion are not explicitly listed in a table format within this submission. Instead, there's a comparison table (Section G) that shows some specifications for the proposed device and its predicate.
To extract acceptance criteria and reported performance, we can infer some from the predicate comparison and the standards mentioned. The document doesn't explicitly state "acceptance criteria" for each performance parameter but rather implies that the device met the requirements of the standards and performed as expected.
| Feature / Performance Parameter | Predicate ATTO Mobility Scooter (K160909) | Proposed ATTO Mobility Scooter (K222703) | Implied Acceptance Criteria (Based on comparison/standards compliance) | Reported Device Performance (K222703) |
|---|---|---|---|---|
| Max Load | 100 kg | 120 kg (ATTO, ATTO Sport), 136 kg (ATTO SPORT MAX) | Must meet or exceed predicate, and comply with safety standards for load capacity. | 120 kg (ATTO, ATTO Sport), 136 kg (ATTO SPORT MAX) |
| Maximum speed (forward) | 6.4 km/h | 6.4 km/h (ATTO, ATTO Max), 9.6 km/h (Max SPORT) | Must function as expected and be safe. Consistency or improvement over predicate. | 6.4 km/h (ATTO, ATTO Max), 9.6 km/h (Max SPORT) |
| Maximum speed (reverse) | 4 km/h | 4 km/h | Must function as expected and be safe. Consistent with predicate. | 4 km/h |
| Travel distance | 15 km | 20/17 km | Must meet or exceed predicate. | 20/17 km |
| Braking Time | Not publicly available | 0.5s | Must be safe and within acceptable limits for mobility scooters. | 0.5s |
| Braking Distance | Not publicly available | 1.1m (horizontal plane), 2.2m (6° slope) | Must be safe and within acceptable limits for mobility scooters. | 1.1m (horizontal plane), 2.2m (6° slope) |
| Slope handling | (Implied from general use) | Handles a 6° slope | Must enable safe operation on slopes as specified. | Handles a 6° slope |
| Full stop within | N/A | 1.1m (horizontal), 2.2m (6° slope) | Must comply with safety standards for braking effectiveness. | 1.1m (horizontal), 2.2m (6° slope) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size used for the test set" or the "data provenance" (country of origin, retrospective/prospective). The testing described is non-clinical performance and safety testing of the device itself, rather than a study involving human subjects or a dataset derived from patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The submission describes non-clinical performance and safety testing of a mobility scooter against engineering standards (ISO 7176 series and EN 12184:2014). It does not involve "experts" in the sense of medical professionals establishing a "ground truth" for a diagnostic or AI-driven decision. The "ground truth" here is adherence to technical specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As explained above, this is non-clinical device testing, not a diagnostic study requiring expert adjudication of ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The submission is for a mobility scooter, which is not an AI-assisted diagnostic device or one that involves human "readers" or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to national and international safety and performance standards (ISO 7176 series and EN 12184:2014) and the manufacturer's own design specifications, which are benchmarked against the predicate device. It's based on objective measurements and engineering principles, not medical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing pertains to the physical device.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set, there is no ground truth for it.
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