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Rapid DeltaFuse is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images.

Data and images are acquired through DICOM compliant imaging devices.

Rapid DeltaFuse provides both viewing and analysis capabilities for imaging datasets acquired with Non-Contrast CT (NCCT) images.

The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue including overlays of time differentiated scans of the same patient.

Rapid DeltaFuse is intended for use for adults.

Rapid DeltaFuse (DF) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform. It provides visualization of time differentiated neuro hyperdense and hypodense tissue from Non-Contrast CT (NCCT) images.

Rapid DF is integrated into the Rapid Platform which provides common functions and services to support image processing modules such as DICOM filtering and job and interface management along with external facing cyber security controls. The Integrated Module and Platform can be installed on-premises within customer's infrastructure behind their firewall or in a hybrid on-premises/cloud configuration. The Rapid Platform accepts DICOM images and, upon processing, returns the processed DICOM images to the source imaging modality or PACS.

The provided FDA 510(k) clearance letter for Rapid DeltaFuse describes the acceptance criteria and the study that proves the device meets those criteria, though some details are absent.

Here's a breakdown of the information found in the document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantified manner as a target. Instead, the document describes the type of performance evaluated and the result obtained.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 14 cases were used for the co-registration analysis. The sample size for other verification and validation testing is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This information is not provided in the document. The document refers to "performance validation testing" and "software verification and validation testing" but does not detail the involvement of human experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was reported. The document focuses on the software's performance (e.g., DICE coefficient for co-registration) rather than its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The reported DICE coefficients (0.94 and 0.95) are measures of the algorithm's performance in co-registration and overlay addition, independent of human interaction.

7. Type of Ground Truth Used

• The document implies that the ground truth for co-registration and overlay performance was likely established through a reference standard based on accurate image alignment and feature identification, against which the algorithm's output (DICOM images with overlays) was compared. The exact method of establishing this reference standard (e.g., manual expert annotation, a different validated algorithm output) is not explicitly stated.

8. Sample Size for the Training Set

• The document does not specify the sample size used for training the Rapid DeltaFuse algorithm.

9. How Ground Truth for the Training Set Was Established

• The document does not specify how the ground truth for the training set was established.

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LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.

• Coupling of femoral modular heads with DELTA Acetabular System is indicated for use for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
• · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• · Rheumatoid arthritis;
• · Post-traumatic arthritis,
• · Correction of functional deformity;
• · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• · Revisions in cases of good remaining bone stock.
• · Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)

The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;

• · rheumatoid arthritis;
• · osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
• · treatment of femoral head and neck fractures (Minima S and MasterSL stems)
• · correction of functional deformity (MODULUS stems);
• · revisions in cases of good remaining femoral bone stock.

The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.

• Coupling of femoral modular heads with Cemented Cup is intended applications in hip arthroplasty where the acetabular socket needs reconstruction.

LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications.

This procedure is intended for redict of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.

Biolox® Delta Revision heads consist of a Biolox® Delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the Biolox® Delta ceramic material (K141327, K182099) and come in various outer diameters. The ceramic Biolox® Delta ball head is assembled with the corresponding titanium sleeve and is then placed over the taper of an in-situ hip stem prosthesis, during revision of a previously implanted femoral head:

K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855

The titanium sleeve has an inner 12/14 taper which fits the dimensions of a metallic hip stem prosthesis, and the Biolox® Delta ball head has a 16/18 taper which fits to the dimensions of the outer diameter of the titanium sleeve. The ball head then articulates against an acetabular insert:

K112898, K141395, K182099, K181491, K191622, K200656

The titanium sleeves are available in sizes -3, 0, +4, and +7 (S, M, L, XL) and the ball heads of the Biolox® Delta Revision heads are available with outer diameters ranging from 28mm - 40 mm.

Based on the provided text, the device in question is Biolox® Delta Revision heads, which are components of hip joint prostheses. The document is a 510(k) summary from the FDA, indicating a premarket notification for a medical device.

It's important to clarify that this document describes the substantial equivalence of a physical medical device (hip joint components), not a software-based or AI-driven diagnostic device. Therefore, the questions related to AI performance, ground truth establishment for AI, human reader improvement with AI assistance, and specific AI-related acceptance criteria are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to mechanical testing of the physical hip replacement components to demonstrate their performance and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's diagnostic accuracy.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not present performance in a typical "acceptance criteria vs. reported performance" table format for a diagnostic device. Instead, it states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."

The acceptance criteria are implied by the standards chosen for testing, and the performance is implicitly meeting those standards.

2. Sample size used for the test set and the data provenance

The document states, "Mechanical testing was performed on worst case components or constructs." It does not specify the exact number of samples tested (e.g., how many heads or constructs were subjected to each test). This is typical for mechanical testing where a representative "worst case" sample or a small batch is tested to ensure compliance with engineering standards.

• Sample Size: Not explicitly stated as a number of units, but "worst case components or constructs."
• Data Provenance: Not specified (e.g., country of origin). The mechanical testing is conducted by the manufacturer, Limacorporate S.p.A., based in Italy. The data is generated from laboratory testing of manufactured components, not patient data.
• Retrospective or Prospective: Not applicable in the context of mechanical testing of physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical hip implant component, not an AI or diagnostic software. Ground truth in this context would be related to material properties and mechanical integrity, established by engineering specifications and physical testing methods, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical diagnoses, which is not relevant for mechanical testing of a medical device component. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under stress, measured by instruments according to established standards.

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 device is a physical medical implant (hip replacement component), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question refers to AI algorithm performance. The device is a physical hip implant component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering standards and specifications for mechanical integrity and durability. This is established by:

• Physical measurements and material properties of the components.
• Performance of the components when subjected to standardized mechanical loading (e.g., burst, fatigue, pull-off, fretting, torque-off tests) as defined by ISO and ASTM standards.
• Comparison to the performance of legally marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This question refers to machine learning. This device does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. As above, no AI "training set" is involved. The "ground truth" for the device's design and mechanical properties is based on established biomechanical and material science principles, engineering design standards, and the performance characteristics of previously cleared predicate devices.

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1. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.

2. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

This document is a 510(k) Summary for a medical device (pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not provided in this document because the submission relies on non-clinical performance data (bench testing) to demonstrate substantial equivalence, not clinical effectiveness or performance with human-in-the-loop.

Here's a breakdown of the available information based on your request, highlighting what is provided and what is absent:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document primarily discusses acceptance criteria in the context of bench testing. The general acceptance criterion for all non-clinical performance tests is that the device "met acceptance criteria" and "demonstrated compliance to all the design attributes and that the device performs as intended." Specific quantitative acceptance criteria for each test are not explicitly detailed beyond general descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for a Substantial Equivalence (510k) Submission based solely on Non-Clinical Data:

This 510(k) submission states "No clinical testing was required to support substantial equivalence." Therefore, the following points regarding clinical studies, human readers, and ground truth for clinical data are not applicable in this context.

2. Sample sizes used for the test set and the data provenance: Not applicable given "No clinical testing was required." The "test set" here refers to non-clinical bench test samples (e.g., number of devices tested for kink resistance or clot retrieval). The document does not specify the exact number of devices tested for each bench test, but implies sufficient testing to support "Pass" conclusions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcome, which was not established in this non-clinical submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 a medical device for mechanical thrombectomy, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or standard for comparison is defined by engineering specifications, validated test methods (e.g., ASTM standards), and comparability to the predicate device's performance. For instance, in Simulated Clot Retrieval, the ground truth is successful retrieval of synthetic clots under defined conditions.

8. The sample size for the training set: Not applicable. This refers to training data for AI/ML models, which is not relevant for this mechanical device submission.

9. How the ground truth for the training set was established: Not applicable.

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The DELTAWAVE Nasal Pillows System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device.

This medical device is intended for adult patients weighing 66 lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home.

The DELTAWAVE™ Nasal Pillow System is the subject device for this submission. It is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea.

The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.

The DELTAWAVE Nasal Pillows System is a medical device intended to noninvasively deliver pressurized airflow from a CPAP or Bi-Level device to adult patients (weighing 66 lbs or 30kg) who have been prescribed such therapy. It is designed for single-patient reuse in the home.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents a comparison of the DELTAWAVE Nasal Pillow System (subject device) to a predicate device, the Fisher & Paykel EVORA™ Nasal Mask (Model A), across various characteristics and performance metrics. The underlying acceptance criterion for substantial equivalence is that the differences do not raise new or different questions of safety or effectiveness.

Below is a table summarizing the reported device performance, with the implicit acceptance being "similar" or "does not raise new/different questions of safety and effectiveness" compared to the predicate.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing. For specific performance metrics like Dead Space, Resistance, CO2 Rebreathing, and Sound Levels, it is likely that a sample size appropriate for engineering and laboratory testing (e.g., several units per size/type) was used, rather than a large clinical test set. The document does not specify the exact number of devices tested for each non-clinical performance test.

The data provenance is from non-clinical performance testing conducted by the manufacturer of the DELTAWAVE Nasal Pillows System (REMSLEEP Holdings Inc.). This type of data is typically collected prospectively in a laboratory setting. No country of origin for the non-clinical test data is specified, but it accompanies a US FDA submission, implying compliance with US regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is not an AI/CADe/CADx device that would typically rely on expert human interpretation to establish ground truth for a test set. The "ground truth" for the non-clinical performance tests (e.g., resistance, dead space, CO2 rebreathing) is established by using calibrated measurement equipment and adhering to recognized test standards (e.g., ISO, AAMI). Therefore, no human experts were used in this context to establish ground truth for a "test set" in the way it's understood for diagnostic imaging or AI devices. The product development and testing would involve engineers and quality control personnel with relevant expertise.

4. Adjudication method for the test set:

Not applicable, as this is primarily a non-clinical performance evaluation against predefined engineering specifications and international standards, not a diagnostic or AI performance study requiring human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is a physical medical device (nasal pillows system) and not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant or applicable.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:

Not applicable, as this is not an algorithm or AI device. It is a physical accessory for CPAP/Bi-Level therapy.

7. The type of ground truth used:

The ground truth for the performance characteristics (e.g., Dead Space, Pressure Drop, CO2 Rebreathing, Sound Levels) is established through objective, standardized measurements and adherence to international consensus standards (e.g., ISO 17510, ISO 5356-1, various ISO 10993 and ISO 18562 standards for biocompatibility). For biocompatibility, the "ground truth" is defined by the absence of toxicity, irritation, etc., as assessed by validated biological test methods.

8. The sample size for the training set:

Not applicable, as this is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is not a machine learning device.

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1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

4. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated of the acetabulum.

The subject 22.2mm Biolox® delta Ceramic V40™ Femoral Heads with neck length +0mm and +3mm are sterile, single-use devices that are manufactured with high-purity alumina matrix with zirconia reinforcement and are compatible with the 22.2mm ID sizes of compatible acetabular inserts and UHMWPE acetabular cups. The Biolox® delta Ceramic V40TM Femoral Heads may be used in conjunction with compatible V40™ taper femoral stems and acetabular shell components to achieve reconstructive replacement of the hip joint.

This document is a FDA 510(k) premarket notification letter for a medical device, specifically the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed, de novo clinical or algorithmic performance studies typically seen for novel AI/ML or complex diagnostic devices.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm or a complex diagnostic cannot be fully answered by this document. This clearance is for a mechanical orthopedic implant.

However, I can extract the information relevant to device performance and substantiation as presented for this type of mechanical device, even if it doesn't align with the typical AI/ML study parameters.

Here's what can be extracted and how it relates to your request:

Understanding the Device and its Substantiation Approach:

The device is a femoral head for hip joint replacement, a mechanical implant. Its "performance" is assessed through engineering tests (mechanical strength, wear, range of motion, etc.) rather than clinical diagnostic accuracy or algorithmic output. The FDA's acceptance is based on demonstrating substantial equivalence to an existing, legally marketed device (the predicate). This means showing that the new device is as safe and effective as the predicate, typically through comparison of design, materials, intended use, and non-clinical (laboratory) performance data.

Addressing Your Specific Points (adjusted for a mechanical device 510(k) submission):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Mechanical/Engineering Standards): For this type of device, the "acceptance criteria" are the performance specified by recognized consensus standards (ISO, ASTM) for orthopedic implants. The document lists the standards followed, implying the device met the requirements of these standards. It doesn't present a table with specific pass/fail values or measured results against those values, as that level of detail is typically in the underlying test reports, not the 510(k) summary.
   • Reported Device Performance:
     • "The device comparisons and performance testing show that the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads are substantially equivalent to the cited predicate V40™ Biolox® delta Ceramic Femoral Heads cleared via K052718, based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data."
     • Non-Clinical Testing Performed:
       • Burst testing, Fatigue testing and post-fatigue burst testing (ISO 7206-10 and ASTM F2345-21)
       • Axial Pull-off testing
       • Wear evaluation
       • Range of Motion
       • Torsional resistance (ISO 7206-13)
       • MRI Safety testing
     • Coating Characterization Standards (for compatible Accolade II hip stems):
       • ISO 13179-1
       • ASTM F1160
       • ASTM F1147
       • ASTM F1044
       • ASTM F1978
       • ASTM F1580
       • ASTM F1854

   Note: The document only lists the tests and standards; it does not provide the quantitative results or the specific acceptance criteria thresholds for each test. This information would be in the detailed engineering reports submitted to the FDA, not typically in the public 510(k) summary. The "performance" is implicitly stated as meeting the "substantial equivalence" criteria by successfully passing these tests.

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in this summary. For mechanical tests, sample sizes are typically determined by the specific ASTM/ISO standards followed (e.g., n=3 or n=6 for certain fatigue tests).
   • Data Provenance: Not specified for the non-clinical testing. These are laboratory tests, not clinical data from patients.

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 question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for AI/ML) is irrelevant for mechanical performance testing of an orthopedic implant. The "ground truth" here is objective physical measurement against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This question is not applicable. Adjudication is for subjective assessment, often in clinical trials or for establishing ground truth in image interpretation. Mechanical tests are objective.

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 question is not applicable. MRMC studies are for evaluating diagnostic performance of AI or human readers, typically with medical imaging. This is a mechanical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable. This is not an algorithm. "Standalone performance" for this device would refer to its mechanical integrity and function. The non-clinical tests serve this purpose.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: For this mechanical device, the "ground truth" is defined by the objective performance requirements outlined in established international and national engineering standards (ISO and ASTM). Results of the physical tests are measured and compared against the pass/fail criteria defined in these standards.

8. The sample size for the training set:

   • This question is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

   • This question is not applicable. No training set exists.

Summary for this specific document:

This FDA 510(k) clearance document is for a mechanical orthopedic implant, not an AI/ML or diagnostic device. As such, the typical criteria and study types asked about (AI performance, human readers, ground truth consensus, training/test sets for algorithms) are not relevant or applicable to this submission.

The "acceptance criteria" for this device are meeting the requirements of recognized industry standards for mechanical testing (e.g., ISO, ASTM) to demonstrate substantial equivalence in terms of safety and performance to a predicate device. The "study" proving this involves non-clinical (laboratory) testing, the results of which (though not detailed quantitatively in this summary) are presented as having successfully met the engineering specifications for substantial equivalence.

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Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment dose calculation.

Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used radiation oncology personnel for quality assurance purposes.

Delta4 Insight is software specifically design for quality assurance of radiotherapy treatment plans generated by a treatment planning system. The device calculates a secondary dose calculation via an independent Monte-Carlo based dose calculation software and compares this to the treatment planning system dose. The device is used as a secondary check for the results of a TPS and not for comparison with a measurement.

Delta4 Insight is a software module within the General Delta4 software. The software module is independent of all other software modules within the Delta4 software. The device is NOT a treatment planning system or a radiation therapy delivery device. It is only used by trained radiation therapy oncology personnel for the purposes of quality assurance in a hospital setting.

Insight supports treatments with MV photons. No other radiation type is supported.

Here's a breakdown of the acceptance criteria and the study details for the Delta4 Insight device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "Test plans were chosen to span the space of test parameters for the types of treatment types/modalities/energies/TPS/machines that are supported. The variety of plans tested are reflective of common clinical treatments and tumor sites and span many field sizes and tissue depths."
  • Interpretation/Clarification: The exact number of test plans used is not specified. However, the description implies a diverse set of clinically relevant plans.
• Data Provenance: "The dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared."
  • Interpretation/Clarification: The data consists of retrospective, anonymized DICOM patient treatment plans. The country of origin is not specified but is likely from European or North American oncology departments given the context of FDA submission and common practices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not explicitly state that human experts established a "ground truth" for the test set in the traditional sense of clinical assessment.
• Instead, the comparison is made against "reference algorithms" (Acuros, Monaco) which themselves are established dose calculation engines. The accuracy of these reference algorithms is implicit, and one (Acuros) is cited with a publication (Hoffman et al, MedPhys 2018).
• The study focuses on the agreement between software calculations, not expert visual assessment.

4. Adjudication Method for the Test Set

• The concept of "adjudication" (e.g., 2+1, 3+1 expert review) is not applicable to this type of study.
• The comparison method used is a gamma comparison between the Delta4 Insight dose results and the original reference TPS dose. Gamma analysis is a common method in radiation oncology for quantitatively comparing dose distributions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done.
• This device is a "secondary check QA software" designed for an algorithm-to-algorithm comparison (Delta4 Insight's calculation vs. Treatment Planning System's calculation), not for human reader performance evaluation. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance evaluation was indeed done.
• The study explicitly describes comparing "the dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared." This is a direct measure of the algorithm's performance in matching established reference calculations.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the dose calculation results from established "reference algorithms" (Monaco, Acuros) within existing Treatment Planning Systems (TPS). It is not pathology, outcomes data, or human expert consensus in the diagnostic imaging sense. It is a comparison against other validated computational models for dose calculation.

8. The Sample Size for the Training Set

• The document does not specify a separate training set size.
• The description focuses on "validation testing involved testing of clinical treatment plans" and "test plans were chosen to span the space of test parameters." This suggests that the device's algorithms were likely developed and refined using internal data, but the 510(k) summary only describes the validation/test set and its performance.

9. How the Ground Truth for the Training Set Was Established

• Since a training set is not explicitly mentioned with its own ground truth establishment in this document, this information is not provided.
• Typically, for a dose calculation algorithm, "ground truth" during development (training) would involve comparing the algorithm's output against physical measurements (e.g., phantom measurements, ionization chamber data) and/or highly accurate, gold-standard Monte Carlo simulations for a variety of beam configurations and patient geometries. However, this 510(k) summary focuses on the comparative performance against other clinical TPS algorithms for validation.

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BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.

The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.

This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

9. How the ground truth for the training set was established

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.
The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table: .
• Control Desk/Image Storage (UIMS). .
  The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
  The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
  The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
  The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the document is a 510(k) submission for a Delta III Pro Lithotripter, which is a medical device for fragmenting urinary tract stones. The submission focuses on demonstrating substantial equivalence to a predicate device (Dornier Delta III Lithotripter, K201074) based on minor modifications.

The "Performance Data" section describes compliance with electrical safety, electromagnetic compatibility, radiation protection, safety of lithotripsy equipment, safety and performance of x-ray equipment, and usability engineering standards (IEC standards), as well as software verification and validation. These are engineering and regulatory compliance criteria, not performance metrics like sensitivity or specificity for a diagnostic AI.

Here's a breakdown of why the requested information for acceptance criteria and related study details cannot be found in the provided text:

• This is not an AI/ML device in the context of diagnostic performance: The device is a lithotripter, which physically breaks down stones. Its performance is measured by its safety, efficacy in stone fragmentation, and compliance with various engineering standards, not by diagnostic accuracy.
• The "Performance Data" section refers to regulatory compliance and non-clinical testing: "Non-clinical functional testing successfully passed and met all design requirements" and compliance with IEC standards are mentioned. This refers to engineering verification and validation, not a clinical study comparing its diagnostic performance against a ground truth with human experts.
• No mention of human readers, AI assistance, or diagnostic metrics: The text does not discuss human interpretation of images/data, AI algorithms for analysis, or metrics like accuracy, sensitivity, specificity, AUC, etc.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I cannot create the table or answer the questions the way they are designed for an AI/ML diagnostic device.

However, I can extract the information that is present regarding "performance" in the context of this device and its submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for diagnostic performance, but it lists standards with which the device complies. The "reported device performance" is primarily stated as successful compliance with these standards and established design requirements.

2. Sample size used for the test set and the data provenance
This information is not provided because it's a non-clinical, engineering verification for a physical device, not an AI/ML diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" in the diagnostic sense is established for this type of device.

4. Adjudication method for the test set
Not applicable.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the diagnostic sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks for stone fragmentation, which are not detailed in this summary.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context.

9. How the ground truth for the training set was established
Not applicable.

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The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.

The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.

The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.

The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).

Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").

Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.

Acceptance Criteria and Reported Device Performance

As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.

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The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy.

DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation or diagnosis of acute encephalopathy.

The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed healthcare physician.

The use environment is in hospitals:

· non-sterile environments;

· ICUs, wards, and other patient evaluation locations;

The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary connector design.

The DeltaScan Monitor provides EEG signal acquisition and analysis technology intended for use as an adjunct to clinical judgment. The DeltaScan Monitor provides support in clinical decision-making by providing an assessment for a patient having acute encephalopathy or not, based on a measure of the detected polymorphic delta (PMD) waves in the EEG.

The DeltaScan Monitor consists of a Monitor and a Patch connector. The Patch connector contains the EEG amplifier hardware. The Monitor contains electronics for galvanic isolation to the EEG cable with Patch connector, storage of EEG recording and log files (eMMC memory chip), processing capacity to run software (DeltaScan Monitor Application, or DMA), user interface elements (e.g., screen, keys, recording button), battery (FEY PA-IEC-LNB162Q.R001), and the charging circuitry. EEG data is collected by the DeltaScan Monitor using a DeltaScan Patch. Collected EEG signals are amplified, digitized, and then processed by the software algorithms to provide the user with the DeltaScan Output. The DeltaScan Monitor Application is stand-alone software running on an Embedded Linux OS.

This document describes the acceptance criteria and the study that proves the device (DeltaScan Monitor R2) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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