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510(k) Data Aggregation
(120 days)
ITX
The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the of the upper airways and tracheobronchial tree and surrounding organs.
Ultrasonic Probes UM-S20-17S and UM-S20-20R are designed to be used in conjunction with bronchoscopes. The Probes are inserted into the patient through a channel of the endoscope.
The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.
The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.
The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.
The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.
UM-S20-17S and UM-S20-20R use direct contact method only.
The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).
The provided FDA 510(k) clearance letter for the Olympus Ultrasonic Probes (UM-S20-17S and UM-S20-20R) details the acceptance criteria and the study that proves the device meets those criteria. However, it's crucial to note that this document pertains to ultrasonic probes (hardware) and does not involve Artificial Intelligence (AI). Therefore, many of the typical elements related to AI/ML device testing (e.g., training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission.
The "studies" described here are non-clinical performance tests (bench testing), demonstrating the safety and effectiveness of the physical medical device by comparing its characteristics and performance to a legally marketed predicate device.
Acceptance Criteria and Device Performance for Olympus Ultrasonic Probes
The acceptance criteria for these ultrasonic probes are predominantly based on meeting the performance specifications of the predicate and reference devices, and complying with established medical device standards for safety and functionality. The "reported device performance" indicates that the subject devices met all the acceptance criteria through various non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Based on Predicate/Reference & Standards) | Reported Device Performance |
|---|---|---|
| Acoustic Output | Compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 21, 2023). This includes parameters like: |
- Frequency: 20 MHz (matching Reference Device UM-3R)
- Axial Resolution: 2mm or less (matching Reference Device UM-3R)
- Lateral Resolution: 2mm or less (matching Reference Device UM-3R)
- Frame Rate: 6.67rps (matching Reference Device UM-3R)
- Scanning Field of View: 360° (matching Reference Device UM-3R)
- Display Mode: B-mode (matching Predicate and Reference Devices) | All acoustic output parameters passed/met the specified criteria and standards. |
| Durability | Demonstrated adequate operational lifespan and resistance to wear and tear. Specific quantitative thresholds are not detailed but are implied by "Durability" testing. | Testing passed/met acceptance criteria. |
| Measurement Accuracy | Verified the accuracy of measurements obtained using the ultrasonic probes. Specific accuracy metrics are not detailed but are implied by "Measurement Accuracy" testing. | Testing passed/met acceptance criteria. |
| Human Use Factors | Compliance with FDA Guidance Documents: Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016). Ensures safe and effective use by healthcare professionals. | Testing passed/met acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993 series (ISO 10993-1, -5, -10, -12, -17, -18, -23). Ensures materials are safe for patient contact. | Testing passed/met acceptance criteria. |
| Reprocessing Validation | Compliance with ISO 17664-1, AAMI TIR12, ANSI AAMI ST98, ANSI AAMI ST58, ISO 11135, ISO 11138-2. Ensures safe and effective cleaning and sterilization through methods like ETO. | Testing passed/met acceptance criteria. |
| Electrical Safety/EMC | Compliance with IEC 60601-1, IEC ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, IEC TR 60601-4-2. Ensures electrical safety and electromagnetic compatibility. | Testing passed/met acceptance criteria. |
Study Details (Applicable to Non-AI Hardware Verification)
As this is a hardware device 510(k) submission, the study methodology focuses on non-clinical performance data and bench testing rather than clinical trials with human subjects or AI-specific assessment methods.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of cases or patients, as the testing was non-clinical (bench testing). The "test set" in this context refers to the manufactured probes themselves and the conditions under which they were tested (e.g., phantom models for acoustic output, simulated use for durability, material samples for biocompatibility).
- Data Provenance: The tests were conducted internally by Olympus Medical Systems Corporation and its manufacturing site, SHIRAKAWA OLYMPUS CO., LTD. in Japan. The data is from bench testing and in-house validation, not from real-world patient data (retrospective or prospective). The manufacturing site is in Japan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This concept is not applicable to this type of hardware 510(k) submission. "Ground truth" for these tests is established by adhering to widely accepted international standards (ISO, IEC, AAMI) and FDA guidance documents for medical device performance, safety, and manufacturing. These standards define the measurable physical and electrical properties that the device must meet. The experts involved would be engineers, quality control specialists, and regulatory affairs personnel responsible for designing, manufacturing, and testing the probes to these standards.
4. Adjudication Method for the Test Set:
- This concept is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of medical images or data, which is relevant for AI image analysis or clinical trials. For hardware testing, "adjudication" is replaced by adherence to established test protocols, measurement equipment calibration, and standard-defined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not performed. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant for this non-AI hardware device. The equivalence claim for this device is based on technical specifications and non-clinical performance data compared to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance test was not done. This device is a physical diagnostic ultrasonic transducer, not a software algorithm. Its "performance" refers to its ability to generate images when connected to an ultrasound center, which is then interpreted by a human operator.
7. The Type of Ground Truth Used:
- The "ground truth" for this hardware device is defined by engineering specifications, physical measurements, and compliance with national and international medical device standards. For example, acoustic output parameters are measured against specific limits defined in IEC standards, and biocompatibility is confirmed by testing against ISO 10993. There is no "expert consensus" on imaging findings, pathology, or outcomes data used as ground truth for this device's clearance.
8. The Sample Size for the Training Set:
- This concept is not applicable. There is no "training set" as this is not an AI/ML device that requires machine learning.
9. How the Ground Truth for the Training Set was Established:
- This concept is not applicable as there is no training set.
In summary, the FDA 510(k) clearance for the Olympus Ultrasonic Probes is based on a comprehensive set of non-clinical, bench-level performance tests demonstrating technical equivalence to a predicate device and compliance with relevant safety and performance standards for diagnostic ultrasonic transducers. It does not involve AI/ML components or associated clinical study designs like MRMC or standalone algorithm performance assessment.
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(131 days)
ITX
The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.
The Mendaera Guidance System is a software-controlled, electromechanical system designed to provide guidance for precise placement of common interventional devices during ultrasound-guided percutaneous procedures. The Mendaera Guidance System is intended to be used in percutaneous procedures with live 2D ultrasound imaging.
The primary components of the Mendaera system are the electromechanical arm ("Robot"), Cart, Drape Kit, and Universal Instrument Guide Kit.
The Robot is a handheld component that attaches to a compatible ultrasound probe and is responsible for establishing and maintaining a deterministic trajectory for the interventional device or needle. The Robot has features that allow for rigid, deterministic coupling between the robot and the probe, and the two are secured together via a locking mechanism.
The Cart includes a touchscreen, a graphical user interface ("GUI") for visualizing the live 2D ultrasound image and overlays, and a computer which runs the Mendaera software.
The Drape Kit contains a sterile drape to act as a barrier between the operator or patient and re-usable components of the system.
The Universal Instrument Guide Kit contains the instrument guide, Universal instrument adapter, and gauge inserts. The Universal instrument adapter enables coupling to interventional instruments ranging from 14G to 25G. The adapter and gauge insert both attach to the instrument guide, which connects to the robot. Movement of the interventional instrument is translated to the robot, and allows for the display of an estimate of the instrument position on the live 2D ultrasound image. Rotational motion of the gauge insert and separation of the instrument adapter enables the instrument guide, robot, and ultrasound probe to be removed while leaving the interventional instrument in place.
The Drape Kit and Universal Instrument Guide Kit are provided in two configurations each:
- Universal Instrument Guide Kits: for compatible instruments in long and short lengths
- Drape Kits: for covering all aspects of the handheld or robot only
The robot and cart are provided non-sterile and are reusable. The contents of the Drape Kit and Universal Instrument Guide Kit are provided sterile and are intended for single-use.
The system is used interoperably with compatible, commercially available ultrasound systems. The system is designed to work in both in-plane (longitudinal) and out-of-plane (transverse) configurations. The list of compatible ultrasound systems and associated probes is:
- EchoNous Kosmos (K212100): Lexsa, Torso-One
The provided FDA 510(k) clearance letter and 510(k) Summary for the Mendaera Guidance System primarily focus on establishing substantial equivalence through non-clinical testing. It does not contain details about acceptance criteria for device performance (e.g., accuracy, precision) in a quantifiable manner, nor does it describe a study specifically designed to prove the device meets such criteria through a comparative clinical effectiveness study or standalone performance study in humans.
The document highlights various non-clinical tests conducted to support substantial equivalence, but it lacks the specific metrics and study designs typically associated with proving quantitative performance against defined acceptance criteria.
Therefore, I cannot fulfill all parts of your request based on the provided text. I will extract the information that is present and indicate where information is missing.
Overview of Device Performance and Supporting Studies
The Mendaera Guidance System underwent a range of non-clinical tests to demonstrate substantial equivalence to its predicate device (Verza Guidance System, K160806). The studies focused on various aspects including biocompatibility, reprocessing/sterilization, EMC and electrical safety, software verification and validation, bench testing, animal testing, and human factors validation. While these studies confirm the device's adherence to safety and fundamental functionality standards, the provided text does not define specific quantitative acceptance criteria for core performance metrics (e.g., accuracy, precision, latency) and associated clinical study results proving the device meets these criteria in a human population.
Missing Information:
- Specific quantifiable acceptance criteria for device performance (e.g., accuracy in mm, latency in ms).
- Reported device performance against these quantifiable criteria.
- Details of a study proving the device meets these specific performance criteria in humans.
- MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
- Standalone (algorithm-only) performance study details.
- Type of ground truth used for performance evaluation (beyond "technical feasibility and safety" in animal models).
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not provide specific quantifiable acceptance criteria or reported performance metrics for the device's guidance capabilities (e.g., accuracy of instrument placement, latency). It generally states that "bench testing verified that the design specifications and customer requirements have been met" and "a live animal study demonstrated that the system can be used safely and effectively."
| Acceptance Criteria (Quantitative Metric) | Reported Device Performance |
|---|---|
| Not Specified in Document | Not Specified in Document |
| (e.g., Accuracy of Instrument Guidance: X mm) | (e.g., Achieved Y mm accuracy) |
| (e.g., Latency: Z ms) | (e.g., Achieved W ms latency) |
The document outlines types of testing performed, which imply functional acceptance criteria were used internally, but these are not disclosed as specific quantifiable values in the provided text. For example, "accuracy" is mentioned as a design input requirement for bench testing, but no specific accuracy value is given as an acceptance criterion or reported performance.
2. Sample Size and Data Provenance for Test Set
The document mentions several types of testing but does not clearly delineate "test sets" in the context of human clinical data or imaging datasets used for performance evaluation in the way requested.
- Human Factors Validation Study: Conducted to evaluate usability and critical tasks. No specific sample size (number of users) is provided, nor is the provenance of the "data" (e.g., simulated environment, specific patient population).
- Animal Testing: Performed on a "live model." No specific sample size (number of animals or procedures) is provided.
- Bench Testing: Performed to verify design input requirements (workflow, latency, accuracy, etc.). This typically involves engineering test data rather than patient data.
Sample Size for Test Set: Not specified for any human-relevant performance evaluation.
Data Provenance:
* Human Factors: Implied simulated-use environment, but no geographic or retrospective/prospective details.
* Animal Testing: "live model," but no specific details on animal type, origin, or retrospective/prospective nature.
* Bench Testing: Laboratory environment, engineering data.
3. Number of Experts and Qualifications for Ground Truth
The document does not detail the establishment of ground truth by experts for a performance test set, especially in a clinical context.
- Experts Used: Not specified.
- Qualifications of Experts: Not specified.
The closest mention relates to human factors testing, where users (medical professionals) evaluated usability, but this is distinct from establishing ground truth for device performance metrics.
4. Adjudication Method for Test Set
Since there is no clearly described "test set" with expert interpretations requiring adjudication for ground truth, no adjudication method is detailed.
- Adjudication Method: Not applicable/Not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that an MRMC comparative effectiveness study was done to assess how human readers/operators improve with AI vs. without AI assistance. The focus is on the device's capability to provide guidance, not in improving human diagnostic or interventional accuracy through AI assistance compared to unassisted performance.
- MRMC Study Done: No.
- Effect Size of Human Improvement (with AI vs. without AI): Not applicable, as no MRMC study performed per the document.
6. Standalone (Algorithm Only) Performance Study
The Mendaera Guidance System is described as a "software-controlled, electromechanical system" providing physical guidance for instrument placement visualized on ultrasound. It's an active guidance system, not a passive AI algorithm for image analysis or diagnosis. Therefore, a "standalone algorithm only" performance study, as typically understood for AI diagnostic algorithms, is not directly applicable to this type of device in the same way. The software's function is integrated into the electromechanical system to provide the guidance; its "performance" is implicitly tied to the overall system's function.
- Standalone Performance Study Done: Not applicable in the context of an algorithm-only diagnostic output; the software's performance is integral to the entire system's guidance function, which was evaluated via bench and animal testing.
7. Type of Ground Truth Used
The document primarily relies on engineering specifications and "technical feasibility and safety" demonstrated in animal models rather than clinical ground truth obtained from pathology, outcomes data, or expert consensus on patient cases for performance evaluation.
- Type of Ground Truth:
- Bench Testing: Design input requirements (e.g., workflow, latency, accuracy, ultrasound image display, robot controls, functional safety features) served as the "ground truth" or target for verification. These are engineering specifications.
- Animal Testing: Demonstrated "technical feasibility and safety" in a live model, implying successful instrument placement and lack of adverse events in animals as the "ground truth" for basic function and safety.
8. Sample Size for Training Set
The document describes the device as a "guidance system" which implies a hardware and software system, not necessarily an AI/ML model that requires a "training set" in the traditional sense of large datasets for model learning (e.g., image recognition). While the software likely was developed using internal data and iterative testing, no "training set" sample size is mentioned.
- Sample Size for Training Set: Not applicable/Not specified as the document does not describe an AI/ML model trained on a data set in the traditional sense for diagnostic or predictive purposes.
9. How Ground Truth for Training Set was Established
Given that a "training set" for an AI/ML model is not described, the method for establishing its ground truth is also not applicable. The software verification and validation would have been against defined design specifications and requirements, as stated.
- How Ground Truth for Training Set was Established: Not applicable/Not specified.
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(115 days)
ITX
The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system.
The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide.
The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.
The Accuro® 3S Needle Guide Kit consists of the following single use sterile disposable components: Accuro® 3S Needle Guide with integrated probe cover, conductive ultrasound gel, and a patient drape with two integrated probe elastic bands.
The kit components are assembled into a sterilized CSR Wrap then packaged in a sterile tray.
The final kit is sterilized under ethylene oxide.
This document describes the FDA 510(k) clearance for the Accuro® 3S Needle Guide Kit. The clearance is based on a determination of substantial equivalence to a legally marketed predicate device (K171348 Pinpoint™ GT Needle Guide Kits), supported by non-clinical testing.
Here's an analysis of the provided text in relation to acceptance criteria and study details:
Key Takeaway Points from the provided text:
- Device: Accuro® 3S Needle Guide Kit (needle guide for ultrasound-guided procedures).
- Clearance Type: FDA 510(k) (Premarket Notification).
- Basis for Clearance: Substantial Equivalence to a predicate device (K171348 Pinpoint™ GT Needle Guide Kits).
- Key Difference from Predicate: Inclusion of a patient drape with elastic bands to stabilize the needle guide.
- Study Type: Primarily non-clinical benchtop testing and simulated use evaluations. No clinical studies were required or performed to support this 510(k) submission. This means the acceptance criteria and performance data are entirely based on non-clinical methods.
Given that no clinical studies were performed, and the evaluation focused on non-clinical testing to demonstrate substantial equivalence, several of the requested points related to clinical studies, human-in-the-loop performance, and expert ground truth cannot be answered from this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the types of non-clinical tests performed but does not explicitly list quantitative acceptance criteria with corresponding performance results in a structured table. It states that "Design functionality of the subject device was tested to ensure that it meets the requirements of the intended end users" and lists various tests without specifying the target values or the measured outcomes.
However, based on the non-clinical tests listed, we can infer the categories of acceptance criteria and the nature of the "reported device performance" (which is implied to be successful since clearance was granted).
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Performance | |
| Needle guide dimensions accuracy | Met specified dimensional requirements |
| Needle insertion force & damage during insertion | Acceptable force for insertion, no damage to needle or guide |
| Needle angulation accuracy | Maintained accurate angulation relative to ultrasound plane |
| Needle tip depth accuracy | Maintained accurate needle tip depth |
| Needle guide attachment/removal force | Acceptable force for attachment and removal, secure connection |
| Needle gate pinch force | Acceptable pinch force (e.g., to hold the needle securely but allow movement) |
| Elastic bands holding force | Sufficient force to stabilize positioning |
| Elastic bands attachment durability | Durable attachment, withstood simulated use conditions |
| Integrity & Sterility | |
| Sterile barrier integrity | Maintained sterility, no breaches |
| Packaging integrity | Packaging remained intact and protected sterility |
| Ethylene Oxide Sterilization Residuals | Residues within acceptable limits (per ISO 10993-7) |
| Biocompatibility | |
| In vitro Cytotoxicity | No cytotoxic effects (per ISO 10993-5) |
| Bacterial Endotoxins | Endotoxin levels within acceptable limits (per AAMI/ANSI ST72) |
| Assessment of Hemolytic Properties | No significant hemolytic properties (per ASTM F756) |
| Irritation and Skin Sensitization | No significant irritation or sensitization (per ISO 10993-10) |
| Systemic Toxicity | No systemic toxic effects (per ISO 10993-11) |
| Imaging Quality | |
| Imaging quality following administration of needle guide and probe cover | Uncompromised ultrasound imaging quality |
| Probe midline needle insertion | Needle path aligned with probe midline |
| General | |
| Material dimensions | Met specified material dimensions |
| Packaging configuration | Packaging configuration was appropriate and consistent |
| Risk analysis | Risks identified and mitigated as per ISO 14971 |
| Quality System Compliance | Met 21 CFR Part 820 requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for each non-clinical test. It generally states that "Design functionality...was tested" and lists the types of tests (e.g., "Needle guide dimensions," "Needle angulation accuracy").
- Data Provenance: The studies were non-clinical benchtop testing and simulated use evaluations. The document does not explicitly state the country of origin for the data collection, but it is implied to be internal testing by Rivanna Medical, Inc. (located in Charlottesville, Virginia, USA). The studies were prospective in nature, designed specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: For the "simulated use evaluations," the document mentions evaluations "performed by representative end users." It does not specify the number or detailed qualifications of these representative end users.
- Qualifications of Experts: The term "representative end users" implies healthcare professionals who would typically use such a device (e.g., radiologists, interventionalists, nurses who perform ultrasound-guided procedures). However, specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. Given the non-clinical nature, this would likely be an engineering/usability assessment by medical professionals rather than a clinical "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
Since the studies were non-clinical benchtop and simulated use evaluations, the concept of an "adjudication method" as typically applied to human readers or clinical image interpretation (e.g., 2+1, 3+1 consensus) is not applicable. The "ground truth" for these tests would be established by engineering specifications, physical measurements, and direct observation of functionality and usability by testers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Accuro® 3S Needle Guide Kit, did not require clinical studies to support the determination of substantial equivalence." An MRMC study is a type of clinical study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. The Accuro® 3S Needle Guide Kit is a physical medical device (a needle guide and cover), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.
7. The Type of Ground Truth Used
- Given that no clinical studies were performed, the "ground truth" was established through non-clinical methods:
- Engineering Specifications/Benchtop Measurements: For tests like dimensions, force, angulation, and depth accuracy.
- Simulated Use Observations: For usability, attachment durability, and general functionality assessments by "representative end users."
- Adherence to Standards: For sterility, biocompatibility, and packaging integrity, the “ground truth” is compliance with, or passing, specified international standards (e.g., ISO 10993 series, ASTM standards).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical kit, not an AI/ML algorithm or software that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
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(81 days)
ITX
The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.
The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.
The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.
The provided text is a 510(k) summary for the Vitrolife Ultrasound Transducer Cover. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate safety and effectiveness.
However, the document does not contain information about:
- Acceptance criteria in the context of a statistical study with specific thresholds for performance metrics.
- A study proving the device meets acceptance criteria related to diagnostic accuracy, especially not for an AI/ML-enabled device as implied by the detailed questions about ground truth, expert consensus, MRMC studies, and standalone performance.
- Sample sizes for test sets or training sets in the context of an AI/ML study.
- Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types pertaining to an AI/ML diagnostic system.
- Training set size or how its ground truth was established.
The document is for a physical medical device (an ultrasound transducer cover) and focuses on biocompatiability, functional performance (e.g., leakage, ultrasound visibility), sterilization, and shelf-life testing, demonstrating substantial equivalence to a predicate device. It explicitly states "Clinical Testing: Not applicable."
Therefore, I cannot populate the requested table and provide answers for the specific points related to AI/ML device validation because the provided text does not contain this information.
The existing text is a regulatory submission for a simple medical device, not an AI/Machine Learning diagnostic device.
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(244 days)
ITX
UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the potential transfer of contaminants and biological risk agents that may be introduced during ultrasound scanning and needle-quided procedures. It also serves as a transparent dressing to protect and secure devices to the patient's skin when required. UltraDrape UGPIV Barrier and Securement is indicated for adults and pediatric patients. For use by healthcare professionals appropriately trained in ultrasound within healthcare settings utilizing ultrasound.
UltraDrape UGPIV Barrier and Securement is a uniquely designed, sterile, dual-action barrier and securement dressing designed for use during Ultrasound-Guided Peripheral Intravenous (UGPIV) procedures. UltraDrape is 3.25"(8.25 cm) wide x 5.8" (14.72 cm) long. UltraDrape UGPIV Barrier and Securement is sterile, nonirritating, non-sensitizing and is not made with natural rubber latex. Ultrasound imaging is not impaired by use of UltraDrape UGPIV Barrier and Securement as it is intended. The ultrasound gel is applied to a removable Polyurethane film layer to prevent contamination of the injection site. Convenient adhesive strips on the release film provide added securement of tubing and catheter hub surround. The bifurcated, "stand-alone" design prevents gel from reaching the IV site while enabling seamless catheter insertion and securement. UltraDrape UGPIV Barrier and Securement is furnished in sterile condition, for single use patient/procedure use, disposable. UltraDrape UGPIV Barrier and Securement is used with commercially available ultrasound probes.
The provided text describes a medical device called "UltraDrape UGPIV Barrier and Securement" and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria and a study that proves the device meets those criteria in the format requested.
The document discusses:
- Device Description and Intended Use: The UltraDrape UGPIV Barrier and Securement is a sterile, single-use, disposable device for use with ultrasound transducers to shield patients from contaminants and biological risk agents during ultrasound scanning and needle-guided procedures. It also protects and secures devices to the patient's skin.
- Comparison to a Predicate Device (K221278 - Hony Medical Co. Transducer Probe Covers): The text details similarities and differences in intended use and technological characteristics to argue for substantial equivalence.
- Non-Clinical Tests Summary & Conclusions: It lists several tests that were completed according to FDA recognized consensus standards to determine substantial equivalence. These tests include:
- Viral Penetration (ASTM 1671 20 nm Rodent Protoparvovirus PB627-001-V2)
- Tear Resistance (ASTM D1004)
- Burst Strength (ASTM F1140/F1140M-13)
- Velocity Testing (Acoustic Measurements Report)
- Tensile Strength (STA-040 Stability Report Accelerated 2 year 60C Ultradrape, ASTM D5035-11)
- Ultrasound Image Quality and Artifact ("FTR-003 UltraDrape UGPIV Image Clarity and Artifact Report")
The document does not provide:
- A table of specific acceptance criteria values and reported device performance values against those criteria for most of the tests. For "Viral Penetration," it mentions the device has "viral prevention against 20 nm or greater viruses" while the predicate has "viral prevention against 25 nm or greater viruses," which implies the device meets or exceeds a criterion of 20nm. For "Ultrasound Image Quality and Artifact," it states "UltraDrape® UGPIV has minimal impact on the acoustic output, imaging clarity, and presence of artifact," and "no measurable attenuation at the UltraDrape film does not impact the depth of image penetration or spatial resolution," but doesn't provide specific numerical criteria or results.
- Sample sizes for the test set or data provenance (country, retrospective/prospective).
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Information about a standalone (algorithm only) performance study. (This device appears to be a physical barrier, not an algorithm, so this section is likely not applicable).
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set. (Again, likely not applicable as it's not an AI/algorithm-based device).
- How the ground truth for the training set was established. (Not applicable).
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Viral Penetration: Block viruses of a certain size (e.g., 20nm or greater) (Based on ASTM F1671/F1671-M) | Viral prevention against 20 nm or greater viruses. (Stated the predicate has viral prevention against 25nm or greater, implying the UltraDrape meets/exceeds 20nm.) |
| Tear Resistance: Meet standards for tear resistance (Based on ASTM D1004) | Test performed ("Tear Resistance Result UltraDrape"). Specific numerical performance not provided. |
| Burst Strength: Meet standards for burst strength (Based on ASTM F1140/F1140M-13) | Test performed ("UltraDrape DDL Package Validation Report - Burst Strength"). Specific numerical performance not provided. |
| Velocity Testing: (Likely related to acoustic properties) | Test performed ("Acoustic Measurements Report"). Specific numerical performance not provided. |
| Tensile Strength: Meet standards for tensile strength (Based on ASTM D5035-11) | Test performed ("STA-040 Stability Report Accelerated 2 year 60C Ultradrape"). Specific numerical performance not provided. |
| Ultrasound Image Quality and Artifact: Minimal impact on acoustic output, imaging clarity, and no significant artifacts. (Based on FTR-003 UltraDrape UGPIV Image Clarity and Artifact Report) | Minimal impact on the acoustic output, imaging clarity, and presence of artifact during ultrasound procedures. No measurable attenuation at the UltraDrape film does not impact the depth of image penetration or spatial resolution in ultrasound-guided procedures. (Specific numerical criteria for "minimal impact" or "no measurable attenuation" not quantified.) |
| Sterility: Furnished in sterile condition (Implied by gamma radiation sterilization) | Provided in a sterile format (sterilized via gamma radiation). |
2. Sample size used for the test set and the data provenance
Not specified in the provided text. The tests listed are non-clinical (material and performance characteristics) rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified in the provided text, as this is a physical device and the tests conducted are non-clinical performance and material tests, not diagnostic accuracy studies requiring expert ground truth on patient data.
4. Adjudication method for the test set
Not applicable/Not specified.
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 not an AI/software product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI/software product.
7. The type of ground truth used
For the listed non-clinical tests, the "ground truth" would be established by the standardized methods and measurements defined by the ASTM standards (e.g., direct measurement of tear strength, burst pressure, viral penetration, acoustic properties) rather than expert consensus, pathology, or outcomes data typically associated with diagnostic performance studies.
8. The sample size for the training set
Not applicable. This device is not an AI/software product that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(28 days)
ITX
Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.
The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for body surface, endocavity and intra-operative diagnostic ultrasound. This may help with easier cleaning and disinfection of the probe.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
The subject device is furnished in sterile condition, for single use patient/procedure use, disposable.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
This document is a 510(k) summary for a Transducer Probe Cover. It primarily discusses the equivalence of the subject device to a predicate device, focusing on an expanded indication for use. Therefore, the information provided does not describe a study to prove the device meets acceptance criteria in the typical sense of performance metrics for an AI/algorithm-based device.
Instead, the document asserts substantial equivalence based on the device's characteristics and the performance of its predicate, along with additional biocompatibility testing for the expanded use.
Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria for performance as would be expected for an AI/algorithm. Instead, it compares the subject device's technological characteristics to predicate devices to establish substantial equivalence. The "performance" here refers to the device's characteristics fulfilling its intended purpose (acting as a barrier and not impairing ultrasound imaging).
| Characteristic | Subject Device (K241615) | Predicate Device (K221278) | Conclusion (compared to Predicate) |
|---|---|---|---|
| Product Code | ITX | ITX | Same |
| Regulation No. | 21 CFR 892.1570 | 21 CFR 892.1570 | Same |
| Class | II | II | Same |
| Intended Use/Indication for Use | Transducer Probe Cover for body surface, endocavity, and intra-operative diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field. | Transducer Probe Cover for external intact skin diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field. | Expanded scope (endocavity, intra-operative) |
| Materials & Construction | Polyurethane, tubular, sealed | Polyurethane, tubular, sealed | Same |
| Model | Various Size | Various Size | Same |
| Microbial Barrier | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | Same |
| Acoustic Performance | Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ) | Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ) | Same |
| Sterile | EO sterilization, SAL 10^-6^ | EO sterilization, SAL 10^-6^ | Same |
| Disposable, Single Use Only | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) - Additionally, Thrombogenicity and Complement Activation Testing per ISO 10993-4 were performed due to expanded contact level. | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11). Biocompatibility test results for predicate also valid and support proposed device. | Additional tests performed due to expanded indication |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. This submission is for a physical medical device (transducer probe cover), not an AI/algorithm. Therefore, there isn't a "test set" in the context of data for an algorithm. The evaluation is based on non-clinical testing of the physical properties and biological compatibility of the device.
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 applicable and not provided. As this is a physical device, not an AI, there is no "ground truth" establishment by experts for a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As this is a physical device, not an AI, there is no "adjudication method" for a test set of data.
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 information is not applicable and not provided, as this is a physical device and not an AI or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided, as this is a physical device and not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For this physical device, "ground truth" would refer to established standards for material properties, sterilization efficacy, biocompatibility, and barrier function, which are evaluated through standardized non-clinical tests (e.g., ASTM F1671-13 for microbial barrier, ISO 10993 for biocompatibility).
8. The sample size for the training set
This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "training set" in the data science context.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "ground truth" establishment for a "training set."
Summary of the Study and Acceptance Criteria (as interpreted for this device type):
The "study" presented here is a pre-market notification (510(k)) submission seeking to demonstrate substantial equivalence to a previously cleared predicate device (K221278), with an expanded indication for use.
The primary "acceptance criterion" for this submission is that the device is as safe, as effective, and performs as well as the legally marketed predicate device and raises no new questions of safety or effectiveness.
The "study" to prove this involves:
- Technological Characteristic Comparison: Detailed comparison of the subject device's design, materials, manufacturing, and performance characteristics (e.g., microbial barrier, acoustic properties, sterilization, shelf life) to the predicate device. The conclusion is that these characteristics are largely identical.
- Non-Clinical Testing Confirmation: Because there were no changes in materials, structure, dimensions, or performance that were deemed to impact the previous clearance, no new performance bench testing was considered necessary, except for additional biocompatibility evaluation related to the expanded indications for use.
- Biocompatibility Testing: For the expanded scope to include endocavity and intra-operative diagnostic ultrasound, additional biocompatibility tests (Thrombogenicity and Complement Activation Testing per ISO 10993-4) were conducted. The results of these tests, along with the previously reviewed biocompatibility data for the predicate, were deemed valid and supportive.
In essence, the "study" is a comparative analysis and targeted supplementary testing demonstrating that the changes (expanded indications) do not introduce new hazards and that the device remains substantially equivalent to market predicates under the new conditions of use.
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(86 days)
ITX
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.
- . Prostate - Biopsy and minimally invasive puncture
- . Surgical (Prostate) - Biopsy and minimally invasive puncture
The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.
The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.
The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Not Explicitly Stated as Numerical) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 requirements for limited contact duration. | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen testing performed in accordance with ISO 10993. |
| Guide Tangential Clocking force testing | Guide adequately attaches to round probe such that it will not rotate. | Confirmed adequate attachment and no rotation in typical use. |
| Guide Axial Loading force testing | Guide adequately attaches to round probe such that it will not slide forward. | Confirmed adequate attachment and no sliding forward in typical use. |
| Guide Dislodge Force Test | Guide adequately attaches to round probe such that it will not dislodge under force. | Confirmed adequate attachment and no dislodgement under worst-case force. |
| Needle Holder Force (horizontal) Test | Force to dislodge needle holder from clamped horizontal position meets requirements. | Confirmed force to dislodge meets requirements at worst-case position. |
| Needle Holder Force (angled) Test | Force to dislodge needle holder from clamped, angled position meets requirements. | Confirmed force to dislodge meets requirements at worst-case position and approximately 20° angle. |
| Assemble/Removal Force with Neoguard Cover Test | Force required to assemble/remove guide with Neoguard cover meets requirements. | Tested force required; implicitly meets established requirements. |
| Guide Clamp Knob Torque Test | Guide not damaged when user applies torque to clamp knob. | Confirmed guide is not damaged with user-applied torque to clamp knob. |
| Extract/Insert Needle Holder in Tower Force | Force to extract/insert needle holder meets requirements. | Tested force to extract/insert, implicitly meets established requirements. |
| Introducer needle initial insertion force | Initial insertion force of introducer needle meets requirements. | Tested force, implicitly meets established requirements. |
| Introducer needle In and out of the needle holder force test | Force to move introducer needle meets requirements. | Tested force, implicitly meets established requirements. |
| Simulated Usability Testing | Design conforms to user needs and intended use. | Evaluations performed by customers to ensure conformity to user needs and intended use. |
| Guidance Standards | Complies with BS EN ISO 9626:1995. | Introducer needle evaluated and believed to comply with the standard. |
(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
- Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.
7. Type of Ground Truth Used
- Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.
8. Sample Size for the Training Set
- Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.
9. How Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.
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(189 days)
ITX
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.
Modes of Operation: B-mode
Never use this product for any other purposes.
FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.
Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.
This document describes the Fujifilm Endoscopic Ultrasonic Probe (P2612S-L/P2620S-L), which is a medical ultrasonic probe intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs in adults.
Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria for performance metrics (like accuracy or sensitivity) for the ultrasound imaging itself. The performance data presented are related to safety and compatibility with regulatory standards.
| Acceptance Criteria (related to safety/technical performance) | Reported Device Performance |
|---|---|
| Reprocessing efficacy (cleaning, disinfection, sterilization) | Validated on P2612S-L/P2620S-L |
| Biocompatibility (cytotoxicity, sensitization, irritation) | Evaluated in accordance with FDA guidance (ISO 10993-1, -5, -10, -23) |
| Electrical Safety | Tested according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007 (for P2612S-L/P2620S-L) |
| Electromagnetic Compatibility (EMC) | Evaluated according to IEC 60601-1-2:2014 (for P2612S-L/P2620S-L with SP-900) |
| Ultrasonic Probe Specifications (e.g., insertion diameter, working length, scanning method) | Differences from predicate/reference devices were evaluated and determined not to raise new concerns for safety or efficacy. Specific technical specifications like axial and lateral resolution, sound operating frequency, and penetration were also compared and tested according to 60601-2-37. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a test set in the context of clinical performance or image analysis. The "testing" mentioned refers to engineering and safety performance evaluations. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided here for clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As no clinical performance test set involving image interpretation or diagnosis is described, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set:
Since a clinical test set requiring expert adjudication is not present, this information is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document states, "Clinical testing is not applicable to this submission." Therefore, an MRMC comparative effectiveness study was not done, and there is no reported effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasonic probe, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
This device is an ultrasonic probe, a hardware component for ultrasound imaging. It does not contain an algorithm for standalone performance evaluation in the context of AI or diagnostic software. Therefore, a standalone performance study was not done.
7. Type of Ground Truth Used:
For the technical and safety evaluations, the "ground truth" was established by adherence to recognized international standards and guidance documents (e.g., ISO 10993, ANSI/AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2) confirmed through specific tests. For example, biocompatibility tests themselves generate the "ground truth" (e.g., cytotoxicity results, sensitization/irritation responses).
8. Sample Size for the Training Set:
This device is a hardware component and is not an AI/ML-driven device that requires a training set in the typical sense. Therefore, information regarding a training set sample size is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/ML algorithm described, this information is not applicable and not provided.
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(151 days)
ITX
This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.
Transvaginal - Diagnostic ultrasound needle / instrument quided procedures such as tissue biopsy. fluid aspiration, catheter placement, treatment, and oocyte retrieval.
Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.
The VitroPRO disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.
The FDA 510(k) summary for the VitroPRO device (K231783) outlines the acceptance criteria and the study performed to demonstrate the device meets these criteria, specifically in relation to the added indication for oocyte retrieval.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Mouse Embryo Assay (MEA) | ≥80% embryos expanded to blastocyst at 96 hours | Met acceptance threshold requirements and showed passing results |
| Limulus Amebocyte Lysate (LAL) | ≤ 20 EU/device | Met acceptance threshold requirements and showed passing results |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the MEA and LAL tests. For the MEA, it mentions "One-cell mouse embryos" were incubated, implying a certain number of embryos were used, but the precise count is not provided. For LAL, it refers to "EU/device," meaning a certain number of devices were tested, but the exact quantity is not stated.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a premarket notification for an FDA submission, the studies would typically be prospective and conducted under controlled laboratory conditions to demonstrate safety and effectiveness for regulatory clearance in the US.
3. Number of Experts and Qualifications for Ground Truth:
- This device is a medical instrument (needle guide) and not an AI or diagnostic imaging device that requires interpretation by human experts (e.g., radiologists) for ground truth establishment.
- The ground truth for the performance tests (MEA and LAL) is established through standardized laboratory assays with objective, measurable endpoints (e.g., percentage of blastocyst development, endotoxin units). Therefore, no "experts" in the sense of clinical reviewers (like radiologists) were utilized to establish ground truth for this type of testing.
4. Adjudication Method:
- Not applicable as the tests are laboratory-based assays with objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is a passive medical instrument (needle guide) and not a diagnostic imaging or AI-powered device that aids human interpretation, which would typically necessitate an MRMC study to evaluate improved reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This is not an algorithm or AI device. The tests performed (MEA and LAL) evaluate the biological safety and pyrogenicity of the device material, which are inherent properties of the device itself.
7. Type of Ground Truth Used:
- The ground truth used is based on objective laboratory assay results against predefined biological and chemical thresholds.
- For MEA: The objective metric is the percentage of embryos developed to the expanded blastocyst stage, compared to a control group.
- For LAL: The objective metric is the endotoxin units (EU) per device.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
In summary, the VitroPRO device demonstrates its safety and effectiveness for the expanded indication of oocyte retrieval through established biological and chemical material compatibility tests (MEA and LAL), rather than clinical performance studies involving human readers or AI algorithms. The acceptance criteria are objective thresholds for these laboratory tests.
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(236 days)
ITX
Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
The provided document is a 510(k) Pre-market Notification for a medical device called "Disposable Needle Guides and Grids" by Advance Medical Designs, Inc. This document details the device's characteristics, indications for use, comparison to predicate and reference devices, and testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria through the various tests and their corresponding pass/fail conditions. While not presented in a single table, the summary of non-clinical and bench testing demonstrates the device's performance against these criteria.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 and ASCA-Pilot Biocompatibility Guidance requirements for limited contact duration (surface devices of breached/compromised surface, external communicating tissue, indirect blood path). Specific tests include: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (ISO 10993-11 and USP 151), Direct/Indirect Hemolysis/Hemocompatibility (ISO 10993-4 and ASTM F756). | Sufficient evidence provided to validate AMD's claim that subject materials/device are non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. (Section 10) |
| Mechanical Performance | Cover Breach and Probe Damage Testing: No damage to cover or probe due to material attachment of needle guide over a cover. | Water leak testing performed during Design Input, Design Output, and Design Validation stages demonstrated material attachment of needle guide over a cover did not cause damage to cover or probe. (Section 11) |
| Retention and Movement Testing: Minimum force of 8N to dislodge the guide. | Force testing on needle guide attachment ensured a minimum force of 8N would not cause the guide to dislodge. (Section 11) | |
| Needle Drag Testing: Force less than 1.5N when passing a cannula through the needle guide, with no binding. | Force testing performed by passing a cannula through the needle guide ensured binding would not occur and force was less than a 1.5N threshold. (Section 11) | |
| Needle Path Verification Testing: Needle path falls within specified design tolerances. | Needle guides tested on test fixtures to ensure needle path falls within the design tolerances specified for the design. (Section 11) | |
| Usability | Simulated Usability Testing: Design conforms to user needs and intended use. | Simulated use evaluations performed by customers ensured the design of the needle guide conforms to the user needs and intended use, as well as imaging testing conducted through laboratory evaluations. (Section 11) |
| Sterilization | Ethylene Oxide sterilization with SAL 10⁻⁶. | The manufacturing process includes 100% EtO sterilization with SAL 10⁻⁶, which was evaluated for biological effects. (Section 10) |
| Shelf-Life | 3 Years. | Device has a 3-year shelf-life, matching the predicate device. (Section 9) |
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 explicitly state the sample sizes for the specific tests, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective nature of the test subjects if applicable). The tests mentioned are predominantly non-clinical bench tests and simulated use evaluations, implying laboratory settings rather than patient data.
- Bench Testing: The description of tests like "Water leak testing," "Force testing," and "Needle path verification testing" suggests that these were conducted on a sample of the manufactured devices.
- Simulated Usability Testing: "Simulated use evaluations were performed by customers." The number of customers involved or how the evaluation was conducted (e.g., number of sessions, different scenarios) is not specified.
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):
The concept of "ground truth" and "experts" as typically understood in studies involving diagnostic accuracy (e.g., image interpretation by radiologists) is not directly applicable here. This device, "Disposable Needle Guides and Grids," is a mechanical accessory; its primary function is to physically guide a needle.
- For the mechanical performance tests, the "ground truth" is established by engineering specifications and physical measurements (e.g., 8N force threshold, 1.5N drag threshold, design tolerances for needle path). These are typically assessed by engineers or quality control personnel.
- For simulated usability testing, "customers" performed evaluations. Their qualifications are not mentioned, but it's implied they are intended users (physicians or clinicians) who would assess the device's ease of use and how well it meets their needs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like "2+1" or "3+1" are relevant for studies where expert disagreement on diagnostic interpretation needs to be resolved. Since this device is a mechanical guide and the testing focuses on physical and biological performance, such adjudication methods are not applicable. The bench test results would likely be determined by meeting predefined engineering specifications.
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:
An MRMC comparative effectiveness study was not done. The device is a physical accessory, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance does not apply. The submission explicitly states: "Clinical tests were not required to demonstrate substantial equivalence." (Section 12).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is also not applicable. The device is a physical, non-electronic accessory. There is no algorithm or standalone performance in the sense of an AI or software product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed in point 3, the "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications/Physical Measurements: For mechanical performance tests (retention, drag, needle path accuracy).
- Biocompatibility Standards: ISO 10993 series and ASCA-Pilot Biocompatibility Guidance for material safety.
- User Feedback: "Simulated use evaluations were performed by customers" to ensure conformity to user needs.
There is no mention of expert consensus, pathology, or outcomes data, as these types of ground truth are usually associated with diagnostic or therapeutic efficacy studies involving patient data, which was not the focus of this 510(k) submission.
8. The sample size for the training set:
There is no mention of a "training set" as this device is not a machine learning or AI-based product. The testing performed is to validate the physical and biological characteristics of the manufactured device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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