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VERAFEYE Imaging Catheter: The VERAFEYE Imaging Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

VERAFEYE Imaging System: The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies. The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen. The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.

This appears to be a 510(k) Pre-market Notification document for the VERAFEYE System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence, rather than detailing a study used to prove the device meets specific acceptance criteria in the context of an AI/ML study.

Therefore, the requested information points (1-9) which are typically associated with performance evaluations of AI/ML devices, are not directly addressed in this document. The document focuses on regulatory comparison and safety/effectiveness based on non-clinical data and equivalence to existing devices.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document doesn't provide a table of acceptance criteria for AI performance or reported device performance in that context. It focuses on functional and technological comparisons with predicate devices.
• Sample Size and Data Provenance (Test Set): Not applicable as this is not an AI/ML performance study.
• Number of Experts and Qualifications (Ground Truth): Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data."
• Standalone Performance Study (Algorithm Only): Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily makes a case for substantial equivalence based on technical characteristics, intended use, and non-clinical performance data, rather than reporting on an AI/ML specific performance study. It lists various safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1) that the device was tested against to demonstrate safety and effectiveness for regulatory clearance.

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The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).

The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.

Here's a breakdown of the acceptance criteria and study information for the Veraband™ device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for test set, if applicable)

The document primarily describes non-clinical engineering and performance testing. It does not explicitly state a "test set" in the context of clinical data. For the "VERABAND™ intended use" test, it states "Simulated users wearing the device perform activities at different intensities of motion and wear compliance times." While it implies subjects, no specific sample size is provided. The data is non-clinical/simulated.

3. Number of Experts for Ground Truth and Qualifications (for test set, if applicable)

Not applicable, as the provided data focuses on non-clinical and simulated testing for performance validation rather than expert-derived ground truth for a test set of patient data.

4. Adjudication Method (for test set, if applicable)

Not applicable. The reported tests are primarily objective engineering and performance validations against predefined criteria, not subjective human evaluations requiring adjudication.

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

No. The document explicitly states: "The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device." Therefore, no MRMC study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Yes, the majority of the reported testing falls under standalone performance. The "non-clinical testing summary" details various tests (e.g., accelerometer accuracy, battery life, sampling rate, frequency response, report generation comparison) that evaluate the device's technical functionality and performance in isolation or in comparison to a predicate device's output, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

For the non-clinical tests, the ground truth was based on:

• Established engineering specifications and requirements (e.g., full-range accuracy, required light level, expected device life, minimum number of cleanings, sampling rate, full-scale dynamic range, predicate's bandwidth, repeatability and reproducibility for activity levels, predicate comparison requirements for output metrics).
• Recognized consensus standards (e.g., IEC, ISO, ASTM).
• Simulated motions and user activities.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The device is described as an activity monitoring device with an accelerometer to acquire and store data, which is then post-processed. It doesn't appear to be an AI/ML-driven diagnostic device that would typically involve a training set for model development.

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

Not applicable, as there is no mention of a "training set" for an AI/ML model. The device's operation relies on sensor data acquisition and processing based on established algorithms and engineering principles, not on a trained machine learning model.

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The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated.

For use as a tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.

The VERASENSE for Exactech Equinoxe is sterile, for single patient use.

The VERASENSE for Exactech Equinoxe device is an intelligent disposable humeral insert trial that measures dynamic loads on the humeral insert and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application for Shoulder (VSA-S). The VSA-S provides the surgeon with a graphical and numerical presentation of the glenohumeral load magnitude and center of load (COL) location (weighted average) from the humeral to glenoid components. Individual VERASENSE for Exactech Equinoxe devices are packaged sterile, for single patient use with a shim set for thickness adjustments.

The provided text describes the VERASENSE for Exactech Equinoxe device, but it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm's performance.

Instead, the document primarily focuses on demonstrating the substantial equivalence of the VERASENSE for Exactech Equinoxe to a predicate device (VERASENSE for Zimmer Biomet Persona) for regulatory clearance. This involves a comparison of technological characteristics, mechanical and functional features, electrical properties, environmental conditions, and materials.

The performance data section mentions:

• Biocompatibility testing: Conducted according to ISO 10993-1.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: For sensor firmware and software application accessory, categorized as "minor" level of concern.
• Performance Testing (Bench): Covering usability, sterilization, packaging integrity, shelf life, biocompatibility, electrical safety, software V&V, and EMC.

Crucially, it explicitly states:

• Performance Testing Animal: "This submission does not include any animal performance testing. We determined that no such testing was required to demonstrate substantial equivalence."
• Performance Testing Clinical: "This submission does not include any clinical performance testing. We determined that no such testing was required to demonstrate substantial equivalence."

Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria for an AI/ML algorithm's performance, as no such study is detailed.

The device, VERASENSE for Exactech Equinoxe, is described as a tool for "measuring load magnitude and displaying center of load (COL) location (weighted average) of the humeral component on the glenosphere component during a reverse total shoulder arthroplasty (rTSA)." This describes a sensor-based measurement device rather than an AI/ML diagnostic or assistive algorithm.

The closest information available regarding "performance" that could be interpreted as "acceptance criteria" related to the device's core function (load and COL measurement) is in the comparison table:

Table of Acceptance Criteria and Reported Device Performance (as inferred from comparison with predicate and functional specifications)

None of the other requested information (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is present in the provided document, as it pertains to AI/ML algorithm validation, which is not described for this device.

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VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.

VERASENSE is sterile, for single patient use.

The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.

This document describes a 510(k) premarket notification for the VERASENSE for Stryker Triathlon device. It is a re-submission for a device that has previously been cleared for other implant systems (VERASENSE for Zimmer Biomet Persona, K180459). Therefore, the provided text focuses on demonstrating substantial equivalence to existing predicate devices, rather than a full de novo acceptance criteria and performance study for a novel device.

As a result, many of the typical elements of an acceptance criteria and performance study (like specific performance metrics from a clinical study, sample size for testing, expert validation process, MRMC studies) are not present in this document, as the primary goal is to show that the modified device functions similarly and safely to already-cleared devices.

However, I can extract the information that is present and highlight what is not available based on the request.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are not expressed as specific performance thresholds for a new clinical trial, but rather as demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device meets the same specifications and standards as the predicate devices, despite minor technological differences.

Table of Acceptance Criteria (vs. Predicate Device) and Reported Device Performance:

Identified Technological Differences (and justification for substantial equivalence):

Study Details (Based on Substantial Equivalence Demonstration Documentation)

Given this is a 510(k) submission for substantial equivalence based on prior clearances and design modifications, the "study" is primarily a verification and validation (V&V) assessment of the changes, rather than a prospective clinical trial proving de novo performance.

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

   • The document does not specify a sample size in terms of clinical cases or patients for a test set. The "test set" here refers to engineering and bench testing to verify the changes and demonstrate that the device still meets its specifications, rather than a clinical dataset.
   • Data Provenance: Not explicitly stated as "country of origin" for data, but the V&V activities align with FDA regulations for device modification. The studies mentioned are verification and validation activities for compliance with 21 CFR 820.30 design controls. These would typically be internal testing data (bench, pre-clinical if necessary) to support the safety and effectiveness of the modified device. These are retrospective in the sense that they are conducted on the modified device to confirm its performance against established specifications, not prospective in gathering new clinical outcome data.

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

   • This information is not provided in the document. Ground truth, in the context of device performance for substantial equivalence, relies on the device meeting its established technical specifications (e.g., load accuracy, battery life, communication range) rather than expert interpretation of clinical outcomes for a new clinical efficacy claim.

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

   • This information is not applicable/provided. Adjudication methods are typically for clinical studies involving human interpretation (e.g., image reading), which is not the primary focus of this type of 510(k) submission for substantial equivalence based on technical specifications. The V&V activities would involve engineering and quality assurance reviews against defined acceptance criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is an intraoperative mechanical assessment tool, not an AI-assisted diagnostic imaging device requiring human reader improvement studies. Its function is to provide force and load data to a surgeon, not to interpret images or assist in diagnosis.

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

   • The device itself provides objective measurements (load data). The algorithm in the software (VSA) processes this data to display force vectors and positional data. The document states that the Load Range and Accuracy is 5-40 lbf $\leq$ 3.5 lbf, demonstrating a standalone performance metric for the sensor and its associated processing. However, a dedicated "standalone performance study" as would be defined for an AI diagnostic algorithm is not described, as the device's role is to provide real-time data during surgery for human decision-making, not to replace it.

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

   • The "ground truth" for demonstrating substantial equivalence and device performance in this context is primarily derived from engineering specifications, bench testing, and conformity to recognized standards (e.g., IEC standards). For mechanical and functional aspects, this would involve validated measurement equipment and calibration standards. For software, it would involve software verification and validation against requirements and design specifications. There is no mention of clinical outcomes data, expert consensus, or pathology as a ground truth, as the submission is for substantial equivalence of modifications, not a de novo clinical claim.

7. The sample size for the training set:

   • This information is not applicable and not provided. This device is not an AI/ML algorithm that is "trained" on data in the traditional sense. It is a sensor-based device with a fixed algorithm for processing sensor data.

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

   • This information is not applicable and not provided for the same reason as point 7.

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The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.

VERASENSE for Zimmer Biomet Persona provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE for Zimmer Biomet Persona consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE for Zimmer Biomet Persona parent device. Individual VERASENSE for Zimmer Biomet Persona devices are packaged sterile, for single patient use with a shim set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

VERASENSE for Zimmer Biomet Persona devices are implant system specific due to variations in implant design and is compatible with the Zimmer Biomet Persona Knee System.

The VERASENSE for Zimmer Biomet Persona is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and angular velocity and acceleration for the alignment functionality. The data from the sensor is wirelessly transmitted to the LinkStation MINI or LinkStation MINI Evaluation Kit which runs the VSA and is located outside the sterile field in the operating room. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee, center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only, static measurement of the coronal alignment of the tibial resection relative to the patient specific tibial reference axis defined by the system registered anatomical landmarks, and numerical value of the varus/valgus tibial mechanical alignment.

The provided text describes the VERASENSE for Zimmer Biomet Persona device, an intraoperative tool for Total Knee Arthroplasty (TKA), and specifically focuses on a 510(k) submission (K193580) for a modified version of the device. This modification primarily involves an updated firmware and software application to enable and utilize an IMU (inertial measurement unit) chip for measuring tibial implant coronal alignment.

The document states that performance studies were conducted to demonstrate that the product meets established acceptance criteria. However, it does not provide a detailed table of acceptance criteria and reported device performance for the alignment functionality. Instead, it broadly states that "Performance studies demonstrated the product meets established acceptance criteria."

Based on the information provided, here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table listing specific numerical acceptance criteria alongside
corresponding reported device performance for the alignment function. The only specific performance metric mentioned for the alignment function is:

• Tibial Mechanical Alignment Range: varus/valgus ± 7°
• Accuracy: ± 3°

However, it does not state the actual measured performance against this accuracy or range in a reportable format beyond "performance studies demonstrated the product meets established acceptance criteria."

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Performance Testing Bench" including "Benchtop Design, Cadaver Design, Benchtop Sensitivity analysis, Usability, Software Verification." It also states, "The method for calculating alignment was verified through sensitivity analysis and a mathematical simulation." While these imply testing, the sample sizes (e.g., number of cadavers, number of benchtop tests) are not provided.
• Data Provenance: The studies appear to be benchtop and cadaver-based. The country of origin is not specified, but the device manufacturer is OrthoSensor, Inc., located in Dania Beach, Florida, USA. The studies seem to be retrospective or laboratory-based, as it explicitly states, "This submission does not include any clinical testing."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: Given the nature of a medical device submission without clinical trials for the specific modification, it's highly likely that engineering or testing personnel established the "ground truth" for the benchtop and cadaver studies. However, this is not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Given that no clinical studies with human readers or experts are described for the performance evaluation of the alignment function, an adjudication method for a test set is not relevant.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "This submission does not include any clinical testing. We determined that no such testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI assistance vs. without AI assistance can be reported. The device is a measurement tool, not an AI-assisted diagnostic tool for image interpretation by clinicians.

6. Standalone Performance (Algorithm Only)

Yes, standalone performance was assessed. The "Performance Testing Bench" section describes how the "Alignment function calculation" was tested and verified through "sensitivity analysis and a mathematical simulation." This implies testing of the algorithm's performance in a controlled, non-human-in-the-loop environment. The device itself (VERASENSE for Zimmer Biomet Persona) with its integrated IMU and associated software (VSA) acts as the "algorithm only" system in the context of this specific regulatory submission for its alignment measurement capability.

7. Type of Ground Truth Used

The ground truth used for the benchtop and cadaver studies was established through:

• Experimental/Physical Measurement: For benchtop design and cadaver studies, the ground truth for alignment would have been established using highly accurate physical measurement tools (e.g., optical tracking systems, precise goniometers, or reference jigs) against which the device's measurements were compared.
• Mathematical/Simulated Ground Truth: For the "sensitivity analysis and a mathematical simulation," the ground truth would have been derived from theoretical models or known inputs within the simulation environment.

The document does not explicitly state these methods but they are implied by the nature of benchtop and simulation testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The document describes a "510(k) premarket notification" for a hardware/firmware/software modification to an existing device. It does not describe the development or training of a de novo AI/ML model for which a training set would typically be referenced. The "software accessory" is stated as a "minor" level of concern and primarily reports calculated values, not predictions from a data-driven learning model.

9. How Ground Truth for Training Set was Established

Not applicable, as a training set for an AI/ML model is not described as being part of this submission for this specific modification. The "Software Verification and Validation Testing" section refers to standard software testing procedures, not AI model training.

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A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

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This FDA 510(k) clearance letter for the Vera device does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of the study that proves the device meets those criteria. The letter primarily confirms the device's substantial equivalence to predicate devices and outlines regulatory obligations.

However, based on the provided text, I can infer some information and highlight what is explicitly missing.

Information that CAN be extracted or inferred:

• Device Name: Vera
• Intended Use: A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults (upper extremity, trunk, and lower extremity) in the clinic and at home, with audiovisual feedback, graphic movement representations for patients, and remote access to patient exercise videos for clinicians. Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.
• Regulatory Status: Cleared as a Class II medical device (Product Code LXJ), Regulation Number 21 CFR 890.5360 (Measuring Exercise Equipment).
• Use Type: Prescription Use.

Information that is NOT present in the provided text and is crucial for your request:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically found in the 510(k) summary or the full submission, not in this clearance letter.
2. Sample sizes used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not mentioned, and generally less common for this type of device (measuring exercise equipment).
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned, though the device has a standalone component (the software system itself). The performance metrics for this standalone component are what's missing.
7. The type of ground truth used: Not mentioned. For a rehabilitation device, this could involve motion capture systems, clinical assessments, or expert observation.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain the specific information you are looking for (acceptance criteria, study details, performance metrics, ground truth methods, sample sizes), you would need to access the full 510(k) submission for K192474, which may be available through the FDA's website or by filing a Freedom of Information Act (FOIA) request. The public 510(k) summary, if available, would be the most likely place to find a high-level overview of the performance data.

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Not Found

The provided text is an FDA 510(k) clearance letter for the device "Vera" by Reflexion Health, Inc. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance data, study design parameters (sample size, data provenance, expert qualifications, adjudication methods), or details about training sets or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The document is essentially a regulatory clearance notice, not a clinical study report or a technical performance specification document.

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The VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.

VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE parent device. The LinkStation MINI / LinkStation MINI Evaluation Kit is capable of running the VSA and communicating wirelessly with the VERASENSE from outside the sterile field in the operating room. Individual VERASENSE devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI Evaluation Kit. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. The VSA also provides location of the center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments for reference only.

VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems:

• VERASENSE for Biomet Vanguard
• VERASENSE for Stryker Triathlon
• VERASENSE for Zimmer NexGen
• VERASENSE for Smith & Nephew Legion
• VERASENSE for Smith & Nephew Journey II
• VERASENSE for Zimmer Biomet Persona

The provided text describes the VERASENSE for Zimmer Biomet Persona device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text primarily focuses on bench testing and software verification. There are no specific "test set" sample sizes mentioned for clinical or animal studies, as they were not deemed necessary for this submission. The performance data is derived from:

• Bench Performance Testing: The specific sample sizes for these tests (e.g., number of devices tested for load accuracy or operating range) are not explicitly stated in the document.
• Biocompatibility Testing: Conducted on the final VERASENSE for Zimmer Biomet Persona and its raw materials. The sample size for these tests is not specified.
• Electrical Safety and EMC Testing: Conducted on the VERASENSE for Zimmer Biomet Persona and required accessories. The sample size for these tests is not specified.
• Software Verification and Validation Testing: Documentation provided.

The provenance (country of origin, retrospective/prospective) of this data is not explicitly stated, but it would have been generated internally by OrthoSensor, Inc. through their product design and development procedures.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert review for ground truth. The acceptance criteria relate to physical performance, electrical safety, biocompatibility, and software functionality, which are typically assessed through objective measurements and established standards, rather than expert consensus on diagnostic interpretations.

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

Not applicable, as this is not an AI/ML diagnostic tool requiring human adjudication for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The VERASENSE is an intraoperative orthopedic joint assessment aid that measures dynamic loads; it is not an AI-assisted diagnostic tool that would involve human readers.

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

This refers to the performance of the device itself (the VERASENSE sensor and its software application) without direct human intervention in its measurement process, though it is a tool for human use in surgery. All performance testing (bench, biocompatibility, electrical safety, software) described can be considered "standalone" in this context, in that it assesses the device's inherent characteristics and compliance with standards. The device is intended to provide real-time data to a surgeon, who then uses that information for adjustment during TKA.

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

The "ground truth" for this device's performance is based on:

• Physical measurements and established engineering standards: For operating range, load accuracy, maximum safe load, usability, sterilization, packaging integrity, and shelf life, the ground truth is determined by precise measurements and adherence to predefined engineering specifications and internal procedures.
• International standards and guidance documents: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1), the ground truth is compliance with these recognized standards.
• Software verification and validation documentation: For software, the ground truth is adherence to the documented requirements and design specifications as per FDA guidance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device 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 an AI/ML algorithm.

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The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.

The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.

The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.

The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.

The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.

The Veraview X800 has three main radiographic modes as follows:

• Panoramic tomography including linear tomography and scanogram -
• Cephalometric radiography -
• -Cone beam computed tomography

Here's a breakdown of the acceptance criteria and study information for the J.Morita USA, Inc. Veraview X800, 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:

The document states that non-clinical testing was conducted. This typically refers to physical phantom testing and bench testing rather than testing on a "test set" of patient data. Therefore, information about patient data sample size or provenance is not applicable/provided in this 510(k) summary for the performance verification. The data provenance would be from laboratory or manufacturing testing environments.

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

Since the testing was non-clinical and involved phantom measurements and compliance with standards, there are no experts mentioned as establishing ground truth for a patient test set. The ground truth is inherent in the physical phantoms and the established scientific principles of the standards (e.g., IEC 61223-3-4).

4. Adjudication Method for the Test Set:

Not applicable, as no patient-based "test set" requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "There were no clinical tests performed for Veraview X800." Therefore, an MRMC study using human readers was not conducted.

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

This device is an X-ray imaging system, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm performance" study is not applicable in the context of this 510(k) summary. The performance metrics evaluated are for the image acquisition and reconstruction capabilities of the device itself.

7. The Type of Ground Truth Used:

The ground truth used for the performance evaluation was established through recognized international standards and physical phantom measurements. For example:

• Spatial Resolution: Measured using line pair phantoms as per IEC 61223-3-4.
• Noise and Low Contrast Resolution: Measured using contrast phantoms as per IEC 61223-3-4.
• MTF (Modulation Transfer Function): Measured using standardized methods to assess the system's ability to transfer contrast at different spatial frequencies.

8. The Sample Size for the Training Set:

This device is a hardware X-ray system that produces images. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense for image interpretation. Therefore, information about a training set sample size is not applicable/provided.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set discussed for an AI/ML algorithm.

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The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE Knee System is sterile, for single patient use.

The VERASENSE Knee System provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA) intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior, and anterior slope positioning, etc.) after insertion into the space between the tibia and femur.

The VERASENSE™ Knee System is an intra-operative device for use in primary or revision total knee arthroplasty (TKA), where all patient contacting components are made of biocompatible polycarbonate and adhesive.

The VERASENSE™ Knee System is an intelligent disposable tibial insert that wirelessly transmits the measured data to the OrthoSensor LinkStation for surgeon visualization. Individual VERASENSE™ devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments.

The OrthoSensor LinkStation and VERASENSE™ Knee System Software Application are required for use of the VERASENSE™ Knee System device. The LinkStation contains a computer and all peripheral equipment required to display the measured data by providing a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. VERASENSE™ Knee System devices are implant system specific due to variations in implant design.

This submission (K150372) is a Traditional 510(k) for the VERASENSE Knee System, which is an intra-operative device used in Total Knee Arthroplasty (TKA). The primary purpose of this submission is to update the intended use statement for the device. Therefore, it does not include new performance data or clinical studies for acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states "Performance Data: N/A" and "Clinical Data: N/A". This 510(k) is for an update to the intended use statement of an already cleared device. Therefore, no new acceptance criteria or device performance data are presented in this specific submission. The substantial equivalence is based on the previously cleared predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No new test set data is presented in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new test set data is presented in this submission.

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

Not applicable. No new test set data is presented in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-based diagnostic or assistive reading tool. It is an intra-operative tool for surgeons.

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

Not applicable. This device is an intra-operative tool that provides real-time data to a surgeon, rather than a standalone algorithm.

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

Not applicable. No new performance studies requiring ground truth are presented.

8. The sample size for the training set:

Not applicable. No new algorithm training data is presented.

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

Not applicable. No new algorithm training data is presented.

Summary of what the document does provide regarding the device's meeting of criteria:

The document emphasizes Substantial Equivalence to previously cleared predicate devices (K131767, K130380, and K090474). The claim is that the VERASENSE™ Knee System has equivalent manufacturing materials, operating principles, and physical/operational specifications as compared to the predicate devices. The changes in this submission, primarily an update to the intended use statement, are determined to have no impact on safety or effectiveness. Therefore, the device meets the regulatory acceptance criterion of substantial equivalence rather than new performance criteria.

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