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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 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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