(107 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operating Range | 5 - 40 lbf (as per predicate device) |
| Load Accuracy | ± 3.5 lbf (as per predicate device) |
| Load Values Displayed for Reference only | 41-70 lbf (as per predicate device) |
| Maximum Safe Load | 70 lbf (as per predicate device) |
| Electrical Safety | Complies with AAMI ANSI ES60601-1:2005 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2007AC:2010 |
| Biocompatibility | Meets requirements outlined in EN ISO 10993-1:2009/AC:2010 |
| Software Verification & Validation | Documentation provided as per FDA guidance, "minor" level of concern |
| Usability | Verified according to OrthoSensor, Inc.'s procedures |
| Sterilization | Verified according to OrthoSensor, Inc.'s procedures |
| Packaging Integrity | Verified according to OrthoSensor, Inc.'s procedures |
| Shelf Life | Verified according to OrthoSensor, Inc.'s procedures |
| Design Verification & Validation | Verified |
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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).