(172 days)
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)
| Acceptance Criteria (from Subject Device K200587 specifications) | Reported Device Performance (from Subject Device K200587 specifications) |
|---|---|
| Load Range and Accuracy: | |
| 5 - 40 lbf | $\le 3.5 \text{ lbf}$ |
| 41 - 70 lbf | $\le 15%$ |
| Maximum Safe Load | 70 lbf |
| Center of Load (COL) Location Accuracy: | $\le 3\text{mm}$ |
| Mechanical Dimensions: | Equal to the dimensions of the implant humeral liner $\pm 0.50\text{ mm}$ under all operating conditions |
| Battery Life: | 40 min |
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.
§ 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).