(427 days)
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.
§ 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).