(100 days)
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.
§ 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).