(29 days)
The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented. The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.
The provided FDA 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free does not contain explicit acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.
The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the modifications to the predicate device (adding femoral tracking capabilities) do not raise new safety or efficacy issues and that the fundamental technology remains the same.
Here's an breakdown of the information that can be extracted and the information that is not present based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document indicates "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system in depicting the positioning of the femoral THR component was adequate for its intended use." This is a general statement, not a quantifiable criterion.
- Reported Device Performance: Not explicitly provided with numerical values. The conclusion states the device is "substantially equivalent" and implies adequate accuracy and performance, but no specific metrics (e.g., accuracy, precision, sensitivity, specificity) are reported.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not mentioned. The device's function involves a surgeon (user) identifying and digitizing key anatomical landmarks. Therefore, the "ground truth" during operation relies on the surgeon's input, but for formal testing, details about expert involvement are absent.
4. Adjudication Method for the Test Set:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is mentioned. The document is for a computer-assisted surgical navigation system, not an imaging diagnostic device typically requiring MRMC studies for reader performance.
6. Standalone (Algorithm Only) Performance Study:
- The document describes "non-clinical tests" to verify accuracy and performance. While this implies a standalone assessment of the system's ability to track and display positions, no specific quantitative results or details of such a study are provided.
7. Type of Ground Truth Used:
- The system itself determines alignment axes based on "user-identified anatomical landmarks." For non-clinical testing, the "ground truth" would likely involve highly precise measurements using phantoms or cadaveric models, but this is not detailed. The document does not specify the ground truth used for performance assessment.
8. Sample Size for the Training Set:
- Not mentioned. Surgical navigation systems like this typically rely on pre-programmed anatomical models and algorithms rather than a "training set" in the machine learning sense for image recognition. The "training" would be in the form of algorithm development and refinement, not typically dataset-driven.
9. How the Ground Truth for the Training Set Was Established:
- Not mentioned, as the concept of a "training set" in the machine learning context isn't directly applicable or described here.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence based on technological comparisons and a general statement about non-clinical testing for accuracy and performance for "intended use." It lacks the detailed quantitative performance data, specific acceptance criteria, and study methodologies typically found in submissions for AI/ML-driven diagnostic devices or those requiring extensive clinical validation with detailed ground truth establishment. The nature of this device (a surgical navigation system) means its "performance" is often evaluated differently than a diagnostic imaging 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).