(68 days)
The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing 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 femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components.
Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components.
The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system.
In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.
The provided text describes a 510(k) premarket notification for the Navitrack® System – Partial Hip Resurfacing Universal. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study demonstrating acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided document.
However, I can extract the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (General Statement in the document) |
|---|---|
| Accuracy and performance for intended use (Inferred requirement, likely derived from predicate device performance) | "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use, equivalently as in the Navitrack® predicates." |
| Specific quantitative accuracy thresholds (e.g., in mm or degrees for component placement) | Not provided. |
| Clinical outcomes or precision of component positioning in humans | Not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Non-clinical tests" without detailing specific test sets, cases, or the number of components tested.
- Data Provenance: Not specified, but given the non-clinical nature of the tests, it would likely be laboratory or bench testing data rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. Since the tests were "non-clinical," traditional ground truth established by medical experts for a diagnostic or interventional outcome is not described. The "accuracy and performance" would likely be compared against a known physical reference or measurement in a laboratory setting.
4. Adjudication Method for the Test Set
- Not applicable/Not specified, as no expert review or adjudication process for a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on establishing substantial equivalence through non-clinical accuracy and performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device is a "computer controlled image-guidance system equipped with a three-dimensional tracking sub-system" intended to "assist the surgeon." The description of the device's function implies human-in-the-loop operation, as it "displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components." While "non-clinical tests" were done, it's not specified if these were purely standalone algorithmic evaluations or if they simulated the full human-in-the-loop workflow. However, the phrasing "accuracy and performance of the system was adequate for its intended use" suggests evaluating the device in its intended assistive role.
7. The Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used. For "non-clinical tests" assessing "accuracy and performance" of a surgical navigation system, the ground truth would typically be established by high-precision measurement tools (e.g., CMM, optical trackers, or precise mechanical fixtures) against known geometric configurations or reference points in a laboratory setting. This would serve as the "true" position or alignment against which the system's measurements are compared.
8. The Sample Size for the Training Set
- Not applicable/Not specified. The document describes a "stereotaxic instrument" and "image-guidance system" which implies a rule-based or model-based system for tracking and display, rather than a machine learning model that requires a "training set" in the conventional sense. The "models" mentioned ("specific implant models... to also be included in the system") refer to CAD models of implants, not training data for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified, as there is no mention of a training set for a machine learning model. The "ground truth" for the system's underlying operations (e.g., tracking accuracy, display fidelity) would be established by engineering specifications and metrology.
§ 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).