(25 days)
The UNI KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : - UniKnee Arthroplasty .
As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - UNI KNEE SURGETICS software . The main modifications to the predicate devices concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
The provided document, a 510(k) summary for the UNI KNEE SURGETICS Navigation System, describes performance testing. However, it does not detail specific quantitative acceptance criteria or a study designed to prove the device met such criteria in the manner requested.
Instead, the document states that the system was tested to assess that no new safety and efficiency issues were raised compared to its predicate devices. The conclusion is based on an assessment that the "accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices." This is a qualitative statement of equivalence rather than a report of specific metrics meeting predefined thresholds.
Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth establishment for training sets, are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative thresholds for this device. The implied criterion is "no new safety and efficiency issues" and "accuracy and performance... not reduced in comparison to the predicate devices." | "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The study was a "non clinical setting (bench testing, specimen)". This implies the use of anatomical specimens or phantoms, rather than human patient data, and was conducted by the manufacturer (Praxim).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No. This device is a surgical navigation system, not an AI-assisted diagnostic tool. No human "readers" are involved in the performance testing described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The described "non clinical setting (bench testing, specimen)" appears to be a standalone performance assessment of the system's accuracy and performance. However, specific metrics are not provided. The system is designed to aid the surgeon, implying a human-in-the-loop during actual clinical use, but the testing described focuses on the system's inherent capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not specified beyond "bench testing, specimen." For a navigation system, ground truth would typically refer to highly accurate measurements of actual anatomical positions or implant alignments, often established using precise measurement tools (e.g., CMM, optical trackers or highly accurate physical models) during bench testing.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable/not specified. The document describes a "navigation system" and software modifications, but not a machine learning model that would typically require a training set in the conventional sense. The "training" here refers to software development and validation, not model training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/not specified.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through qualitative assessment of "accuracy and performance," rather than presenting a detailed, quantitative study against explicit acceptance criteria as would be expected for a novel device or an AI/ML product.
§ 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).