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The TOTAL 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 : . Total Knee Arthroplasty

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software . The main modifications to the predicate device 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 text for the TOTAL KNEE SURGETICS Navigation System does not contain specific acceptance criteria or a detailed study report with quantitative performance metrics. Instead, it makes a general statement about performance testing and substantial equivalence to a predicate device.

Here's an analysis based on the given information, highlighting what is and is not present:

Acceptance Criteria and Device Performance:

The document states: "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." However, no specific accuracy metrics (e.g., in millimeters, degrees of rotation) or performance thresholds (acceptance criteria) are provided in the document. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text.

Study Details:

The document mentions "Performance Testing" but does not provide a detailed study design or results.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified.
   • Data Provenance: The testing was "non clinical setting (bench testing, specimen)". No country of origin is mentioned for the data, and it was not human patient data (retrospective or prospective).

2. 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 specified. The document does not describe the establishment of a ground truth by experts for the test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified.

4. 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:

   • A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The performance testing mentioned was "non clinical setting (bench testing, specimen)." This implies a standalone evaluation of the system's accuracy in a controlled environment, likely without human surgical intervention as part of the test (though it's intended for use with human surgeons). The document states, "Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device." This indicates a standalone assessment was performed to compare it with the predicate device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified. Given it was "bench testing, specimen," the ground truth would likely involve highly precise measurements against known physical standards or anatomical landmarks on the specimens using a highly accurate reference system, but the document does not detail this.

7. The sample size for the training set:

   • Not applicable/Not specified. This is a navigation system, not a machine learning model that typically requires a discrete training set in the sense of a diagnostic AI. The software modifications concern "internal architecture," "integrating new implants," and "adapting the workflow to different surgical techniques," rather than training a predictive algorithm with a large dataset.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. (See point 7).

Summary of what is present:

• Device Type: Surgical navigation system (TOTAL KNEE SURGETICS Navigation System).
• Intended Use: Aid surgeons in locating anatomical structures and aligning endoprostheses during Total Knee Arthroplasty.
• Testing Conducted: Non-clinical bench testing on specimens.
• Conclusion: Accuracy and performance were "adequate for its intended use and not reduced in comparison to the predicate device."
• Predicate Device: Surgetics ORTHO KNEELOGICS Navigation System (K031196).
• Modifications from Predicate: Internal software architecture for easier integration of new implants and adaptation of workflow, new instruments for new implants.

In essence, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, and while it mentions performance testing, it does not provide the granular data or criteria usually expected in a detailed study report for acceptance criteria. The FDA's acceptance of the 510(k) implies that the provided (but non-public) testing information was sufficient for their "substantial equivalence" determination.

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