(97 days)
The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES 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 TOTAL KNEE SURGETICS NAVIGATION SYSTEM, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES consists of the following major components and subsystems:
- The Station (Surgetics or NanoStation), consisting of a mobile computer . system and an optical localizer
- Ancillary instruments, specific motorized cutting block and reflective . markers used for reference and registration
- TOTAL KNEE SURGETICS with Praxiteles software ●
The main modification to the predicate device K060282 concerns the use of a new motorized cutting block PRAXITELES®.
The provided text describes the 510(k) summary for the TOTAL KNEE SURGETICS Navigation System with Praxiteles. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria. Instead, it refers to a qualitative assessment against the predicate device.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| No new safety and efficiency issues are raised. | 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. |
| Accuracy and performance are adequate for intended use. | 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. |
| Performance is not reduced compared to the predicate device (K060282). | The underlying technology... is the same as for the predicate device K060282. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery... The accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The study involved "non clinical setting (bench testing, specimen)." The number of specimens used is not specified.
- Data Provenance: The study was conducted in a "non clinical setting (bench testing, specimen)." This indicates it was a laboratory or cadaveric study, not on live human patients. The country of origin of the data is not specified, but the submitter is based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study was non-clinical, so expert involvement in establishing ground truth for clinical cases would not be applicable in the same way.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the nature of the non-clinical testing, a typical adjudication method for clinical studies (e.g., 2+1) would not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical testing, comparing the modified device to a predicate, rather than human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The description of the "bench testing" and "specimen" analysis, focusing on "accuracy and performance of the system," suggests that standalone performance of the device's navigation and motorized cutting block components was evaluated. The device's function is to "aid the surgeon in locating anatomical structures and aligning the endoprostheses," implying the algorithm's performance in guiding and positioning.
7. The Type of Ground Truth Used:
The type of ground truth used is not explicitly stated but can be inferred from the "bench testing, specimen" context. For mechanical accuracy assessments in a non-clinical setting, ground truth would likely be established through:
- Precise measurements using calibrated instruments or reference standards.
- Verification against known anatomical landmarks or pre-defined surgical plans on cadaveric specimens.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The document describes a 510(k) submission for a device, TOTAL KNEE SURGETICS Navigation System with Praxiteles, which is an image-guided surgical navigation system with a motorized cutting block. This type of device typically does not involve machine learning algorithms that require a "training set" in the conventional sense for image classification or prediction tasks. Its core functionality relies on optical tracking and pre-programmed algorithms for surgical guidance and positioning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reason as in point 8.
§ 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).