(117 days)
The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.
The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks.
Example procedures include but are not limited to:
Hip arthroplasty
As the equivalent TOTAL KNEE SURGETICS navigation system, the TOTAL HIP SURGETICS navigation system consists of the following major components and subsystems:
- The Navigation Station, consisting of a mobile computer system and an . optical localizer
- . Ancillary instruments and reflective markers used for reference and registration
- . TOTAL HIP SURGETICS software
The provided text is a 510(k) summary for the TOTAL HIP SURGETICS Navigation System (K072267). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, nor does it provide the requested information about sample sizes, ground truth establishment, or expert qualifications.
The paragraph titled "8. Performance Testing" makes a general statement: "The TOTAL HIP SURGETICS Navigation System was tested to assess that no safety and efficiency issues were raised in the device. 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." This is a conclusion, not a description of the test itself nor the specific criteria or results.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document only states that "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." No specific metrics or quantitative results are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The document doesn't detail how "accuracy and performance" were assessed beyond a general statement.
4. Adjudication method for the test set:
- Not mentioned.
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:
- Not mentioned. The device is a surgical navigation system, not an AI diagnostic tool primarily evaluated by human reader performance on cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The performance testing mentioned (paragraph 8) appears to be for the system as a whole, which inherently involves the algorithm's performance in guiding the surgeon. However, a specific "standalone" study (without a human) is not described.
7. The type of ground truth used:
- Not mentioned.
8. The sample size for the training set:
- Not mentioned. The document primarily focuses on claiming substantial equivalence to predicate devices rather than detailing development and training processes.
9. How the ground truth for the training set was established:
- Not mentioned.
In summary, this 510(k) summary provides a high-level overview and a claim of substantial equivalence but lacks the detailed performance data, acceptance criteria, and study methodology typically expected for a comprehensive understanding of device validation.
§ 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).