(125 days)
Intended Use: The Stryker® Navigation System - iNfinitus Hip Resurfacing Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
Indications for Use: The system is indicated for partial hip resurfacing, to assist in precise positioning of hip femoral resurfacing component. The system must be used within the operating room and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
Stryker® Navigation System - iNfinitus Hip Resurfacing Module is part of the product series of the Stryker® Navigation System. The system comprises software for intraoperative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated hip resurfacing surgery. The Stryker® Navigation System - iNfinitus Hip Resurfacing Module is based on the previously cleared Stryker® Navigation System - Hip Module. The Hip Resurfacing module is tailored to the workflow of hip resurfacing procedures and consists of planning and preparing the acetabular side with depth to seat measurement for the cup and planning and preparation tasks for the femoral component.
Here's a breakdown of the acceptance criteria and study information for the Stryker Navigation System - iNfinitus Hip Resurfacing Module, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text for K072271 does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. It primarily focuses on the device description, intended use, and indications for use, and a comparison to predicate devices, which implies the new device performs similarly or equivalently to the predicate to warrant substantial equivalence.
Stryker Navigation System - iNfinitus Hip Resurfacing Module is being cleared as substantially equivalent (SE) to the predicate devices K022365 Stryker Navigation - Hip Module and K063028 VectorVision Hip SR. Therefore, its performance is considered acceptable if it is comparable to these predicate devices. The submission and clearance focus on the safety and effectiveness being equivalent to these existing technologies for computer-assisted hip surgery navigation.
Key Study Information from K072271:
The provided 510(k) summary does not contain details of a specific performance study in the format requested. 510(k) clearances for navigation systems often rely heavily on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than extensive clinical efficacy studies with detailed performance metrics like sensitivity/specificity or reader studies.
The information provided is typical for a 510(k) submission where substantial equivalence is demonstrated through comparison to legally marketed predicate devices, focusing on:
- Device Description: What the device is and how it functions.
- Intended Use & Indications for Use: What the device is meant to do.
- Technological Characteristics: How the device achieves its function.
- Comparison to Predicate Devices: Demonstrating that the new device is as safe and effective as existing, legally marketed devices.
Therefore, the following points cannot be extracted directly from the provided text, as a detailed performance study report is not present:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion:
Based on the provided 510(k) summary for K072271, the clearance relies on demonstrating substantial equivalence to predicate devices (K022365 Stryker Navigation - Hip Module and K063028 VectorVision Hip SR) rather than presenting a detailed independent performance study with quantitative acceptance criteria and results for the new iNfinitus Hip Resurfacing Module. The document does not contain the specific study details or performance metrics you requested.
§ 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).