(149 days)
The Stryker® Power Tool Navigator attachment is intended to enable spatial localization and identification of Stryker Power Tools by the Stryker® Navigation System.
The Stryker® Power Tool Navigator (PTN) attachment is a tracking device designed for use with Stryker Surgical Power Tools. The PTN attachment is an optical surgical navigation tracker that attaches to a power tool, allowing that tool to be tracked by a Stryker Navigation System. The device employs an array of optical IR LEDs and an IR communications link to interface with the Navigation System.
This document is a 510(k) premarket notification for the Stryker® Power Tool Navigator. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.
Based on the information provided:
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A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the 510(k) summary. The document states that the "Stryker® Power Tool Navigator attachment does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed." This implies that the acceptance criteria are met if the device is found to be substantially equivalent to predicates, meaning its performance is considered comparable and acceptable without specific numerical thresholds being outlined in this summary. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The 510(k) summary does not describe a performance study with a distinct test set. -
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)
This information is not provided. No "ground truth" establishment for a test set is described. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. -
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
No MRMC comparative effectiveness study is mentioned. The device is a "Power Tool Navigator" which is an optical tracking device for surgical tools, not an AI-assisted diagnostic tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device described is a hardware attachment for surgical power tools that enables spatial localization. It is not an algorithm in the sense of an AI or diagnostic software. Its functionality is to track tools, which inherently involves interaction within a larger "Navigation System." Therefore, a standalone algorithm performance evaluation in the typical sense (e.g., for an AI diagnostic tool) is not applicable or described. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided, as no specific performance study with a ground truth is described. -
The sample size for the training set
This information is not provided. No "training set" in the context of machine learning is applicable or mentioned for this hardware device. -
How the ground truth for the training set was established
This information is not provided, as no training set or its ground truth establishment is mentioned.
Summary of the Study (as described in the 510(k) content):
The "study" presented in this document is a substantial equivalence (SE) rational rather than a traditional performance study with specific acceptance criteria and detailed quantitative results.
- Rationale for Substantial Equivalence: The primary "study" or justification for clearance is that the Stryker® Power Tool Navigator attachment is equivalent in "intended use, safety, and effectiveness" to existing, legally marketed Stryker devices (K993239 Stryker® Navigation System - Neuro Module, K010204 Stryker® Navigation System - KneeTrack Module, K022365 Stryker® Navigation System - Hip Module). The document explicitly states that it "does not raise any new safety and efficacy concerns" compared to these predicate devices.
- Safety and Effectiveness: The device is designed and manufactured in accordance with Stryker Instrument's Quality Management System covered by QSR 21CFR 820. This indicates adherence to established quality and manufacturing standards, which contribute to safety and effectiveness.
In conclusion, this 510(k) submission seeks clearance based on demonstrating that the new device is fundamentally similar to existing, cleared devices, rather than through a novel performance study with specific, quantifiable acceptance criteria.
§ 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).