(70 days)
The Stryker Maestro Pneumatic system is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
The Stryker Maestro Pneumatic System is a pneumatic, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories.
This document is a 510(k) summary for the Stryker Maestro Pneumatic System, a surgical drill motor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria for device performance.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical performance studies of diagnostic or AI-driven devices.
Here's a breakdown of why the requested information is absent and what the document does provide:
Why the requested information is not present:
- Device Type: The Stryker Maestro Pneumatic System is a surgical instrument (a drill motor). For such mechanical devices, the regulatory pathway (510(k)) primarily requires demonstrating that its technological characteristics and performance are substantially equivalent to a predicate device already on the market. This typically involves engineering benches tests, material compatibility tests, and comparison of performance specifications rather than clinical trials with human subjects and statistical performance metrics like sensitivity, specificity, or AUC against a ground truth.
- 510(k) Process: A 510(k) summary focuses on comparing the new device to a predicate based on intended use, technological characteristics, and performance data to show that it is as safe and effective. It does not usually require a clinical study with acceptance criteria in the way an AI/diagnostic device would.
- Timeframe: The document is dated 2004. Diagnostic device regulations, especially for AI/ML, have evolved significantly since then, often requiring more rigorous clinical validation.
What the document does state regarding "performance":
The document states:
- "The Stryker Maestro Pneumatic System... has the same intended use as the Medtronic Legend®. This device and the predicate device have the same technological characteristics, the same operating principles, use the same patient contacting materials, and have similar performance characteristics."
- "Based upon the comparison to the predicate devices, the Stryker Maestro Pneumatic System is substantially equivalent to legally marketed devices."
This "similar performance characteristics" is the closest the document comes to discussing performance. However, it does not quantify these characteristics, define acceptance criteria, or describe a study designed to statistically prove performance against specified targets.
Therefore, I cannot fill out the requested table and answer the study-related questions from the provided text. The information simply isn't there for this type of device and regulatory submission.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).