Search Results

The Stryker Pi Drive Plus Motor is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, drilling, reaming, decorticating, shaping and smoothing of bone cement and teeth in a variety of surgical procedures, including but not limited to Dental, ENT (ear, nose and throat), Neuro, Spine and Endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The Stryker Pi Drive Plus Motor is a non-sterile, reusable, electric powered (40V DC) motor that rotates cutting accessories up to speeds of 75,000 RPM. It is powered by the CORE console. The cable of the Pi Drive Plus Motor is integrated into the proximal end and connects directly to the CORE console. The subject drill speed is controlled by a foot switch (connected to the CORE Console) or a removable handswitch which triggers a sensor within the handpiece. A variety of attachments and accessories can be used in conjunction with the drill. The motor (drill), cable, handswitch and footswitch are considered non-patient contacting device.

The Extender is an optional direct drive accessory that attaches to the distal end of the drill and transmits torque from the drill to various attachments. The Extender provides an option to add length to the drill, based on the user preference. The Extender is delivered non-sterile, re-usable, constructed of stainless steel material and is considered a non-patient contacting device.

The provided document describes the Stryker Pi Drive Plus Motor, an ENT electric or pneumatic surgical drill, and its substantial equivalence to a predicate device (Stryker S2 Drill). However, it does not contain information regarding traditional acceptance criteria and studies typically associated with AI/ML-based medical devices or diagnostic tools. This document focuses on the technical and functional comparison of a surgical drill to its predicate for a 510(k) submission.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML are not applicable here. There is no mention of sensitivity, specificity, accuracy, F1-score, AUC, or other metrics typical for diagnostic/AI products.

Here's a breakdown of the available and inapplicable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical surgical drill, the "acceptance criteria" are related to its functional performance, integrity, and safety, not statistical diagnostic performance metrics. The document states that the device meets performance requirements.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a hardware device. The "test set" would be the manufactured devices undergoing various engineering tests. The document doesn't specify a sample size for these tests, just that "the following verification tests were performed on the subject device." Data provenance (country of origin, retrospective/prospective) is not relevant to testing a physical drill.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This is a hardware device, not a diagnostic one requiring expert interpretation for ground truth. Ground truth for a drill would be engineering specifications and measurements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in diagnostic studies. This is not relevant for testing a surgical drill.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance

Not applicable. An MRMC study with AI assistance is entirely irrelevant for a surgical drill device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a surgical drill and does not involve any algorithm or AI/ML. Its performance is always "human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

For the physical device, the "ground truth" would be established by:

• Engineering Specifications: The design parameters and expected performance characteristics of the motor and extender.
• Physical Measurements and Functional Checks: Verification tests against these specifications (e.g., measuring RPM, checking electrical functionality, assessing material integrity).
• Safety Standards: Compliance with relevant medical device safety standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI/ML product that would have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth for it.

In summary, the provided document describes a 510(k) premarket notification for a physical medical device (surgical drill) and focuses on demonstrating substantial equivalence through non-clinical performance testing against engineering and safety criteria, rather than clinical performance or AI/ML-related metrics.

Ask a specific question about this device