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The Pi Drive 2 and Pi Drive 2 Plus Motors are 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, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental, ENT (Ear, Nose and Endoscopic Applications. They are also usable in the placement or cutting of screws, metals, wires, pins, and other fixation devices.

The Pi Drive 2 and Pi Drive 2 Plus Motors are non-patient contact, reusable, electric powered (40 VDC) motors that are supplied non-sterile and intended to be to be sterilized by the user prior to each use. The devices are driven by a three-phase, four-pole, brushless DC motor that is housed in a black anodized aluminum body and directly rotates cutting accessories up to speeds of 75,000 RPM. A 4.6 m long cord is integrated into the proximal end of each motor which is used to connect directly to the CORE 2 Console. The CORE 2 Console is used to supply power to the motors and in conjunction with a foot switch (connected to the console) is used for motor activation and speed control. The Pi Drive 2 Plus contains circuitry that also allows it to be operated using a Stryker handswitch for activation and speed control. Both motors are identical in technology, functionality, indications for use, and are compatible with the same attachments and cutting accessories. The Pi Drive 2 Plus motor is approximately 10.3 mm longer and weighs 85 grams more than the Pi Drive 2 motor, this additional length accommodates use of the Stryker handswitch.

Here's a breakdown of the acceptance criteria and study information for the Stryker Pi Drive 2 Motor and Pi Drive 2 Plus Motor, based on the provided FDA 510(k) submission:

The submission is for a medical device that does not involve AI; it's an electric surgical drill. Therefore, many of the questions related to AI device performance (effect size of human readers with AI vs. without AI, standalone AI performance, ground truth for training set, etc.) are not applicable to this document. The document describes a "Special 510(k)" submission for a line extension of an existing predicate device, focusing on demonstrating substantial equivalence through non-clinical testing.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical testing, which typically refers to laboratory or bench testing rather than studies involving human subjects or real-world data like clinical trials. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of patient data are not applicable. The testing would have involved a sufficient number of device units to demonstrate statistical confidence in the stated performance characteristics, but specific numbers are not provided in this summary.

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

This question is not applicable as the device is not an AI diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed through engineering and functional testing.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reason as above. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

No. This is not an AI algorithm. Its performance is inherent to its mechanical and electrical design, and its operation is always human-in-the-loop (a surgeon using the drill).

7. The Type of Ground Truth Used:

For the non-clinical testing of this surgical drill, the "ground truth" would be established by:

• Engineering specifications and design requirements: The device is expected to meet predefined performance metrics (e.g., maximum RPM, torque, electrical safety limits).
• Established industry standards: Adherence to standards like ISO 14971 (risk management), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC/EMI) serves as the "ground truth" for compliance.
• Predicate device performance: The performance of the predicate device (Stryker® Pi Drive Plus Motor K152641) acts as a benchmark, with the new device demonstrating "substantial equivalence" in safety and effectiveness.

8. The Sample Size for the Training Set:

This question is not applicable as there is no training set for an AI algorithm here.

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

This question is not applicable as there is no training set for an AI algorithm here.

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