(71 days)
The Stryker S2 Drill 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, 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 S2 Drill is an electric powered (40V DC) motor. When connected to the CORE console, it directly rotates cutting accessories up to speeds of 75,000 RPM.
This document describes the Stryker S2 Drill, an electric powered surgical drill, and its substantial equivalence to a previously cleared predicate device, the Stryker CORE Sumex Drill. The document does not describe an AI/ML device, therefore, many of the requested criteria are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal 'acceptance criteria' in the quantitative sense typical for performance metrics of AI/ML devices. Instead, it demonstrates the device meets design input requirements through verification tests.
| Performance Metric (Acceptance Criteria) | Reported Device Performance (Stryker S2 Drill) |
|---|---|
| Verification of improved rotor driveshaft | Tests performed, results demonstrate functionality, integrity, safety, and effectiveness. |
| Simulated use tests | Tests performed, results demonstrate functionality, integrity, safety, and effectiveness. |
| Temperature testing of different torque-speed setting | Tests performed, results demonstrate functionality, integrity, safety, and effectiveness. |
| Substantial Equivalence to Predicate Device (Stryker CORE Sumex Drill) | Deemed substantially equivalent in intended use, technological characteristics, safety, and effectiveness. Modifications raise no new issues of safety and effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "verification tests" and "simulated use tests" but does not specify the sample sizes used for these tests. There is no information regarding data provenance (country of origin, retrospective/prospective). This is non-clinical performance data.
3. 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 is not applicable as the device is a physical surgical drill and not an AI/ML diagnostic or assistive device that would require expert-established ground truth on a test set. The "ground truth" here is the physical performance and safety of the device as measured by engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication of output.
5. 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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for this device involves engineering specifications, functional requirements, and safety standards for a surgical drill. This is established through internal design specifications and regulatory requirements. The tests performed verify that the device meets these pre-defined engineering and safety criteria.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria consists of non-clinical performance testing.
- Tests Performed:
- Verification of the improved rotor driveshaft
- Simulated use tests
- Temperature testing of different torque-speed settings
- Results: The results of these tests demonstrated that the functionality, integrity, safety, and effectiveness of the Stryker S2 Drill are sufficient for its intended use.
- Conclusion: Based on these non-clinical tests, the Stryker S2 Drill was deemed substantially equivalent to the existing predicate device (Stryker CORE Sumex Drill) in terms of intended use, technological characteristics, safety, and effectiveness. The modifications introduced (e.g., changes in housing material, motor diameter, length, and weight) raised no new issues of safety and effectiveness.
- Clinical Testing: No clinical testing was deemed necessary for this 510(k) submission, as substantial equivalence was established through non-clinical performance and engineering comparisons.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.