(23 days)
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.
This is a 510(k) premarket notification for the Stryker Consolidated Operating Room Equipment (CORE) System, specifically the console. It doesn't contain information about AI/ML models or clinical studies to establish performance metrics as would typically be found for AI-driven diagnostic devices. This submission is for a traditional medical device (a surgical console) and demonstrates substantial equivalence to previously cleared devices. Therefore, many of the requested categories related to AI/ML performance and studies are not applicable.
Here's an analysis of the provided text based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This is achieved by showing that the new device has similar intended use and technological characteristics, and does not raise new questions of safety or effectiveness. The document itself is the comparison table demonstrating this equivalence.
| Acceptance Criteria | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: Device is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in various surgical procedures (including ENT), and placement/cutting of screws, metal, wires, pins, and other fixation devices. | Equivalent: The Stryker CORE ENT System Console's intended use is identical to previously cleared predicate devices (e.g., Stryker CORE Console K032303, Stryker TPS Plus K032117) for cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, and other bone-related tissue, including placement or cutting of screws, metals, wires, pins, and other fixation devices. |
| Technological Characteristics: Similar outer profile, handpiece connectors, footswitch connectors, adjustable operating parameters, system status display, software (microprocessor), non-volatile memory, power sources, power output, wireless tag technology, window jog capability, enhanced serial interface, and auxiliary control as legally marketed predicate devices. | Equivalent: The "TABLE 1-COMPARISON" explicitly demonstrates that the Stryker CORE ENT System Console has identical or substantially similar technological characteristics across all listed elements (Outer Profile, Handpiece Connector, Footswitch Connector, Adjustable Operating Parameters, System Status Display, Software, Non-volatile Memory, Power Source, Power Output, Wireless Tag Technology, Window Jog Capability, Enhanced Serial Interface, Auxiliary Control) when compared to its predicate devices like the Stryker CORE Console (K032303) and Stryker TPS Plus (K032117). Variations are noted for some predicates (e.g., power output difference with TPS Dental, lack of wireless tag/window jog/serial interface on some TPS systems), but the subject device aligns with at least one or more predicates that possess these features. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness. | Implied: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This determination implicitly confirms that the FDA found no new questions of safety or effectiveness for the device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" for this device is demonstrating substantial equivalence through a comparative analysis of its design and technical specifications against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment from experts for a test set in a 510(k) submission for a non-AI surgical console. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process for performance evaluation in this 510(k) submission.
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-assisted device, and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device (surgical console) and does not deploy an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As described above, the "ground truth" concept is not directly applicable in the context of this traditional medical device 510(k) submission. The basis for approval is the demonstrated substantial equivalence to established predicate devices whose safety and effectiveness have already been determined.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model or training set.
§ 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.