(237 days)
The Stryker ® Consolidated Operating Room Equipment (CORE) System is intended for use in the 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, 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 Consolidated Operating Room Equipment (CORE) System is an electrically powered system. This system includes a console, irrigation accessories, footswitches, handswitches, and handpiece cords which drive a variety of devices including saws, drills, wire drivers, microdebriders, and bone mills.
The provided text is a 510(k) summary for the Stryker® Consolidated Operating Room Equipment (CORE) System. This document details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence. It is not a study that proves the device meets specific performance acceptance criteria in terms of diagnostic accuracy or a similar measure typically associated with AI/software performance studies.
Therefore, many of the requested categories for AI/software-centric studies (e.g., sample size, ground truth, expert qualifications, MRMC comparative effectiveness, standalone performance) are not applicable to this document. The document describes a medical device (a surgical console) and its accessories, not an AI or software algorithm designed for diagnostic or analytical tasks.
However, I can extract information related to the device's "performance" in the context of its regulatory submission, which focuses on safety and effectiveness compared to predicate devices.
Here's the breakdown of the information available in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical surgical console, "acceptance criteria" here refers to demonstrating safety and effectiveness compared to predicate devices, rather than specific performance metrics like sensitivity or specificity.
| Aspect of Performance/Comparison | Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance/Characteristics |
|---|---|---|
| Intended Use | Similar to predicate devices. | The Stryker® CORE System is intended for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement, and teeth in various surgical procedures (dental, ENT, neuro, spine, endoscopic), and the placement/cutting of screws, metal, wires, pins, and other fixation devices. This is stated to be similar across all predicate devices. |
| Technology Characteristics | Similar to predicate devices. | Power Output: 400 Watts (identical to Stryker® System and TPS). |
| Handpiece Connectors: Three, allowing two handpieces simultaneously (identical to Stryker® System, more than Synthes EPD). | ||
| Footswitch Connectors: Two, allowing two footswitches simultaneously; capable of wireless footswitch (more flexible than Synthes EPD or TPS, but similar general function). | ||
| Adjustable Operating Parameters: LCD screen for user-set parameters, also obtained from accessories (similar software feature to TPS and previously-cleared CORE Console). | ||
| Wireless Tag Technology: Accessories recognized and identified on console screen (similar software feature to TPS and previously-cleared CORE Console). | ||
| Torque Control: Mechanism to allow user to specify torque profile (similar to Synthes EPD System). | ||
| Safety and Effectiveness | Does not raise any new issues of safety and effectiveness compared to legally marketed predicate devices. | "The results of this testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device." |
| "The Stryker® Consolidated Operating Room Equipment (CORE) System does not raise any new issues of safety and effectiveness and is substantially equivalent to legally marketed devices." | ||
| Software Review | Undergoes code review, error messaging evaluation, adherence to standards, and analysis of new hazards and software requirements. | Each software revision underwent "a code review by a team of internal experts," evaluation of error messaging, and verification of adherence to standards. Analysis of new hazards and software requirements was performed. Documented in SRS and risk analysis. |
| Verification/Validation Testing | System and Unit box testing to confirm continued safety and effectiveness. | Subsequent verification/validation testing, including system and Unit box testing, was performed. |
| Biocompatibility | Not required for non-patient contact devices. | "A biocompatibility evaluation for the CORE Console is not required due to the non-patient contact intended use of this medical device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a surgical console, not an AI/software device that processes data for diagnostic or analytical tasks. The "testing" mentioned refers to engineering, software V&V, and comparison to predicate devices, not clinical studies with patients or data sets in the typical sense this question implies for AI.
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)
- Not applicable. No ground truth in the context of diagnostic accuracy is established for this device. The software review was done by "a team of internal experts," but their qualifications are not specified beyond that, and it's for code review, not clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication in this sense is described.
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 diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth is described in this document. The "ground truth" for the device's functionality would be adherence to engineering specifications and regulatory requirements.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not have a 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.