(87 days)
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console 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. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker CORE 2 Console is a modernization of the currently marketed CORE Console. The CORE 2 Console supplies power to a variety of devices, which include small and large bone handpieces, footswitches, and a bone mill. The CORE 2 Console contains a touch screen graphical user interface (GUI), which allows the user to program a number of customized settings related to the connected devices and irrigation.
This FDA 510(k) summary is for the Stryker Consolidated Operating Room Equipment (CORE) 2 Console. It asserts substantial equivalence to a predicate device (Stryker Consolidated Operating Room Equipment (CORE) System, K112593) rather than defining specific acceptance criteria for a novel device and then proving it meets them. Therefore, many of the requested categories related to algorithmic performance and ground truth establishment are "Not Applicable" or "Not Provided" in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, explicit quantitative acceptance criteria for novel performance metrics are not specified in the document. Instead, the focus is on demonstrating that the device meets established regulatory standards and performs comparably to its predicate.
| Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | The device complies with the IEC 60601-1 standard for safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | The device complies with the IEC 60601-1-2 standard for EMC. |
| Software Verification & Validation | Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Software verification and validation testing was conducted, and documentation was provided as recommended by FDA guidance. |
| Mechanical Performance | Correct functionality of the console as specified, reliability, use life, compatibility with accessories, torque mapping, capacitive touchscreen. | Design verification activities performed to ensure correct functionality: Reliability and Use Life Testing, Compatibility Testing, Performance testing for torque mapping capability and capacitive touchscreen. Results are not quantified but assumed to be acceptable. |
| Human Factors/Usability | Compliance with FDA's "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1 | Human factors analysis and usability testing was performed in accordance with the specified FDA guidance and IEC standard. |
| Biocompatibility | No direct or indirect patient contact (matching predicate) | Not required as the CORE 2 Console is identical to the predicate device in that there are no components with direct or indirect patient contact. |
| Clinical Performance | Not applicable for this device as per the submission. | Not applicable – data from clinical studies was not provided. Clinical studies are not required to demonstrate safety or feasibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the performance tests. The document broadly states "Reliability and Use Life Testing," "Compatibility Testing," and "Performance testing for torque mapping capability and capacitive touchscreen" were conducted but does not provide numbers of units tested or duration of tests.
- Data Provenance: Not explicitly stated, but given it's a device manufacturer submitting to the FDA, it is presumed to be internal testing data from the company's facilities. The document does not indicate country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable/Not Provided. For a device of this nature (surgical console), "ground truth" usually refers to the accuracy or correctness of an AI algorithm's output relative to established medical fact. As this is not an AI-driven diagnostic or prescriptive device, and the submission is focused on substantial equivalence of hardware/software functionality, this concept of "ground truth" in the context of expert review does not apply directly. The performance tests would be validated against engineering specifications and industry standards by qualified engineers and testers.
4. Adjudication Method for the Test Set
- Not Applicable/Not Provided. Adjudication methods (like 2+1, 3+1 for consensus) are typically used in clinical studies or for evaluating AI diagnostic performance where human expert discrepancy needs resolution. This submission focuses on engineering and regulatory compliance, not clinical diagnostic accuracy requiring expert consensus adjudication.
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
- No. An MRMC comparative effectiveness study was not conducted as this is not an AI-assisted diagnostic or interpretation device that would involve human "readers" or image interpretation. The device is a surgical console that powers other instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-driven algorithm with a "standalone" diagnostic or predictive function. The software mentioned "accommodate internal circuitry redesigns" and manages "illumination rings," "GUI workflow," and "transfer saved use-preference profiles." The "software verification and validation testing" would assess the standalone functionality of the software's control over the console's operations, but not in the sense of an "AI algorithm."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Regulatory Standards. For this device, the "ground truth" for its performance tests would be adherence to documented engineering specifications and compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the stated indications for use.
8. The Sample Size for the Training Set
- Not Applicable/Not Provided. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The "software was rewritten" and verified/validated, but this refers to traditional software development, not AI model training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable/Not Provided. As there is no "training set" for an AI model, this question is not relevant to this submission.
§ 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.