Consolidated Operating Room Equipment (CORE) 2 Console

• K Number: K243958
• Device Name: Consolidated Operating Room Equipment (CORE) 2 Console
• Manufacturer: Stryker Instruments
• Date Cleared: 2025-03-21 ( 88 days)
• Product Code: OLO , ERL , HBE , HWE
• Regulation Number: 882.4560
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K241171

Intended Use

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 orthopedic, 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 CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

Device Description

The CORE 2 Console is a non-sterile, 120V AC-powered, reusable device that is intended for use outside of the sterile environment during surgery. The console supplies 40V DC power to a range of motors for use in a variety of surgical procedures as described in its labeling. It also provides a means for irrigation through an integrated irrigation pump. The console has three motor ports, two footswitch ports, and one irrigation cassette port. CORE 2 receives identification and configuration information from connected devices including Stryker handpieces, footswitches, cutting attachments with RFID, and irrigation cassettes. The console allows further device configuration through its graphical user interface (GUI).

The primary modules that comprise CORE 2 are its power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker, touchscreen, USB interface, and an Ethernet interface. The CORE 2 is responsible for the integration of these modules and control of the console's software receives identification and configuration from connected devices. This information is monitored and processed based on current system configurations, and can be used to activate handpiece motors, change motor speed, and activate or deactivate irrigation, among other functions.

The device modifications in scope of this premarket notification consist of updates to the CORE 2 software to allow for its use within a RISE (Reimagining Integrated Surgical Experience) ecosystem. RISE is an optional software functionality that allows for Ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System, and Sonopet iQ consoles) and utilizes the DCM (Device Communication Module) protocol.

RISE provides for an integrated OR (Operating Room) solution to healthcare facilities to simplify workflows and reduce OR clutter. In a RISE configuration, adjustment of CORE 2 power, irrigation, and handpiece settings can be made directly on a Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console. RISE functionality also allows for the activation of the subject device output via a remotely connected foot pedal. The functional output tasks that the software performs are the same as that of the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Consolidated Operating Room Equipment (CORE) 2 Console. However, the document does not contain specific acceptance criteria, reported device performance data, or details about a study that proves the device meets specific performance criteria in the way that would typically be presented with quantitative metrics (e.g., sensitivity, specificity, accuracy, precision).

The submission focuses on demonstrating substantial equivalence to a predicate device (CORE 2 Console, K241171) following a software modification. The core argument for safety and effectiveness relies on the fact that the "functional output tasks that the software performs are the same as that of the predicate device" and that "no changes made to the intended use, indications for use, design, materials, or fundamental scientific technology."

Instead of explicit acceptance criteria and corresponding performance metrics, the document outlines the types of testing performed to support the substantial equivalence claim:

• Software and wireless technology testing per FDA guidance documents and recognized standards
• EMC and Electrical Safety testing per FDA recognized standards
• Bench testing per various internal protocols
• Simulated use testing per various internal protocols
• Human factors testing per FDA guidance documents and recognized standards

The "Conclusions Drawn from Testing Performed" states: "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the subject device is sufficient for its intended use. Verification test results for the CORE 2 Console confirm that the differences in technology raise no new issues of safety or effectiveness when compared to the predicate device."

Therefore, based on the provided text, it is not possible to fill out the requested table or answer most of the detailed questions about acceptance criteria and quantitative study results. The submission is a regulatory document asserting substantial equivalence through comparison to a predicate, rather than a detailed report of a performance study against specific acceptance metrics.

Here's what can be extracted/inferred from the document given the constraints:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be provided as specific quantitative acceptance criteria and reported performance metrics are not detailed in the document. The general acceptance criterion is that the device "demonstrate that the modifications to the subject device are as safe and effective as the predicate" and "raise no new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance:

   • Not specified. The document mentions "bench testing," "simulated use testing," and "human factors testing," but does not provide details on the number of samples, test cases, or data provenance (e.g., country of origin, retrospective/prospective).
   • The testing described (Software and wireless technology testing, EMC and Electrical Safety testing, Bench testing, Simulated use testing, Human factors testing) are typically conducted in a controlled lab or simulated environment rather than with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. Given the nature of the device (surgical console, not a diagnostic AI system), "ground truth" in the clinical sense established by experts is not described as part of the testing. The ground truth for engineering and performance testing would typically be engineering specifications and functional requirements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. This pertains to clinical studies often involving human interpretation and consensus, which is not described here.

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 study was not done. This type of study is relevant for diagnostic AI systems with human-in-the-loop components. The CORE 2 Console is a surgical instrument console with software modifications for integration into an operating room ecosystem, not a diagnostic imaging AI.

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

   • Not applicable/Not explicitly detailed as such. While the software itself was tested, it's not a standalone diagnostic algorithm that would typically be evaluated without human interaction. Its performance is tied to its function as a controller for surgical tools. The testing described (software, EMC, bench, simulated use, human factors) would cover the "standalone" functional behavior of the software and hardware components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Inferred: The ground truth for the various engineering and performance tests (software, EMC, bench, simulated use) would likely be engineering specifications, functional requirements, and recognized industry standards. For "human factors testing," the ground truth relates to usability and safety heuristics / guidelines. Clinical ground truth like pathology or outcomes data is not mentioned as being used for this specific submission's testing.

8. The sample size for the training set:

   • Not applicable/Not specified. This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. This is a traditional software and hardware update submission.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).