(175 days)
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
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.
The provided text is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. This document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested details about acceptance criteria and study design are not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily on new clinical performance studies with predefined acceptance criteria.
However, I can extract information related to the device description and the comparison to predicate devices, which implicitly serves as the "study" for a 510(k) application in the sense of demonstrating equivalence.
Here's a breakdown of the information that can be extracted and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Devices | The Stryker Consolidated Operating Room Equipment (CORE) System is deemed substantially equivalent to the following legally marketed predicate devices: |
- Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541)
- TPS Hermes (K991696)
- Stryker Navigation System (K012380)
- Dyonics (K771218)
The technological characteristics of the CORE Console are stated to be the same as previously cleared predicate devices. This implies that the performance characteristics (e.g., power output, rotational speed, torque, vibration, material compatibility of cutting accessories, sterilization compatibility) meet or exceed those of the predicate devices. |
Explanation: In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means the new device is as safe and effective as the predicate device(s). The "reported device performance" is essentially that its technological characteristics are the same as or comparable to the cleared predicates for the stated intended uses. Specific quantitative performance metrics (e.g., "95% accuracy in tissue identification") are typically not required or provided unless the device has novel technology or a different intended use compared to its predicates, which would necessitate a more rigorous performance study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. A 510(k) for a system like the CORE Console, which is a surgical tool based on established technology, generally relies on engineering testing, performance bench testing, and comparisons to predicate devices rather than a "test set" of patient data as you might see for an AI/diagnostic device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is not applicable in the context of this 510(k) submission. The "ground truth" for a mechanical surgical system like this would be established through engineering specifications, material science, and clinical experience with the predicate devices, not typically by expert consensus on a test set of data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable.
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
This information is not provided and is not applicable. The Stryker CORE System is a surgical tool, not an AI-assisted diagnostic or interpretative device that would involve human "readers."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The CORE System is a human-operated surgical console, not an "algorithm only" device.
7. The Type of Ground Truth Used
The "ground truth" for a device of this nature is implicitly established through:
- Engineering specifications and standards: The console and its accessories are designed to meet certain power outputs, safety features, ergonomic requirements, and material compatibility.
- Performance of predicate devices: The functionality and safety profile of the predicate devices (Stryker TPS, TPS Hermes, Stryker Navigation System, Dyonics) serve as the benchmark or "ground truth" for what is considered safe and effective for the stated intended uses.
- Clinical experience and literature: The acceptance of the intended uses (cutting, drilling, reaming, etc., in neuro and endoscopic procedures) is based on established surgical practices and the proven utility of similar devices.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This device is not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable. This device is not an AI/machine learning model.
In summary:
The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices. It does not present a clinical performance study with specific acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics (like MRMC or standalone algorithm performance). The "study" in this context is the comparison of technical characteristics and intended use to the predicate devices to argue for substantial equivalence.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).