Search Results

The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, teeth and other related tissue in a variety of surgical procedures, including but not limited to Dental, ENT, Neuro and Endoscopic. 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 document is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information is typically found in performance testing sections of a 510(k) submission, which evaluates quantifiable metrics like accuracy, precision, or other performance characteristics of the device.

The provided document is limited to:

• Device identification: Trade Name, Common Name, Classification Names, Equivalent predicate devices, Device Description, Intended Use, Technological Comparison.
• Regulatory correspondence: A letter from the FDA confirming substantial equivalence and outlining general controls.
• Indications for Use Statement: Detailing the surgical procedures and materials the device is intended for.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document focuses on demonstrating substantial equivalence to predicate devices, implying that its safety and effectiveness are established by comparison to existing, legally marketed devices with similar technological characteristics and intended uses, rather than through a new, standalone performance study with detailed acceptance criteria as one might see for novel AI/software devices.

Ask a specific question about this device

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

• 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.

Ask a specific question about this device