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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.

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The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. 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 is a 510(k) premarket notification for the Stryker Consolidated Operating Room Equipment (CORE) System, specifically the console. It doesn't contain information about AI/ML models or clinical studies to establish performance metrics as would typically be found for AI-driven diagnostic devices. This submission is for a traditional medical device (a surgical console) and demonstrates substantial equivalence to previously cleared devices. Therefore, many of the requested categories related to AI/ML performance and studies are not applicable.

Here's an analysis of the provided text based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This is achieved by showing that the new device has similar intended use and technological characteristics, and does not raise new questions of safety or effectiveness. The document itself is the comparison table demonstrating this equivalence.

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

Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" for this device is demonstrating substantial equivalence through a comparative analysis of its design and technical specifications against predicate devices.

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

Not applicable. There is no "ground truth" establishment from experts for a test set in a 510(k) submission for a non-AI surgical console. The "ground truth" here is the established safety and effectiveness of the predicate devices.

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

Not applicable. There is no test set or adjudication process for performance evaluation in this 510(k) submission.

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 device, and no MRMC studies were conducted.

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

Not applicable. This is a hardware device (surgical console) and does not deploy an algorithm for standalone performance evaluation.

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

Not applicable. As described above, the "ground truth" concept is not directly applicable in the context of this traditional medical device 510(k) submission. The basis for approval is the demonstrated substantial equivalence to established predicate devices whose safety and effectiveness have already been determined.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable. There is no AI/ML model or training set.

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Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Reprocessed Arthroscopic Burs are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a Bur or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the Bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur on blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site

The provided document K012652 is a 510(k) summary for "Reprocessed Arthroscopic Burs" and does not describe an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance typical for AI/ML devices, such as those involving sensitivity, specificity, or human expert performance.

Specifically, the document focuses on demonstrating substantial equivalence of reprocessed medical devices to predicate devices. The performance data mentioned relates to:

• Biocompatibility
• Validation of reprocessing
• Function Test(s)

The conclusion states that performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended, implying that they meet the same performance standards as new, unreprocessed devices, which are the predicate devices.

Since this is not an AI/ML device submission, the requested information elements such as a table of acceptance criteria vs. reported AI performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and are not present in the provided text.

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