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The MIS Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the MIS Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/ Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

MIS Attachments and Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the MIS Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic and Orthopedics. The Stryker MIS Attachments are available in straight, curved and angle styles and in two lengths - 13 cm and 16 cm.

Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The MIS Cutting Accessories are designed to fit the corresponding MIS Attachments. The cutting accessories when used with a high speed drill and MIS Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

Here's a breakdown of the acceptance criteria and study information for the Stryker MIS Attachments and Cutting Accessories, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance tests as "verification tests" and states the "results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker MIS Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence." Since specific numerical acceptance criteria (e.g., minimum tensile strength, maximum temperature) are not explicitly detailed in the public summary, the "Reported Device Performance" here refers to the device meeting the underlying requirements for each test category.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each performance test. The nature of these tests (e.g., life testing, temperature testing, slippage testing) suggests these would be controlled laboratory or bench trials using a representative number of devices and components, rather than human subject data.

• Sample Size: Not explicitly stated.
• Data Provenance: The tests are described as "verification tests," implying internal testing conducted by the manufacturer (Stryker Corporation). The document does not specify the country of origin of the data, but since Stryker is based in Kalamazoo, Michigan, USA, it's highly probable the testing was conducted in the USA or by labs commissioned within its network. The studies are prospective in the sense that they were conducted specifically to evaluate the performance of these new devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For the performance and biocompatibility tests described, the concept of "ground truth established by experts" as typically applies to diagnostic or prognostic AI/medical image analysis is not directly relevant. These are engineering, material science, and biological safety tests. The "ground truth" for these types of tests is defined by established international standards (like ISO 10993 for biocompatibility) and engineering specifications. The results are objective measurements or categorical observations (e.g., "non-toxic," "pass") against these predefined targets or benchmarks.

• Number of Experts: Not applicable in the context of human interpretation of data for ground truth.
• Qualifications of Experts: Not applicable. The "experts" in this context would be the engineers, technicians, and toxicologists conducting the tests with expertise in their respective fields (mechanical engineering, materials science, toxicology, etc.) and knowledge of the relevant standards.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments where discrepancies need to be resolved. For performance and biocompatibility tests of a physical device, results are generally objective and either meet or do not meet a predefined specification.

• Adjudication Method: 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:

The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size regarding human readers improving with AI assistance (or any other assistance) is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is a surgical instrument (attachments and cutting accessories for powered drills), not an algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's "standalone" performance is evaluated through the physical and biological tests listed (Life, Functional, Temperature, Slippage, Whip, Chatter, Biocompatibility).

7. The Type of Ground Truth Used:

For the performance tests: The ground truth implicitly would be the specified engineering performance requirements (e.g., durability under certain loads, maximum temperature reached, absence of slippage/whip/chatter beyond acceptable limits).
For biocompatibility tests: The ground truth is defined by the criteria within the referenced standards (AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013). This includes established biological responses considered "non-cytotoxic," "non-sensitizing," etc.

8. The Sample Size for the Training Set:

This device is not an AI/ML product; therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of medical device.

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