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The iBur™ Hubs 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 iBur™ Hubs 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 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.

iBur™ 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 iBur™ Hubs 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. 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 iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

This document is a 510(k) premarket notification for a medical device, the Stryker iBur™ Hubs and Cutting Accessories. It outlines the modifications to an existing device, compares it to a legally marketed predicate device (K210377), and provides performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding numerical performance metrics for the iBur™ device. Instead, it makes a general statement about meeting acceptance criteria and demonstrating sufficiency for intended use.

However, it does indicate the types of performance tests conducted and their qualitative outcomes:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "performance testing was conducted on the proposed devices" but does not specify the number of devices or units tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this document. The device is a surgical cutting accessory, not an AI/diagnostic device that requires expert-established ground truth from a test set. The validation focuses on the device's physical performance characteristics.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this 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

This information is not applicable. The device is a surgical tool, not an AI system.

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

This information is not applicable. The device is a surgical cutting accessory, not an AI algorithm.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI or diagnostic device. For this type of device (surgical cutting accessory), the "ground truth" for performance is established through engineering and material science testing, ensuring the device meets predefined technical specifications for cutting efficacy, safety (e.g., temperature), and structural integrity. This is indicated by the mention of "all acceptance criteria were met for the performance testing."

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable. The device is a physical product, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a modified medical device. It focuses on demonstrating that the device's modifications do not alter its fundamental scientific technology or intended use and that its performance remains substantially equivalent to a predicate device through non-clinical performance testing. The questions regarding AI, expert ground truth, and training data are not relevant to this type of device submission.

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