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The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.

The provided text describes a 510(k) premarket notification for a surgical drill system. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a study with quantifiable performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

However, I can provide information based on the typical content of a 510(k) summary regarding performance claims and testing.

Here's an analysis of the provided information relative to your request:

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

This document does not provide a table of acceptance criteria with corresponding performance metrics in the way one might expect for an AI/CAD diagnostic device. The "performance" described is largely functional and safety-based, focused on equivalence to predicate devices and suitability for expanded indications.

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

• Test Set (Cadaveric Testing): The document mentions "Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers." However, the specific sample size of cadavers used is not provided.
• Data Provenance: Not specified, but likely from a laboratory or clinical setting where cadaveric studies are conducted. It would be considered prospective for the purposes of evaluating the device for expanded indications.

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)

• The document states "Users evaluated the acceptability...". The number and specific qualifications of these "users" (likely surgeons or medical professionals) are not provided. Their role was to evaluate the acceptability of the drill system, which serves as the "ground truth" for its functional performance in a surgical simulation.

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

• The document does not describe a formal adjudication method (like 2+1 or 3+1) for the cadaveric testing. The phrase "Users evaluated the acceptability" suggests a direct evaluation by the involved parties, but no specific adjudication process is detailed.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a surgical drill system, which does not involve "human readers" in the context of image interpretation.

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

• No, a standalone AI algorithm performance study was not done. This device is a physical surgical instrument, not an AI algorithm. Its performance is intrinsically linked to human-in-the-loop operation by a surgeon.

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

• For the cadaveric testing: The "ground truth" was established by the evaluation and assessment of the surgical performance and acceptability by the "users" (presumably surgeons) during simulated surgical procedures on cadavers. This would fall under a form of expert assessment/consensus regarding functional performance and safety.
• For the clinical literature review: The "ground truth" was based on existing published clinical evidence regarding the safe and effective use of drill systems.

8. The sample size for the training set

• Not applicable. This document describes a physical surgical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a physical surgical device and its suitability for expanded indications through functional testing and literature review, rather than quantifiable performance metrics typical of AI or diagnostic devices. Therefore, many of the specific questions about AI study design and ground truth establishment for AI models are not relevant to this document.

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