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The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.

The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors.

The EasyDrill Autostop Cranial Perforator device is a bone cutting and drilling instrument used in conjunction with a surgical motor and a Hudson Chuck - speed reducer attachment, to drill access holes through a patient's skull. When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone.

The EasyDrill Autostop Cranial Perforator is a mechanically powered tool, designed to create an access hole through the skull. The subject Perforator device derives its mechanical torque and rotational speed from various legally marketed Electric and/or Pneumatic Drill Motors. The EasyDrill Autostop Cranial Perforator device is latched onto a Hudson Chuck device, which is in turn attached to the Drill Motors.

The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.

This document is a 510(k) summary for the EasyDrill Autostop Cranial Perforator. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a structured study validating those criteria. Therefore, several requested points, particularly those related to AI algorithm performance (such as MRMC studies, standalone AI performance, sample sizes for training/test sets as relevant to AI, and ground truth establishment methods typical for AI studies), cannot be fully addressed from the provided text.

However, I can extract the information relevant to the device's performance validation as described in the document.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of quantitative acceptance criteria. Instead, it describes performance testing aimed at demonstrating safety, effectiveness, and equivalence to predicate devices. The "reported device performance" is qualitative and focused on meeting intended use and safety standards.

2. Sample sized used for the test set and the data provenance:

• Cadaver Study: The document mentions "human cadaveric specimen - skull" (singular, implying one or more but not a large number specified). The exact sample size (number of cadavers or number of drilling sites) is not provided.
• Bench Top Testing: The study was performed "in a Bovine Scapula" (singular, implying one or more but not a large number specified). The exact number of bovine scapulae or test instances is not provided.
• Endotoxin Testing: The sample size for endotoxin testing is not specified, but it refers to "subject EasyDrill Autostop Cranial Perforator devices."
• Data Provenance: Not explicitly stated, but the cadaver and bovine scapula tests would be prospective experimental data generated specifically for this submission. The country of origin for the data is not mentioned.

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

This information is not provided in the document. The studies described are performance tests of a mechanical device, not diagnostic studies requiring expert interpretation for ground truth.

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

This information is not applicable and therefore not provided. The studies described are performance tests of a mechanical device, not diagnostic studies requiring adjudication of output.

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 device is a mechanical cranial perforator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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 device is a mechanical cranial perforator, not an algorithm.

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

For the Cadaver and Bench Top studies, the "ground truth" implicitly was the functional performance observed (e.g., successful perforation, automatic disengagement, lack of adverse events such as plunging, comparison to predicate performance). For Endotoxin testing, the ground truth was the analytical result against the specified limit. These are direct measurements of physical or biological properties, not ground truth established from expert consensus or pathology in the context of diagnostic performance.

8. The sample size for the training set:

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm.

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