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The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:

• 14mm (blue ABS sleeve) – product number: 26-1221
• 11mm (green ABS sleeve) product number: 26-1222 ●
• 9mm (yellow ABS sleeve) product number: 26-1223 ●

This document describes a 510(k) premarket notification for "Codman Disposable Perforators," which are medical devices used to perforate the cranium. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

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

The document mentions a "full dose mapping study" but does not explicitly state the sample size used for this study. The data provenance is not specified, but given it's a regulatory submission for a medical device manufacturer (Integra LifeSciences Corp. in Mansfield, MA, USA), it's highly likely to be prospective data generated internally for the purpose of this submission.

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 is not applicable to this type of submission. The "ground truth" here is the adherence to sterilization standards (ISO 11137-1) for a physical device. Expert clinical or image-based review is not part of this evaluation. The expertise would lie in sterilization validation specialists who conducted and analyzed the dose mapping study.

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

Not applicable. This is a technical validation of a manufacturing process (sterilization), not a subjective assessment requiring adjudication. The study results are objectively measured against established standards.

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 submission is for a disposable perforator, a physical surgical tool. It does not involve AI, image analysis, or human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the dose mapping study is the regulatory standard for sterilization (ISO 11137-1), which defines requirements for achieving a Sterility Assurance Level (SAL) of 10^-6. The study aimed to demonstrate that the new gamma radiation sterilization cycle meets this standard and achieves the required dose uniformity.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set. The "training" in the context of device manufacturing refers to process validation.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the overall device's safety and effectiveness relies on its previous 510(k) clearances and the demonstration that the only change (the sterilization cycle) does not compromise those established safety and effectiveness parameters, as verified by adherence to international sterilization standards.

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