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The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patien's skull. The system is intended for use in neurosurgery.

The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System. the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter. Sodem is not manufacturing "Cranial Perforator attachment". The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System. The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor). This safety device is functional so far the speed range is being respected. The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation.

This 510(k) summary (K993851) for the Sodem Perforator Drive does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on claiming substantial equivalence to predicate devices. Therefore, much of the requested information about a specific study and its methodology for meeting acceptance criteria cannot be extracted.

However, based on the provided text, we can infer some "acceptance criteria" through the basis of substantial equivalence:

Inferred Acceptance Criteria from Substantial Equivalence Claim:

Since no specific study is described in the provided text, the following information cannot be extracted:

1. Reported device performance: Not available as no study details are provided. The only performance metric mentioned is the power range (0-950), which is stated to be "comparable."
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: 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: Not applicable (this is a medical device, not an AI/imaging device with readers).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Explanation of the Document's Nature:

This document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). For this type of submission, extensive new clinical studies or performance testing against specific acceptance criteria with defined outcomes are often not required if substantial equivalence can be demonstrated through comparison to a predicate device already on the market. The core of this 510(k) is the claim of substantial equivalence based on shared fundamental characteristics (intended use, materials, sterility, power, operational principles) with existing predicate devices.

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