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The Sodem High Speed System includes a pneumatic motor which allows the fixation of spindles, adapters and attachments, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for different applications and surgeries.

The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery) applications.

The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) used to cut hard tissue or bone.

The Sodem High Speed System (Pneumatic) is a complete system including:

• a High Speed motor, -
• a foot pedal,
• dedicated hoses to connect the motors and the foot pedal, -
• adapters (angled adapter)
• attachments/spindles, (angled attachments, straight attachments standard and tapered, craniotomes)
• drills, burs and cutters

The Sodem High Speed System (Pneumatic) is a surgical instrument motor and accessories intended for use in Ear, Nose, and Throat (plastic reconstructive surgery) applications. It is designed to drill, cut, and sculpt hard tissue and bone.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices, specifically the Anspach Black Max/Micromax systems. The "reported device performance" in this context refers to the characteristics and specifications of the Sodem High Speed System Pneumatic) itself, which are compared against the predicate.

2. Sample size used for the test set and the data provenance

This submission is a 510(k) Pre-Market Notification based on substantial equivalence, not a clinical trial evaluating device performance with patient data. Therefore, there is no "test set" in the traditional sense (i.e., a set of patient cases or samples) for which data provenance or geographic origin would apply. The "test" consists of a comparison of the device's technical specifications and intended use against legally marketed predicate devices.

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

As this is a substantial equivalence submission, no external experts were used to establish ground truth for a test set in the way one would for evaluating diagnostic accuracy or clinical outcomes. The "ground truth" is established by the detailed technical specifications and intended uses of the predicate devices already cleared by the FDA. The FDA reviewers (Office of Device Evaluation, Center for Devices and Radiological Health) act as the authoritative body in determining if the comparison demonstrates substantial equivalence.

4. Adjudication method for the test set

Not applicable. There was no test set requiring expert adjudication. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation.

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 device is a powered surgical drill, not an AI-assisted diagnostic tool or imaging system. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" is the technical specifications, intended use, and performance characteristics of the legally marketed predicate devices (Anspach Black Max/Micromax System and others). The applicant compared their device's attributes against these established products to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/ML-driven device that requires a training set.

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

Not applicable. No training set was used.

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The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.

This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot ... ) applications.

The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic).

The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) and especially Drill Guide Attachment used to make holes in the bone with an adjustable depth.

The Sodem High Speed System (Pneumatic) is a complete system including:

• a High Speed motor, .
• . a foot pedal,
• dedicated hoses to connect the motor and the foot pedal, -
• adapters (angled adapter)
• Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes)
• drills, burs and cutters -

The Sodem High Speed System (Pneumatic) for use in Neurology applications is the same product as the Sodem High Speed System (Pneumatic) already submitted for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174) and currently submitted for ENT and Dental surgery. The difference is the addition of a new attachment PN 3105 DG : Drill Guide Attachment.

The provided text is a 510(k) premarket notification for a medical device, the "Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through a clinical trial or performance study with detailed metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not present in this document. The 510(k) process relies on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of intended use, technological characteristics, and materials.

Here's a breakdown of why each specific point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria for the Drill Guide Attachment in the way a clinical trial would. Its performance is implicitly deemed acceptable if it is substantially equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance: No test set or associated data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no "test set" and thus no ground truth established by experts within this document. The FDA reviews the submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or adjudication process described.
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 device is a surgical drill attachment, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No "ground truth" as typically defined in diagnostic studies is used here. The basis for acceptance is substantial equivalence to a predicate device in terms of intended use, materials, and technological characteristics.
8. The sample size for the training set: Not applicable, as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or required for this type of device submission.

In summary, the provided document demonstrates substantial equivalence, not performance against specific acceptance criteria through empirical study results. The "study" in this context is the FDA's review of the comparison between the new device and predicate devices.

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