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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 Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone (knee, ankle, hand, foot, facial and maxillary bones) for orthopedics and general plastic surgery.

Motor, attachments and cutting tools are for use in general orthopedics and general plastic surgery.

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

• two motors (a Skull Perforator motor* and a High Speed motor), -
• a foot pedal, -
• a console allowing to connect the motors and to select their max. operating speed, -
• dedicated wires to connect the motors, the foot pedal and the console, -
• attachments/spindles, -
• drills, burs and cutters -

• This 510(k) doesn't deal with the skull perforator motor because we have submitted a separate 510(k) for neuro/spine applications.

The motor is to be attached to the Sodem High Speed console and is operated with a foot pedal.

The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.

The provided text describes a 510(k) submission for the Sodem High Speed System (Electric), focusing on its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy or performance study (e.g., clinical trials, algorithm performance testing). Instead, the submission argues for substantial equivalence based on comparisons of intended use, materials, sterility status, system description (console, accessories, electrical power), and speed.

Therefore, a table of acceptance criteria and reported device performance or details of a study structured around those criteria cannot be directly extracted from this document, as the document's purpose is to demonstrate equivalence rather than report on a performance study against specific acceptance metrics.

However, I can extract the information that is present according to your numbered list, acknowledging that many points will be stated as "Not applicable" or "Not provided" given the nature of a 510(k) summary for a high-speed surgical system based on equivalence.

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

This document does not present a table of acceptance criteria and reported device performance for a study in the context of efficacy or clinical outcomes. Instead, it compares the Sodem High Speed System (Electric) to predicate devices based on various technical and operational characteristics to establish substantial equivalence.

The "performance" is demonstrated by showing that the device's technical specifications are comparable to predicate devices. For example:

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

Not applicable. The document describes a 510(k) submission based on substantial equivalence to predicate devices, not an independent performance study with a test set of data. No data provenance or sample size for a test set is provided.

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)

Not applicable. This document is a regulatory submission for device clearance, not a study evaluating human performance or diagnostic accuracy where expert ground truth would be established.

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

Not applicable. No test set or expert adjudication is 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

Not applicable. This document pertains to a high-speed surgical system, not an AI-assisted diagnostic or interpretive device. No MRMC study, human reader improvement, or AI assistance is mentioned.

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

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

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

Not applicable. The concept of "ground truth" as used in diagnostic or AI studies is not relevant to this 510(k) submission for a surgical instrument. The "truth" in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. This document does not describe the development of an algorithm using a training set.

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

Not applicable. This document does not describe the development of an algorithm using a training set or its associated ground truth.

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The Sodem High Speed motor allows the fixation of spindles and craniotomes, which opcrate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones.

The Sodom High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodcm, but is available on the market from other manufacturers.

Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.

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

• two motors (a Skull Perforator motor and a High Speed motor), -
• a foot pedal, -
• a console allowing to connect the motors and to select their max. operating speed, -
• dedicated wires to connect the motors, the foot pedal and the console -
• attachments/spindles and craniotomes -
• drills, burs and cutters -

The motors are to be attached to the Sodem High Speed console and are operated with a foot pedal.

The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.

The provided document is a 510(k) premarket notification for a medical device, the Sodem High Speed System (Electric). It focuses on establishing substantial equivalence to predicate devices already on the market, rather than delineating specific acceptance criteria and detailed study results to prove device performance against those criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this document.

Here is a summary of what can be gleaned from the document regarding the device's characteristics and the basis for its clearance:

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

The document does not provide a table of acceptance criteria with specific numerical performance targets (e.g., accuracy, precision, speed, torque) or a comparison of the device's measured performance against such targets.

Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices. The performance characteristics of the Sodem High Speed System (Electric) are described in comparison to the predicates in terms of:

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

The document does not describe a specific "test set" or data provenance in the context of a performance study with patient data or human subjects. The basis for substantial equivalence is a comparison of technical specifications and intended use against existing cleared devices, not a clinical trial with a test set.

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)

Not applicable. As noted above, there was no "test set" requiring ground truth established by experts in the context of this 510(k) submission.

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

Not applicable. No test set was used for this type of performance 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 or therapeutic device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This device is a physical surgical tool, not an algorithm.

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

Not applicable. Ground truth as typically understood for diagnostic or AI devices is not relevant to this submission. The "truth" for substantial equivalence lies in the established safety and efficacy of the predicate devices based on their specifications and market history.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable for the same reason as above.

In summary: This 510(k) submission is for a traditional medical device (a surgical drill) and relies on demonstrating substantial equivalence to predicate devices. It does not involve the type of acceptance criteria, performance studies, test/training sets, or expert evaluations that would be typical for more complex diagnostic or AI-powered devices. The "study" that proves the device meets the (implied) acceptance criteria is the comparison of its design, materials, intended use, and technical specifications with already legally marketed devices. The FDA's clearance letter confirms that this comparison was deemed sufficient to establish substantial equivalence.

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The Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for ear, nose and throat surgery.

Motor, attachments and cutting tools are for use in ear, nose and throat surgery.

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

• two motors (a Skull Perforator motor* and a High Speed motor), -
• a foot pedal, -
• a console allowing to connect the motors and to select their max. operating speed, -
• dedicated wires to connect the motors, the foot pedal and the console, -
• ー. attachments/spindles,
• drills, burs and cutters -

• A separate 510(k) Premarket Notification has been submitted for neurolspine surgery, so on this 510(k) submission, we will cover only the High Speed Motor and its use in ear, nose and throat surgery.

The motor is to be attached to the Sodem High Speed console and is operated with a foot pedal.

The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.

The Sodem High Speed System (Electric) is very similar in terms of use and technological characteristics to products currently on the market (TPS from Stryker and E9000 / Advantage from Linvatec).

Also, the Sodem High Speed System (Electric) is equivalent in terms of use with the Sodem High Speed System (Pneumatic) already submitted (K954717).

The provided text is a 510(k) Summary for the Sodem High Speed System (Electric) and a subsequent FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, efficacy studies, or specific performance metrics demonstrating that the device meets acceptance criteria.

The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market (TPS from Stryker and E9000/Advantage from Linvatec). This means the manufacturer argued that their new device is as safe and effective as the existing devices, primarily by comparing their intended use, materials, sterility, system description (console, accessories), and electrical power characteristics.

Therefore, I cannot provide the requested information. The document explicitly states:

• No acceptance criteria are listed.
• No studies proving the device meets acceptance criteria are described.
• No sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or ground truth details are present.

The crucial comparison points for substantial equivalence are highlighted in section 6 and confirm similarities in:

• Intended use: Both Sodem and predicate devices are for ear, nose, and throat surgery for drilling, cutting, and sculpting hard tissue and bone.
• Materials: All patient contact materials are surgical stainless steel.
• Sterility Status: All are supplied non-sterile (except specific drills/burs with their own 510k) and require steam sterilization after use.
• System Description (Console, Accessories, Electrical Power):
  • Consoles connect motors and select speed, with similar functionalities.
  • Accessories like chucks, adapters, spindles, and burs are comparable.
  • The nominal power output is "identical or substantially equivalent."
  • The maximum drill speed is within a similar range (Sodem: 0-80,000 rpm; Linvatec: 0-80,000 rpm; Stryker: 0-75,000 rpm).

The manufacturer's conclusion is that "any differences between the Sodem High Speed System (Electric) and these other currently available powered systems are minor and raise no new issues of safety and effectiveness."

In summary, the provided text does not contain the information requested regarding acceptance criteria and performance study details because the clearance was based on substantial equivalence, not on specific performance data against predefined acceptance criteria for a new clinical efficacy claim.

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