(134 days)
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.
| Feature/Acceptance Criteria (Predicate) | Reported Device Performance (Sodem High Speed System) |
|---|---|
| Used in ENT surgery | Yes |
| Pneumatic power source | Yes |
| Drill Function | Yes |
| Supplied non sterile (except burs) | Yes (except burs) |
| Recommended sterilization by steam | Yes |
| Patient contact materials: Principally surgical stainless steel | Yes (Surgical stainless steel and titanium (Ti 6-Al 4-V)) |
| Angled nose piece | Yes |
| Foot pedal | Yes |
| Spindles multiple length | Yes |
| Change burs without wrench | Yes |
| Change spindles without wrench | Yes |
| Motor speed (RPM) | 0-85'000 rpm |
| Rotation mode | Forward only |
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.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.