(82 days)
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:
| Characteristic | Sodem High Speed System (Electric) | Predicate Devices (Stryker TPS, Linvatec E9000/Advantage) | Equivalence Justification/Performance Statement |
|---|---|---|---|
| Intended Use | Neurosurgery (cranio & spinal) | Same clinical applications and intended use (neurosurgery - spine and craniotomy) | Equivalent - "share the same clinical applications and intended used" |
| Materials | Surgical stainless steel | Patient contact materials consist of surgical stainless steel | Equivalent - "Patient contact materials for all systems consist of surgical stainless steel." |
| Sterility Status | Non-sterile (except burs/drills) | Supplied non-sterile (except burs/drills), requiring reprocessing. Sterilization by steam. | Equivalent - "All systems are supplied non-sterile...requiring reprocessing...Sterilization...using steam." |
| Console | Two specific connections | Multiple connections (e.g., Linvatec E9000 one for 14 hand pieces, Stryker TPS 3 for ~10 hand pieces) | Similar - All operated using electrical power console, allow motor selection, speed choice. Difference: Sodem has two specific connections, not interchangeable. (Considered minor difference) |
| Accessories | Chuck, adapters, spindles, burs | Wide variety of accessories: chuck, adapters, spindles, burs. Angled nose pieces (Stryker & Sodem), integral angling (Linvatec) | Similar - "All offer a wide variety of accessories..." "technical characteristics...identical or similar." "All hand pieces are designed with a terminal angle." |
| Electrical Power | Foot pedal controlled | Foot pedal controlled | Equivalent - "All cited systems are operated using an electrical power source controlled by a foot pedal." |
| Nominal Power Output | Identical or substantially equivalent | Commercially available electrical motors (Linvatec, Stryker) | Equivalent - "The nominal power output...is identical or substantially equivalent" |
| Max. Drill Speed (High Speed Motor) | Adjustable 0-80,000 rpm | Linvatec E9000/Advantage: 0-80,000 rpm; Stryker TPS: 0-75,000 rpm | Equivalent/Similar - Within comparable range of predicate devices. |
| Max. Drill Speed (Skull Perforator Motor) | Fixed 800 rpm | Linvatec: Fixed 800 rpm | Equivalent - "The skull perforator motors of Sodem and Linvatec have maximum and fixed speed of 800 rpm." |
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.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).