(82 days)
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:
| Characteristic | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Sodem High Speed System) |
|---|---|---|
| Intended Use | Orthopedics and general plastic surgery (drilling, cutting, sculpting hard tissue and bone) | Orthopedics and general plastic surgery (drilling, cutting, sculpting hard tissue and bone) |
| Patient Contact Materials | Surgical stainless steel | Surgical stainless steel |
| Sterility Status | Non-sterile (except burs/drills), steam sterilizable after reprocessing | Non-sterile (except burs/drills), steam sterilizable after reprocessing |
| Console Connection | Multiple connections for various hand pieces/motors | Two specific connections (one for High Speed Motor, one for Skull Perforator Motor) |
| Accessories | Wide variety (chuck, adapters, spindles, burs), identical or similar technical characteristics | Wide variety (spindles, burs), identical or similar technical characteristics |
| Angled Nose Piece | Linvatec: integral angling capability; Stryker: angled nose | Angled nose |
| Electrical Power Source | Electrical power source controlled by foot pedal | Electrical power source controlled by foot pedal |
| Max Drill Speed (RPM) | Linvatec E9000/Advantage: 0-80,000 rpm; Stryker TPS: 0-75,000 rpm | Adjustable from 0-80,000 rpm |
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.
§ 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).