(245 days)
The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc.
The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.
The provided text describes the regulatory clearance of a medical device, the ELAN 4 Electro Motor System, not an AI/ML powered device. As such, information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC) that would typically apply to AI/ML devices is not applicable or present in this document.
The document discusses "performance data" in the context of:
- Bench testing: In-house design verification to ensure mechanical and functional requirements, including design specifications, were met.
- Biocompatibility: Evaluation according to ISO-10993.
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and UL 2601-1 standards for safety and IEC 60601-1-2 for EMC.
- Software Verification and Validation Testing: Conducted in accordance with FDA guidance for software in medical devices, with the software considered a "moderate" level of concern.
Summary of available information:
1. A table of acceptance criteria and the reported device performance:
| Test | Test Method Summary | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Ensuring the function between two service intervals for the ELAN 4 Electric Drill | Demonstrate functionality, performance characteristics, and the safety of the product based on the intended use within a service interval of one year. | All requirements to be met | Pass: All requirements met |
| Verification of the reactions times of the ELAN 4 Wireless Foot Control | Demonstrate the reaction time in the time between changing the logic level of the function and change in the button status byte. | All requirements to be met | Pass: All requirements met |
| Biocompatibility | Evaluation according to International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and FDA Guidance. | Compliance with ISO-10993 standards | Compliant based on material equivalence to predicate devices. |
| Electrical Safety and EMC (Control Unit, Wireless Foot Control, and Drill) | Testing conducted on the ELAN 4 Electro Motor System. | Compliance with IEC 60601-1, UL 2601-1, and IEC 60601-1-2. | Complies with the specified standards. |
| Software Verification and Validation Testing (ELAN 4 Software V3.00) | Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Documentation provided as recommended. | Documentation provided, software assessed as "moderate" level of concern. |
2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are primarily engineering and regulatory compliance tests, not studies involving datasets for AI/ML performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to established engineering specifications, regulatory standards, and functional requirements for the device.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).