(205 days)
The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.
The device under review is a family of cranial drill bits and accessories. These cranial drill bits and accessories are applied to create a hole through the skull in support of neurological procedures. Cranial drill bits are twist drill bits used for drilling holes in the skull, supporting access to the brain for brain biopsy, brain contacting electrode placement, electrode accessory placement such as Anchor Bolts or other needs as determined by the user. The cranial drill bit variations are 16 cm to 30 cm length and 2.4 mm to 3.2 mm outer diameter. Accessories to the cranial drill bits include: Drill Stop, Drill Stop Wrench, Drill Sleeve Guide, Guide Block.
The provided document is a 510(k) summary for Ad-Tech Medical Instrument Corporation's Cranial Drill Bits and Accessories. It outlines the device's indications for use, technological characteristics, and performance tests for demonstrating substantial equivalence to predicate devices. This document does not pertain to an AI/ML powered medical device, an autonomous AI device, or other medical device software. Therefore, the questions regarding acceptance criteria and studies for AI-powered devices are not applicable.
Here's an analysis of the provided information, addressing the closest relevant aspects:
Acceptance Criteria and Device Performance for (Non-AI) Cranial Drill Bits and Accessories
The acceptance criteria are not explicitly titled as "acceptance criteria" but are embedded within the "Summary of Requirement" for the performance tests conducted. The device performance is reported as "Pass" for all listed tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Summary of Requirement) | Reported Device Performance |
|---|---|
| Drill through simulated skull material in |
§ 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).