(71 days)
The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull.
The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.
The Bioplate® Battery Powered Drill is comprised of a metal housing, containing the motor, designed to withstand steam sterilization. Two forward speeds are activated using control buttons on the body of the unit. There is no reverse. The operating portion of the instrument has a quick release mechanism that is designed to hold stainless steel drill bits for drilling pilot holes into bony tissue prior to insertion of self-tapping bone screws. Four (4) AAA batteries (sterile, unitized or non-sterile) are inserted into the back portion of the handle prior to use.
This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2002. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt.
The document primarily focuses on establishing "substantial equivalence" of the Bioplate® Battery Powered Drill to existing predicate devices. This type of regulatory submission in 2002 generally relies on comparing the new device's technical characteristics and intended use to already legally marketed devices, rather than presenting a standalone clinical study with detailed performance metrics and acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set or how ground truth for a training set was established.
The "Summary of Safety and Effectiveness" section within the 510(k) summary for this type of device typically just states that the device is substantially equivalent to predicates and that any minor differences raise no new issues of safety and effectiveness, based on comparison of technical specifications rather than clinical trial data meeting predefined acceptance criteria.
§ 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).