(334 days)
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
Biomet Microfixation Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
The subject submission seeks to add the 2.1 x 255mm Drill, 22mm Stop to the Lorenz Twist Drills family to be used in neurosurgical procedures.
2.1 x 255mm Drill, 22mm Stop manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterile, to be sterilized by the end-user prior to use.
This document is a 510(k) summary for a medical device (a drill for neurosurgical procedures), not a study report for an AI/ML powered medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or ground truth establishment for an AI/ML system.
The document focuses on demonstrating substantial equivalence of a new physical drill (2.1 x 255mm Drill, 22mm Stop) to an existing predicate device (Walter Lorenz Surgical, Inc; Lorenz Twist Drills - K062842). This is done through:
- Comparison of Indications for Use, Technological Characteristics, and Material: The document explicitly states that the subject and predicate devices are similar in these aspects.
- Performance Testing: Mechanical tests (Static Cantilever Bend Testing, Static Torsion Testing, and Lifecycle testing) were performed on the subject drill. The conclusion states that "the results have shown them to be substantially equivalent to the predicate device."
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, details of a study involving human readers, or ground truth establishment based on this document.
The document describes a traditional medical device submission, not an AI/ML one.
§ 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).