(215 days)
The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).
The Surgical Straight/Angle Handpiece features an allowable maximum motor speed at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed with an angle appearance and a straight appearance. Models are available to be connected directly onto motors compliant to ISO 3964. All the devices are manufactured using stainless steel with some aluminum, and use a Bur Lock Ring Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight (1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S.
The provided text is a 510(k) summary for the "Nakanishi Inc. Surgical Straight/Angle Handpiece." This document describes a medical device seeking substantial equivalence to existing devices, not an AI/ML powered device. As such, it does not contain information related to acceptance criteria or studies involving AI/ML algorithms, human readers, ground truth, or training sets.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from the given text.
The document discusses:
- Device Name: Surgical Straight/Angle Handpiece
- Intended Use: Oral surgical and dental use (e.g., sectioning and removal of wisdom teeth, oral surgery, implant treatment).
- Technological Characteristics: Maximum motor speed, non-optic, Bur Lock Ring Chuck Design, materials (stainless steel, aluminum), external water supply.
- Performance Testing: Bench testing against technical standards and internal specifications, sterilization validation (AAMI/ANSI/ISO 17665-1:2006, FDA Guidance for Reprocessing Medical Devices), biocompatibility evaluation (AAMI/ANSI/ISO 10993-1, FDA Guidance), and electrical safety (ISO 14457).
- Conclusion: The device is considered substantially equivalent to predicate devices based on similarities in intended use, principles of operation, functional design, and established medical use.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.