(127 days)
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- · Scaling applications, including:
- · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts.
This is a 510(k) premarket notification for a medical device (Piezosurgery Touch), not a study report. Therefore, much of the requested information about device performance and ground truth establishment from a study is not present in this document.
However, I can extract information related to the device name, classification, and intended use.
Here's a breakdown of what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
This document describes a premarket notification for a medical device, not a performance study result. Acceptance criteria and reported device performance from a clinical study are not provided. The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the regulatory acceptance criteria for 510(k) clearance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This document is a regulatory approval notice, not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This document is a regulatory approval notice, not a study report.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This document is a regulatory approval notice, not a study report.
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. This device is a bone cutting instrument and ultrasonic scaler, not an AI-powered diagnostic device that would involve human readers for comparative effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document is a regulatory approval notice, not a study report. The "ground truth" for 510(k) clearance is substantial equivalence to a predicate device, which is based on similar technological characteristics and intended use, not necessarily comparison to a 'ground truth' in a clinical study sense.
8. The sample size for the training set
Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.
§ 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.