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K Number
K100647
Device Name
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
Manufacturer
A-DEC, INC.
Date Cleared
2010-07-09

(123 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is intended for use in dental treatment procedures. The pneumatically operated sonic device can be used, in conjunction with the appropriate tips, for the removal of supra and subgingival calculus, and teeth cleaning procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding a dental device. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML performance study would.

The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not on specific performance metrics or a detailed clinical study demonstrating new or improved efficacy against defined acceptance criteria.

Therefore, I cannot provide the requested information from this document:

  1. A table of acceptance criteria and the reported device performance: Not present. This document is about regulatory clearance based on substantial equivalence, not performance against specific criteria.
  2. Sample size used for the test set and the data provenance: Not present. No clinical or performance study with a test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  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 present. This device is a sonic scaler handpiece, not an AI-powered diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a physical dental instrument.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

The document's purpose is to confirm that the A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is "substantially equivalent" to existing devices, allowing it to be marketed. It refers to general controls, registration, labeling, and good manufacturing practices but does not include data from a performance study.

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.