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K Number
K992269
Device Name
VENTIL-A ORAL PROTECTOR
Manufacturer
SOMATICS, INC.
Date Cleared
1999-10-25

(111 days)

Product Code
JXL
Regulation Number
882.5070
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, or for protection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Ventil-A," an oral protector. The letter indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain specific information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot provide the requested information, which includes:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone (algorithm only) performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a performance study report.

§ 882.5070 Bite block.

(a)
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.(b)
Classification. Class II (performance standards).