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K Number
K974007
Device Name
SHAH PERMAVENT
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1997-12-12

(52 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

In the treatment of:

  • otitis media with effusion (glue ear)
  • eustachian tube dysfunction
  • other condition requiring ventilation of the middle ear cleft, e.g. retraction pockets in the tympanic membrane, adhesive otitis media, where long-term ventilation is indicated.
Device Description

A middle ear ventilation tube, fabricated in silicone rubber and featuring a single, circular, bevelled flange.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and the study description as requested. The document is a 510(k) Pre-Market Notification Summary for a medical device (Shah Permavent Tympanostomy Tube) and an FDA clearance letter.

While it specifies the device's intended use and compares it to predicate devices, it does not include any performance data, acceptance criteria, details of a study with sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory equivalence rather than a clinical or performance study report.

Therefore, I cannot extract the following information from the provided text:

  • A table of acceptance criteria and reported device performance.
  • Sample size for the test set or data provenance.
  • Number of experts or their qualifications for ground truth.
  • Adjudication method for the test set.
  • Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Whether a standalone (algorithm only) performance study was done.
  • The type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.