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K Number
K983348
Device Name
DYNAREX TRACHEOSTOMY SPONGE
Manufacturer
DYNAREX CORP.
Date Cleared
1998-12-11

(79 days)

Product Code
EFQ,EFO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.

Device Description

Tracheostomy Sponge

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Dynarex Tracheostomy Sponge." This type of document does not typically contain the detailed information necessary to answer your questions about acceptance criteria and a study proving a device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical performance data in the way a PMA (Premarket Approval) would require.

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

  1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the tracheostomy sponge, nor does it provide a table of reported performance. Its purpose is to state that the device is substantially equivalent to existing ones.
  2. Sample size used for the test set and the data provenance: Not applicable, as a clinical study with a test set is not described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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 physical medical dressing, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document only states the device's Indications for Use: "A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids." The FDA's determination is based on the device being "substantially equivalent" to predicate devices already on the market, implying that it performs similarly for these stated indications.

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