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The Grace Medical PC Coated Tympanostomy Tubes have primary intended use as the predicate devices - A device that is intended to be implanted for ventilation or drainage of the middle ear.
Indications for Use 1)
(a) Chronic otitis media with effusion (serous, mucoid, or purulent).
(b) Recurrent episodes of acute otitis media despite conventional medical treatment.
(c) A record of persistent high negative middle ear pressure associated with one or more of the following svmptoms:
(i) Conductive hearing loss that is symptomatic.
(ii) Persistent or recurrent otalgia.
(iii) Persistent or recurrent vertigo, tinnitus, or both.
(d) Retraction pocket of the tympanic membrane.

The Grace Medical PC Coated Tympanostomy Tubes are manufactured from medical grade silicone. Each tube is coated with a layer of PC1036 phosphorylcholine. Various designs of tubes are available to meet physician preference. The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation.

The provided text is a 510(k) summary for Grace Medical PC Coated Tympanostomy Tubes. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report or a technical performance assessment in the way one might evaluate an AI/ML device.

Therefore, most of the requested information (acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this type of regulatory submission because it is not required for a 510(k) for a physical medical device like tympanostomy tubes.

A 510(k) for such a device focuses on demonstrating substantial equivalence in terms of intended use, materials, design, and performance characteristics (often bench testing, biocompatibility, sterilization, etc.) compared to existing devices. Clinical efficacy studies and detailed performance metrics, as would be expected for a diagnostic AI algorithm, are typically not part of these submissions unless there's a significant change in the device's fundamental technology or intended use that warrants new clinical evidence.

The relevant information that can be extracted or inferred from this document is:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria for a "device performance" in the sense of an algorithm's output. Instead, it describes the characteristics and intended use of the Grace Medical PC Coated Tympanostomy Tubes and compares them to predicate devices to demonstrate substantial equivalence.

2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML device or a study involving a "test set" in that context. The "test" here refers to the overall regulatory review for substantial equivalence, not a clinical trial or algorithm validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a medical device (tympanostomy tube), not a diagnostic algorithm requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) 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.

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 consensus, 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.

Study/Evidence that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" or evidence provided is primarily a comparison to predicate devices and reference to in vitro testing for the coating characteristic:

• Predicate Device Comparison: The core of the 510(k) submission is to demonstrate that the Grace Medical PC Coated Tympanostomy Tubes are "substantially equivalent" to legally marketed predicate devices:

  • Grace Medical, Inc. silicone tympanostomy tubes (K943325 & K981575)
  • PC Coated Tympanostomy Tubes (Pacific™) (K000801) marketed by Gyrus ENT
    This comparison is made across intended use, material, coating characteristics, and shipping method. The key argument is that any differences (specifically the PC1036 coating on a silicone tube) "should not affect the safety or effectiveness."

• In Vitro Testing for Coating: To support the claim of the coating's beneficial characteristic, the document explicitly states: "The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation." It cites one reference:

  • Berry JA, et.al.: In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngology Head and Neck Surgery. 2000 Sep;123(3):246-51.

The FDA's decision letter (K062672) indicates that they reviewed the premarket notification and "determined the device is substantially equivalent... to legally marketed predicate devices." This FDA determination serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under a 510(k) pathway.

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