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• 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
• 2. Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• 3. A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus.
• 4. Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.

The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

This document describes an FDA 510(k) premarket notification for a medical device, specifically a Tympanostomy Tube. The submission aims to demonstrate "substantial equivalence" to previously cleared devices rather than providing clinical performance data with acceptance criteria for a new AI application.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable to this document.

This document focuses on:

• Device: Grace Medical, Inc. ETFE Tympanostomy Tube (K232059)
• Predicate Devices: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228)
• Primary Change: Material change from PTFE to ETFE for the Grace Medical device.
• Demonstration of Substantial Equivalence: By comparing technological characteristics, indications for use, and presenting non-clinical bench testing, biocompatibility, sterility, and packaging testing data.

There is no mention of an AI component or software in this document.

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When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.

The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:

• Chronic otitis media with effusion characterized as serous, mucoid, or purulent
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
• A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
• Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Medtronic® Xomed® Ventilation (tympanostomy) Tubes are small tubular implants available in a variety of biocompatible materials including silicone elastomer, fluoroplastic. C-FLEX® TPE. stainless steel and titanium. Numerous designs and sizes are available with single or multiple flanges to satisfy various surgical techniques for insertion and to facilitate short or long-term communication of the auditory canal with the middle ear. Some tubes are fitted with semi-permeable membranes intended to allow free passage of air while preventing movement of fluids into the middle ear.

The provided text describes a 510(k) premarket notification for "Ventilation (Tympanostomy) Tubes" by Medtronic Xomed, Inc. This submission is for consolidating previously cleared and preamendment ventilation tubes and claims substantial equivalence to predicate devices. As such, it does not contain information about a study to prove acceptance criteria for a new device or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document. This submission relies on the existing clearance and established performance of the predicate devices.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This submission is for devices that have already been cleared or were preamendment devices, meaning their performance and safety were established previously. No new performance acceptance criteria or study results are presented in this document. The document asserts "same" for all comparative characteristics with existing predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No new test set or data provenance is mentioned as no new performance testing was conducted for this 510(k). The document states, "The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No test set or ground truth establishment relevant to the performance of a new device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or related adjudication method is mentioned.

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 is not an AI device, and no MRMC study was conducted or referenced for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No new ground truth for performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/algorithm device and thus has no training set.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/algorithm device and thus has no training set or associated ground truth establishment.

Summary of Relevant Information from the Document:

The document focuses on demonstrating substantial equivalence to existing predicate devices. The key argument is that the proposed Ventilation (Tympanostomy) Tubes are identical in intended use, indications for use, technological characteristics, and principle of operation to 12 previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be meeting the characteristics of the predicate devices, thereby establishing substantial equivalence. The reported "performance" is implicitly that these devices function identically to the legally marketed predicates.

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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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