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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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Conditions for which tympanostomy tubes are indicated include: Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent otitis media that fails to respond to conventional medical treatment A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. Retraction pocket of the tympanic membrane.

The Tympanostomy Tube is a silicone tube that is intended to provide ventilation and/or drainage to the middle ear. The Tympanostomy Tube is available in two types: Donaldson and Paparella.

"The provided text contains a 510(k) summary for a Tympanostomy Tube and a letter from the FDA confirming its substantial equivalence. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the format requested. The document states broadly that ""The Tympanostomy Tube met all performance acceptance criteria.""

To answer your request, I will extract relevant information, but please note that some points you asked for, such as the sample size for test and training sets, the number and qualifications of experts, adjudication methods, MRMC study details, and specific ground truth mechanisms, are not explicitly present in the provided text for a performance study. The submission appears to rely on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria and outcome metrics for the new device.

Here's the information based on the provided text, with explicit notes where information is missing:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not specified. The document states "relevant tests" were conducted, but details on the nature or sample size of these tests are not provided.
   • Data Provenance: Not specified.

2. 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):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

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

   • Not specified.

4. 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:

   • No MRMC or AI-assisted study is mentioned. This device is a physical medical device (Tympanostomy Tube), not an AI diagnostic tool.

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

   • Not applicable. This is a physical medical device.

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

   • Not explicitly stated for specific performance acceptance criteria. The basis for safety and effectiveness appears to be substantial equivalence to predicate devices through "relevant tests," which would likely compare physical and material characteristics, and possibly functional performance against established standards for tympanostomy tubes.

7. The sample size for the training set:

   • Not applicable/Not specified. This is a physical medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

Summary of the study mentioned (or lack thereof):

The document is a 510(k) premarket notification for a Tympanostomy Tube. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed performance study data in the way one might for a novel diagnostic or AI device. The document explicitly states: "The Tympanostomy Tube met all performance acceptance criteria" and "The Tympanostomy Tube is substantially equivalent to the predicate devices as confirmed through relevant tests."

Therefore, the "study" referred to is likely a set of engineering and bench tests designed to ensure the new device meets the same performance characteristics and safety profile as the predicate devices. These tests would typically cover aspects like material biocompatibility, structural integrity, dimensions, and possibly flow rates or insertion characteristics, rather than diagnostic accuracy or human reader performance. Specific details of these "relevant tests," their methodologies, sample sizes, and expert involvement are not included in this summary document."

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Indications for insertion of a tympanostomy tube into an incision in the tympanic membrane include any of the following:

• . Chronic otitis media with effusion characterized as either 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 that is symptomatic, persistant or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus
• . Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Tympanostomy Tube

The provided text describes a 510(k) premarket notification for a Tympanostomy Tube. However, the document is a regulatory approval letter and an enclosure listing different tympanostomy tube models with their inner diameters. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device