Search Results

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.

The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the Solo+ Tympanostomy Tube Device (TTD) and its substantial equivalence determination. However, it does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance, as typically seen in submissions for AI-powered devices. The device described, the Solo+ TTD, is a physical medical device for placing tympanostomy tubes, not an AI/software device.

Therefore, many of the requested points in your prompt are not applicable to the provided document. I can, however, extract the relevant information regarding the clinical study performed to demonstrate the device's safety and effectiveness compared to a predicate device.

Here's the closest possible answer based on the provided text, focusing on the clinical study conducted for the physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The study conducted for the Solo+ Tympanostomy Tube Device (TTD) was a multi-site clinical study designed to demonstrate substantial equivalence to its predicate device, the Preceptis Hummingbird TTS, for in-office tympanostomy procedures in pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the "acceptance criteria" (though not explicitly labeled as such, these are the primary outcomes measured for comparison of substantial equivalence) as clinical outcomes compared between the Solo+ TTD and the predicate device.

2. Sample Size and Data Provenance:

• Test Set Sample Size: A total of 20 patients (40 ears).
• Data Provenance: Conducted in a multi-site study across 2 sites. The country of origin is not explicitly stated, but the applicant company is based in Ireland. The study was a clinical study, implying a prospective design for the purpose of demonstrating substantial equivalence.

3. Number of Experts and Qualifications: Not applicable. This was a clinical study involving patients and the mechanical placement of a device, not an AI/image-based diagnosis requiring expert readers for ground truth establishment.

4. Adjudication Method: Not applicable. (See #3)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was not a study evaluating human reader performance with or without AI assistance but rather the performance of a physical surgical device.

6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used: The "ground truth" for this study was the observed clinical outcome of the tympanostomy tube placement (i.e., whether the tube was successfully placed and if additional instruments were needed). This is essentially outcomes data directly observed during the procedure and initial follow-up.

8. Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established: Not applicable. (See #8)

Ask a specific question about this device

• 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.

Ask a specific question about this device