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The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short term medical device, normally intended for continuous use for not more than 29 days. It needs periodic replacement.

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is a bi-flanged silicone device connected with a stretchable (elastomeric) beaded stem. Both flanges are the same diameter for a given size device. The inner flange is flexible enough to allow folding for trans-fistula insertion by a trained physician. The device is fabricated from implant grade silicone. The product will be offered in three sizes: 25mm, 38mm and 50mm. The size is the outside diameter of the sealing flange size options allow the device to accommodate the size of the fistula in the tissue. The three (3) sizes offered are to close fistulas of size between approximately 6 mm diameter and 25 mm diameter, and tissue thickness from approximately 1.5mm to 25mm. The flanges, which are flexible, allow the device to conform to the contours of the tissue at the site yet minimize leakage. The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter is supplied as an accessory to insert or remove the 25 mm and 38 mm Blom-Singer ® Adjustable Bi-Flanged Fistula Prostheses.

The provided text describes the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis, a Class I medical device for managing hypopharyngeal fistulae. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on non-clinical testing and a retrospective clinical review.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it details various non-clinical tests with their outcomes. For the clinical aspect, it reports on the efficacy and safety observed in a retrospective case review.

2. Sample Size Used for the Test Set and Data Provenance

The primary "test set" for clinical performance was a retrospective review of existing cases.

• Sample Size: 25 patients.
• Data Provenance: Retrospective review from ten (10) institutions. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the data is likely from the U.S. or North America.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not specify the number of experts or their qualifications used to establish the "ground truth" for the retrospective clinical cases. The review relies on clinical outcomes reported from the institutions that treated the patients with custom-fabricated devices. It states that the custom devices were "technologically similar" to the proposed device.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the retrospective clinical review. It appears to be a summary of reported outcomes from the treating institutions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a retrospective review of clinical cases using a technologically similar device. There is no mention of comparing human readers' performance with and without AI assistance. This device is a physical medical prosthesis, not an AI-powered diagnostic tool.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical prosthesis, not an algorithm or AI system. The design verification testing could be considered a "standalone" evaluation of the physical device's performance characteristics.

7. The Type of Ground Truth Used

For the non-clinical tests (cytotoxicity, sensitization, irritation, performance characteristics, sterility, shelf-life), the "ground truth" was established by accepted industry standards and laboratory testing protocols (e.g., ISO 10993-1:2009 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterilization, physical testing for mechanical properties and shelf life).

For the retrospective clinical review, the "ground truth" was based on reported clinical outcomes from the treating institutions regarding salivary leakage control/elimination and the absence of serious adverse events. This essentially relies on the clinical judgment and patient follow-up records from the physicians involved in those cases.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI. All clinical data presented is from a retrospective "test set" used to demonstrate safety and effectiveness for substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific "training set" referenced for an algorithm. The custom-fabricated devices used in the retrospective review could be loosely considered analogous to "training data" in the sense that they provided prior clinical experience for the design of the Blom-Singer® device. However, this is not a formal training set with established ground truth for an AI model.

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