(274 days)
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.
| Acceptance Criteria (Inferred from Non-Clinical Tests and Clinical Review) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Non-cytotoxic | Device found to be non-cytotoxic |
| Non-sensitizing | Device found to be non-sensitizing |
| Non-irritating | Device found to be non-irritating |
| Prosthesis closes and seals when placed and adjusted (snug fit) | Met all performance characteristics |
| Stem does not tear or break when placed and adjusted | Met all performance characteristics |
| Locking loop functions as designed to prevent loss of proper fit | Met all performance characteristics |
| Sterility (SAL of 10^-6 at 25 kGy) for Prosthesis | All samples passed sterility |
| Sterility (SAL of 10^-6 at 25 kGy) for Catheter | All samples passed sterility |
| 1-year and 3-year shelf life (burst, dye migration, label integrity) | Product passed acceptance criteria after 1-year and 3-year accelerated aging |
| Catheter 1-year and 3-year shelf life (no deterioration/damage) | Met acceptance criteria |
| Catheter dimensional inspection within tolerance | All samples passed |
| Catheter eyelet ultimate tensile strength (≥ 2.0 pounds) | All samples met requirement |
| Catheter eyelet to beaded stem placement tensile strength (≥ 0.5 pounds) | All samples met requirement |
| Catheter eyelet to beaded stem removal tensile strength (≥ 0.5 pounds) | All samples met requirement |
| Clinical Performance (Retrospective Review) | |
| Control or elimination of salivary leakage | 21 out of 25 (84%) patients reported control/elimination |
| No serious adverse events | Absence of any serious adverse events reported |
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.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.