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510(k) Data Aggregation
(135 days)
The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.
The Blom-Singer Indwelling TEP Occluder is designed to provide fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. The Indwelling TEP Occluder has been modified from its predicate devices by the inclusion of the Indwelling Low Pressure Voice Prosthesis design, and is now available in 16 and 20 fr. Sizes. In addition, this device will be offered in a large esophageal flange version. This version will be identical except for an esophageal flange which is greater in diameter to deter leakage around the device in individuals with unique physiology. These devices are manufactured from medical grade silicone and are latex-free.
Here's an analysis of the provided text regarding the Blom-Singer® Indwelling TEP Occluder, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a medical device, the Blom-Singer® Indwelling TEP Occluder, and references "functional equivalency tests" that demonstrate its performance. However, it does not explicitly state specific quantifiable acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices by meeting their established performance characteristics.
The "reported device performance" is a qualitative statement of equivalency rather than measured individual performance metrics against predefined criteria.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Fistula Maintenance and Leakage Prevention: Device should maintain the TE puncture and prevent leakage of liquids from the esophagus into the trachea. | The device provides fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. Functional equivalency tests demonstrated the equivalency of device performance with the three designs (including predicate devices). |
| Pressure Decay: Performance regarding pressure decay should be equivalent to predicate devices. | Non-clinical tests, including Pressure Decay, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided). |
| Flange Retention Force: Performance regarding flange retention force should be equivalent to predicate devices. | Non-clinical tests, including Flange Retention Force, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided). |
| Gel Cap Insertion Method: The gel cap insertion system should facilitate placement effectively and be equivalent to predicate devices. | Non-clinical tests, including Gel cap Insertion method, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. The gel cap insertion system facilitates placement. (Specific performance values or equivalence margins are not provided). |
| Biocompatibility/Material Safety: Device should be made from safe, medical-grade materials. | Manufactured from medical grade silicone and are latex-free. Predicate devices are also manufactured from medical grade silicone and latex-free. |
2. Sample Sizes Used for the Test Set and Data Provenance
The text describes "non-clinical tests" (Pressure Decay, Flange Retention Force, and Gel Cap Insertion method).
- Sample Size: The document does not specify the sample sizes used for these non-clinical tests.
- Data Provenance: The document does not provide information on the country of origin of the data, nor does it specify if the data was retrospective or prospective. Given these are "non-clinical tests," they likely involved laboratory testing of the devices themselves rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not provided in the document. As the tests were non-clinical, they likely involved engineers or technicians conducting laboratory measurements, rather than clinical experts establishing ground truth in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the non-clinical nature of the tests, an adjudication method for human interpretation (like 2+1 or 3+1) is not applicable. The tests likely involved direct measurement and comparison to established specifications or predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not done. The application describes non-clinical, functional equivalency tests comparing the device to predicate devices, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- A standalone performance study in the context of an algorithm's performance was not done. This device is a physical medical device, not an AI algorithm. The performance described relates to its physical and functional properties.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests appears to be established performance characteristics of the predicate devices and general safety/effectiveness standards for similar medical devices. The tests aimed to demonstrate that the new device's performance was "as well or better than the predicate devices" for the specific functional attributes (Pressure Decay, Flange Retention Force, Gel Cap Insertion method). This is a form of engineering or functional validation against existing benchmarks.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model.
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