Search Results

The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professonal.

The Blom-Singer Dual Valve Indwelling Voice Prosthesis is provided for the same indications for use as the other Blom-Singer Indwelling Voice Prosthesis product lines. The Dual Valve Indwelling Voice Prosthesis has been modified from its predicate devices by the addition of a second valve intended to continue to function when leakage occurs in the primary valve.

The Blom-Singer Dual Valve Indwelling Prosthesis has been modified from its predicate devices by the addition of a second valve, consisting of a valve and valve seat, intended to continue to function when leakage occurs in the primary valve. The prosthesis is still primarily silicone. A second modification is the introduction of a slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap containing the prosthesis' esophageal flange. When the gel cap dissolves the inserter moves forward, indicating flange deployment.

Accessory Devices: The device will be offered with the following accessories: inserter stick, flushing device, flange introducer, gel caps, and lubricant,

The provided document is a 510(k) summary for the Blom-Singer Dual Valve Voice Prosthesis. It does not contain information typically found in a study proving a device meets acceptance criteria, such as a detailed clinical study with specific acceptance criteria, sample sizes, expert involvement, or statistical analysis.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional equivalency tests.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

Acceptance Criteria and Device Performance Study Details (Blom-Singer Dual Valve Voice Prosthesis)

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The document explicitly states: "The conclusions drawn from the nonclinical tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" and "functional equivalency tests" but does not provide any numerical sample sizes for these tests.
• Data Provenance (Country of origin, retrospective/prospective): Not specified. These were likely bench tests conducted by the manufacturer, Helix Medical, LLC, which is based in Carpinteria, CA, USA. The nature of the tests (non-clinical) implies they are not human clinical data, and thus the terms "retrospective" or "prospective" as applied to clinical studies are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring expert-established ground truth.

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

• This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring adjudication.

5. 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

• This information is not applicable. The device is a voice prosthesis, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.

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

• This information is not applicable. The device is a physical medical device (voice prosthesis), not an algorithm or software.

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

• The "ground truth" for the non-clinical functional equivalency tests would be established by engineering specifications and performance metrics derived from the predicate devices. The tests aimed to show that the new device's performance in specific areas (Airflow, Pressure Decay, Flange Retention Force, Valve Attachment Integrity, Inserter Deployment) was "equivalent" to the predicate devices.

8. The sample size for the training set

• This information is not applicable. The document describes the submission of a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

• This information is not applicable. As above, the device is not a machine learning model.

Ask a specific question about this device