(49 days)
The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.
The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the current Blom-Singer Indwelling Low Pressure Voice Prosthesis. Both devices are manufactured sterile and nonsterile, out of medical grade silicone elastomer, and are comprised of a body with an outer esophageal flange and a tracheal flange with a strap. Both devices utilize a flap valve to control the passage of air through the device. The Blom-Singer Indwelling 2000 has the addition of an assembled cartridge, consisting of a valve seat, to optimize the valve performance and longevity. The valve now has an additive which has demonstrated antibacterial properties in in-vitro studies. To aid in placing the gel cap onto the device, the esophageal flange on the outer portion of the device has been modified. The esophageal flange now has contoured areas, which allow the flange to fold along the contours for easy insertion into a gel cap for atraumatic placement of the device.
The provided text is a 510(k) summary for a medical device called the "Blom-Singer Indwelling 2000 Voice Prosthesis." It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study or data proving the device meets specific acceptance criteria.
The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." However, it does not provide any details about these tests, such as:
- Specific acceptance criteria: What metrics were used to define "equivalency of valve performance"? What were the thresholds for acceptance?
- Reported device performance: What were the results of these tests?
- Study design: What type of study was this? How many devices were tested? What was the methodology?
- Sample size and data provenance: How many devices were in the test set? Where did the data come from?
- Ground truth establishment: How was the "true" valve performance determined for comparison?
- Adjudication method, MRMC studies, or standalone performance: These concepts are not applicable to the type of "functional equivalency tests" alluded to for a device like this, which focuses on mechanical performance rather than diagnostic accuracy.
- Training set sample size and ground truth establishment: Not applicable as this is a mechanical device, not an AI/algorithm-based diagnostic tool.
Therefore, I cannot provide the requested table and detailed study information because the input document does not contain this specific data.
Here's what I can extract based on the available information:
1. Acceptance Criteria and Reported Device Performance:
The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." This implies that the acceptance criterion was "equivalency of valve performance" between the new device and its predicate. However, no specific quantitative criteria or reported performance metrics are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalency of valve performance with predicate device | Demonstrated equivalency (no specific quantitative data provided) |
| Antibacterial properties (in-vitro studies) | Demonstrated antibacterial properties (no specific quantitative data provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: The document only mentions "in-vitro studies" for antibacterial properties and "functional equivalency tests." No information is provided about the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. The "functional equivalency tests" would likely involve objective measurements of physical properties, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or specified.
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: Not applicable. This is a medical device (voice prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "functional equivalency tests," the ground truth would likely be established through objective physical measurements and engineering specifications, not expert consensus or clinical outcomes in the typical sense for diagnostic devices. No explicit details are given.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on establishing substantial equivalence for regulatory purposes based on design, materials, and intended use, rather than presenting detailed performance study data with specific acceptance criteria.
§ 874.3730 Laryngeal prosthesis (Taub design).
(a)
Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.(b)
Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.