(10 days)
The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.
The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice prosthesis equipped with a safety medallion, an insertion tool and some accessories.
The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly detailed in a quantifiable manner (e.g., specific thresholds for success, failure rates, etc.). Instead, the study's goal was to demonstrate that the device's performance satisfies its "design intent" and that it is "substantially equivalent" to predicate devices. The study results are reported qualitatively as supporting this conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalency to predicate devices in valve performance | "Functional equivalency test have been performed on the three prostheses, which demonstrate the equivalency of the valve performance with the three designs." |
| Device performance satisfies the design intent | "Test results support the conclusion that the actual device performance satisfies the design intent." |
| Substantial equivalence to predicate devices in design, intended use, and materials of manufacture | "The proposed device is substantially equivalent to the legally marketed predicate Technological Characteristics devices in design, intended use and materials of manufacturer." |
| Provides voicing after total laryngectomy | "The Provox® NID™ Rehabilitation System is provided for the same indications for use as its predicate devices... All three devices are designed to provide voicing after total laryngectomy." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 14 patients
- Data Provenance:
- Country of Origin: Brisbane, Australia (Performed by Princess Alexandra Hospital)
- Retrospective or Prospective: Prospective (implied by "participated in this clinical trail" and the approval by a Research Ethics Committee)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions the study was "Performed by Princess Alexandra Hospital," implying clinical oversight and assessment, but no specific number or roles of independent experts for ground truth establishment are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a clinical trial with patients using the device, but it does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device itself is a physical voice prosthesis, not an AI diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The Provox® NID™ Voice Rehabilitation System is a medical device (voice prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth or evaluation standard implicitly revolves around clinical assessment of "voicing" effectiveness and the patient's ability to use the device as intended. The "functional equivalency test" for valve performance would likely involve objective measurements, but the specific type of ground truth for overall device performance is not detailed beyond demonstrating that it "satisfies the design intent" and is "substantially equivalent" to predicate devices. Prior to the study, patients were using the Blom-Singer Low Pressure Voice Prosthesis, suggesting a baseline for comparison in terms of patient experience or outcome.
8. Sample Size for the Training Set
Not applicable. As this is a medical device (voice prosthesis) and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device.
§ 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.