(122 days)
The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis.
The entire device is for single patient use and the HME-part is for single use, i.e, it has to be exchanged at least every 24 hours.
Environments of use include: Hospitals, ICU, sub-acute care institutions and home.
The Provox FreeHands consists of two functional units that work together, a speech valve unit in a reusable housing and a disposable Provox FreeHands HME Cassette, which is connected to the lower part of the valve housing before it is ready to use.
The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It has three interchangeable membranes (Light, Medium and Strong).
The HME unit of the Provox® FreeHands HME® is a full heat-and-moisture-exchanger, which is used for partial restoration of the lost upper airway functions. It also separates the speech valve from direct contact with the airway and, thus, prevents mucous from being coughed into the valve part of the device. It also reduces the risk of inhalation of small particles, e.g., coming from a defective valve.
After proper adjustment and attachment of the speech valve unit and HME cassette, the completed Provox FreeHands HME is inserted into either Provox Adhesive base plate or Provox LaryTube with ring.
This document describes the non-clinical testing for the Provox FreeHands FlexiVoice device, comparing it to a predicate device, the Atos Medical - Provox FreeHands HME (K022125).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it describes general performance characteristics that were verified and then makes a comparative statement that the new device's performance is "very similar" or "a bit lower" (which is presented as an improvement in flow resistance).
| Acceptance Criteria (Inferred) | Reported Device Performance (Provox FreeHands FlexiVoice) |
|---|---|
| Closing Flow Rate | Approximately the same as the predicate Provox FreeHands HME. Only a small adjustment based on experience. |
| Opening Pressure | Verified (specific values not provided, but implied to meet requirements) |
| Cough-Out Pressure | Verified (specific values not provided, but implied to meet requirements) |
| Moisture Loss | Very similar to the predicate Provox FreeHands HME. |
| Airflow Resistance | A bit lower than the predicate Provox FreeHands HME (considered an improvement based on experience). |
| Leakage Test | Very similar to the predicate Provox FreeHands HME. |
| Attachment and Detachment Forces | Verified in different interfaces, including durability. |
| Durability | Verified for the devices. |
| Function after Fatigue Test, Climate Testing, Aging & Transport | Verified. |
| Usability (Simulated Use) | Conducted. |
| Risk Management (ISO 14971) | Conducted. |
| Overall Safety and Effectiveness | As safe and effective, and performs as well or better than the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the non-clinical tests. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as non-clinical, suggesting they were likely conducted in a lab setting rather than with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The non-clinical testing described focuses on device performance parameters rather than diagnostic accuracy requiring expert panel review. While a "usability study" was conducted, details about experts involved or ground truth establishment are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document the studies were non-clinical verification and validation tests rather than clinical trials requiring adjudication of human observations.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a medical prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical prosthesis, not an algorithm. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests (closing flow, moisture loss, etc.), the "ground truth" would be the measured physical properties of the device under specific test conditions, consistent with engineering and materials science standards. For the simulated use/usability study, the ground truth would be based on user feedback and observations of proper device function. There is no mention of complex ground truth types like pathology or outcomes data.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical 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.