Search Results

The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

The Provox® FreeHands system consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position".

The provided text describes the "Provox® FreeHands HME™" device and references a clinical test. However, it does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is primarily a 510(k) summary, focusing on substantial equivalence to predicate devices rather than a full performance study.

Based on the available information, here's what can be extracted and what is missing:

The document mentions a "clinical test" and states that "Test results support the conclusion that the actual device performance satisfies the design intent." However, the specifics of this "design intent" (i.e., the acceptance criteria) are not detailed with numerical thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The general statement is that "Test results support the conclusion that the actual device performance satisfies the design intent."
• Reported Device Performance: The document states that a comparison was made between the Provox® FreeHands HME™, Provox® HME Cassette, and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap. The implication is that the Provox® FreeHands HME™ performed acceptably compared to these predicates, but specific performance metrics (e.g., heat/moisture retention percentages, speech clearness, breathability) are not provided.

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

• Sample size: Not specified.
• Data provenance: The clinical test was performed by the Netherlands Cancer Institute. It's described as a "clinical test," implying prospective collection, but not explicitly stated.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Not 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

• This device is a physical medical device (HME with speech valve), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI assistance" is not applicable.

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

• This device is a physical HME, not an algorithm. This question is not applicable.

7. The type of ground truth used

• Given it's a physical HME device, the "ground truth" would likely be objective measurements of HME performance (e.g., heat/moisture exchange efficiency), patient comfort, ease of speech, and potentially clinical outcomes related to respiratory health. However, the exact type of ground truth or specific metrics used in the "clinical test" are not detailed in the provided text.

8. The sample size for the training set

• The document describes a clinical test for evaluation, not a training/test set split as commonly found in machine learning/AI studies. Therefore, a "training set" in that context is not applicable.

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

• As above, a "training set" is not mentioned in the context of this device evaluation.

In summary, while a clinical test was conducted by the Netherlands Cancer Institute, the provided 510(k) summary is very high-level and lacks the detailed performance metrics, sample sizes, expert qualifications, and adjudication methods that would constitute a comprehensive description of acceptance criteria and the study proving it.

Ask a specific question about this device