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510(k) Data Aggregation
(128 days)
To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
Please note: The provided text is a 510(k) summary for a medical device (Shikani-French Speaking Valve) seeking market clearance based on substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI algorithm.
The document focuses on establishing equivalence rather than presenting an independent performance study with detailed acceptance criteria and results.
Therefore, many of the requested categories for AI/algorithm-based studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics for the Shikani-French Speaking Valve. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria Category | Reported Device Performance / Equivalence Claim |
|---|---|
| Intended Use | "To redirect exhaled air over the vocal cords to allow speech in tracheostomized patient." This matches the intended use of predicate devices. |
| Technological Characteristics | "The technological characteristics are the same as, or equivalent to, predicate devices by Passy Muir (K944451), Willy Rüsch (K964056), and A&M speaking valves." This is the primary "performance" claim – that its design and function are sufficiently similar to devices already on the market. |
| Safety and Effectiveness | Implied to be equivalent to predicate devices, as a 510(k) clearance signifies a finding of substantial equivalence in this regard. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes a device, not a data-driven model or algorithm that would have a "test set." The basis for equivalence is the design and function of the device compared to predicate devices, not data analysis on a specific patient population.
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)
- Not applicable / Not provided. Ground truth for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication is not relevant in this context.
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
- No. This is a hardware medical device (a speaking valve), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / No. This is a hardware device; there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / No explicit ground truth. The "truth" in this context is the established safety and effectiveness of the predicate devices and the new device's demonstrable similarity to them in design, materials, and intended use. Performance is implicitly validated by comparison to these established devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
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