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The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.

The Flexiblade™ is a rigid laryngoscope featuring a flexible blade. The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free. This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.

The provided text describes a 510(k) submission for the Flexiblade™ - Flexible Laryngoscope. This is a Class I (exempt) device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a detailed study with acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and statistical analyses are not applicable or cannot be extracted from this type of regulatory document.

Here's an analysis of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria or quantified device performance metrics are provided in the document. The substantial equivalence claim is based on a series of performance testing and clinical experience, but the details of these tests and their outcomes against pre-defined criteria are not disclosed in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "a series of performance testing and clinical experience" without indicating the number of subjects, cases, or tests conducted.
• Data Provenance: Not specified. It's unclear if the "clinical experience" or "performance testing" was retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of analysis is common for diagnostic algorithms, but not for a physical device like a laryngoscope demonstrating substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned or described. This type of study comparing human readers with and without AI assistance is not relevant to a physical medical device like a laryngoscope.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical instrument, not an algorithm, so a "standalone" algorithmic performance study is irrelevant.

7. Type of Ground Truth Used:

Not applicable in the context of an "algorithm" or "diagnostic" ground truth. For a physical device demonstrating substantial equivalence, the "ground truth" would be its functional performance in comparison to predicate devices and general safety/effectiveness considerations. The document indicates this was evaluated through "performance testing and clinical experience" against "voluntary standards ASTM F965-85 and ISO 7376-1."

8. Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is not an AI algorithm.

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