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The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.

The device system described in this 510(k) consists of a sterile, single use protective sheath for use with the VSI ENT-2000 scope.

The provided submission is for a medical device called the "Slide-On™ EndoSheath® System for Sensory Testing." This device is a sterile, single-use protective sheath for an endoscope. The submission states that substantial equivalence was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. However, the document does not describe specific acceptance criteria with numerical targets or a detailed study proving the device met those criteria in a way that aligns with the specific questions about AI/algorithm performance and ground truth establishment.

The provided text focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than presenting a performance study with detailed acceptance criteria and results in the manner requested. The device is a physical sterile sheath, not an AI or algorithmic diagnostic tool, therefore many of the requested fields are not applicable.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available or not applicable for this type of device submission:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of numerical acceptance criteria for specific performance metrics in the way one would expect for an AI/diagnostic algorithm. Instead, it lists types of performance testing conducted to demonstrate safety and effectiveness for a physical device (sheath). The "acceptance criteria" for a physical device like this are generally that it functions as intended without failure and maintains the integrity required for its purpose (e.g., sterility, protective barrier). The "reported device performance" is a general statement that the testing supported substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "performance testing" but does not detail the number of units tested for each specific test (burst, tensile, articulation, air pulse).
• Data Provenance: Not specified. It's internal company testing (Vision-Sciences, Inc.) but location, retrospective/prospective nature, and specific data origin are not provided.

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)

• Number of Experts & Qualifications: Not applicable. This device is a physical sheath, not an AI or diagnostic algorithm that requires expert-established ground truth for its performance evaluation (e.g., interpreting images or signals). The performance testing described (mechanical integrity, functional use with an endoscope) does not involve expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or performance evaluations for diagnostic algorithms where there is ambiguity in "ground truth" labels. Here, the tests are primarily objective physical or functional assessments.

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

• MRMC Study: No. This device is a sterile protective sheath for an endoscope, not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

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

• Standalone Study: No. This refers to the performance of an algorithm without human interaction. As the product is a physical medical device (sheath), this concept is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable in the context of diagnostic performance evaluation. For a physical device like an endosheath, "ground truth" would relate to objectively measurable properties such as material strength, impermeability, or proper mechanical fit, rather than diagnostic labels from expert consensus or pathology. The "ground truth" for these tests are the physical standards and functional requirements of the device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical device like this.

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