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VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.

The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages:

• Longer life (150 hours vs. typically 40 hours).
• Low energy at the light guide end virtually eliminating problems with burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.)
• 3400% color temperature.
• Better utilization of the available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle.
  The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords.
  The fully assembled system meets the current UL544 current leakage requirements.
  The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.

The provided text describes a medical device, the AngioLaz VES 0281-m Video Endoscopic System, but it does not contain a detailed study report with specific acceptance criteria, method sections, or outcome measures that would allow for a comprehensive answer to all points of your request.

The document is a safety and effectiveness summary for a 510(k) premarket notification. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA for this type of submission.

However, I can extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document does not describe a formal "test set" in the way a clinical or technical validation study would. It refers to the device's performance based on its design and comparison to existing technology.
• Data Provenance: Not applicable, as detailed test set data is not presented. The statements are general claims about the device's characteristics and equivalence.

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

• This information is not provided in the document. The submission is a regulatory filing, not a scientific publication detailing a study with expert ground truth.

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

• This information is not provided in the document. No adjudication method for a test set is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a video endoscopic system (hardware), not an AI-powered diagnostic tool. The document predates widespread AI in medical devices (1998).

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

• Not applicable. This device is hardware (a video endoscopic system). It does not involve a standalone algorithm in the sense of AI.

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

• This information is not explicitly stated as a method for establishing the performance claims. The "effectiveness" is stated as being "the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators." This suggests a reliance on generally accepted performance standards for video endoscopy systems rather than a specific ground truth derived from expert consensus or pathology data for a new diagnostic claim.

8. The sample size for the training set

• Not applicable. This submission describes a hardware device, not an algorithm that would require a training set.

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

• Not applicable. As above, this is a hardware device, not an algorithm requiring a training set.

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