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The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.

The provided text is a 510(k) summary for a medical device called Endomark™ Sterile India Ink. This is a premarket notification for a Class II medical device, and as such, it does not typically involve a detailed study with acceptance criteria and device performance as seen in clinical trials for new drug applications or more complex-device PMAs.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, primarily through technological characteristics and, in this case, limited performance testing.

Therefore, many of the requested categories for a study proving acceptance criteria are not explicitly present in the provided document.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria in a quantitative or qualitative table format that is then directly linked to reported device performance metrics in the way a clinical trial would. The "performance testing" mentioned is focused on demonstrating safety and equivalence.

The closest we can come to "acceptance criteria" and "reported device performance" from the text is:

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

The document mentions "clinical experience" as part of the performance testing but does not provide details on:

• Sample size used.
• Country of origin of the data.
• Whether the data was retrospective or prospective.

Given the context of a 510(k) for a relatively low-risk device, "clinical experience" might refer to data from investigator use, previous marketing of similar products, or limited observational studies, rather than a formal, large-scale clinical trial.

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)

This information is not provided in the document. The concept of "ground truth" established by experts in a structured test set is not detailed here, as the submission relies on demonstrating equivalence rather than proving novel clinical efficacy with a defined ground truth.

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

This information is not provided in the document. An adjudication method is typically part of a formal clinical study design, which is not described here.

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, an MRMC comparative effectiveness study was not done. This device is an India ink marker for endoscopic use, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.

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

The document does not explicitly state the "type of ground truth used" in a formal sense for the "clinical experience." For a simple marker, the "ground truth" would likely be the visual confirmation by an endoscopist that the mark was successfully placed, visible, and persistent for the intended duration. However, the document does not detail how this "ground truth" was formally established or measured.

8. The sample size for the training set

This is not applicable as this device is not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above.

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IS INDICATED FOR ENDOSCOPICALLY MARKING LESIONS IN THE GE TRACT MARKING LESTONS IN CONSTITUTIONATES WHEN THE REQUIRE SURGICAL REMOVAL WITHIN (30) THEFTY DAYS .

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria.

The document is a letter from the FDA to "Chek-Med Systems, Inc." regarding their "Spot Endoscopic Marker" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
5. A standalone performance study.
6. The type of ground truth used.
7. Information about training set size or how its ground truth was established.

The letter primarily concerns the regulatory approval status of the device based on substantial equivalence and general controls provisions of the Act.

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