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The indications for use of the Joey Clamp Opening Tool is to open the Joey Clamp® umbilical cord clamp.

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This document is a 510(k) summary for the "Joey Clamp Opening Tool". It states that the device is "substantially equivalent" to an existing legally marketed device, the "Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263]". This type of submission (510(k)) does not typically require extensive clinical studies with detailed acceptance criteria and performance data as would be found in a Premarket Approval (PMA) application. For 510(k) devices, the primary demonstration is substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.), and expert qualifications is not explicitly provided in this 510(k) summary because it is generally not a requirement for this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

However, I can extract and infer some high-level information based on the document:

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

Since this is a 510(k) submission, there isn't a table of quantitative acceptance criteria and reported device performance in the same way a clinical trial would present it. The acceptance is based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

• Acceptance Criteria for 510(k): The device is substantially equivalent to the predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or it has the same intended use and different technological characteristics but the new device does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
• Reported Device Performance: "The Joey Clamp Opening Tool is substantially equivalent to the Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263] that is legally marketed in the U.S." The stated intended use is "to open the Joey Clamp umbilical cord clamp." The performance required is simply the ability to open the specified clamp in a safe and effective manner, comparable to the predicate device.

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 for this 510(k) summary. No specific clinical test set details are 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):

Not applicable for this 510(k) summary. No ground truth establishment by experts for a test set is described.

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

Not applicable for this 510(k) summary. No adjudication method for a test set is described.

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:

Not applicable for this device. This is a manual tool, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable for this device. This is a manual tool, not an algorithm.

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

Not applicable for this 510(k) summary. The "ground truth" for a 510(k) generally refers to the safety and effectiveness profile of the predicate device, which is already legally marketed.

8. The sample size for the training set:

Not applicable for this device. No training set is involved as it is not an AI/ML device.

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

Not applicable for this device. No training set ground truth establishment is described.

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