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Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery

"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.

"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.

The provided text is a 510(k) summary for the Regular and Special Umbilical Cord Clamp and Cutter. It outlines the device description, intended use, and comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria beyond a general statement.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Details: The document states that "Bench testing was performed to ensure that the 'Regular and Special Umbilical Cord Clamp and Cutter' met its specifications. All tests were verified to meet acceptance criteria." However, it does not enumerate these specific acceptance criteria (e.g., what is the required clamping force? What is the maximum number of cuts before failure? What is the acceptable deviation for the electronic clock if applicable?). It also doesn't provide the numerical results for any of these tests, only a blanket statement of compliance.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified, but given the manufacturer is "Ningbo Feite Medical Device Co., Ltd." in China, it's highly probable the testing was conducted in China. The study is retrospective in the sense that the testing was performed before the 510(k) submission, but it's not a retrospective review of existing patient data. It refers to laboratory/bench tests.

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

• Not applicable. This device is a manual instrument, not an AI/software device that requires expert consensus for ground truth establishment. The testing would primarily involve engineers or technicians evaluating physical properties and performance against specifications.

4. Adjudication method for the test set

• Not applicable. This type of physical device testing does not involve adjudication methods like those used for diagnostic AI where multiple experts might review cases.

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. This is not an AI-assisted diagnostic device, so a MRMC comparative effectiveness study is not relevant or included.

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

• Not applicable. This is a manual medical instrument, not an AI algorithm. The "Special Umbilical Cord Clamp and Cutter" has an "electronic clock function," which might involve some internal algorithm for timekeeping, but its performance is evaluated as part of the total device functionality, not as a standalone AI component.

7. The type of ground truth used

• For physical characteristics (e.g., dimension, material, single use): Comparison to the predicate device and engineering specifications.
• For functional performance (e.g., clamping, cutting): Performance against pre-defined functional specifications (though these specific acceptance criteria are not detailed in the summary).
• For biocompatibility: Compliance with established biocompatibility standards (e.g., ISO 10993) via specific tests.
• For sterility: Compliance with sterilization efficacy standards for EO sterilization.

8. The sample size for the training set

• Not applicable. This device does not use an "AI algorithm" in the conventional sense that would require a training set.

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

• Not applicable. As above, no AI-specific training set.

In summary, the document states that bench testing was performed and "All tests were verified to meet acceptance criteria" and "Biocompatibility testing demonstrated that the devices are biocompatible." However, it lacks the specifics commonly requested for AI/diagnostic devices such as detailed acceptance criteria, numerical performance data, and the methodologies for establishing ground truth relevant to such devices. The nature of this device (a manual surgical instrument) means many of the requested points are not applicable.

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