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The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.

The SCC-23 Safety Clamp and Cutter is a pre-sterilized, ready-to-use, disposable obstetric instrument comprising a piston housing and two clamps manufactured of Polyamid 6.6 (nylon) which, upon incineration, converts to water vapor. The product also incorporates a stainless steel blade protectively sealed within the piston. The entire device weighs approximately 0.8 ounces or 23 grams. The clamp weighs approximately 0.1 ounces or 2.8 grams.

The provided document is a 510(k) summary for the SCC-23 Safety Clamp and Cutter, which is a medical device intended to simultaneously cut and clamp the umbilical cord. This submission is for substantial equivalence to a predicate device, not for a de novo marketing authorization that would typically require extensive clinical studies to establish acceptance criteria and device performance. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment.

Here's an explanation based on the available information:

1. A table of acceptance criteria and the reported device performance: Not available. This document is a 510(k) summary focusing on substantial equivalence, not a clinical trial report with performance metrics and acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. No clinical study data is presented.
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 available. No study requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No study requiring adjudication 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. This device is a manual obstetric instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual obstetric instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. No study requiring ground truth is described.
8. The sample size for the training set: Not applicable. This device is a manual obstetric instrument, not a learned algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The 510(k) submission for the SCC-23 Safety Clamp and Cutter focuses on its substantial equivalence to a predicate device, Veridien Corporation's umbilical clamping shear (K963428).

• Intended Use: "The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases."
• Comparison: Both devices "comprise two clamps and a cutter designed to simultaneously clamp and cut the umbilical cord."
• Conclusion: The FDA determined the device to be "substantially equivalent" to the predicate, allowing it to be marketed. This determination is based on the comparison of technological characteristics and intended use, rather than extensive clinical performance studies that would establish specific acceptance criteria and provide detailed study results as requested in your prompt.

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