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A Circumcision Clamp is an instrument used in a procedure to compress the foreskin of the penis during circumcision of male infant or child.

The Fine Surgical Gomco Circumcision Clamp is a disposable medical device that is constructed of chrome plated brass. The device will be sold non sterile for further processing (ie. Packaging and sterilization) by the final distributor. We do not intend to sell these devices directly to the end user.

Here's an analysis of the provided text regarding the Fine Surgical Circumcision Clamp's acceptance criteria and the study (or lack thereof) to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No test set was used because no non-clinical or clinical tests were performed.
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth was established from experts for a test set, as no tests were performed.

4. Adjudication method for the test set:

• Not applicable. No test set was used.

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 surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

• Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used:

• Implicit Ground Truth: The ground truth for the acceptability of the Fine Surgical Circumcision Clamp is based on its substantial equivalence to a legally marketed predicate device (Centurion® CirClamp™). The predicate device's prior marketing and presumed safety/effectiveness serve as the "ground truth" for the new device's acceptance.

8. The sample size for the training set:

• Not applicable. This device is a manual surgical instrument and does not involve AI or machine learning, thus no training set was used.

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

• Not applicable. There was no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, "no clinical testing was performed" and "non Clinical testing was not performed."

The "study" that proves the device meets the acceptance criteria is explicitly stated as a comparison to a predicate device (the Centurion® CirClamp™). The submitter, Fine Surgical Instruments, Inc., argues that their device is "identical in materials, design, and intended use" to the predicate, with two minor differences:

1. It will be offered non-sterile for further processing.
2. A larger size will be available (1.6 cm, designated "Child").

The FDA's finding of substantial equivalence allows the device to be marketed. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was on the market prior to May 28, 1976 (or a reclassified device that doesn't need premarket approval). The acceptance criteria are "met" by demonstrating that the new device is essentially the same as an already accepted device.

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