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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 TS Medical Circumcision Clamp is a stainless steel, reusable, and "mogenstyle" circumcision clamp. The T.S. Medical Circumcision Clamps are constructed of stainless steel that meets the requirements of ASTM-F 899, Stainless Steel Bullet. Bar and Wire for Surgical Instruments. The following size will be offered: 2.5 mm.

The provided documentation for the T.S. Medical Circumcision Clamp (K033403) states that no non-clinical or clinical tests were performed to establish acceptance criteria or demonstrate device performance.

Therefore, most of the requested information cannot be provided from this document.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable, as no tests were performed.

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

• Not applicable, as no tests were performed.

4. Adjudication method for the test set:

• Not applicable, as no tests were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No, an MRMC study was not done.

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

• No, this device is a physical medical instrument, not an algorithm. Therefore, standalone performance in this context is not applicable.

7. The type of ground truth used:

• Not applicable, as no tests were performed.

8. The sample size for the training set:

• Not applicable, as no tests were performed.

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

• Not applicable, as no tests were performed.

Summary of what the document states instead:

The submission for the T.S. Medical Circumcision Clamp (K033403) relies on substantial equivalence to predicate devices rather than new performance data.

• The device is described as identical in materials, design, and intended use to the circumcision clamps marketed by Tri-State Medical Corp. (K935491) and the "grandfathered" Mogen Circumcision Clamp marketed by Mogen Circumcision Instruments, Ltd.
• Non-clinical tests were not performed.
• Clinical tests were not performed.
• The conclusion is that the device is "safe and effective for its intended use" based on this substantial equivalence argument.

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