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DISPOSABLE, STERILE UMBILICAL CORD CLAMP
TO BE USED FOR OBSTETRICS USE ONLY.
UMBILICAL CORD CLAMP WITH SIDE FASTENERS
TO PREVENT THE UMBILICAL CORD FROM GOING
OUT OF THE BLOCKING COMBS
IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL
OPENING.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp, dated December 12, 1997. It primarily confirms the device's substantial equivalence to a pre-amendment device and outlines regulatory requirements. The second page details the device name and its indications for use.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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DISPOSABLE STERILE VAGINAL SPECULUM USED TO EXAMINE THE INTERIOR OF THE VAGINA DURING GYNECOLOGICAL PROCEDURES HAS A REGULATING SCREW TO ALLOW A GRADUAL OPENING

Vaginal Speculum

This document is a 510(k) clearance letter from the FDA for a Vaginal Speculum (HOSPITAL'S SPEC). It does not contain information about acceptance criteria or a study proving the device meets said criteria.

The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This means the FDA determined the device is as safe and effective as a legally marketed predicate device, rather than requiring a new study with specific acceptance criteria.

Therefore, the requested information cannot be extracted from the provided text. The document is primarily a regulatory communication confirming that the device can be legally marketed.

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