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The Transvaginal Ultrasound Probe Holder device is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.

Transvaginal Ultrasound Probe Holder

The provided text is a 510(k) clearance letter from the FDA for a "Cervical Tenaculum/Transvaginal Ultrasound Probe Holder." This document does not describe acceptance criteria or a study proving the device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria in the way a PMA device would require. The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, I cannot extract the requested information from the provided text because it does not contain:

1. A table of acceptance criteria and the reported device performance: This type of information is not part of a 510(k) clearance letter.
2. Sample size used for the test set and the data provenance: No new 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: Not applicable for a 510(k) based on substantial equivalence.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or required for this type of clearance.
6. Standalone performance: No standalone algorithm performance is discussed as this is a physical medical device, not an AI/software device.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/ML model training).
9. How the ground truth for the training set was established: Not applicable.

The document is primarily a regulatory approval letter based on the device's substantial equivalence to existing devices.

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