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Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content.

Endometrial Sampler

This document is a 510(k) clearance letter from the FDA for an "Endometrial Sampler" device (K990387). It states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence to an existing device rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets them (such as AI performance, expert ground truth, sample sizes, etc.) is not applicable to this document.

For the vast majority of 510(k) clearances, the manufacturer demonstrates that their new device is as safe and effective as a legally marketed predicate device. This often involves:

• Bench testing: To ensure the device meets engineering specifications.
• Performance testing: To show it functions as intended, often in comparison to the predicate.
• Biocompatibility testing: If applicable, to ensure materials are safe for human contact.
• Sterilization validation: If the device is sterile.
• Software validation: If the device contains software.

These tests are designed to show equivalence, not necessarily to meet new, standalone acceptance criteria with performance metrics like accuracy, sensitivity, or specificity in the way one might evaluate an AI-powered diagnostic device.

In summary, none of the requested information (table of acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) is present or relevant to this 510(k) clearance document for an Endometrial Sampler.

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