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The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.

The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.

The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.

Here's an analysis of the FemChec™ Pressure Management Device's acceptance criteria and the study used to demonstrate its performance, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for FemChec™ Pressure Management Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document describes non-clinical methods used for testing. This means the testing was likely conducted in a laboratory setting or on simulated systems, not on human subjects.

• Sample Size for Test Set: The document does not specify the exact number of devices or components tested for each criterion. It only lists the types of tests performed.
• Data Provenance: The data is from non-clinical testing, meaning it's not derived from human patients. The country of origin for the data is not explicitly stated, but given the 510(k) submission to the FDA, it would typically be generated by the manufacturer's own internal testing or by a contracted lab, likely in the US or a country with comparable regulatory standards. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Since the testing was non-clinical, there were no human experts establishing a "ground truth" for the performance characteristics in the way they would for a diagnostic accuracy study. The "ground truth" for the functional tests (e.g., pressure limiting) would have been defined by the device's design specifications and accepted engineering principles, verified through instrument measurements.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The "experts" involved would be engineers and lab technicians conducting the tests according to established protocols.

4. Adjudication Method

• Adjudication Method: Not applicable. Non-clinical performance testing typically involves objective measurements against predefined specifications, rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The submission describes non-clinical performance testing, not a clinical study involving human readers.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted, and the device is a mechanical pressure management system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, in a sense. The described testing focuses solely on the performance of the device itself (e.g., its ability to limit pressure, its biocompatibility, its functionality) in a laboratory setting, independent of human interaction beyond operating the device. However, "standalone" in this context typically refers to AI algorithm performance without human intervention, which is not relevant here.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the non-clinical tests was based on engineering specifications and objective measurements. For instance, the "pressure testing < 200 mm Hg" would involve measuring the pressure exerted by the device and verifying it does not exceed the 200 mmHg limit. Biocompatibility relies on adherence to established international standards (ISO 10993).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical medical device, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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