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The Hysteroscopy Pump HM4 is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Hysteroscopy Pump HM4 consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures. The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0 -2000 ml.

The provided text describes a 510(k) summary for a medical device, the Hysteroscopy Pump HM4. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or expert review.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria (e.g., pressure range, fluid loss accuracy) or a table of reported device performance values. It broadly states the device "will comply" with certain international and national standards.

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

Not specified. The document refers to compliance with standards, implying internal testing, but no details on sample size or data provenance (country, retrospective/prospective) are provided.

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

Not applicable. This type of detail is usually found in clinical performance studies, which are not described in this 510(k) summary. The submission focuses on technical specifications and substantial equivalence, not clinical effectiveness studies requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a hysteroscopy pump, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not feature an algorithm for standalone performance assessment in the context of diagnostic or interpretive tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this type of device would likely relate to the accuracy of its physical functions (e.g., pump pressure, fluid volume monitoring) against calibrated standards, rather than clinical outcomes or interpretations. These details are not provided.

8. The sample size for the training set:

Not applicable. This device is a hardware pump, not a machine learning model, so there is no "training set."

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

Not applicable. As above, there is no training set for this device.

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