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FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.

Here's a breakdown of the acceptance criteria and the studies mentioned for the FemVue MINI Saline-Air Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that "all predetermined acceptance criteria were met" for various tests. Therefore, the table below is constructed by inferring the acceptance criteria from the type of test conducted.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the individual bench performance tests. It only states that these tests were conducted. It also does not explicitly state the data provenance (e.g., country of origin) or if the studies were retrospective or prospective, though bench testing is inherently prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily physical, chemical, and functional bench tests, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench tests, it's unlikely a formal adjudication method (like 2+1, 3+1) would be applicable. The tests likely have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data for a device, not a diagnostic algorithm that would typically require such a study to assess human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (algorithm only) was not done. This device is a manual instrument, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance studies described, the "ground truth" refers to established engineering standards, material specifications, and functional requirements for a medical device. This is determined by the specific ASTM and ISO standards cited (e.g., ISO 11135 for sterility, ISO 10993 for biocompatibility, ASTM F1980-16 for accelerated aging). The concept of expert consensus, pathology, or outcomes data as ground truth is not applicable to these types of engineering and functional tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a hardware product, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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