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The ABBI (Air Bubble Based Infuser) is indicated for the following:

• Instillation of 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 (SonoHSG).

• Instillation of saline as a continuous stream of contrast media into the used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).

The Air Bubble-Based Infuser (ABBI™) is a dual-barrel syringe that can be connected to an intrauterine infusion catheter to instill a saline-air mixture as contrast media during sono-hysterosalpingogram (Sono HSG) procedures and saline only during hysterosonography (SIS) procedures. The device has a selector valve that allows the user to select infusion of a saline-air mixture for a Sono HSG procedure or saline alone for a SIS procedure. These procedures are used for the evaluation of the fallopian tube(s) selectively and/or the uterus.

The ABBI™ is labeled for use with the H/S Elliptosphere Catheter Set (K013972).

The device is a single use only and provided sterile using an ethylene oxide sterilization method. The device is intended to be used in a healthcare facility or hospital.

The provided text describes the Air Bubble-Based Infuser (ABBI™) and its substantial equivalence to a predicate device, focusing on non-clinical performance data. It does not contain information about the use of AI, so I cannot provide details on AI-related aspects.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence. The "performance" is implicitly stated as "demonstrates that the ABBI™ is substantially equivalent to the proposed predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for any of the non-clinical tests or the cadaver study. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. The studies mentioned are primarily non-clinical device performance and biocompatibility tests, which typically do not involve establishing ground truth by human experts in the same way clinical diagnostic studies would. The "Summative Usability Assessment" might have involved human participants evaluating the device, but the number and qualifications of evaluators are not detailed.

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

This information is not provided. Adjudication methods are typically associated with clinical studies involving interpretation of results, which is not described here.

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:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance and substantial equivalence to a predicate device, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document.

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

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an algorithm or AI.

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

Given the nature of the tests (filling, volume, pressure, torque, deformation, biocompatibility), the "ground truth" would be established by physical measurements, chemical analyses, and biological responses according to established engineering and ISO standards, rather than expert consensus on diagnostic images or pathology. For the cadaver study, the ground truth would be the direct observation of the device's function within the cadaver.

8. The sample size for the training set:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

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

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

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