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Injection of saline in the examination of the uterus using ultrasound techniques.

The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter will be available in a 5-French diameter with a length of 33 cm. The distal end will have either a side port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip. The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 cm. long, and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

This 510(k) summary describes a device focused on mechanical characteristics and equivalence, not algorithmic performance. Therefore, many of the requested categories related to AI/algorithm performance and clinical study design for such algorithms are not applicable.

Here's the information that can be extracted or deduced from the provided text:

Acceptance Criteria and Device Performance Study

Detailed Analysis of Requested Information:

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

   • See table above. The core acceptance criterion is "substantial equivalence" to predicate devices in terms of materials, construction, indications for use, safety, and effectiveness. The reported performance confirms these equivalences.

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

   • Test Set Sample Size: Not applicable. This is not an AI/algorithmic device requiring a dedicated test set with performance metrics like accuracy, sensitivity, specificity, etc. The "performance data" refers to the equivalence to predicate devices and their established clinical use.
   • Data Provenance: The "Clinical results" section refers to "Procedures for hysterosonography using the predicate IUI Set." This implies retrospective clinical experience with the predicate device(s). No specific country of origin is mentioned.

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)

   • Not applicable. There is no "ground truth" establishment in the context of an algorithmic test set described here. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own clinical trials and usage, but details are not provided here beyond general mention.

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

   • Not applicable. No 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

   • No. This device is a physical medical instrument (catheter set) used for a procedure (hysterosonography), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

   • Not applicable. This is not an AI algorithm.

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

   • For the predicate device's safety and effectiveness, the "ground truth" would likely be derived from clinical outcomes data observed during hysterosonography procedures. However, the document only broadly states that clinical results "demonstrate the safety and effectiveness."

8. The sample size for the training set

   • Not applicable. There is no AI algorithm being trained.

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

   • Not applicable. There is no AI algorithm being trained.

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