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The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.

The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.

The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.

The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.

The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.

Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.

The provided document focuses on the K181770 510(k) submission for the Intrauterine Access Balloon Catheter and the Selective Salpingography Catheter, demonstrating substantial equivalence to predicate devices. It does not contain information about a study proving device meets acceptance criteria in the manner described in the request, such as a clinical study with a test set, expert ground truth, multi-reader, multi-case study, or standalone algorithm performance.

However, the document does list performance data from bench studies that were conducted to ensure reliable design and performance, with predetermined acceptance criteria being met. This implies that the device does meet specific acceptance criteria based on these bench tests.

Here is the information extracted from the document regarding the acceptance criteria and the "studies" (bench performance tests) that prove the device meets them:

Acceptance Criteria and Reported Device Performance

Note: The document describes "predetermined acceptance criteria" rather than specifying precise quantitative values for each. The reported performance indicates that these criteria were met.

The remaining requested information pertains to clinical performance studies, which are not detailed in this 510(k) submission as no such studies were needed for substantial equivalence based on the provided document. The document lists bench performance studies as the primary evidence.

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

• Not applicable / Not provided for the device. The document describes bench performance studies (e.g., tensile testing, lumen patency, balloon integrity). These are laboratory tests on device units, not tests on clinical patient data. Therefore, concepts like "test set" in the clinical sense, "data provenance," "country of origin," or "retrospective/prospective" do not apply.

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

• Not applicable / Not provided. The device performance was assessed against engineering specifications and industry standards in bench testing, not against expert clinical ground truth.

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

• Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of the described bench performance tests.

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, an MRMC study was not done. This type of study is for AI/human-in-the-loop performance, which is not relevant to this medical device submission.

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

• No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an AI algorithm.

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

• Engineering specifications, industry standards, and internal procedures served as the "ground truth" or reference for the bench performance tests. For instance, material properties (tensile strength), dimensional tolerances, and functional requirements (balloon integrity, lumen patency) were assessed against predefined, objective criteria.

8. The sample size for the training set

• Not applicable / Not provided. No "training set" in the context of machine learning or clinical data was mentioned or used for this device. The bench tests involved samples of manufactured devices.

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

• Not applicable / Not provided. As there was no training set in the clinical or AI context, no ground truth needed to be established for it. The "ground truth" for the device's acceptable performance was established by engineering design specifications, relevant ISO standards, ASTM standards, and Cook's internal procedures.

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