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The H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

The H/S Elliptosphere Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.

The provided text describes a 510(k) summary for the H/S Elliptosphere Catheter Set. It asserts that the device is substantially equivalent to a predicate device, but it lacks detailed acceptance criteria and a comprehensive study description that typically accompanies medical device submissions.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state specific, quantitative acceptance criteria for the device's performance. Instead, it relies on a general statement of meeting performance requirements and being "safe and effective."

Reported Device Performance:

Missing Information Regarding the Study that Proves the Device Meets Acceptance Criteria

The provided text does not contain the detailed study information required to answer most of the requested points. The submission is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed performance metrics.

Here is an outline of the missing information:

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

• Not mentioned.

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

• Not mentioned.

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 MRMC study was mentioned. This device is a catheter set, not an AI-assisted diagnostic tool, so an MRMC study would be irrelevant.

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

• Not applicable. This device is a physical medical instrument, not an algorithm.

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

• Not mentioned, likely because the performance verification was based on pre-clinical testing for equivalence, not a diagnostic accuracy study.

8. The sample size for the training set:

• Not applicable/Not mentioned. As this is a physical device and not an AI/algorithm, there is no "training set" in the conventional sense.

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

• Not applicable/Not mentioned. Similar to point 8, this concept does not apply to a physical medical device.

Summary of the Available Information from the Provided Text:

The submission for the H/S Elliptosphere Catheter Set (K013972) is a 510(k) summary. The primary claim for regulatory approval is substantial equivalence to an existing predicate device (Modified Hysterosalpingography Set with Polyurethane Balloon, K961752).

The "study" referenced is "Pre-clinical testing" which aimed to "verify that the product meets the performance requirements described" and determined that it "performs safely and effectively." There are no details beyond this general statement. The 510(k) process often relies on demonstrating that a new device shares the same technological characteristics and intended use as a legally marketed predicate device, thereby inferring safety and effectiveness without requiring extensive new clinical trials with detailed performance metrics like sensitivity, specificity, or reader studies.

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