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THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS INDICATED FOR USE TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS

The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip. The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 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.

The provided text describes a 510(k) submission for a medical device (5F SH Catheter) claiming substantial equivalence to a predicate device. This type of submission does not typically include detailed studies with acceptance criteria for device performance as a standalone product in the way AI/ML algorithms or novel devices would. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, largely based on a comparison of technological characteristics.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of regulatory document.

However, I can extract the relevant information where available and explain why other points are not present based on the nature of a 510(k) submission for this specific device.

Description of Acceptance Criteria and Study for the 5F SH Catheter

The acceptance criteria and "study" for this device are fundamentally wrapped in the concept of Substantial Equivalence (SE) to a predicate device. The performance of the new device is accepted if it is demonstrated to be identical or similar enough to a legally marketed predicate device such that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "study" in this context is the comparison itself, as presented in the "Summary comparing technological characteristics with other predicate device" (Section 14). The acceptance criterion for each characteristic is that the new device must be "Identical" to the predicate, or "Similar" in a way that doesn't raise new safety or effectiveness concerns (e.g., sterilization method). The reported "performance" for the new device is its characteristic relative to the predicate, as shown in the "Comparison result" column.

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 a device like a catheter seeking substantial equivalence through a direct comparison of characteristics, a "test set" in the sense of clinical data or image data is typically not required or detailed in this summary. The comparison is based on the design, materials, and intended use of the device itself against the predicate. If any limited testing was performed (e.g., for biocompatibility or mechanical safety), the sample size and provenance are not disclosed in this 510(k) summary. The document states "limited testing information is sometimes required," but does not provide details for this specific submission.

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 / Not Provided: Since there isn't an explicit "test set" or diagnostic performance claim being evaluated via expert review, there is no mention of experts establishing ground truth for a test set. The evaluation is primarily by the FDA reviewers against the characteristics of the predicate device.

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

• Not Applicable / Not Provided: As no specific test set or clinical data requiring adjudication is presented in this summary.

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

• Not Applicable: This device is a catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to its regulatory submission.

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

• Not Applicable: This device is a catheter, not an algorithm.

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

• Not Applicable / Not Explicitly Stated: The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device (Ultra Catheter Set for Sonohysterography from Lyco Enterprises, Inc.). The new device is considered acceptable if its characteristics align with this predicate, implying it will have similar safety and effectiveness.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no "training set" in the context of this catheter device. The device's design, materials, and manufacturing are based on established engineering principles and comparison to the predicate, not machine learning training.

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

• Not Applicable / Not Provided: As there is no training set for this device.

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