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Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.

HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (HSG Catheter Set). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document. The letter simply states that the FDA has found the device substantially equivalent to legally marketed predicate devices.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data.

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HSG Catheter Set (5F & 7F) is indicated for use to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus.

The device is to be used by physicians in hospitals. The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath. The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F. The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.

The provided text is a 510(k) summary for the HSG Catheter Set (5F and 7F). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed clinical study data showing primary safety and effectiveness.

Therefore, the document does not contain a traditional study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or a novel, high-risk device would. Instead, it relies on demonstrating that its technological characteristics are equivalent to a predicate device that has already been deemed safe and effective.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly met by demonstrating "substantial equivalence" to the predicate device. The performance is deemed "Identical" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, where the manufacturer provides a detailed comparison of their device to a legally marketed predicate device (K943494 from Lyco Enterprises. Inc.). The FDA reviewed this descriptive information and concluded that the device is substantially equivalent, thereby accepting the manufacturer's claim of identical performance and safety, with a minor difference in sterilization method.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not mention a test set with a specific sample size for evaluating the new device's performance in a clinical or user-based study. The determination of substantial equivalence is primarily based on a comparison of technological characteristics with the predicate device, not on new clinical performance data from a test set.

The data provenance for the comparison itself is the manufacturer's internally generated comparison table and potentially existing data/information from the predicate device within FDA files or literature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" for a test set, typically established by experts, is relevant for performance studies (e.g., diagnostic accuracy for AI devices). This submission focuses on demonstrating equivalence through comparison of design, materials, and intended use, not through a new performance study requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Without a specific test set or performance study, there's no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This device is a catheter for hysterisalpingography, and the submission's focus is substantial equivalence based on design and materials, not diagnostic interpretation.

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

No, a standalone performance study was not done. This concept is primarily relevant for AI algorithms. The HSG Catheter Set is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used here is a comparison to the established characteristics of the predicate device (Lyco Enterprises. Inc.'s HSG Catheter Set, K943494). The predicate device serves as the benchmark against which the new device's technological characteristics, safety, and performance are evaluated for equivalence. This is not "expert consensus," "pathology," or "outcomes data" for the new device, but rather a reference to an already cleared device's known attributes.

8. The Sample Size for the Training Set

This information is not applicable or not provided. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or not provided. As there is no training set mentioned, there is no method for establishing its ground truth.

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