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The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:

• For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
• Hormone therapy monitoring. .
• Endometrial dating .
• Detection of endometrial carcinoma .
• Bacterial culturing .

This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.

The provided document set describes the Rocket Medical plc Endometrial Sampling Syringe, which was submitted for 510(k) clearance. This means the device demonstrated substantial equivalence to a predicate device already on the market, rather than proving its safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is largely inapplicable or not detailed in this specific submission.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) submission focused on substantial equivalence:

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

For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating equivalence in design, materials, and intended use to a predicate device. "Reported device performance" in this context refers to the comparison against the predicate, primarily on physical characteristics.

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

• Sample Size: Not applicable. The submission states, "The device has yet to be clinically evaluated but has been subjected to a real laboratory performance testing against competitor product." This indicates in vitro or bench testing, not human subject testing with a "test set" in the sense of clinical data. There is no information on the number of samples used in this laboratory testing.
• Data Provenance: The device is manufactured by Rocket Medical plc in Tyne & Wear, England. The laboratory performance testing would have been conducted internally or by a contracted lab. The data is likely non-clinical/bench test data, not patient data.

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. As described, no clinical "test set" with human subjects requiring expert ground truth establishment was used for this 510(k) submission. The evaluation was laboratory-based comparison to a predicate device.

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

Not applicable. No clinical "test set" with human subjects requiring adjudication was used.

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 an endometrial sampling syringe, not an AI-assisted diagnostic tool or a device that impacts human reader performance. No MRMC study was performed.

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

Not applicable. This is a medical device (syringe), not an algorithm or AI system.

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

Not applicable. For the in vitro or bench testing, the "ground truth" would be the measurable physical and functional specifications of the predicate device, against which the new device was compared. For example, comparing the actual sampling hole size of the Rocket syringe to the stated size of the Unimar Pipelle. There's no pathological, outcomes, or expert consensus ground truth mentioned for this type of submission.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

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