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This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.

Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The documents are a regulatory approval letter (K972655) for "Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205" and an "Indications For Use" statement.

Specifically, the text is missing:

1. A table of acceptance criteria and reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and data provenance: No details about a test set or its characteristics are provided.
3. Number of experts and their qualifications for ground truth: No mention of experts or ground truth establishment for a test set.
4. Adjudication method: Not discussed in the provided documents.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information on such a study.
6. Standalone performance study: No details about an algorithm-only performance study.
7. Type of ground truth used: Not specified, as no study details are given.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The documents focus solely on the regulatory approval process based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria.

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The intended use is to direct the flow of fluids, via the stopcock arrangement, into tubing, catheters and collection systems during a heart catheterization procedure.

Manifold

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "Manifold", indicating its substantial equivalence to a predicate device. It briefly mentions the intended use, but there are no details about specific performance metrics, clinical studies, sample sizes, expert qualifications, or ground truth establishment.

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