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The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.

The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.

The provided document is a 510(k) premarket notification for a medical device (Biosearch Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study that establishes acceptance criteria for a new device's performance against clinical endpoints.

Instead, the document focuses on safety and effectiveness primarily through demonstrating:

1. Substantial Equivalence: By comparing the device's features and intended use to an existing legally marketed device (MILL-ROSE "Cleaning Adapter" {K922204}).
2. Biocompatibility: By detailing tests performed on the materials used in the device.

Therefore, the requested information about acceptance criteria, device performance from a study, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical efficacy or diagnostic accuracy is not applicable to this document. The device is a cleaning pump, not a diagnostic or therapeutic clinical device that would require such studies for its clearance.

However, I can extract information related to the material safety (biocompatibility) tests which serve as acceptance criteria for the various materials used in the device.

Acceptance Criteria and Study for Material Safety (Biocompatibility)

The "studies" described here are biocompatibility tests for the materials used in the device. The acceptance criterion is generally compliance with USP Class VI requirements or specific extractable/cytotoxicity test results.

1. Table of Acceptance Criteria and Reported Device Performance (Material Biocompatibility)

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

• Sample Size: Not explicitly stated in terms of number of test subjects or samples per test for each material. Biocompatibility tests usually involve a statistical number of in vitro or in vivo samples (e.g., cell cultures, animal models) as defined by the specific USP or ISO standards for each test. This document only reports the results against the standard.
• Data Provenance: "Vendor Supplied" for many materials, indicating the data was provided by the raw material manufacturers. Some tests have specific dates (e.g., 6/26/91-6/28/91), suggesting they were conducted at specific times, likely by the material vendors or contract labs. The country of origin for the data is not specified, but the applicant company is US-based. These are typically retrospective reports on material properties.

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

• Not Applicable. For biocompatibility tests, the "ground truth" is defined by the established scientific protocols and criteria within the USP (United States Pharmacopeia) guidelines or similar international standards (e.g., ISO 10993). The interpretation is typically performed by specialists in toxicology or microbiology, rather than expert consensus as in a clinical diagnostic study. No specific number or qualifications of "experts" are provided in this document as would be for clinical endpoint studies.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human interpretations of clinical data. This is not relevant for standardized laboratory biocompatibility tests, where results are objectively measured against defined pass/fail criteria.

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 manual cleaning pump, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed or is relevant.

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

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

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

• The "ground truth" equivalent for these material tests is compliance with established biological safety standards and test parameters (e.g., USP Class VI requirements, specific elution limits, absence of cytotoxicity). These standards are developed through extensive scientific research and consensus in the field of biocompatibility.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI-driven device, so there is no "training set."

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

• Not Applicable. (No training set).

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