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The Endoscopic Irrigation Pump Series is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

The Endoscope Irrigation Pump Series (Beamer AVEOTM Pump "AVEOPUMP" and ENDOLINQ Endoscopic Irigation Pump "JSFP-2") is the second-generation pump developed by Chougging Jinshan. Both models can provide an adjustable flow-rate from 0-1000 mL/min, and the pump flow can be adjusted in 100 mL/min increments, total 10 configurations available. The series works by turning a penstaltic roller pump head to move liquid through a tube set and into an endoscopic system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated.

The provided text is a 510(k) summary for the "Endoscopic Irrigation Pump Series." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data and a comparison of technological characteristics. It does not contain information related to an AI/ML powered device, nor does it contain a study that proves the device meets specific acceptance criteria based on AI/ML performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML powered device, as the document does not discuss such a device or study.

The document discusses acceptance criteria and performance data for a medical device (an irrigation pump). However, it does not involve AI or machine learning. The acceptance criteria and the study that proves the device meets them are based on non-clinical performance tests, not AI/ML performance.

Here's an analysis of the provided text, focusing on the information that is present:

Device: Endoscopic Irrigation Pump Series

Type of Device: This is a physical medical device (a pump) used for endoscopic irrigation, not an AI/ML algorithm.

Acceptance Criteria and Study:
The document states:

• "To demonstrate safety and effectiveness of Endoscopic Irrigation Pump Series and to show substantial equivalence to the predicate device, Jinshan completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met."
• "The Endoscopic Irrigation Pump Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."

The acceptance criteria are implied to be conformance with internal requirements and relevant international standards for medical devices and irrigation pumps. The "study" is a series of non-clinical performance tests.

Since the device is a physical pump and not an AI/ML system, the following details specifically requested for AI/ML devices will be N/A or not applicable based on the provided text:

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

   • Acceptance Criteria: Conformance with internal design inputs, performance specifications, and international standards (e.g., electrical safety, electromagnetic compatibility, biocompatibility, flow rate accuracy, pressure limits, durability, material compatibility, etc. - these specific standards and internal requirements are not detailed in the provided text but are implied by "non-clinical tests" and "international standards shown below").
   • Reported Device Performance: "The Endoscopic Irrigation Pump Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness..."
     • The document states the pump can provide an adjustable flow rate from 0-1000 mL/min, adjustable in 100 mL/min increments (10 configurations). This is a functional specification, but not detailed performance results against acceptance criteria. A table is not provided.

2. Sample sizes used for the test set and the data provenance: N/A (for AI/ML test sets). For physical device testing, it would involve a certain number of units built and tested, but this detail is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML ground truth). Experts would be involved in designing and evaluating the physical device hardware and software, but not in establishing ground truth for an AI/ML model for diagnostic purposes.

4. Adjudication method: N/A (for AI/ML test set ground truth adjudication).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A, as this is for diagnostic imaging systems with human readers, not a physical irrigation pump.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A, as there is no standalone algorithm.

7. The type of ground truth used: N/A (for AI/ML ground truth). For a physical device, "ground truth" would relate to precise measurements of its physical parameters (e.g., actual flow rate during tests, pressure) compared to specified ranges.

8. The sample size for the training set: N/A (no AI/ML algorithm exists here).

9. How the ground truth for the training set was established: N/A (no AI/ML algorithm exists here).

In summary, the provided FDA 510(k) summary pertains to a physical medical device (an irrigation pump) and its substantial equivalence demonstration through non-clinical performance testing against internal requirements and international standards, not an AI/ML powered device. Therefore, most of the requested information for AI/ML performance evaluation cannot be extracted from this document.

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