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The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

The LAP-Pump PP110 is a suction and irrigation pump for use during laparoscopic procedures. The irrigation and suction functions are used to facilitate the removal of debris and fluids during laparoscopy. The pump consists of the following main components: : (1) a power supply, (2) a power switch, (3), a START/STOP button for the irrigation function, (4), a START/STOP button for the suction function, (5) a roller wheel, (6) a pump head, (7) suction pump and (8) a casing. The pump is a microprocessor controlled single roller pump that functions according to the peristaltic principle and is to be used with specially designed sterile, single use irrigation tube sets with or without hand piece, a sterile outflow tube set and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.

This is a 510(k) premarket notification for the LAP-Pump PP110, a suction and irrigation pump for laparoscopic procedures. The document asserts substantial equivalence to predicate devices based on similar intended use, basic technological characteristics, and performance testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Test results demonstrate that the proposed device conforms to the above standards" and "Design verification testing of the LAP-Pump PP10 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness."

The "performance data" section focuses on compliance with various international standards for medical devices and sterility.

Here's a summary of the reported device performance in relation to the standards it aims to meet:

2. Sample size used for the test set and the data provenance

The document does not provide information on the sample size for any specific test sets. It mentions "Design verification testing," "ETO sterilization validation," "Package and product integrity" testing, and "Biocompatibility testing," but not the number of units or samples used for these tests.

The data provenance is implied to be prospective testing conducted by the manufacturer and independent laboratories to demonstrate compliance with standards for the specific device being submitted. There is no mention of country of origin of the data beyond the standards themselves being international.

There is no mention of any clinical study involving a "test set" of patients or data in the context of diagnostic accuracy or clinical outcomes. The performance data is focused on engineering, safety, and sterilization validation.

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

This information is not applicable and not provided in the document. The performance data presented relates to engineering and safety testing, not to the establishment of ground truth by clinical experts for diagnostic or treatment outcomes.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data, which are not described here.

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

There is no mention of an MRMC study, AI involvement, or human readers/assistants in the document. This is a submission for a physical medical device (pump for laparoscopy), not an AI-powered diagnostic or decision support system.

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

This is not applicable. The device is a physical pump, not an algorithm, so the concept of standalone algorithmic performance is irrelevant here.

7. The type of ground truth used

For the various engineering and safety tests, the "ground truth" implicitly refers to the specifications and requirements defined by the referenced international standards (e.g., AAMI ANSI ES60601-1 for electrical safety, ISO 11135-1 for sterilization). The device's performance is measured against these established engineering and safety benchmarks.

For the flow rate, the ground truth is simply the stated flow rate of 3 l/min, which is compared to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical pump, not a machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

This is not applicable for the same reason as point 8.

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