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The LAP-WAVE 3000 (P07) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation.

The LAP-WAVE 3000 (P07) (K990732) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation. Irrigation fluid is transported from the fluid container to the instrument inserted in the patient by means of a roller-wheel pump at the device and a disposable PVC tubing set. A trumpet valve instrument (not provided with device) is used to manipulate the flow of fluid into the patient. A pressure sensor at the device is used to regulate pressure at the instrument (trumpet valve). Irrigation is initiated by opening the instrument and discontinued by closing the instrument. Also, a tubing set for connection to a central suction system is provided with the device to allow for removal of the fluid from the patient.

The provided text describes a 510(k) premarket notification for the LAP-WAVE 3000 (P07) laparoscopic irrigation pump. It establishes substantial equivalence to a predicate device, the Surgipump (K935763). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in the way a modern medical device submission would.

Instead, the summary for this device relies on historical experience with similar devices and a literature review to assert safety and effectiveness.

Here's an attempt to answer your questions based on the provided text, highlighting what is
and isn't present:

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

The document does not specify formal acceptance criteria in a quantitative, measurable way that would typically be presented in a table for a performance study. It states qualitative performance characteristics.

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

• No specific test set or clinical study data is provided for the LAP-WAVE 3000 (P07).
• The justification for safety and effectiveness is based on "extensive experience with suction/irrigation systems in operative laparoscopy without complications" and a review of medical literature. This implies a large, retrospective summation of real-world usage from various sources over many years, rather than a controlled, prospectively collected dataset for this specific device.
• The provenance would be general clinical practice of laparoscopic irrigation/suction systems, likely international, given the references include German publications.

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. There was no specific test set requiring expert ground truth establishment for this device in the provided submission.

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

• Not applicable. No test set or expert adjudication process is described.

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. The LAP-WAVE 3000 (P07) is a mechanical irrigation pump, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

• Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant.

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

• The "ground truth" used is essentially historical clinical outcomes data (absence of reported complications over many years of use of similar devices) combined with expert consensus/established clinical practice as documented in relevant medical literature. The document argues that the procedure (laparoscopic irrigation/suction) is safe and effective based on widespread acceptance and lack of reported complications, and since the device's performance specifications align with these established requirements, the device itself is also safe and effective.

8. The sample size for the training set

• Not applicable. This device's approval is based on substantial equivalence to a predicate and general clinical experience with the procedure, not a machine learning model requiring a training set.

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

• Not applicable. (See point 8).

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