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Intended for the application of two non-homogenous liquids.

The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar.

The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts:

• . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately)
• Stainless steel shaft connecting hub to Pebax ●
• Flexible Pebax portion connecting stainless steel shaft to distal tip
• Fixed-position distal tip. ●

Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media.

The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.

This document describes the Laparoscopic Spray Applicator with Spinning Luers and its substantial equivalence to a predicate device. It explicitly states that no clinical performance data was provided as a basis for substantial equivalence. Therefore, the device relies on non-clinical performance data to demonstrate its safety and effectiveness.

Here's an analysis of the provided information based on your requested criteria:

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

The document lists various tests performed and states that the "test articles met the pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test nor the quantitative results of the device's performance. It only states that the device "met the pre-defined acceptance criteria."

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

The document does not specify the sample size used for any of the non-clinical tests. The data provenance is also not explicitly stated, but since it's an FDA submission for a device manufactured by Micromedics Inc. (d/b/a Nordson Medical) in St. Paul, Minnesota, it can be inferred that the testing likely occurred in the US and was prospective for the purpose of this submission.

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)

This question is not applicable as the study did not involve human interpretation or subjective assessment that would require external experts to establish a "ground truth" in the traditional sense (e.g., for image analysis). The ground truth was established through adherence to engineering specifications and international standards for device performance.

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

This question is not applicable as the non-clinical testing for this device did not involve subjective human assessment requiring adjudication. The results were based on objective measurements against pre-defined engineering and performance 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

No MRMC comparative effectiveness study was done. This device is a laparoscopic spray applicator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This question is not applicable. This device is a physical medical device, not a software algorithm.

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

For the non-clinical performance tests, the "ground truth" was based on pre-defined engineering specifications, design requirements, and adherence to relevant international standards (e.g., ISO 10993 for biocompatibility, ISO 594-1 and -2 for luer connections). It was not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies or diagnostic evaluations.

8. The sample size for the training set

This question is not applicable. There was no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There was no training set.

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