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The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.

This 510(k) Premarket Notification for the Apple Medical Corp. Pneumo-Matic Insufflation Needle does not contain the information requested in your prompt.

The document describes a medical device (a Veress needle for insufflation) and its premarket notification to the FDA. It outlines the device's description, indications for use, and summaries of biocompatibility and safety and performance tests.

However, the prompt is geared towards evaluating a system that would typically involve an algorithm or AI, requiring metrics like sensitivity, specificity, or improvement in human reader performance. None of that information is present in this filing.

Specifically, the following points from your prompt cannot be addressed by the provided text:

1. Table of acceptance criteria and reported device performance: While there are lists of "tests performed," there are no specific numerical acceptance criteria or performance metrics reported that would be relevant to evaluating an AI or algorithm. For example, there's a "Needle Puncture Test" but no pass/fail criteria or results like "penetration achieved 99% of the time."
2. Sample size used for the test set and the data provenance: Not applicable; this is a physical medical device.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable; there is no AI or human reader involved in the performance of this physical device in the context described.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the AI/algorithm sense. The "ground truth" for these tests would be objective physical measurements or observations (e.g., did the spring obturator operate correctly), not expert consensus on an image or data.
8. Sample size for the training set: Not applicable; no AI or algorithm for this device.
9. How the ground truth for the training set was established: Not applicable.

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