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The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.

The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.

This document describes the premarket notification (510(k)) for the GRI-Alleset Veress Needle, a disposable, single-use, sterile device intended for establishing pneumoperitoneum in minimally invasive abdominal procedures. The submission aims to demonstrate substantial equivalence to a predicate device, the Ethicon Endopath Ultra Veress Needle (K983925).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table as "acceptance criteria." Instead, the document outlines performance tests that were conducted and states that the "results show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications." The direct comparisons are made against the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the test sets used in the biocompatibility, sterilization, mechanical bench testing, or shelf-life studies. It only mentions that these tests were "conducted in comparison with the predicate." The data provenance is not specified, but typically such testing would be performed in a controlled laboratory environment. The studies are prospective in the sense that the new device was evaluated against established standards and a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For medical devices like a Veress needle, "ground truth" is typically established through adherence to engineering standards, validated test methods, and comparison data from a legally marketed predicate, rather than expert consensus on a test set in the way AI algorithms are evaluated (e.g., image interpretation). The "experts" would be the engineers, quality specialists, and toxicologists conducting and interpreting the tests according to relevant ISO standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic accuracy assessments where there might be disagreement among human readers or interpreters. For device performance testing against engineering standards, results are typically objective and measurable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human interpretation is involved. The GRI-Alleset Veress Needle is a surgical instrument, and its effectiveness is assessed through physical and mechanical performance tests, not through reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The GRI-Alleset Veress Needle is a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Established ISO Standards: For biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
• Performance Specifications: The device must meet its own design specifications and perform comparably to the legally marketed predicate device (Ethicon Endopath Ultra Veress Needle).
• Predicate Device Performance: The predicate device itself serves as a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning models. The GRI-Alleset Veress Needle is a hardware medical device, and its development does not involve machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for a hardware medical device.

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