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The U-Blade Veress 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 U-Blade Veress Needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a surgical/radiological procedural method. It is used for percutaneous insertion into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The device consists of an external stainless steel needle tube with a sharp point to puncture tissue. It is also equipped with an internal spring-loaded round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage to internal organs from the sharp point. The subject device also has a handle with a red indicator mark to verify when the spring-loaded obturator is retracted and a valve connector which connects to an insufflation pump.

As described in the following table, the U-Blade Veress Needle is available in 120mm and 150mm needle lengths and two types of handles with different shapes (U shape and Bugle).

This is a sterile and single-use device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "U-Blade Veress Needle." It outlines the device's intended use, description, non-clinical testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:

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

The document states that "The performance test results demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values for each test are not quantitatively detailed in this summary. Instead, it lists the types of performance tests conducted:

2. Sample sizes 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 sizes used for the non-clinical performance tests (Tip Pull, Switch Operation, Spring Obturator Operation, Needle Puncture Force Tests). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission from "Tianjin UWell Medical Device Manufacturing Co. Ltd." located in China, it's highly probable the testing was conducted in China, but this is not explicitly stated as the data provenance.

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 section is not applicable to the type of testing described in the document. The studies were non-clinical performance (mechanical/material) tests of a physical device, not studies involving human subjects, image interpretation, or diagnostic accuracy where expert consensus or ground truth would be established by medical professionals.

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

This is not applicable to the non-clinical performance tests conducted. Adjudication methods are typically used in clinical studies or studies involving subjective assessments (e.g., image interpretation) to resolve disagreements among reviewers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as part of this submission. This type of study is relevant for AI-powered diagnostic devices, which the U-Blade Veress Needle is not. It is a physical surgical instrument.

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

A standalone algorithm performance study was not conducted. This device is not an algorithm or software. It is a manually operated surgical instrument.

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

For the non-clinical performance tests, the "ground truth" (or reference standard) would be the specific engineering and material specifications of the device and relevant industry standards (e.g., ISO, ASTM). For example, the "Needle Puncture Force Test" would have an expected range of force for successful puncture, defined by engineering requirements, rather than expert consensus or pathology. The document lists compliance with several ISO standards (ISO 10993-1, -5, -10, -12; ISO 11137-1, -2) which serve as the "ground truth" for biocompatibility and sterilization.

8. The sample size for the training set

There is no mention of a training set because this is not an AI/ML device. The testing described is for a physical medical instrument.

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

This is not applicable as there is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical performance tests and biocompatibility tests.

• Non-Clinical Performance Tests: These included "Tip Pull Test," "Switch Operation Test," "Spring Obturator Operation Test," and "Needle Puncture Force Test." The document states that these tests were performed and their results "demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the actual numerical acceptance criteria and the quantitative test results are not provided in this summary document.
• Biocompatibility Tests: These tests were conducted in accordance with ISO 10993 series standards, specifically ISO 10993-1 (general), -5 (cytotoxicity), -10 (irritation and sensitization), and -12 (sample preparation). The device was categorized as an external communicating device with limited contact duration (

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