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The NeatClose Suturing Device has three major component: 1) a reusable Handle, 2) a single-use disposable cartridge (containing a natented needle guides and needles), and 3) a suture. The cartridge (including the pre-loded suture) is assembled onto the Handle. The device is then inserted through the access site through the port working channel (or without it), the needle guides are deployed and the device is withdrawn till the needle guides contact the inner abdominal wall. Then the needles are deployed, penetrating the tissue and retrieved in the cartridge. Right after, automatically, the needle guides are retracted to the cartridge as well. Then the device is completely withdraws, leaving the suture to be tied by the surgeon as he/she routinely with

AI/ML Overview

The provided text describes the NeatClose Suturing Device, a manual surgical instrument intended for approximation and/or ligation of soft tissues in laparoscopic procedures. The documentation focuses on demonstrating substantial equivalence to predicate devices and provides details about performance testing, including an animal study. However, it does not explicitly define acceptance criteria as a table of performance metrics with specific thresholds. Instead, it describes the conclusion of the study that the device is "effective, completely safe, reliable, fast and user-friendly."

Therefore, I will synthesize the information provided into the closest approximation of the requested table and then address the other points.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Feasibility	Demonstrate ability to be used for suturing in laparoscopic procedures	"Very effective" in the closure of port access in laparoscopic procedures.
Safety	No adverse events or unacceptable risks identified	"Completely safe"
Efficacy	Achieve successful tissue approximation and ligation comparable to existing methods.	"Very effective" in the closure of port access in laparoscopic procedures. Successfully performed suturing comparable to hand suturing and three other marketed devices.
Ease of Use	User-friendly operation	"User-friendly"
Speed/Duration	Comparable or improved speed of use	"Fast"
Reliability	Consistent performance	"Reliable"
Suture Characteristics (after sterilization and packaging)	Preservation of manufacturer's characteristics (degradation, tensile strength, diameter, needle attachment) and USP standards	Suture characteristics (tensile strength, diameter, needle attachment) preserved according to USP general chapters 71, 881, 861, and 871.
Sterility	Meet USP general chapter 71 standards	Tested and met USP general chapter 71 for sterility.
Sterilization Validation	Validated according to international standards	Sterilization validated per international standards.
Packaging and Shelf-life	Validation to be completed before commercial marketing	"In progress and will be completed before commercial marketing." (Implied acceptance is successful completion)

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

Test Set Sample Size: Two pigs were used for the comparative animal study, with 8 access sites in each pig (total of 16 access sites evaluated in the main comparative study). An additional pig was used later for an acute experiment focusing solely on the Neatstitch device in 6 access ports. So, a total of up to 3 pigs and 22 access sites were directly evaluated during the animal study.
Data Provenance: The study was a prospective animal study conducted in a controlled environment, likely in Israel, given the sponsor's location (Or Akiva, Israel).

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the animal study. The assessment of "ease of use, duration, safety and efficacy" was likely performed by the researchers/veterinarians conducting the study, who would be qualified in animal surgery and observation. However, specific numbers or detailed qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the animal study. It appears to be a direct observation and measurement study by the research team.

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 this is a physical medical device (suturing device), not an AI-powered diagnostic or assistive tool for human readers.

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

A standalone (algorithm-only) performance evaluation was not done as this is a physical medical device and does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

The ground truth for the animal study was established through direct observation, comparative performance (against hand suturing and three other marketed devices), and measurement of parameters such as ease of use, duration, safety, and efficacy in a live biological system (pigs). Additionally, the ground truth for suture characteristics (tensile strength, diameter, needle attachment, sterility) was based on established USP general chapters and manufacturer-defined specifications.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device and not an AI/machine learning model. The animal study described serves as the primary "test set" for performance evaluation, not a training set.

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

As explained in point 8, the concept of a training set is not applicable to this device.

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