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The NeatClose Suturing Device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.

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the access site through the port working channel (or without it), the needle guides are deployed and the device is withdrawn till the needle guides contact the inner abdominal wall.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

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

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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Approximation of soft tissue

The LSI "R" Series Suturing Device and Accessories Product, like the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.

This looks like a 510(k) premarket notification for a surgical instrument, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth establishment (which are typical for AI/ML device evaluations) are not present in the provided document.

The document describes a traditional medical device submission for the LSI "R" Series Suture Placement Device and Accessories Product. Its purpose is to demonstrate substantial equivalence to a predicate device (LSI Suture Placement Device and Accessories (K981531)).

Here's how to interpret the provided information in the context of a traditional device submission:

1. A table of acceptance criteria and the reported device performance: This type of table is not directly applicable to this traditional device submission. For such devices, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:

   • Indications for Use: Both the new device and the predicate device have the same indication: "Approximation of soft tissue."
   • Technological Characteristics: The new device, like the predicate, is described as a "Manual surgical instrument for general use" intended for "passing ligature through said soft tissue." The submission would contain detailed comparisons of materials, design, manufacturing processes, and performance characteristics (e.g., tensile strength, biocompatibility, sterilization validation) to support this claim, but these details are not provided in the summary.
   • Safety and Effectiveness: Substantial equivalence implies that the new device is as safe and effective as the predicate. This is typically established through non-clinical bench testing, and sometimes animal studies, but generally not human clinical trials for simple instruments compared to highly similar predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission. There isn't a "test set" in the AI/ML sense. Substantial equivalence is often supported by engineering tests and comparisons.

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): Not applicable. There is no ground truth in the sense of expert annotation for a medical image or diagnostic task.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a traditional surgical instrument would be its ability to perform its intended function safely and effectively, as demonstrated by engineering tests and conformance to standards, not by comparison to expert-labeled data.

8. The sample size for the training set: Not applicable, as there is no AI/ML model to train.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The LSI "R" Series Suture Placement Device and Accessories Product gained FDA clearance (K040232) based on its substantial equivalence to a previously legally marketed predicate device (LSI Suture Placement Device and Accessories, K981531). The key elements for this determination were:

• Identical Intended Use: Both devices are intended for "Approximation of soft tissue."
• Similar Device Description: Both are manual surgical instruments for general use for passing ligatures through soft tissue.

The "acceptance criteria" implicit in this type of submission are that the new device must share the same intended use and similar technological characteristics with a predicate device, and any differences in technological characteristics must not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" would have been a comparative analysis (not a clinical study in the AI/ML sense) demonstrating this substantial equivalence, likely through bench testing and detailed engineering comparisons, the specifics of which are not detailed in this summary document.

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