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The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Like the original iMESH Tacker, the modified iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer (PLA/PGA). The modified device's implantable Tack is violet colored. The Applicator is pre-loaded with up to 30 Tacks.

The iMESH Tacker is comprised of 3 parts:

• An in-line handle,
• A shaft with an articulating tip
• The bio-absorbable Tacks

The modified iMESH Tacker is identical to the original iMESH Tacker with the exception of a change in the color of the tacks to violet, several minor internal changes and slight changes to packaging and certain components.

This document is a 510(k) Special Summary for the THD Lap Ltd's modified iMESH Tacker (IMT). It describes a medical device, not a software algorithm, therefore the requested information regarding AI performance and studies is not applicable.

However, I can extract information about the acceptance criteria and the studies performed to demonstrate the device's safety and effectiveness in comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document pertains to a physical medical device (tacker) and its manufacturing and material properties, not a data-driven AI device. Therefore, the concept of "test set" and "data provenance" (in the context of clinical data for AI) is not directly applicable. The "tests" mentioned are engineering and biological evaluations of the device itself. The document does not specify the sample sizes for these non-clinical tests (e.g., number of tacks tested for strength, number of animals for in-vivo degradation).

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 is not applicable as the document describes non-clinical performance data for a physical device, not the validation of an AI algorithm based on expert-labeled data.

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

This is not applicable, as there is no mention of expert adjudication for a "test set" in the context of an AI algorithm. The performance evaluation is based on engineering and biological test results.

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

This is not applicable. The device is a surgical tacker, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the non-clinical tests mentioned, the "ground truth" would be established by defined engineering standards, material specifications, and biological safety parameters. For example, for strength testing, the ground truth would be a measurement against a predetermined force threshold. For endotoxin testing, it would be a measurement against a regulatory limit.

8. The sample size for the training set

This is not applicable, as this is not an AI device.

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

This is not applicable, as this is not an AI device.

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The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

The iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is pre-loaded with 30 tacks.

The iMESH Tacker is a device for fixing prosthetic material to soft tissue, primarily in hernia repair. The acceptance criteria and the study proving it meets these criteria are based on its substantial equivalence to predicate devices, namely the Covidien Protack (K090470) and Absorbatack (K071061).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The only stated differences are the iMESH Tacker's helical, bio-absorbable tack (Protack also has a helical tack, Absorbatack has screw) and its articulating tip to facilitate tack placement (the predicates have non-articulating tips). These differences were not considered to preclude substantial equivalence as the performance data demonstrated similarity or improvement where applicable.

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

The provided document does not specify a separate "test set" in the context of an AI/ML device. The performance data is presented as a comparison of the iMESH Tacker's fixation force with that of a predicate device (Absorbatack, K071061).

• Sample Size: The exact sample size (number of tacks, trials, etc.) for the fixation force testing is not explicitly stated. The data provided (e.g., "On implantation 17.07 N") represents the results of the tests, not the number of samples used to achieve those results.
• Data Provenance: The document implies the testing was conducted by EasyLap Ltd., the manufacturer based in Kfar Truman, Israel. The data would be considered prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's performance.

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

This information is not applicable to this 510(k) submission. The device is a mechanical surgical instrument, not an AI/ML diagnostic or prognostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is derived from physical and mechanical testing (e.g., fixation force measurements) against a specified standard or comparison to a predicate device's established performance.

4. Adjudication Method for the Test Set

This information is not applicable. Since the "ground truth" is based on physical performance measurements, there is no need for human adjudication of results in the way there would be for an image-based diagnostic AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The iMESH Tacker is a surgical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement are not relevant to its evaluation.

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

This information is not applicable. The iMESH Tacker is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the iMESH Tacker's performance validation is based on objective physical and mechanical performance data, specifically:

• Fixation Force measurements: Quantifying the force required for a tack to remain in place on implantation and after a set period (14 days).
• Comparison to Predicate Device Performance: The primary "ground truth" or benchmark is the established mechanical performance of a legally marketed predicate device (Covidien Absorbatack). The claim of substantial equivalence hinges on demonstrating that the iMESH Tacker's performance characteristics align with or are superior to the predicate, within acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. The iMESH Tacker is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this context.

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