(141 days)
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
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Strength Testing | Demonstrate adequate mechanical strength for its intended use. | Device passed all tests and successfully met all acceptance criteria. |
| Functional Testing | Demonstrate proper function and operation as intended. | Device passed all tests and successfully met all acceptance criteria. |
| In-vivo Degradation Tests | Demonstrate predictable and safe degradation in biological systems. | Device passed all tests and successfully met all acceptance criteria. |
| Mechanical testing | Demonstrate mechanical properties meet specifications. | Device passed all tests and successfully met all acceptance criteria. |
| Use simulation test | Demonstrate safe and effective performance during simulated use. | Device passed all tests and successfully met all acceptance criteria. |
| Endotoxin testing | Meet pyrogenicity limits. | Device passed all tests and successfully met all acceptance criteria. |
| Shelf life using real-time aging | Maintain sterility and functional integrity over its shelf life. | Device passed all tests and successfully met all acceptance criteria. |
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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.