(84 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.
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
| Acceptance Criteria (Comparison to Predicate: Absorbatack K071061) | Reported Device Performance (iMESH Tacker) |
|---|---|
| Indications for Use: Identical for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair. | Met (Identical) |
| Technology: Similar technology including in-line handle, tip, and pre-loaded tacks. | Met (Similar) |
| Material: Identical to predicate device (Absorbatack). | Met (Identical) |
| Environment of Use: Identical (Hospitals, sub-acute care institutions, and surgery centers). | Met (Identical) |
| Performance Specifications - Fixation Force (Degradation and Consistency): Similar to predicate (Absorbatack). | On Implantation: 17.07 N (iMESH Tacker) vs. 16.46 N (Absorbatack) - Similar |
| After 14 Days: 18.82 N (iMESH Tacker) vs. 8.35 N (Absorbatack) - Improved performance for iMESH Tacker, still deemed similar/acceptable. | |
| Mid-section average: 17.06 N (iMESH Tacker) vs. 11.50 N (Absorbatack) - Similar/Acceptable | |
| Upper and lower sections average: 17.08 N (iMESH Tacker) vs. 22.113 N (Absorbatack) - Similar/Acceptable |
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.
§ 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.