(88 days)
Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material.
The provided text describes a 510(k) premarket notification for the Mesynthes Endoform™ Reconstructive Template surgical mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in the way a novel device might.
Therefore, the information you're requesting regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of specific performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply directly to this 510(k) summary.
Instead, the submission focuses on demonstrating that the new device has "technological characteristics and substantial equivalence" to existing predicate devices.
Here's an breakdown based on the information provided, keeping in mind the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the format of defined metrics and targets for clinical performance that the device directly "meets." Instead, the acceptance is based on demonstrating similarity to predicate devices through a series of non-clinical performance tests and animal testing.
The "performance" described is about demonstrating similarity or equivalence to predicates, rather than achieving specific quantitative clinical thresholds.
| Test Type | Comparison/Performance Description |
|---|---|
| Non-Clinical Biophysical Tests | The Endoform™ Reconstructive Template performed similarly to its predicate devices in: |
| - Ball burst strength | |
| - Uniaxial strength | |
| - Suture retention strength | |
| Biocompatibility Tests | The product meets biocompatibility requirements of the ISO standard (ISO10993-1) for: |
| - Cytotoxicity | |
| - Sensitization | |
| - Irritation | |
| - Systemic Toxicity | |
| - Subacute Toxicity | |
| - Genotoxicity (Ames, chromosomal aberration and mouse lymphoma) | |
| - Implantation | |
| Animal Testing (In vivo studies) | The performance was substantially equivalent to the predicate device based on: |
| - Incorporation into new tissue | |
| - Inflammatory response | |
| - Strength of the graft |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the individual biophysical, biocompatibility, or animal tests. It only states that these tests were "performed on finished, terminally sterilized product" and in "a model of soft tissue reinforcement" for animal studies. The data provenance is implied to be from internal lab testing by Mesynthes Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided in the context of this 510(k) submission. "Ground truth" established by experts is typically relevant for studies validating diagnostic algorithms or clinical evaluations, which were not conducted here as per Section 9.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) submission.
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 done. This type of study focuses on the impact of a device on human performance, often in diagnostic imaging, which is not relevant for a surgical mesh device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a surgical mesh device. Standalone performance refers to the accuracy of an automated system without human intervention, typically in AI/diagnostic applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical and animal studies, "ground truth" implicitly refers to the established scientific and engineering standards for measuring device properties (e.g., strength, biocompatibility), and histopathological or physiological assessment in animal models for tissue integration and inflammatory response. These are not typically established via expert consensus in the same way as clinical diagnostic accuracy.
8. The sample size for the training set
This information is not applicable/not provided. "Training set" is a concept related to machine learning and AI development, which is outside the scope of this medical device submission.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.