(90 days)
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
This document is a 510(k) premarket notification for the Miromatrix Biological Mesh RS, declaring its substantial equivalence to a previously cleared predicate device, the Miromatrix Biological Mesh (K134033). As such, it does not describe a study involving acceptance criteria and device performance in the typical sense of a rigorous clinical or standalone performance study for an AI/device algorithm.
Instead, the core of this submission is to demonstrate that the new device (Miromatrix Biological Mesh RS) is substantially equivalent to a legally marketed predicate device (Miromatrix Biological Mesh, K134033). This means that the acceptance criteria are implicitly met by demonstrating sameness or very similar characteristics and performance to the predicate device, which has already been deemed safe and effective.
Here's an breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present due to the nature of a 510(k) substantial equivalence submission for a physical medical device (not an AI algorithm):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as numerical thresholds in this document for a "new" device performance study. Instead, the "acceptance criteria" are effectively that the new device (Miromatrix Biological Mesh RS) is identical in materials and design and has similar indications for use and the same intended use as the predicate device (Miromatrix Biological Mesh, K134033). The "reported device performance" is essentially the equivalence shown in the comparison table.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Materials & Design | Single-layer biologic mesh derived from porcine liver tissue; acellular, not cross-linked; provides scaffold; terminally sterilized, hydrated, moist, flexible. | Identical: Single-layer biologic mesh derived from porcine liver tissue. The mesh is acellular and not cross-linked. The mesh provides a scaffold during tissue repair. The mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. |
| Indication for Use | Intended to be implanted to reinforce soft tissue. | Similar: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. (The document argues this extension to plastic/reconstructive surgery does not raise new safety/effectiveness questions and thus is similar, not a new intended use). Note: This is the primary point of differentiation from the predicate, but it's argued not to be a significant difference. |
| Sizes | Available in various sizes; can be cut to shape. | Identical: Available in sizes ranging from 1x2cm to 20x30cm. Can be cut to shape. |
| Thickness | 0.5-3 mm | Identical: 0.5-3 mm |
| Tissue Origin | Porcine | Identical: Porcine |
| Single Use | Yes | Identical: Yes |
| Sterile | Yes | Identical: Yes |
| Biocompatibility, Bench, Animal Testing | (Met by predicate device, K134033) | No New Testing Required: "Because the materials and design of the subject Miromatrix Biological Mesh RS are identical to that of the predicate Miromatrix Biological Mesh (K134033), no new biocompatibility, bench or animal testing is required to support the substantial equivalence to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This is not a study assessing performance on a test set of data. It's a regulatory submission demonstrating equivalence of a physical medical device to an existing one.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not an AI algorithm.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
- Not applicable in the context of an AI algorithm. For this physical device, the "ground truth" for its safety and effectiveness is established by the prior clearance of the predicate device (K134033) and the demonstration that the subject device is essentially the same.
8. Sample Size for the Training Set
- Not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI algorithm.
In summary: The provided text is a 510(k) premarket notification for a physical medical device (surgical mesh), not an AI algorithm. The core of such a submission is to argue that a new device is "substantially equivalent" to an already cleared predicate device. Therefore, the questions related to studies, test sets, training sets, ground truth, and expert adjudication, which are typical for AI/algorithm performance evaluations, are not addressed in this type of document. The "acceptance criteria" here are met by the demonstration of material, design, and functional similarity to the predicate device.
§ 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.