(194 days)
The Kensey Nash Bioresorbable Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tissue attachment to the bioresorbable surgical mesh is minimized in case of direct contact with the viscera.
The Kensey Nash Bioresorbable Mesh is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The Kensey Nash Bioresorbable Mesh is available in various sizes and thickness for use in maintaining the relative position of healing tissues. The implants maintain the stability of soft tissues during the healing period and minimize the attachment of the device. The Kensey Nash Bioresorbable Mesh material is subsequently reabsorbed by the body once the soft tissues have healed. The implants are not intended for use where permanent implants are required.
This document is a 510(k) premarket notification for a medical device called the "Kensey Nash Bioresorbable Surgical Mesh". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a PMA (Premarket Approval) application.
Medical devices cleared through the 510(k) pathway do not typically involve the type of acceptance criteria and clinical study designs seen in AI/software as a medical device (SaMD) or drug approval processes. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise different questions of safety and effectiveness.
Therefore, the requested information (acceptance criteria, specific study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is generally not applicable to a 510(k) submission for a physical medical device like a surgical mesh. These questions are more relevant to performance studies for diagnostic devices, AI algorithms, or clinical trials for drug products.
However, I can extract information related to the demonstration of "substantial equivalence" as it functions similarly to meeting "acceptance criteria" for physical devices. The "study" in this context is the comparison to predicate devices, supported by in vitro and in vivo testing.
Here's an attempt to adapt your request to the provided document, focusing on "substantial equivalence" as the "acceptance criteria":
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The "acceptance criteria" for the Kensey Nash Bioresorbable Surgical Mesh are met by demonstrating substantial equivalence to legally marketed predicate devices. This demonstration involves showing that the new device has the same intended use and substantially equivalent technological characteristics (design, materials, mechanical performance) to the predicates, and that any differences do not raise new questions of safety or effectiveness.
The "study" proving this substantial equivalence primarily involved comparative analysis with predicate devices, supported by in vitro and in vivo testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as demonstrated in the submission) |
|---|---|
| Intended Use: Identical to predicate devices. | The Kensey Nash Bioresorbable Surgical Mesh shares identical indications for use principles with the predicate devices (MacroPore Surgi-Wrap (TS) and MacroPore Surgi-Wrap MAST). Both are indicated for temporary wound support, reinforcing soft tissues, and repair of hernia/fascial defects, minimizing tissue attachment to viscera. |
| Design Principles: Substantially equivalent to predicates. | Physical designs are substantially equivalent, consisting of thin, semi-rigid, bioresorbable sheets manufactured by the same process. Both allow for contouring when heated (e.g., Kensey Nash device and Surgi-Wrap predicate are fully contourable at ~55°C). |
| Materials: Identical or substantially equivalent. | Made from the identical bioresorbable PLA raw material: amorphous biodegradable copolymer 70:30 poly (L-lactide-co, DL-lactide). |
| Physical Characteristics (Thickness, Shapes, Sizes): Substantially equivalent to predicates. | Thickness: Thinnest device (0.02mm) is identical to the Surgi-Wrap predicate. Sizes: Rectangular sheets ranging from 25mm x 25mm to 500mm, with thickness ranges from 0.02mm to 1.0mm, substantially equivalent to predicates. Both can be cut to specific shapes/sizes by the end user. |
| Mechanical Characteristics: Substantially equivalent. | Mechanical characteristics are substantially equivalent to the predicate devices with respect to mechanical strength. (Specific quantitative comparisons are not detailed in this excerpt but are implied to be part of the full submission). In vitro testing showed inherent viscosity remained appropriate when heated. Aging and mechanical testing for adequacy for indications. |
| Safety and Efficacy: Demonstrated via testing. | In Vitro Testing: Confirmed material integrity and stability when heated (relevant for surgical preparation). Aging and mechanical testing supported adequacy for indications. |
| In Vivo Testing: Animal studies shown to demonstrate the device material is safe and efficacious for the indications for use. | |
| Biocompatibility/Resorption: Consistent with predicates. | Material degrades and resorbs in vivo by hydrolysis and is metabolized by the body into CO2 and H3O, consistent with the known behavior of the identical raw material also used in predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- In Vitro Testing: The document mentions "Testing has shown inherent viscosity remains within an appropriate range over 120 minutes when heated to 60°C in saline" and "Aging and mechanical testing shows that the device material is adequate."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; likely internal lab testing by Kensey Nash Corporation.
- Retrospective/Prospective: These are typically controlled, prospective laboratory studies.
- In Vivo Testing: The document states "The animal studies have shown that the device material is safe and efficacious for the indications for use."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; generally conducted in research institutions or CROs, often within the US or compliant with international standards.
- Retrospective/Prospective: These are typically prospective animal studies.
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)
- Not applicable in the context of this 510(k) submission for a physical surgical mesh. This type of expert ground truth establishment is primarily for diagnostic devices or AI algorithms. The assessment of substantial equivalence relies on engineering and biological comparative analysis, and animal study results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments, especially in clinical trials or for diagnostic image interpretation. The tests conducted here (inherent viscosity, mechanical testing, animal studies) rely on objective measurements and observations, which do not require interpretive adjudication in the same manner.
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
- Not applicable. MRMC studies are for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers interpreting cases. This device is a surgical implant, not an imaging or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical mesh, not an algorithm or software. Its performance is inherent to its material properties and design, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the comparative analysis to predicate devices, the "ground truth" for substantial equivalence is derived from:
- Predicate Device Specifications: The established indications, design, materials, and mechanical properties of the legally marketed predicate devices (MacroPore Surgi-Wrap and MacroPore Surgi-Wrap MAST).
- Objective Measurements: Results from in vitro (e.g., inherent viscosity, mechanical strength) and in vivo (e.g., safety, efficacy, tissue response in animal models) testing of the Kensey Nash Bioresorbable Surgical Mesh, which are then compared to the expected performance of or actual data from the predicate devices (if available/required for comparison).
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for a physical medical 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.