(258 days)
PREMIUM are surgical meshes that are indicated 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.
PREMIUM medical devices are surgical meshes with light polypropylene. They are non resorbable parietal reinforcement implants.
The provided document describes a 510(k) premarket notification for a medical device called "PREMIUM", which is a surgical mesh. The document details the device's characteristics, intended use, and a summary of performance data to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it refers to conformance with a special control "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh." The reported device performance is that it "conforms to the special control" and the testing "demonstrates that PREMIUM is as safe, as effective, and performs as safety and effectively as its predicate devices."
The specific tests performed are listed, with the implicit acceptance being that the results are comparable or equivalent to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conforms to "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" | PREMIUM conforms to the special control guidance. |
| Tensile strength comparable to predicate | Performed. Implicitly comparable or equivalent to predicate. |
| Stiffness comparable to predicate | Performed. Implicitly comparable or equivalent to predicate. |
| Suture pullout strength comparable to predicate | Performed. Implicitly comparable or equivalent to predicate. |
| Burst strength comparable to predicate | Performed. Implicitly comparable or equivalent to predicate. |
| Tear resistance comparable to predicate | Performed. Implicitly comparable or equivalent to predicate. |
| As safe, effective, and performs as safely and effectively as predicate devices. | Non clinical performance testing demonstrated that PREMIUM is as safe, as effective, and performs as safely and effectively as its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "No clinical data has been presented." This means that the testing was non-clinical. Therefore, there is no test set in the sense of patient data. The "test set" likely refers to the samples of the PREMIUM surgical mesh used for the physical and mechanical property testing.
- Sample Size: Not specified for each test (Tensile strength, Stiffness, etc.).
- Data Provenance: Not applicable as no clinical data was used. The testing was laboratory-based, likely performed by the manufacturer (Cousin Biotech).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Since "No clinical data has been presented," there was no need for experts to establish ground truth on a patient test set. The ground truth for the non-clinical performance tests would be established by validated test methods and reference standards, interpreted by engineers or technicians.
4. Adjudication Method for the Test Set
Not applicable. As no clinical data was used, there was no need for an adjudication method by medical experts for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.
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.
7. The Type of Ground Truth Used
The ground truth used for this non-clinical submission is based on physical and mechanical property measurements of the device (PREMIUM surgical mesh samples). The performance is compared against the known properties and established safety/effectiveness profile of the predicate device (PROLENE SOFT), which presumably has its own performance data and regulatory history. The "acceptance criteria" are implied by conformance to a specific FDA guidance document for surgical meshes, which outlines the required non-clinical tests.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm. The "training" for the manufacturing process would refer to quality control and process validation, which is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 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.