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SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.

SupraMESH EXTRA™ nylon mesh is an 18" x 18" mesh panel woven from USP size 3-0 SUPRAMID EXTRA® nylon suture (FDA N80-838). The nylon used to manufacture this SUPRAMID EXTRA® nylon suture (FDA N80-838) is nylon 6. The knit description of the SupraMESH EXTRA™ nylon mesh panel is 1 x 1 Tricot stitch mesh.

This document is a 510(k) premarket notification for a medical device called SupraMESH EXTRA™. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets a new set of acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document asserts "substantial equivalence" based on the predicate device. It doesn't define new acceptance criteria that the SupraMESH EXTRA™ device must meet with new performance data. The "performance" is considered equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. This is a substantial equivalence submission, not a study with a test set. There are no new patient data presented to evaluate the device.
• Data Provenance: Not applicable for a performance study. K831723, K852011, and K831724 are prior 510(k) notifications for the predicate devices. The current submission relies on the established safety and effectiveness of these predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. No ground truth establishment for a new test set is described.

4. Adjudication Method for the Test Set:

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not mentioned or implied.

6. Standalone Performance Study (Algorithm only without human-in-the-loop):

• No. This is not an AI/algorithm device.

7. Type of Ground Truth Used:

• The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices (Supramid Extra Surgical Mesh, FDA K831723, K852011, and K831724) based on their prior clearances and regulatory history. The current device is being compared to these, not to raw pathology or outcomes data.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

In summary: This document is a 510(k) summary for a medical device. It demonstrates substantial equivalence to previously cleared predicate devices rather than presenting the results of a new clinical or performance study against specific acceptance criteria. Therefore, most of the questions related to new performance testing, sample sizes, and expert review do not apply to this type of submission.

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The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference in...(the) article by James L. Sheehy, M.D. It has also been used to separate nerves and tendons from surrounding tissue to prevent adhesions during healing and then removed after healing is complete. It has been used to repair or replace dura matter in the skull, and in heavier thicknesses it has been attched to bones to give added strength where necessary.

Sterile SupraFOIL Smooth Nylon Foil Sheets

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device called "Sterile SupraFOIL Smooth Nylon Foil Sheets". It states that the device is "substantially equivalent" to a legally marketed predicate device, meaning it doesn't require a new efficacy study.

Therefore, the text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts, or adjudication methods for establishing ground truth.
3. Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
4. Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

Ask a specific question about this device