(32 days)
Surgisis is intended for implantation to reinforce soft tissue. The device is intended for one-time use.
Surgical mesh
This document is a Special 510(k) Premarket Notification for a medical device called Surgisis®, a surgical mesh. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on performance during testing.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria nor reported device performance data in the typical sense of a clinical or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through a comparison of characteristics. The document states:
- "Both pass the same set of internal tests and release criteria."
However, the specific "internal tests and release criteria" are not detailed, nor are the quantitative results of these tests provided.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission hinges on substantial equivalence based on material and process similarities, not on a test set of data from a study.
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)
This information is not applicable and therefore not provided. Since there is no described test set involving human assessment, there are no experts establishing ground truth in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. There is no described test set requiring human adjudication.
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 is not mentioned and is not applicable here. This document is for a surgical mesh, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as Surgisis® is a physical surgical mesh, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable in the context of the provided document. The regulatory submission relies on demonstrating that the device is "substantially equivalent" to an already approved predicate device, meaning it has the same intended use, operating principles, basic design, materials, shelf-life, and passes the same internal tests and release criteria. The "ground truth" here is the established safety and effectiveness of the predicate device, which is inferred by the similarities.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set.
Summary of Acceptance Criteria and Study:
The provided document is a Special 510(k) submission for a surgical mesh (Surgisis®). The regulatory pathway for this device, a 510(k), primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new, elaborate clinical or performance studies with specific statistical acceptance criteria for device performance as one might see for novel high-risk devices or AI/ML technologies.
The "acceptance criteria" and "study" in this context are interpreted as the comparison points and the process of demonstrating substantial equivalence:
| Acceptance Criteria (Demonstrated Similarity to Predicate) | Reported Device Performance (as stated in the submission) |
|---|---|
| Same intended use | "Both have the same intended use." |
| Same operating principles | "Both use the same operating principles." |
| Same basic design | "Both incorporate the same basic design." |
| Same materials | "Both incorporate the same materials." |
| Same shelf-life | "Both have the same shelf-life." |
| Pass same set of internal tests and release criteria | "Both pass the same set of internal tests and release criteria." (Specific tests and results not detailed in submission for public review, but affirmed to be the same) |
| Packaged and sterilized using same materials and processes | "Both are packaged and sterilized using the same materials and processes." |
The "study" that proves the device meets these "acceptance criteria" is the Special 510(k) submission itself, which presents a direct comparison between the new Surgisis® device and its identified predicate. The "proof" lies in the detailed technical information provided to the FDA (which is not fully available in this excerpt) asserting these similarities and justifying that a process change did not affect specifications or performance. This is a regulatory assessment, not a scientific study with a traditional experimental design, test sets, or ground truth adjudication by experts in the sense of AI/ML or diagnostic device validation.
§ 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.