(86 days)
PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.
Acceptance Criteria and Device Performance Study for PROCEED* Trilaminate Surgical Mesh
The provided document describes the predicate equivalence of the PROCEED* Trilaminate Surgical Mesh. The nature of this submission (a 510(k) for a medical device) means that the "acceptance criteria" are primarily related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics with predefined thresholds like a diagnostic AI model.
The study presented focuses entirely on non-clinical laboratory and in-vivo animal testing to demonstrate comparability and intended performance. It does not involve human readers, AI algorithms, or clinical trials with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Findings) |
|---|---|
| Technological Characteristics: The device should have similar technological characteristics to the predicate devices. | PROCEED* has similar technological characteristics as the predicate devices. The addition of an Oxidized Regenerated Cellulose (ORC) layer to the standard base surgical mesh material is common to other predicate devices (W.L. GORE & Associates, Inc. DualMesh** Biomaterial (K963619), the Genzyme Corp. Sepramesh** Biosurgical Composite (K994328) and the Bard Composix** Mesh (510K K971745), with a performance characteristic of minimizing tissue attachment to the base mesh material. With the addition of the ORC layer, the PROCEED* Mesh continues to meet the functional requirements of a surgical mesh. |
| Performance: The device should perform comparably to standard surgical mesh devices indicated for hernia repair and other fascial deficiencies. | Non-clinical laboratory testing was performed, demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Additionally, in-vivo testing was provided, showing that the device performed as intended and as claimed. |
| Intended Use/Indications: The device's intended use and indications for use should be consistent with predicate devices. | The intended use for PROCEED* Mesh is for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result, which is consistent with the predicate device (PROLENE Soft Polypropylene Mesh) and other similar mesh products. |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical laboratory testing and in-vivo testing.
- Sample size for test set: Not explicitly stated. The nature of the non-clinical lab and in-vivo testing (which implies animal studies in this context) would typically involve specific numbers of samples or animals, but these are not provided in this summary.
- Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would primarily be generated by the manufacturer (Ethicon, Inc.) through their own testing facilities or contracted labs. The "in-vivo testing" suggests animal studies were conducted. It is retrospective in the sense that the testing was completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for a surgical mesh device would be derived from physical property measurements and biological responses in animal models, not expert interpretations of data.
4. Adjudication method for the test set
This question is not applicable. There is no adjudication method described as the study does not involve human interpretation or consensus for a test set.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a surgical mesh and does not involve AI assistance, human readers, or diagnostic performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm only) performance study was not done. This study is for a surgical mesh and does not involve any algorithms or AI.
7. The type of ground truth used
The ground truth used for this type of device would be:
- Benchtop Data: Physical and mechanical properties of the mesh (e.g., tensile strength, pore size, burst strength, pliability) compared to predicate devices and engineering specifications.
- In-vivo (Animal) Data: Biological response and performance in animal models (e.g., tissue integration, adhesion formation, inflammatory response, degradation profile, functional outcome related to hernia repair).
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI surgical device. All testing described falls under verification and validation activities.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned or implied by the type of device and study.
§ 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.