(156 days)
PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
PARIETEX™ Plug and Patch is a kit composed of:
• A pre-cut non absorbable patch made out of polyester monofilament.
• A semi-absorbable disk made from the assembly of two textile layers. This disk is composed of polyester monofilament and polylactic acid monofilament.
The provided document is a 510(k) summary for the PARIETEX™ Plug and Patch surgical mesh. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies with specific performance metrics for acceptance criteria in the way a new drug or novel AI device would.
Based on the provided text, there is no detailed information about specific acceptance criteria or an analytical or clinical study designed to prove the device meets such criteria in terms of outcomes or effectiveness on patients. The submission relies on demonstrating technological characteristics equivalency and bench testing.
Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility | In compliance with ISO 10993-1 and/or USP standards. |
| Technological Characteristics | Similar to predicate devices: BARD® MESH PERFIX® PLUG (K922916), PARIETEX PROGRIP™ Mesh (K081050), PARIETEX™ Lightweight Monofilament Polyester Mesh (K090858), PARIETEX™ PARASTOMAL MESH (K081126). |
| Performance Characteristics | Equivalent to predicate devices: PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh, and BARD® Mesh PerFix® Plug (demonstrated via bench testing). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for bench testing.
- Data Provenance: The "Performance Data" section mentions "Bench testing has been conducted," implying laboratory-based testing rather than clinical data from human subjects. No country of origin is specified for this testing. It is inherently retrospective in the sense that it's pre-market testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The evaluation is based on material properties and mechanical performance, not expert-adjudicated clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No clinical adjudication is described.
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, an MRMC comparative effectiveness study was not done. This is a medical device (surgical mesh), not an AI diagnostic or assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to ISO 10993-1 and/or USP standards.
- For technological characteristics: Direct comparison to predicate device specifications (e.g., materials, knitted structure).
- For performance characteristics: Results from bench testing (likely mechanical strength, tear resistance, burst strength, etc., though specific metrics are not detailed). The "ground truth" here is the established mechanical properties of the predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a "training set."
Summary of the Study Proving Acceptance Criteria:
The "study" described in this 510(k) summary is primarily focused on bench testing and demonstrating substantial equivalence to already legally marketed predicate devices. The submission indicates that:
- The PARIETEX™ Plug and Patch is made of biocompatible materials that comply with recognized standards (ISO 10993-1, USP).
- Its technological characteristics (e.g., construction from knitted polyester monofilament and polylactic acid) "are similar to those of the predicate devices."
- "Bench testing has been conducted to evaluate the performance characteristics" and has shown the device to be "equivalent in performance characteristics to the predicates PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh and BARD® Mesh PerFix® Plug."
The document does not detail the specific parameters or results of this bench testing, but the FDA's clearance implies satisfaction with this evidence for substantial equivalence. The "acceptance criteria" here are implicitly that the new device's material properties and mechanical performance attributes are within the acceptable range or "equivalent" to the established performance of the predicate devices.
§ 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.