(44 days)
The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.
The proposed device is a self-expanding, two-layered polypropylene mesh containing an extruded monofilament PET polymer "ring". The top layer of polypropylene mesh has two slits in it to form pockets. The purpose of the pockets is to facilitate placement, positioning and fixation of the device. The mesh is constructed from knitted polypropylene monofilament. The monofilament PET "ring" adds stability to the device facilitating placement and assurance in the proper placement of the patch. A single layer of expanded polytetrafluoroethylene (ePTFE) is attached to the polypropylene mesh. The attachment is accomplished with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge (excluding the off-center opening) of the polypropylene mesh is heat sealed to the ePTFE layer. An off-center opening in the proposed device accommodates the stoma and this opening is surrounded by an ePTFE collar. The ePTFE collar is attached to the mesh side of the proposed device with an interlocking stitch using PTFE monofilament. A slit in the proposed device extends from the opening in the proposed device to the perimeter to facilitate positioning of the proposed device around the stoma. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.
The provided document describes the Bard CK Parastomal Hernia Patch (K042026) and its comparison to predicate devices for 510(k) clearance. The focus of the performance data section is on biocompatibility and bench testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device evaluations.
Here's an analysis based on the provided text, addressing the requested information where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are non-toxic and non-sensitizing to biological tissues | Test results show materials are non-toxic and non-sensitizing consistent with intended use. |
| Bench Testing: Device design and materials meet established specifications for consistent performance during intended use. | Laboratory test results demonstrate materials chosen and design utilized meet established specifications for consistent performance. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set with human subjects or a dataset for AI/ML evaluation. The "tests" mentioned are biocompatibility and bench tests performed on the device itself. Therefore, sample sizes and data provenance in the context of human data are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth as typically defined for AI/ML device evaluation (e.g., expert consensus on medical images or patient outcomes) is not mentioned or required for this type of device and submission.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as no clinical or image-based test set needing expert review is used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh; the evaluation focuses on its physical and biological properties rather than its effectiveness in aiding human readers with diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on established industry standards and regulatory requirements for biocompatibility and mechanical/material properties of surgical meshes. For biocompatibility, this would involve standardized in vitro and in vivo tests to assess cytotoxicity, sensitization, irritation, etc. For bench testing, it refers to pre-defined specifications for material strength, flexibility, porosity, and other physical attributes relevant to its function as a hernia patch.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.