(79 days)
The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.
The Shelhigh No-React® PneumoPledgets strips are glutaraldehyde fixed sheet of bovine pericardium. They are held on the stapler by a unique design of a loop on the anterior part of the PneumoPledgets. It holds the strip by inserting the pointed edge of the staple into the loop. The posterior part (if needed) is held by an "O" ring made of pericardium as well. The PneumoPledgets. strips are customized to fit all sizes and types of staples. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar.
The material exhibits good tensile strength, shrink temperature excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant.
Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
This document describes a 510(k) premarket notification for the Shelhigh No-React® PneumoPledgets, a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, the information provided does not align directly with the typical structure of an AI/software-based device study.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a physical medical device (bovine pericardial patch), not an AI/software device. Its performance is evaluated through physical/mechanical properties and biocompatibility, not typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture Retention | Substantially equivalent to predicate devices. |
| Tensile Strength | Substantially equivalent to predicate devices. |
| Shrink Temperature | Substantially equivalent to predicate devices. |
| Flexibility | Identical to Shelhigh pericardial patch (predicate). |
| Wall Thickness | Identical to Shelhigh pericardial patch (predicate). |
| Shapes and Sizes | Identical to Shelhigh pericardial patch (predicate). Customization to fit all sizes and types of staples. |
| Biocompatibility | Higher level of biocompatibility than conventional glutaraldehyde-treated patches. High level of cytocompatibility compared to conventional glutaraldehyde treated and storage. Detoxification process ("No-React®") validated to not pose new safety/effectiveness questions. Bovine pericardial material has a long history of success as a permanently implanted material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The study conducted was an animal study, not a human clinical trial. The text refers to "an animal study" without specifying the number of animals.
- Data Provenance: The study was an "animal study." No information on the country of origin. It would be considered prospective in the context of comparing the new device against conventional treatment in the animal model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and study. The evaluation of biocompatibility in the animal study would likely be performed by veterinary pathologists or toxicologists, but no details are provided. This is not an image-based diagnostic AI device requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The animal study would involve direct observation and potentially histological analysis by trained personnel, not adjudication among human readers as in an AI study.
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
Not applicable. This is a physical medical device, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used
The ground truth for the animal study was based on direct biological and histological observations and measurements of biocompatibility in the animal model. This would include parameters like tissue reaction, inflammation, and potential adverse effects compared to the control group (conventional glutaraldehyde treated patch).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The device's manufacturing process and materials are established through engineering design, material science, and prior experience with similar glutaraldehyde-treated bovine pericardium.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI model. The "ground truth" for the device's design and manufacturing relies on established biological and material science principles for medical implants, including understanding the properties of bovine pericardium and the effects of glutaraldehyde processing. The "No-React®" detoxification process was validated to improve biocompatibility.
§ 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.