(93 days)
The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.
The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.
The provided document is a 510(k) premarket notification for the Shelhigh No-React® EnCuff Patch, which is a surgical mesh. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria and performance studies in the way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain details of specific acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device). Instead, it focuses on demonstrating technological characteristics and intended use are substantially equivalent to a legally marketed predicate device.
However, based on the information provided, we can infer some "acceptance criteria" in the context of a 510(k) and outline the "study" (bench testing and comparison) used to support equivalence.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferrred from 510(k) Submission) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence | "The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery." This is identical to the predicate device's intended use. |
| Technological Characteristics Equivalence | - "The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process." |
- "The device is provided sterile in 2% benzyl alcohol solution."
- "Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc." |
| Material Properties (Bench Testing) | - "Shelhigh EnCuff material exhibits good tensile strength," - "shrink temperature,"
- "and suture retention."
- "The material reapproximates well around suture holes."
- "It is soft and pliable." |
| Biocompatibility | "The material exhibits excellent biocompatibility, and passed the requirements of all tests." |
| Substantial Equivalence Conclusion | "This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical test sets for performance metrics. The submission refers to material testing, where "sample size" would relate to the number of material specimens tested for physical properties. This specific number is not provided.
- Data Provenance: Not applicable in the context of clinical test sets. The material testing would be conducted in a laboratory setting by the manufacturer, Shelhigh Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is a 510(k) submission for substantial equivalence based on material properties and intended use, not a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a surgical mesh 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- For the material properties, the "ground truth" would be established by standardized laboratory testing methods against pre-defined specifications (though the exact specifications are not detailed in this summary). For biocompatibility, it refers to "passed the requirements of all tests," indicating compliance with established biocompatibility standards.
- For the overall determination of substantial equivalence, the "ground truth" is a comparison to the characteristics and intended use of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.