(687 days)
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
This document is a 510(k) summary for the Shelhigh No-React® Dura Shield, a Class II medical device intended as a dura substitute for closure of dura mater during neurosurgery.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum degradation rate) or a direct comparison of the device's performance against such criteria in a tabular format. Instead, it relies on demonstrating substantial equivalence to a predicate device.
The reported performance aspects, derived from the text, are descriptive rather than quantitative, and are primarily focused on equivalence and biocompatibility:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate | - "Substantially equivalent to the Dura Guard® manufactured by Bio-vascular and identical to the Shelhigh No-React® pericardial Patch manufactured by Shelhigh Inc." |
- "Exhibits substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" to the predicate devices.
- "The Shelhigh No-React® performance in a substantially equivalent to the predicate device and there were no significant differences between the two devices which pose new questions of safety and effectiveness." |
| Biocompatibility | - "The material exhibits excellent biocompatibility." - "An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher level of biocompatibility."
- "The non clinical /Animal testing data showed that the Shelhigh No-React® patch has high level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage." |
| Mechanical Properties | - "The material exhibits good tensile strength, shrink temperature and suture retention." - "The material reapproximates well around suture holes."
- "It is soft and pliable making it convenient to implant." |
| Sterility / Packaging | - "The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar." (Implied acceptance for sterility) |
| Effectiveness of No-React® Process | - "Extensive validation of the effectiveness of the Patch with the Extonoro validation process, No-React® indicates that these differences do not pose new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions an "animal study" to evaluate biocompatibility.
- Sample Size: The specific sample size for the animal study is not provided.
- Data Provenance: The study was an "animal study," but the country of origin or whether it was retrospective or prospective is not specified.
Physical/mechanical test information is "discussed above" in relation to substantial equivalence, implying laboratory testing, but specific sample sizes for these tests are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document describes a device for surgical implantation, not an interpretive diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of a test set (e.g., for image interpretation) is not applicable in the way it might be for an AI diagnostic tool.
The "ground truth" for the animal study would be scientific observations of biocompatibility, tissue response, and macroscopic/microscopic examination, and these would be conducted by qualified veterinarians, histopathologists, and researchers, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set:
Given that this is not an interpretive diagnostic device, an "adjudication method" in the sense of reconciling expert opinions on diagnoses is not applicable.
For the animal study, it's reasonable to assume standard scientific practices for data collection, analysis, and interpretation were followed, potentially involving multiple researchers and statistical analysis, but a specific "adjudication method" is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is typically performed for diagnostic devices where human readers interpret cases with and without AI assistance. This is a standalone medical device (dura substitute) for surgical implantation, not a diagnostic tool that assists human readers.
Therefore, an MRMC comparative effectiveness study was not performed, and is not applicable for this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This device is a physical implant, not an algorithm. Therefore, the concept of a "standalone" study for an algorithm's performance is not applicable. The performance evaluated is the physical and biological performance of the material itself.
7. Type of Ground Truth Used:
The primary "ground truth" used for this device includes:
- Physical/Mechanical Properties: Bench testing data (suture retention, tensile strength, shrink temperature).
- Biocompatibility: Animal study observations and histological findings. These would typically be confirmed by pathology and scientific consensus within the study.
- Clinical Outcomes/Safety in Predicate: The long history of successful use of glutaraldehyde processed bovine pericardium as a permanently implanted material (mentioned in the product description) provides a form of "ground truth" for similar materials.
8. Sample Size for the Training Set:
The concept of a "training set" is primarily relevant for AI/machine learning algorithms. This device is a physical product, not an algorithm, so there is no training set in that context.
The manufacturer likely has internal data and experience from manufacturing previous batches and product iterations, but this isn't a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the development and testing of the Shelhigh No-React® Dura Shield would have been established through standard material science, biocompatibility testing, and preclinical animal models.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).