(24 days)
Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
The provided text describes a 510(k) summary for the Ocu-Guard Supple Orbital Implant Wrap, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way that might be seen for a new, complex algorithm or diagnostic device.
Therefore, many of the requested categories for acceptance criteria and study design are not directly applicable or extractable from this type of regulatory submission. The submission is primarily interested in showing that a modification to an existing product (adding a 1M NaOH treatment) does not negatively impact its safety or effectiveness compared to the previous version of the product.
Here's an attempt to answer as much as possible based on the provided text, with clarifications where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as thresholds, but implied to show no significant difference) | Reported Device Performance |
|---|---|---|
| Material Properties | No significant difference in shrink, suture, and thickness for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
| Biocompatibility | No significant difference in biocompatibility for NaOH-treated vs. non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility. |
| Inflammation | No significant difference in inflammation for NaOH-treated vs. non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in inflammation. |
| Safety Testing | No significant difference in bioburden, sterility, pH, and pyrogen for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
| Chemical Testing | No significant difference in chemical characteristics for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the "test" (NaOH-treated) and "control" (non-NaOH-treated) groups for the various tests (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical, biocompatibility, animal testing).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a manufacturing change, the data would typically be generated by the manufacturer (Bio-Vascular, Inc.) during product development and testing, implying a prospective and in-house provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the type of device and study described. The "ground truth" here is objective laboratory measurements (e.g., shrink, suture strength, pH values) and observations in animal models by scientists/technicians, not expert medical opinion on, for example, diagnostic images.
4. Adjudication method for the test set
Not applicable. This device's evaluation is based on objective measurements and animal studies, not subjective assessments requiring adjudication among experts.
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 not an AI/imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this evaluation was based on a combination of:
- Physical property measurements: Shrinkage, suture retention, thickness.
- Biochemical/Microbiological assays: Bioburden, sterility, pH, pyrogen, chemical analysis.
- Biological responses in animal models: Biocompatibility and inflammation, observed in animal testing.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets. The study described involves comparing two versions of a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this product.
§ 886.3340 Extraocular orbital implant.
(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.