(88 days)
Ocu-Guard™ and Supple Ocu-Guard™ are 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 and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.
Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde.
Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm.
Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.
This 510(k) submission (K973552) for Ocu-Guard™ and Supple Ocu-Guard™ Orbital Implant Wrap does not contain detailed acceptance criteria or a specific study proving the device meets stated acceptance criteria in a format directly comparable to modern AI/ML device submissions. Instead, it relies on a demonstration of substantial equivalence to predicate devices. Therefore, the requested output in the format of acceptance criteria and device performance based on a standalone study cannot be fully extracted.
However, based on the provided text, we can infer the principles of acceptance and the types of studies performed to support the claim of substantial equivalence.
Here's an interpretation of the document in the requested format, with explanations where direct information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Specific Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Configuration (Sizes) | Substantially equivalent to predicate device sizes. | "The sizes of Ocu-Guard and Supple Ocu-Guard are substantially equivalent to those sold by the predicate device." |
| Extension of Indications | No new questions of safety and effectiveness for use as an orbital implant wrap compared to predicate material (ePTFE). | "Extension of these indications to include use as an orbital implant wrap does not pose new questions of safety and effectiveness." This is supported by the historical use of processed bovine pericardium in similar prosthetic applications. |
| Physical/Mechanical Properties | Properties important for performance as an orbital implant wrap are substantially equivalent to the predicate device. | "The physical and mechanical properties important for performance as an orbital implant wrap are substantially equivalent between Ocu-Guard/ Supple Ocu-Guard and the predicate device." |
| Biocompatibility | Long history of biocompatibility, consistent with clinical experience and testing. | "Processed bovine pericardium has a long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems. The biocompatibility testing summarized herein is consistent with this clinical experience." |
| In Vivo Performance (Rabbit Ocular) | Similar function to Peri-Guard and donor sclera in vivo. | "The rabbit ocular implant study shows that Peri-Guard and donor sclera appear to function in a similar manner, in vivo." (Note: The device being reviewed, Ocu-Guard, is a newer variant of Peri-Guard). |
| In Vivo Performance (Canine Implant) | Similar performance to ePTFE in vivo. | "A canine implant study shows that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo." (Note: Supple Peri-Guard is a predicate for Supple Ocu-Guard). |
| Clinical Performance | Safe and effective, and substantially equivalent to the predicate device. | "Preliminary clinical data indicates that our bovine material performs in a safe and effective manner, and in a substantially equivalent fashion to the predicate device." |
2. Sample size used for the test set and the data provenance
- Rabbit Ocular Implant Studies: Sample size is not specified. Likely retrospective, as it refers to a "study" without details on its design or start/end dates for this specific 510(k). Data provenance: Not specified (but likely within the US given the submission to FDA).
- Canine Implant Studies: Sample size is not specified. Likely retrospective. Data provenance: Not specified.
- Clinical Report: "Preliminary clinical data" is mentioned, sample size not specified. Likely retrospective from existing clinical use of the bovine material (Peri-Guard and Supple Peri-Guard). Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe "ground truth" in the context of expert consensus as relevant to AI/ML devices. The "truth" here is established through pre-clinical (animal) studies and preliminary clinical observations by researchers/clinicians, which are then evaluated by the FDA for substantial equivalence. No specific number or qualification of experts establishing ground truth in this manner is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The studies mentioned (animal, preliminary clinical) are experimental observations rather than assessments requiring adjudication of interpretations of data by multiple human readers.
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 submission predates the widespread use of sophisticated AI in medical devices and does not involve human readers interpreting images with or without AI assistance. The focus is on the material's biological and physical performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the animal studies (Rabbit Ocular Implant, Canine Studies) and the biocompatibility testing can be considered "standalone" evaluations of the device material's performance independent of human intervention in its function. These studies assess the biological and physical properties of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating substantial equivalence is primarily derived from:
- Histopathological or gross observation in animal studies (e.g., tissue integration, inflammatory response).
- Biocompatibility testing results (standard tests for cytotoxicity, sensitization, irritation, etc.).
- Mechanical and physical testing results of the material characteristics.
- Clinical observations/outcomes data from the "preliminary clinical data" and "history of safety and effectiveness" for the predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set. The "history of safety and effectiveness" and predicate device data can be conceptualized as a vast "experience base" rather than a formally labeled training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is involved. The "ground truth" for the historical data of processed bovine pericardium (Peri-Guard, Supple Peri-Guard) would have been established through extensive preclinical and clinical use, including pathology, clinical outcomes, and long-term safety monitoring over two decades (since 1982).
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.