(469 days)
The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.
Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.
This 510(k) summary describes a device, "Solid Silicone and Silicone Sponge Implants," used in retinal reattachment surgery. The submission focuses on a change in the silicone material used in the device, demonstrating that the new material is substantially equivalent to the previously cleared material. Therefore, the acceptance criteria and supporting studies are centered on establishing this equivalence, primarily through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the new silicone material) | Reported Device Performance (with new silicone material) |
|---|---|
| Material not substantially different from original Dow Corning material. | Physical testing performed by material supplier confirmed this. Results provided in FDA Master Files. |
| Non-toxic and biocompatible. | Testing demonstrated that the implants were non-toxic and biocompatible according to FDA "Tripartite Guidance" and "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical performance or a specific sample size of devices. The testing described is primarily material-level and biocompatibility testing.
- Test Set Sample Size: Not specified for individual devices; testing was performed on the "new silicone material" and "sterilized finished devices manufactured with new silicone material."
- Data Provenance: The physical testing results were provided by the "material supplier." Biocompatibility testing was performed on finished devices. No country of origin is specified for the raw data or testing facilities. The studies appear to be retrospective in the sense that they are evaluating a material change for an existing device rather than a de novo clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The ground truth for this submission is established through material specifications and standardized biocompatibility testing protocols, rather than expert consensus on clinical images or outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication is typically associated with human review of imaging or clinical data, which is not the nature of the testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is a clinical study involving human readers evaluating cases, often in radiology or pathology. The provided document describes non-clinical material and biocompatibility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Material Specifications: For the "material not substantially different" criterion, the ground truth would be the established physical and chemical properties of the previously cleared Dow Corning silicone material.
- Standardized Biocompatibility Endpoints: For biocompatibility, the ground truth is defined by the specific endpoints and acceptable limits set forth in the FDA "Tripartite Guidance" and "Table IV. Confirmatory Biological Testing" (e.g., non-cytotoxic, non-sensitizing, non-irritating).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no training set.
§ 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.