(49 days)
Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis. Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include: Description, Appearance, Indications, Silicone sphere, Mode of action, Contra-indications, Adverse effects, Recommendation for use, Precautions for use. They are available by units in a wide range of sizes, from 12 to 22mm.
This 510(k) premarket notification is for a Special 510(k), indicating a modification to an already cleared device, not a new device submission requiring extensive clinical studies to establish primary performance. The main change is the material grade and supplier for the silicone, along with labeling and packaging changes.
Therefore, the submission does not contain a traditional performance study comparing the device against acceptance criteria in the way a novel device might. Instead, the "study" demonstrating that the device meets the acceptance criteria is primarily biocompatibility testing to show the new material is equivalent to the old.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for a material change, the "acceptance criteria" are primarily established by demonstrating equivalence to the predicate device and ensuring the new material does not introduce additional risks. The performance is largely implied as "same" or "equivalent" to the predicate, with specific biocompatibility tests performed.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility | No additional risk compared to predicate device material; equivalent biocompatibility. | Equivalent. Silicone manufacturer performed same biocompatibility tests with same results. Additionally, 2 other tests performed on finished device. |
| Material Properties | Suitability for intended use (ophthalmic implant); inertness; documented solid-state properties. | Medical Grade (different grade but equivalent); Inert material (same as predicate); Well documented by manufacturers of silicone resins (same as predicate). |
| Sterility | "Non Sterile" at sale; withstand steam autoclave by user; provide detailed validated sterilization instructions. | Same. Must be sterilized by steam autoclave by the user. Detailed validated steam sterilization instructions provided. |
| Intended Use | Same as predicate. | Same. For enucleation, evisceration, or as secondary implant. |
| Target Population | Same as predicate. | Same. All ages. |
| Design | Same as predicate (Silicone elastomer Eye Sphere). | Same. Silicone elastomer Eye Sphere. |
| Performance Standards | No specific FDA performance standards applicable to "Sphere, Eye Implant". | Same. No performance standards applicable. Risk assessment performed against ISO 14971. |
| Safety (Mechanical/Chemical/Thermal/Radiation/Electrical) | Silicone in solid state well documented; inert material; can be autoclaved/gassed; no electricity/radiation involved. | Same for all categories. |
| Standards Met | None required for predicate. | ISO 14971 (New for the device, but not a performance standard for the implant itself, rather for risk management). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the biocompatibility tests. It would typically involve a certain number of test specimens of the new silicone material.
- Data Provenance: The biocompatibility tests were performed by the silicone manufacturer and by Oculoplastik on the finished device. The location of these labs (e.g., country) is not specified. The studies are most likely retrospective in the sense that they are laboratory tests on manufactured materials, not prospective patient studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a material change and biocompatibility testing, ground truth is established through standardized laboratory test protocols (e.g., ISO standards for biocompatibility), not through expert consensus on interpretation of, for example, medical images. The "ground truth" is the result of the physical/chemical/biological tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation studies where there is subjective human assessment. This submission concerns laboratory testing of material properties. The results of the biocompatibility tests would be considered objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance. This submission does not involve AI or human interpretation of medical cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This device is a passive silicone implant and does not involve any algorithm or software. The submission explicitly states "No software involved for this device."
7. The Type of Ground Truth Used
- Laboratory Test Results (Biocompatibility): The "ground truth" for the new material's equivalence is established by the results of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), which compare the new material's biological response to known safe materials or to the predicate device's material.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
§ 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.