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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.

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.

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The Durette ocular acrylic (PMMA) implants in 4 models 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 space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

The Durette Implant is an acrylic (PMMA) ocular implant available in 4 models. It is quasi-spherical with a smooth surface and a network of 20 interconnected tunnels in the anterior third for suturing muscles and tissue ingrowth. Each model has a slight off-center medial elongation. The models vary in the amount of anterior surface detail, ranging from as spherical as possible with a slight double radius front (#1), to having minute details (#2), low mounds (#3), and still higher mounds (#4). The implants are molded in 2 parts and welded together.

The provided text describes a 510(k) submission for the Durette Implant, an ocular acrylic implant. However, it does not contain information about specific acceptance criteria, a clinical study proving performance against those criteria, or the detailed aspects of a study typically requested (e.g., sample sizes for test/training, expert qualifications, adjudication methods for ground truth, MRMC studies, or standalone performance evaluation).

Instead, the document focuses on:

• Device Description: Explaining the design, materials, and function of the Durette Implant, emphasizing its four models and features like tunnels for suturing and tissue ingrowth.
• Substantial Equivalence Claim: Comparing the Durette Implant to existing predicate devices (e.g., Allen implant, Iowa implant, Universal implant, acrylic sphere implants) based on common characteristics (material, smooth surface) and distinguishing features (quasi-spherical design, tunnels for suturing/ingrowth, suitability for evisceration and secondary implantation).
• Non-Clinical Tests: Mentioning internal quality assurance (ISO 13485, ISO 9000), mold tests for tunnel specifications, and pull-tests for welding integrity.
• Absence of Clinical Data: Explicitly stating that "No clinical trials were made with this estimated equivalent implant device" and that "It is not felt any clinical trials would be needed, as this implant is rather a consolidation of all previously used implants..."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on a study, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these were not part of the 510(k) submission for this particular device. The FDA approved the device based on its substantial equivalence to predicate devices, without requiring new clinical trials for this specific submission.

The ground truth for the predicate devices would have been established through their long-standing clinical use and acceptance in the ophthalmology field. For the Durette implant itself, the "proof" of meeting criteria was established through its similarity to already approved devices and the non-clinical tests described.

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Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), or the space left after the removal of the contents of the eye ball (evisceration). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

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This document is a 510(k) premarket notification decision letter from the FDA for Eye Sphere Implants. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed devices and can be marketed subject to federal regulations.

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