(117 days)
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.
§ 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.