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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 a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Durette ocular implant (K123764):

Summary of Device and Context:
This 510(k) submission (K123764) is for a Durette ocular implant, a Class II device (21 CFR 886.3320). The submission is not for a new device concept but rather for changes to a previously cleared device (K073293). The primary changes are:

1. Welding process: Moving from laser welding (which used a liquid that left a dry residue) to ultrasonic welding (which uses PMMA only).
2. Packaging: Simplified and clearer.
3. Labeling: Revised instructions for use.

The submission explicitly states: "This change does not affect the indication for use, and does not alter the fundamental scientific technology of the device." Since the device is 100% acrylic, biocompatibility issues from the material itself are considered clear. The new welding process was validated for safety and effectiveness over a long period.

No clinical or comparative effectiveness study involving human readers or AI was performed or required for this 510(k) submission. The core of the submission revolves around demonstrating that the changes to the manufacturing process and packaging do not negatively impact the performance of the device, which is already established as substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for manufacturing and labeling changes to an existing, predicate device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or accuracy for an AI system. Instead, they relate to standard manufacturing, sterilization, and material safety parameters to ensure the modified device remains as safe and effective as the predicate.

The table below reflects the relevant parameters explicitly mentioned and the "reported performance" indicates how the new device aligns with these implicit or explicit criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of clinical performance data. The nonclinical tests (bioburden, endotoxin, sterilization validation) would have involved samples from manufacturing batches. The document does not specify the number of units tested for these validations.
• Data Provenance: The studies are nonclinical manufacturing and sterilization validation tests conducted by the manufacturer, Oculo Plastik, in Montreal, Quebec, Canada. These are retrospective in the sense that they are validations conducted on the redesigned product before market release.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This submission does not involve clinical studies requiring expert-established ground truth for a diagnostic or AI device. The "ground truth" here is compliance with engineering, material, and sterilization standards.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of clinical data was performed as part of this 510(k) submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not done. This device is an ocular implant, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical medical implant made of PMMA, not a software algorithm. Therefore, no "standalone" algorithm performance study was done.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Biocompatibility Standards: PMMA's established biocompatibility in ophthalmology.
• Sterilization Standards: Compliance with recognized international and national standards (ISO 11135-1, AAMI ST72, AAMI TIR12:2010 for Ethylene Oxide sterilization).
• Quality Control Metrics: Bioburden and endotoxin specifications for manufactured products.
• Material Safety Standards: ISO 10993-5, ISO 10993-7.
• Risk Management Standards: ISO 14971.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device. There is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, there is no ground truth established for it.

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