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The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.

An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye. The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile

The provided text is a 510(k) summary for the MEDPOR® Ocular Conformer. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial or algorithm validation study would.

Therefore, the requested information elements related to performance metrics, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable to this type of regulatory submission. The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of its characteristics.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device. This means the device must be as safe and effective as a legally marketed device that does not require premarket approval.
• Reported Device Performance: The document explicitly states: "The device of this submission is identical to the predicate device in all aspects except for minor dimensional changes." This statement itself serves as the "reported performance" against the acceptance criterion of substantial equivalence.

2. Sample sized used for the test set and the data provenance

• Not Applicable. This submission does not involve a "test set" in the sense of a clinical or performance study where data is collected and analyzed against specific metrics. The substantial equivalence argument is based on the device's design, materials, and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. There was no "test set" or "ground truth" to be established by experts for performance evaluation in this context.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication was performed for device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-powered device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm, and no standalone performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.

8. The sample size for the training set

• Not Applicable. This is not a device that involves machine learning or a "training set."

9. How the ground truth for the training set was established

• Not Applicable. No training set or ground truth for it was established.

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Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.

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This document is a 510(k) clearance letter from the FDA for an "Ocular Conformer" device, dated July 7, 1997. It explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976.

Based on the content, this letter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process for this type of device typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria as would be expected for novel devices or those undergoing PMA.

Therefore, I cannot provide the requested table and study details. This document simply indicates market clearance based on substantial equivalence.

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Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.

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The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ocular Conformer" device. This document primarily focuses on regulatory approval and does not contain information about a study that would establish acceptance criteria or demonstrate device performance as typically expected for medical device software or AI.

Therefore, I cannot extract the requested information points because they are not present in the provided text. The document is a clearance letter, not a study report.

Here's why each point cannot be addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The letter states the device is "substantially equivalent" to a predicate device, which is a regulatory standard, not a performance metric for this type of detailed analysis.
2. Sample size used for the test set and the data provenance: Not present. There is no mention of a test set or data for a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No test set or ground truth establishment is described.
4. Adjudication method: Not present. No study or adjudication process is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device ("Ocular Conformer") is a physical medical device (an ocular prosthetic), not an AI or software device that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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