(232 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (Wilson Ophthalmic Corp. Ophthalmic Conformer) | Device is identical to predicate in all aspects except for minor dimensional changes. |
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.
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.