(154 days)
OPTIXON I- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)
The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.
The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
The provided document is a 510(k) summary for the OPTIXON 1-DAY contact lenses. It states that no clinical studies were required to demonstrate the safety or effectiveness of the device because its technological characteristics, formulation, manufacturing, and sterilization processes are the same as two predicate devices (Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lenses K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302).
Therefore, there is no information in this document regarding:
- A test set or data provenance for a clinical study
- Experts used to establish ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Training set sample size or ground truth establishment for a training set
However, the document does describe physiochemical and toxicology studies that were conducted to establish substantial equivalence. These studies serve as the "study that proves the device meets the acceptance criteria" in lieu of a clinical trial.
Here's a summary of the acceptance criteria and reported performance from these non-clinical studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physiochemical Studies | Within established specifications for the lenses (per ISO 18369-4:2006 and ISO 18369-3:2006) | Passed |
| Cytotoxicity test | According to EN ISO 10993-5:2009 | Passed |
| Skin sensitization test | According to EN ISO 10993-10:2010 | Passed |
| Ocular irritation test | According to EN ISO 10993-10:2010 | Passed |
| Acute Systemic Toxicity test | According to ISO 10993-11:2017 | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the physiochemical or toxicology tests. The data provenance is not explicitly stated beyond referencing the ISO and EN ISO standards, which implies the tests were conducted in accordance with international standards. There is no indication of retrospective or prospective data as these are laboratory tests, not human trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as these are non-clinical (laboratory) tests, not involving expert interpretation of medical images or data from human subjects.
4. Adjudication method for the test set
Not applicable for non-clinical laboratory tests.
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. No MRMC study was performed as no clinical studies were required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a contact lens, not an AI or algorithmic medical device.
7. The type of ground truth used
For the physiochemical studies, the ground truth is defined by the established specifications for contact lenses as outlined in ISO 18369-4:2006 and ISO 18369-3:2006.
For the toxicology studies, the ground truth is determined by the "Passed" outcome according to the specific biocompatibility standards (EN ISO 10993-5:2009, EN ISO 10993-10:2010, ISO 10993-11:2017). These standards define what constitutes a non-toxic or non-irritating result.
8. The sample size for the training set
Not applicable. The device is a contact lens, not an AI/ML algorithm that requires a training set. The substantial equivalence relies on comparison to predicate devices, not on a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.