(28 days)
The Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and difunctional methacryloxypropyl-terminated poly(dimethylsiloxane).
When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380mm.
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.
The provided text is a 510(k) summary for a medical device, specifically a soft contact lens. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Based on the document, here's what can be inferred and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The document refers to "performance testing specifications" and states that "non-clinical data presented are adequate to support substantial equivalence." This implies that the device met certain pre-defined performance specifications for physical and optical properties like water content and dimensional/optical parameters, as outlined in BS EN ISO 18369-2:2017 and BS EN ISO 18369-4:2017. However, the specific quantitative acceptance criteria (e.g., precise ranges for water content or diameter tolerance) are not explicitly listed in this summary.
- Reported Device Performance:
- Refractive Index: 1.4003
- %Transmittance @ 590nm: 98.13
- %Transmittance @ 280-315nm: 0.71 (less than 5% as per device description)
- %Transmittance @ 316-380nm: 20.62 (less than 50% as per device description)
- Water Content: 56%
- Oxygen Permeability (DK): 60 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg) at 35°C
- Specific Gravity: 1.17
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This information is typically relevant for studies validating AI/ML algorithms. The provided document is for a physical medical device (contact lens) and refers to non-clinical performance testing. It does not describe a "test set" in the context of algorithm validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: This is not relevant for the type of device and testing described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This is not relevant for the type of device and testing described in the document.
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 document describes a physical medical device (contact lens), not an AI/ML-driven diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This document describes a physical medical device (contact lens), not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Implied: For physical and optical properties of a contact lens, the "ground truth" would be established by validated measurement techniques and scientific protocols (e.g., using specialized equipment to measure water content, dimensions, oxygen permeability). The document states, "All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols."
8. The sample size for the training set
- Not Applicable / Not Provided: This is not relevant for the type of device and testing described. The device doesn't have a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This is not relevant for the type of device and testing described.
In summary, the provided text does not describe an AI/ML device or a study validating an AI/ML algorithm. Instead, it is a regulatory submission for a contact lens, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical and optical properties. The acceptance criteria are implicitly derived from ISO standards, and device performance is reported quantitatively for these physical properties.
§ 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.