(231 days)
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) Contact Lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (
This document does not contain an acceptance criteria table or a study proving the device meets specific acceptance criteria in the manner you've requested for an AI/CADe device. This document is a 510(k) premarket notification for a soft contact lens, demonstrating substantial equivalence to a predicate device rather than presenting a novel algorithm's performance against defined metrics.
Here's a breakdown of why the requested information isn't available in this document:
- Device Type: The device is a "Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens," not an AI/CADe device.
- Approval Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This pathway generally relies on demonstrating similar technological characteristics and performance to the predicate, rather than conducting new efficacy studies with acceptance criteria for a novel algorithm.
- "No clinical data is required" statement: The document explicitly states: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte Ltd, therefore no clinical data is required." This directly indicates that the type of study you're asking for (one proving performance against acceptance criteria) was not performed for this submission.
However, I can extract information related to the device and its comparison to a predicate, which are analogues to some of your requested points:
1. A table of acceptance criteria and the reported device performance:
This document does not provide acceptance criteria in the typical "pass/fail" sense for a novel device feature's performance. Instead, it provides a comparison table of characteristics between the applicant's device and the predicate device to demonstrate equivalence. One could interpret the predicate device's established characteristics as the "acceptance criteria" for the new device to be considered substantially equivalent.
| Item | Predicate (K052290) - "Acceptance Criteria" (Analogue) | Device - "Reported Device Performance" (Analogue) |
|---|---|---|
| Product Name | AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens | Largan daily wear soft contact lens |
| Manufacturer | ClearLab Pte Ltd. | Largan Medical Inc. |
| Intended Use | Myopia, Hyperopia, astigmatism | Myopia, Hyperopia, astigmatism, Presbyopia |
| Lens Design | spherical, toric | aspherical, toric, or multifocal |
| Replacement Schedule | Daily Wear | Daily Wear |
| Chemical composition | Hioxifilcon A | Hioxifilcon A |
| Classification | Group II (Nonionic, High water) | Group II (Nonionic, High water) |
| Water Content | 57 % (>50%) | 59 % (>50%) |
| Oxygen Permeability (DK, 35°C) | 20 (Fatt method) | 22 (Fatt method) |
| Base Curve Range (mm) | 8.0 ~ 9.2 | 8.0~9.0 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 |
| Center Thickness | Varies with design and power (0.08 mm at -3.00D) | Varies with design and power (0.102 mm at -1.00D) |
| Powers | -20.00D to +20.00D | -10.00D to +3.00D |
| Refractive Index | 1.4058 | 1.403 |
| Light Transmittance | >95% | 90% |
| Blue handling tint | Reactive Blue 19 | Reactive Blue 247 |
| Method of Manufacture | Cast Molded | Cast Molded |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document explicitly states: "no clinical data is required." Therefore, there is no test set, sample size, or data provenance information of this nature. Non-clinical physiochemical and toxicology studies were performed, but these are for material properties, not a performance evaluation in a test set as you imply for an AI/CADe device.
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. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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 device. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests: The "ground truth" for physiochemical studies would be established specifications and reference standards (e.g., ISO 18369). For toxicology, it would be standard biocompatibility testing protocols, showing the lenses are "non-toxic and biocompatible."
8. The sample size for the training set
- Not applicable. This is not an AI device, so there is no training set in this context.
9. How the ground truth for the training set was established
- Not applicable. No training set.
In summary, this document is a regulatory submission for a medical device (contact lens) through the 510(k) pathway, which focuses on demonstrating substantial equivalence. The specific types of acceptance criteria and studies you've requested are characteristic of AI/CADe devices or PMA submissions for novel devices, neither of which applies here.
§ 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.