(276 days)
miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.
Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.
The color lens may enhance or alter the apparent color of the eye.
Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.
Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.
The lenses may enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus
- They are daily wear soft contact lens for frequent replacement
- They are in a spherical lens design with UV blocker.
- They are available in hemispherical shell.
- The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
- The water content is 46%.
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm.
- The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
- The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
- The lens is supplied in a sterile state, packaged in a buffered saline solution.
miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus
- They are daily wear soft contact lens for daily disposable
- They are in a spherical lens desing with UV blocker.
- They are available in hemispherical shell.
- The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
- The water content is 48%.
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm.
- The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
- The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
- The lens is supplied in a sterile state, packaged in a buffered saline solution.
The provided FDA 510(k) clearance letter and summary describe the safety and effectiveness studies for soft contact lenses, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable and not present in the document.
The document focuses on demonstrating substantial equivalence of the new contact lenses to legally marketed predicate devices through physiochemical studies, biocompatibility testing, and clinical wearer studies. The "acceptance criteria" discussed are primarily about demonstrating non-inferiority in terms of safety and effectiveness for the contact lenses when worn by human subjects, compared to existing, legally marketed lenses.
Here's an attempt to answer the questions based on the provided document, acknowledging where the requested information for AI devices is not relevant or available:
Acceptance Criteria and Study Details for BenQ Materials Corporation Contact Lenses (K242056)
This document describes the safety and effectiveness testing for soft contact lenses, which are physical medical devices, not AI software. As such, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI device (e.g., diagnostic accuracy, sensitivity, specificity, expert adjudication, MRMC studies) are not directly applicable. Instead, the studies aim to demonstrate the non-inferiority of the new contact lenses compared to predicate devices in terms of clinical safety and efficacy in human wearers.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a physical medical device (contact lens) and not an AI device, the "acceptance criteria" are generally framed as demonstrating non-inferiority to existing predicate devices in clinical performance. The document doesn't provide specific quantitative thresholds for "acceptance criteria" in a typical AI sense (e.g., target AUC, sensitivity). Instead, it states the overall finding of "no significant difference."
| Acceptance Criteria (Conceptual for Contact Lenses) | Reported Device Performance |
|---|---|
| Safety: No significant increase in adverse reactions or hazardous, sight-threatening conditions compared to predicate device. | miacare (miafilcon A) & (miafilcon B) Lenses: "No adverse reaction was reported for both test group and control group related to hazardous, sight-threatening condition... (corneal ulcers, severe corneal abrasion > 2mm, iritis, other ocular infections or inflammations, corneal scarring, or permanent loss of vision)." "No statistic significant difference between test lens and control lens with respect to safety data including adverse reaction data, slip lamp findings, symptoms/problems/complications, Keratometry (K) readings, refractive changes (absolute value) and visual acuity (VA) data, average wearing time (AWT), discontinuations and lens replacement." |
| Effectiveness: Achieve comparable visual acuity and intended function (e.g., color enhancement for color lenses) as predicate device. | miacare (miafilcon A) & (miafilcon B) Lenses: "The clinical study shows that no significant difference between the study device and control device in terms of safety and efficacy. Both groups shows that the CVA could reach equal or higher than 1.0 and the color lens will enhance or alter the apparent color of the eye." |
2. Sample Size Used for the Test Set and Data Provenance
-
miacare (miafilcon A) CONFiDENCE Color Contact Lens (vs OxyPure Color Silicone Hydrogel):
- Enrollment: 192 subjects (96 test lenses, 96 control lenses)
- Completed: 172 subjects (85 test group, 87 control group)
- Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)
-
miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens (vs Si-Hy (olifilcon B) Color Silicone Hydrogel):
- Enrollment: 192 subjects (96 test lenses, 96 control lenses)
- Completed: 192 subjects (96 test group, 96 control group)
- Data Provenance: Mainland China, multi-center, open, parallel, randomized controlled comparison study, with 90 days follow-up. (Prospective clinical study)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the study involved clinical performance trials of physical contact lenses on human subjects, not an AI device requiring expert consensus for ground truth on imaging or diagnostic tasks. The "ground truth" here is the observed clinical outcome (e.g., adverse events, visual acuity, slit lamp findings) directly measured from the study participants by eye care professionals involved in the study. The document does not specify the number or qualifications of these eye care professionals, beyond stating the studies were conducted in "3 hospitals."
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in AI studies for resolving discrepancies in ground truth labeling by multiple experts. This concept is not applicable here. Clinical outcomes were presumably recorded by the investigators at different sites. The summary states "No statistic significant difference between test lens and control lens with respect to safety data," implying statistical comparison of observed clinical metrics between groups.
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
This question is not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This document describes a clinical trial evaluating the performance of contact lenses for vision correction and eye health.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. "Standalone performance" refers to the algorithm's performance without human interaction for AI devices. The devices in this submission are contact lenses, which are inherently used by humans.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in these clinical studies primarily consists of:
- Clinical Outcomes Data: Direct observations and assessments from study participants during the 90-day follow-up. This includes:
- Adverse events reported and observed.
- Slit lamp findings (examinations of the eye's anterior segment).
- Symptoms/problems/complications reported by subjects.
- Keratometry (K) readings (corneal curvature).
- Refractive changes (absolute value).
- Visual acuity (VA) data.
- Average wearing time (AWT).
- Discontinuation reasons and lens replacement data.
- Visual Acuity: The ability of the CVA (Corrected Visual Acuity) to reach "equal or higher than 1.0" (presumably 20/20 or better).
- Aesthetic Effect: The color lens's ability to "enhance or alter the apparent color of the eye."
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train an AI model. This document describes clinical trials for physical medical devices (contact lenses), not the development of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no AI training set in this submission.
§ 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.