(83 days)
The UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who may exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Ultra Vue/P, Ultra Vue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lenses are fabricated from hioxifilcon B. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornes and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat wareed: however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight.
This submission is a 510(k) summary for the UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens. It asserts substantial equivalence to predicate devices and focuses on material properties and manufacturing processes rather than a detailed clinical study demonstrating specific performance against acceptance criteria for a new clinical endpoint. Therefore, much of the requested information about clinical acceptance criteria and a study proving device performance against them is not explicitly available in the provided text.
Based on the provided text, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices. The study proving the device meets these "acceptance criteria" is the demonstration of similar characteristics to those predicate devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As specific performance "acceptance criteria" (e.g., visual acuity targets, comfort scores, etc.) are not presented in a quantitative manner in this substantial equivalence submission, the table below will reflect the comparison of physical and material characteristics to predicate devices, which serve as the implicit "acceptance criteria" for substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (UltraVue/P, UltraVue/C Multifocal) |
|---|---|---|
| Material | Hydrophilic Polymer (Similar to Predicates) | Hydrophilic Polymer |
| Production Method | Lathe-Cut | Lathe-Cut |
| Lens Function | Refractive medium for distance, intermediate, near focusing; compensates for refractive error (Same as Predicates) | Refractive medium for near, intermediate, distant focusing; compensates for refractive error |
| Water Content | Similar to 8.4%, 8.0%, 18.1%, 11.3% in predicates | 48% |
| Polymer Content | Similar to predicates | 52% |
| Polymer Type | polymacon, tafilcon, ocufilcon, hetilcon | hioxifilcon B |
| DK Value | Similar to 8.4, 8.0, 18.1, 11.3 | 15 |
| Refractive Index | Similar to predicates | 1.404 (hydrated) |
| Specific Gravity | Similar to predicates | 1.136 (hydrated) |
| Light Transmission | Greater than 95% T | Greater than 95% T |
Note: The "acceptance criteria" in this context are not quantitative performance thresholds from a clinical trial, but rather the demonstration that the new device's characteristics are sufficiently similar to those of legally marketed predicate devices to establish substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document describes a 510(k) premarket notification for substantial equivalence, not a clinical study with a "test set" in the sense of patient data. The "testing" referred to is primarily focused on material properties and manufacturing process equivalence, and pre-clinical toxicology.
- Sample Size for Test Set: Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical and chemical properties of the lens material itself, which would be tested on material samples, not a patient cohort. No specific numbers of samples for these material tests are given.
- Data Provenance: The document is a regulatory submission from a Canadian company (Opti-Center Laboratories) to the US FDA. The "pre-clinical toxicology and manufacturing/chemistry data" mentioned in the "Substantial Equivalence" section would originate from internal company testing or contract laboratories. The specific country of origin for these raw data is not stated, but the submission is for US market approval. The data is pre-marketing, so it would be considered prospective in relation to the submission date, but not "retrospective" clinical data.
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)
This information is not applicable and not provided in the document. This is a 510(k) submission for contact lenses, which relies on demonstrating equivalence through material science and design specifications, not expert-adjudicated clinical "ground truth" data for, for example, image interpretation or disease diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially those involving expert interpretation of medical images or outcomes, to establish a consensus "ground truth." This document is a regulatory filing focused on substantial equivalence of a physical medical device.
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 information is not applicable and not provided in the document. MRMC studies, especially those involving "AI assistance," are relevant for diagnostic imaging devices where human readers interpret medical images. This document is for soft contact lenses, which do not involve AI-assisted diagnostics or human 'readers' in that context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. This device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this device's "study" (i.e., the demonstration of substantial equivalence) is derived from established scientific understanding of material properties, manufacturing processes, and the performance of currently marketed predicate contact lenses.
- The "ground truth" for material properties (e.g., water content, DK value, refractive index) is based on standard scientific measurement techniques.
- The comparison to predicate devices serves as the "ground truth" for what constitutes "safe and effective" performance within this product category for the purpose of a 510(k). The regulatory assumption is that if the new device is sufficiently similar to a legally marketed predicate device, it shares its safety and effectiveness profile.
8. The sample size for the training set
This information is not applicable and not provided in the document. A "training set" refers to data used to train an algorithm, typically in machine learning or AI. This document pertains to a physical medical device (contact lens) and not an algorithmic system.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document, as it relates to training data for algorithms, not a physical medical 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.