(39 days)
The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons.
The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is a lathe-cut soft lens multifocal with an aspheric front surface and a spherical base curve. In the dry (unhydrated) state the lens is machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The progressive optics utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.
The non-ionic lens material, hioxifileon A, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight. when immersed in normal saline solution buffered with sodium bicarbonate. Flexlens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon A are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).
The non-ionic lens material, hioxifileon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. FlexIens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon B are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).
The provided document, K070308, is a 510(k) summary for the Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear. It clarifies that this is a premarket notification for a Class II medical device, and the FDA has determined it to be substantially equivalent to legally marketed predicate devices.
Crucially, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a de novo study with specific acceptance criteria and detailed performance data often seen in AI/algorithm-based device submissions.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not explicitly present in this 510(k) summary. The document primarily refers to "Pre-Clinical Performance Data" in previous 510(k) submissions for the materials themselves (hioxifilcon A and B).
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional contact lens submission, specific "acceptance criteria" and "device performance" metrics in the context of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) are not described. Instead, the document focuses on the physical and optical properties of the lens materials.
| Property | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Flexlens Multifocal Soft Contact Lens) |
|---|---|---|
| For hioxifilcon A: | Should be comparable to predicate devices. | |
| Refractive Index (hydrated) | N/A (implied by predicate) | 1.404 |
| Light Transmission (clear) | N/A (implied by predicate) | > 95% T |
| Light Transmission (tinted) | N/A (implied by predicate) | > 95% T |
| Water Content | N/A (implied by predicate) | 59% |
| Specific Gravity (hydrated) | N/A (implied by predicate) | 1.18 |
| Oxygen Permeability (Dk) | N/A (implied by predicate) | $18 \times 10^{-11}$ (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method) |
| For hioxifilcon B: | Should be comparable to predicate devices. | |
| Refractive Index (hydrated) | N/A (implied by predicate) | 1.404 |
| Light Transmission (clear) | N/A (implied by predicate) | > 95% T |
| Light Transmission (tinted) | N/A (implied by predicate) | > 95% T |
| Water Content | N/A (implied by predicate) | 48 % |
| Specific Gravity (hydrated) | N/A (implied by predicate) | 1.136 |
| Oxygen Permeability (Dk) | N/A (implied by predicate) | $15 \times 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
2. Sample size used for the test set and the data provenance
This information is not provided in the 510(k) summary. The document references "Pre-Clinical Performance Data" in other 510(k) submissions (K983773 and K964528) for the hioxifilcon A and B materials, but it does not detail the specific studies, sample sizes, or data provenance conducted for this particular multifocal lens design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. It's not relevant for a traditional contact lens submission focused on physical/optical properties and chemical composition.
4. Adjudication method for the test set
This information is not provided and is not relevant for the type of device and submission described.
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
No, a MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but a contact lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI/ML algorithm.
7. The type of ground truth used
The concept of "ground truth" as it applies to AI/ML diagnostics (e.g., pathology, outcomes data) is not applicable here. The "truth" for this device relates to its physical, chemical, and optical properties meeting established standards for contact lenses and being comparable to legally marketed predicate devices.
8. The sample size for the training set
This information is not provided and is not relevant as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided and is not relevant as this is not an AI/ML 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.