(426 days)
The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.
The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.
The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.
The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.
The lenses may be disinfected using chemical (not heat) disinfecting systems.
The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.
The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight.
Mangofilcon A is available in clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM).
Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312).
The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.
Diameter(s): Sphere 10.0 mm to 16.0 mm, Multifocal 14.0 mm to 16.0 mm, Toric Not Applicable (N/A), Toric-Multifocal 14.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 6.5 mm - 9.7 mm
Powers: Sphere -20.00 D to +12.00 D, Multifocal -20.00 D to +12.00 D, Toric -20.00 D to +12.00 D, Toric-Multifocal -20.00 D to +12.00 D
Cylinder Powers: Sphere N/A, Multifocal N/A, Toric -0.50 D to 2.50 D in steps of 0.25 D, Toric-Multifocal N/A
Axes: Sphere N/A, Multifocal N/A, Toric 0° to 180°, Toric-Multifocal N/A
Add Powers: Sphere N/A, Multifocal +1.00 D to +3.25 D in steps of 0.25 D, Toric N/A, Toric-Multifocal +1.00 D to +3.25 D in steps of 0.25 D
The physical/optical properties of the lenses are:
Oxygen Permeability (Dk) (35°C, Fatt Units): 49
Refractive Index: Dry - 1.470, Hydrated - 1.413
Specific Gravity: Dry - 1.112, Hydrated - 1.109
Linear Expansion Ratio: 1.26
Water Content: 49%
Visible Light Transmittance: 96%T
Plasma Treatment Required: Yes
Shore D Hardness (in blank form): ≥83
This document describes the premarket notification for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device. The information is extracted directly from the provided text.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens are not explicitly stated as distinct numerical criteria that must be met in a table. Instead, the study aims to demonstrate that the new device is "as safe, as effective and performs as well as the predicate device" through a comparison of physical properties and clinical data. Therefore, the "acceptance criteria" are implied to be achieving comparable safety and effectiveness outcomes and similar physical properties to the predicate device.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Property | LSH Latheable Silicone Hydrogel (mangofilcon A) (New Device) | Predicate Device BENZ 3GX (hioxifilcon B) |
|---|---|---|
| Oxygen Permeability (Dk) (35°C, Fatt Units) | 49 | 15 |
| Refractive Index (Dry) | 1.470 | 1.507 |
| Refractive Index (Hydrated) | 1.413 | 1.425 |
| Specific Gravity (Dry) | 1.112 | 1.308 |
| Specific Gravity (Hydrated) | 1.109 | 1.136 |
| Linear Expansion Ratio | 1.26 | 1.3 |
| Water Content | 49% | 49% |
| Tensile Strength | 3.07 M Pa | 25g/mm2 |
| % Elongation at Break | 470 | 186 |
| Visible Light Transmittance | 96% T | 95% T |
| Plasma Treatment Required | Yes | No |
| Shore D Hardness (in blank form) | ≥ 83 | ≥ 90 |
| Clinical Safety & Efficacy | Demonstrated safe and effective | Established safe and effective (predicate) |
Study Details:
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Sample size used for the test set and the data provenance:
- Test set sample size: "Seventy-five (75) patients were enrolled in the study (56 test/19 control)."
- Data provenance: Not explicitly stated, but clinical studies for such devices are typically conducted in the country where the device is seeking regulatory clearance. Given the 510(k) summary submitted to the FDA, it's highly probable the study was conducted in the United States.
- Retrospective or prospective: The clinical study was described as "A three month clinical study was conducted...", indicating a prospective study design.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For contact lens safety and efficacy studies, the "ground truth" is established through direct observation of physiological responses and visual acuity measurements in patients, rather than expert interpretation of images or other data. The study primarily evaluated safety and efficacy through clinical observation by eye care professionals.
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Adjudication method for the test set: Not applicable in the context of an adjudication method typical for image-based diagnostic AI studies. Safety and efficacy were assessed through direct clinical observations and measurements over a three-month period.
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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 study is for a contact lens, not an AI-powered diagnostic device, so an MRMC study is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study is for a physical medical device (contact lens), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance relies on clinical outcomes data from the three-month study, including patient safety (e.g., adverse events, ocular irritation) and efficacy (e.g., satisfactory visual acuity, correction of refractive errors, comfort).
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The sample size for the training set: Not applicable. This study is for a contact lens, which does not involve a "training set" in the context of machine learning or AI. The physical properties and design are based on manufacturing processes and material science, not trained algorithms.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" for this 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.