(221 days)
The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear aisre indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, 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 cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (lidofilcon A) 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 and appear somewhat warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight.
This document is a 510(k) summary for a soft contact lens, which means it's focused on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial data for novel devices. Therefore, much of the information typically found in an "acceptance criteria and study" report for a high-risk medical device (like AI diagnostics) will not be present.
Based on the provided text, here's what can be extracted and what cannot be provided:
Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the format one might expect for a quantitative performance study (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to a legally marketed predicate device, the "LL-70" manufactured/distributed by Lombart Lenses, LTD. The "performance" is therefore the similarity in material properties and intended use.
| Acceptance Criteria Category (Implicit) | Condition | Reported Device Performance (LM-70) | Predicate Device Performance (LL-70) |
|---|---|---|---|
| Intended Use | Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic | Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic | Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic |
| Functionality | Act as a refractive medium that focus light rays from near and distant objects on the retina. | After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 2 >50% Water, Nonionic Polymers | Group # 2 >50% Water, Nonionic Polymers | Group # 2 >50% Water, Nonionic Polymers |
| Water Content | 70% ± 2 % | 70% ± 2 % | 70% ± 2 % |
| Oxygen Permeability | Comparable oxygen permeability for a soft contact lens | 38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method). | 34.7 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method). |
| Specific Gravity | Comparable specific gravity | 1.061 | 1.073 |
| Refractive Index | 1.52 (dry) 1.41 (hydrated) | 1.52 (dry) 1.41 (hydrated) | Not explicitly stated for predicate in summary table, but implicitly comparable from overall equivalence claim. |
| Light Transmission | greater than 95% | greater than 95% | Not explicitly stated for predicate in summary table, but implicitly comparable from overall equivalence claim. |
| Material Composition | Non-ionic terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with EGDMA and AMA (lidofilcon A) | Terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA) (lidofilcon A) | (lidofilcon A) Implicitly the same material from predicate's name "LL-70 (lidofilcon A)" |
Study Information
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Sample size used for the test set and the data provenance:
The document describes a submission for substantial equivalence based on material properties, manufacturing, and intended use, rather than a clinical "test set" in the context of an AI device. There is no mention of a specific patient-based test set or its provenance (country, retrospective/prospective). The "study" here is mainly a comparison of technical specifications and existing safety profiles. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this submission is established through the chemical and physical properties of the lens material and its manufacturing process, as well as its comparison to a predicate device. This is not a diagnostic device requiring expert interpretation of images or data. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission. -
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 device is a contact lens, not an AI diagnostic or assistance tool, so no MRMC study comparing human readers with or without AI was performed or is relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a contact lens, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission consists of:- Scientific and engineering data: Physical and chemical properties of the lidofilcon A material (water content, oxygen permeability, specific gravity, refractive index, light transmission).
- Manufacturing standards: Compliance with specified process controls and an ISO 9001/9002 and CGMP quality assurance program.
- Preclinical toxicology and manufacturing/chemistry data: Established safety profile of the LM-70 material reported as equivalent to the predicate.
- Comparison to a predicate device: Benchmarking against the LL-70 (lidofilcon A) lens to establish substantial equivalence in terms of intended use, materials, physical construction, and safety & effectiveness.
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The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device would be the extensive research and development involved in material science and manufacturing, which is not quantified as a "training set" in this context. -
How the ground truth for the training set was established:
Not applicable as there is no training set mentioned for this type of 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.