(109 days)
FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permicable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D ad power.
FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 contact lenses are indicated for persons requiring. keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.
FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.
Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin"" bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Keratoconus contact lens designs are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin""), and paflufocon D (FluoroPerm® 151. Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. These products may be plasma treated. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber. Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2,2'-dihydroxy-4,4'dimethoxybenzophenone. The lens designs have a posterior surface consisting of a base curve and a series of four spherical or aspherical curves progressively flatter than the base curve.
This 510(k) summary is for contact lenses, which are medical devices that do not typically involve AI algorithms or software for diagnosis or analysis. The acceptance criteria and study information provided in such documents relate to the physical properties, safety, and efficacy of the lens materials and designs, usually through bench testing, biocompatibility studies, and clinical trials for safety and performance (e.g., visual acuity correction, physiological response of the eye). Therefore, many of the specifics requested in the prompt related to AI/ML device evaluations (like ground truth, expert adjudication, MRMC studies, training/test sets for algorithms) are not applicable here.
However, I can extract the relevant information regarding the acceptance criteria and how the device generally meets them, based on the provided text, and note where other requests are not applicable.
Acceptance Criteria and Device Performance for FluoroPerm® and Paragon HDS® RGP Contact Lenses
This submission is for a traditional medical device (contact lenses) rather than an AI/ML diagnostic or prognostic tool. Therefore, the "acceptance criteria" and "device performance" relate to the physical and chemical properties of the contact lens materials and their demonstrated safety and efficacy through prior regulatory approvals. The "study" proving acceptance criteria is primarily an assertion of substantial equivalence to a predicate device and reliance on previous PMA approvals for the material safety and efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the materials and the intended use. Performance is reported through material specifications and the claim of substantial equivalence to a legally marketed predicate device.
| Property/Criteria | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance (Paragon Lenses) |
|---|---|---|
| Primary Indication | Similar to Boston® II (itafocon A) RGP contact lens approved in PMA P820065. | FluoroPerm® 30/60/92/151, Paragon Thin™/HDS®/HDS® 100 are indicated for daily wear (some for extended wear 1-7 days). Corrects visual acuity in non-aphakic persons with non-diseased eyes (myopic, hyperopic) with corneal astigmatism up to 4.00 diopters. Crucially, they are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. (This keratoconus indication is a key difference from the predicate Boston® II for FluoroPerm® 30/Paragon Thin) |
| Material | itafocon A (for Boston® II predicate) | paflufocon A, B, C, D (fluorosilicone acrylate copolymers) |
| Specific Gravity | Not explicitly stated for predicate; assumed to be within acceptable biological limits. | Range: 1.10 - 1.16 |
| Refractive Index | Not explicitly stated for predicate; assumed to be within acceptable optical limits. | Range: 1.442 - 1.466 |
| % Light Transmittance | Optimal for vision (e.g., >90%) | Range: 93% - 95% (Blue tinted material) |
| % Water Content | Low for RGP lenses | 145 |
| Biocompatibility & Safety | Demonstrated in prior PMA approvals. | Materials (paflufocon A, B, C, D) have demonstrated safety and efficacy in PMA P870024 and its supplements. |
| Manufacturing Process | Same as predicate. | Manufactured by the same manufacturing process as the predicate. |
| Classification | Same as predicate (Class II). | Class II - daily wear contact lens (21 CFR 886.5916). |
| UV Absorber (if applicable) | Effective blockage; biocompatible. | Uvinul D-49, blocking up to 97% of light below 380 nm. Integrated within the polymer matrix. |
| Tinted Lenses (if applicable) | Approved color additives. | Contains D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. |
Note: The keratoconus indication for FluoroPerm® 30 and Paragon Thin™ is explicitly stated as a difference from the predicate in the "Substantial Equivalence Summary Table" (Page 3 of 8), but then indicated within the detailed "Indications For Use" section for all FluoroPerm and Paragon HDS lenses (Pages 1-3, and 6-8). This implies the predicate (Boston® II) did not have a specific keratoconus indication, making the addition of this indication for the new devices a non-trivial aspect of their approval.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable in the context of an AI/ML medical device. For contact lenses, "test sets" would refer to samples used for physical property testing (e.g., Dk measurements), biocompatibility testing, and clinical trials. The document relies on previous PMA approvals (PMA P870024 and supplements) for the materials' safety and efficacy, meaning the data provenance for the foundational studies would be from those prior submissions, not detailed here. No specific "test set" sample sizes are provided for this 510(k) submission as it relies on substantial equivalence and previously approved materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as there is no "ground truth" to establish in the AI/ML sense. The approval relies on scientific and clinical data from previous PMA submissions, which would have involved ophthalmic practitioners and scientists.
4. Adjudication Method for the Test Set
Not applicable. There is no AI/ML adjudication process described. Clinical trial results (from prior PMAs) would have been reviewed by regulatory bodies and independent experts.
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
Not applicable. This is not an AI-assisted diagnostic or prognostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device is a physical contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for contact lenses relates to meeting material specifications, biocompatibility, and clinical performance (e.g., visual acuity, comfort, ocular health parameters) as demonstrated in clinical trials and laboratory testing, often against established standards. The document states that "The safety and efficacy... have been demonstrated in PMA P870024 and various of its supplements." This implies that the 'ground truth' or evidence base is derived from comprehensive preclinical (material science, biocompatibility) and clinical outcomes data from those prior PMA studies.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.