(50 days)
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas is fabricated from polymacon, 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. A tunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [2,3-a:2',3' -i] napth [2',3';.6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or leas abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occhisive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tim Patterns Available:
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- Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12,5 mm.
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- Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
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- Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0,5 mm increments. Clear Pupil diameter range 2.0 mm to 7,5 mm in 0.5 mm increments.
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- Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas 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 leas dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit performance metrics against predefined thresholds. The document compares various material and functional characteristics.
| Characteristic | Acceptance Criteria (Predicate Device: WESLEY-JESSEN PROSTHETIC) | Reported Device Performance (ALDEN CLASSIC PROSTHETIC) |
|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut |
| Lens Function | Enhance or alter apparent eye color, ocular masking, correction of refractive ametropia (myopia, hyperopia, astigmatism), aphakic & non-aphakic persons, occlusive therapy (diplopia, amblyopia, extreme photophobia). | Enhance or alter apparent eye color, ocular masking, correction of refractive ametropia (myopia, hyperopia, astigmatism), aphakic & non-aphakic persons, occlusive therapy (diplopia, amblyopia, extreme photophobia). |
| Material Type | Hydrophilic Polymer | Hydrophilic Polymer |
| Polymer | phemfilcon A | Polymacon |
| Water Content | 38% | 38% |
| Polymer Content | 62% | 62% |
| Dk Value | 12.9 | 9 |
| Refractive Index | 1.440 (hydrated) | 1.43 (hydrated) |
| Specific Gravity | 1.17 (hydrated) | 1.18 (hydrated) |
| Light Transmission | Varies depending on prosthetic lens design | Varies depending on prosthetic lens design |
| Color Additives | Iron oxides, chromium oxide greens, titanium dioxide, [phthalocyaninato (2)] copper, carbazole violet, phthalocyanine green. | Vat Green 1, Vat Brown 1, Vat Blue 6 |
Note: The document explicitly states: "The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Alden Classic, and Alden Classic Tinted (polymacon), 510(k)'s #K973967 and #K980554." This implies that the device's safety and effectiveness are established by showing equivalence to previously cleared devices through shared material and manufacturing characteristics rather than new, independent clinical performance studies with specific numerical acceptance criteria.
The provided document describes a 510(k) submission for a soft contact lens. In the context of 510(k) submissions, the "study that proves the device meets the acceptance criteria" is typically a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance metrics against predefined acceptance criteria.
Here's the breakdown of the information requested, based on the provided text:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission is for a 510(k) premarket notification demonstrating substantial equivalence. It does not refer to a "test set" in the sense of clinical trial data with patient samples. The "testing" involves comparing the device's characteristics to a predicate device.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the characteristics and historical clearances of the predicate devices (WESLEY-JESSEN PROSTHETIC and BENZ-38) and the applicant's previously cleared devices (Alden Classic and Alden Classic Tinted), which would have been marketed in the USA. The submission itself is to the US FDA.
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)
- Not applicable. There is no mention of expert consensus being used to establish a ground truth for a "test set" in this type of submission. The "ground truth" for substantial equivalence is derived from the characteristics and regulatory history of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving human judgment or image analysis requiring adjudication.
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 a contact lens medical device submission for substantial equivalence, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a contact lens medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (WESLEY-JESSEN PROSTHETIC and BENZ-38) and the applicant's previously cleared devices (Alden Classic, and Alden Classic Tinted), as defined and accepted by the FDA when those predicate devices were brought to market. Substantial equivalence means the new device is as safe and effective as a legally marketed device.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As noted above, this is not a machine learning or AI 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.