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510(k) Data Aggregation
(80 days)
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hvperopia.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
l . cannot be adequately corrected with spectacle lenses
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requires a rigid gas permeable contact lens surface to improve vision
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is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities.
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration ( e.g. keratoconus, keratoglobus, pellucid marqinal degeneration. Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome and Filamentary Keratitis}, limbal stem cell deficiency ( e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin ( e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure ( e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
Eyecare practitioners may prescribe the lenses or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Acuity 181™ (tisilfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Contact Lenses are treated to incorporate Hydra-PEG® Technology (HPT), which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When coated with Tangible™ Hydra-PEG® the underlying material, tisilfocon A, is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle compared to untreated lenses).
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens are available in spherical, toric, multifocal/bifocal, orthokeratology, and scleral design for daily wear only.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail sense for its non-clinical studies. Instead, it reports the results of various tests and asserts that the device meets safety and effectiveness requirements. The table below compiles the reported physical properties and biocompatibility findings.
| Test/Property | Acceptance Criteria (Implied by equivalence/safety standards) | Reported Device Performance (Acuity 181™ (tisilfocon A)) |
|---|---|---|
| Cytotoxicity | Not cytotoxic (per ISO 10993-5) | Not cytotoxic |
| Acute Systemic Toxicity | Not acutely systemically toxic (per ISO 10993-11) | Not acutely systemically toxic |
| Acute Ocular Irritation | Does not solicit acute ocular irritation (per ISO 10993-23) | Does not solicit an acute ocular irritation response |
| Physicochemical Properties (general) | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
| Mechanical Properties (general) | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
| Optical Properties (general) | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
| Bioburden Level |
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(29 days)
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise nondiseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eve syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservor and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.
Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device (Rigid Gas Permeable Contact Lenses). It is not a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.
Therefore, I cannot extract the requested information about acceptance criteria, study sizes, expert ground truth establishment, MRMC studies, or training sets, as these concepts are not applicable to the type of device and submission described in the provided document. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for contact lenses based on material properties, manufacturing methods, and intended use.
The "PERFORMANCE DATA VII." section specifically mentions "Non-Clinical Studies" and "Clinical Studies". However, these sections refer to studies that were "addressed through previously cleared 510(k) premarket notifications" for the materials and existing uses of the contact lenses, rather than a new study demonstrating the performance of an AI-powered device.
If you have a document describing an AI/SaMD study, I would be happy to analyze it for the criteria you've outlined.
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