Search Results
Found 42 results
510(k) Data Aggregation
(80 days)
Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable
Contact Lenses
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
-
requires a rigid gas permeable contact lens surface to improve vision
-
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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(159 days)
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased 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 SDJMASTERVISION (fluoroxyfocon 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 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 lens may concurrently provide correction of refractive error.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
The SDJMASTERVISION (fluoroxyfocon A) 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 absorber.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.50mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ± 0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) |
This is an FDA 510(k) summary for a rigid gas permeable contact lens. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against predefined acceptance criteria for a novel device through clinical trials. Therefore, much of the information you requested regarding acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, training set details) is not applicable to this type of submission.
Here's a breakdown of what is available in the document related to acceptance criteria and performance, and why other elements are absent:
Context: This 510(k) submission is for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. The manufacturer is not introducing a new type of device or technology but is demonstrating that their product is "substantially equivalent" to existing, legally marketed predicate devices. For this type of submission, extensive clinical studies and a complex acceptance criteria framework (as would be seen for a novel AI device, for example) are generally not required. The focus is on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate devices.
Acceptance Criteria and Device Performance (as evident from the document):
The acceptance criteria are implicitly based on demonstrating that the device's physical properties and manufacturing quality fall within acceptable ranges and meet the standards set by the predicate devices and relevant industry standards (like ANSI Z80.20 for lens specifications).
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance (as stated or implied) |
|---|---|
| Bench Testing: Manufacturing Verification | The manufacturer demonstrated the ability to produce lenses from fluoroxyfocon A blanks to a variety of prescribed parameters. All manufactured lenses met established finished product specifications within the ANSI Z80.20 tolerance. |
| Bioburden Testing: Colony Forming Units (CFU) per lens | The acceptance criterion was less than 100 CFU per lens. The testing demonstrated that the product met this established acceptance criterion. |
| Biocompatibility Testing: |
- In-Vitro Cytotoxicity
- Systemic Toxicity
- Acute Ocular Irritation | 1. In-Vitro Cytotoxicity: Per ISO 10993-5, results indicated that the finished lenses are not cytotoxic.
- Systemic Toxicity: Per ISO 10993-11, the finished lenses met the requirements of the systemic injection test, and extracts did not induce acute systemic toxicity.
- Acute Ocular Irritation: Per ISO 10993-23, extracts did not induce ocular irritation. |
| Physical Properties (Matching Predicate and Industry Standards) | Specific values are listed, demonstrating they are within typical ranges for such lenses and comparable to predicate devices:
- Refractive Index: 1.430
- Modulus (MPa): 1194
- Hardness (Shore D): 78
- Specific Gravity: 1.18
- Oxygen Permeability (Dk): 200 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
- Water Content:
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(29 days)
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable
Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
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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(72 days)
Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid
Gas Permeable Contact Lens
Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® 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 non-diseased 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 lens may be disinfected using a chemical disinfection system only.
TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected only by using chemical disinfection.
Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).
Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently 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 treated with Tangible™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).
TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently 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 treated with Tangible™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
This document describes the premarket notification (510(k)) for Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.
The acceptance criteria and device performance information related to this submission are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test Category | Specific Test/Characteristic | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|---|
| Bench Performance Testing | |||
| Disinfection Stability | Physical properties after 30 disinfection cycles in Boston Simplus solution at ambient temperatures | Stable physical properties | Physical properties stable |
| Material Properties | Physicochemical and mechanical properties after Tangible™ Hydra-PEG® addition | Unchanged (except wettability) | Unchanged (except wettability) |
| Wettability (Contact Angle) | Sessile Drop Contact Angle - Coated |
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(322 days)
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.
The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.
This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.
| Characteristic | Oxfore®100 (hexafocon A) RGP Lens (New Device) | Boston XO™ (hexafocon A) RGP Lens (Predicate Device) | Implicit Acceptance Criteria (Achieved) |
|---|---|---|---|
| Material | hexafocon A | hexafocon A | Same material (hexafocon A) |
| Production method | Lathe Cut | Lathe Cut | Same production method |
| Actions/Operational Principles | When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity | When placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuity | Same fundamental mechanism of action |
| Product Code | HQD | HQD | Same FDA product code |
| Common Name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | Same classification |
| Device Class | II | II | Same device class |
| CFR Reference | 21 CFR 886.5916 | 21 CFR 886.5916 | Same regulatory classification |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Same FDA material group |
| Indications for Use | Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. Disinfected using chemical disinfection system only. | Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia), management of irregular corneal conditions (keratoconus, etc.), and therapeutic use for ocular surface disease. Disinfected using chemical disinfection system only. | Partially equivalent, with predicate having broader therapeutic indications not claimed by the new device. However, the core refractive correction indication is equivalent. |
| Refractive Index (RGP) | 1.415 | 1.415 | Identical |
| Oxygen Permeability (RGP Center) | 100 | 100 | Identical |
| Specific Gravity (RGP) | 1.27 | 1.27 | Identical |
| Hardness (Shore D) | 81 | 81 | Identical |
| Modulus (MPa) | 1500 | 1500 | Identical |
| Tint | Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18, D&C Red No. 17) | Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18) | Largely similar, with new device having one additional tint (D&C Red No. 17). This is considered a minor difference. |
| Water Content (Soft Skirt) |
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(52 days)
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased 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 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon 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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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.
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for spheres .
- with base curves of 4.0 mm to 11.50 mm ●
- with base curve chord of 6.0 mm to 6.5 mm ●
- with diameters of 7.0 to 21.0 mm
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.
The provided text describes the regulatory clearance of a medical device, the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, based on substantial equivalence to predicate devices, rather than a direct study validating specific acceptance criteria against reported performance in a clinical setting.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in the provided text in the format you requested, as the submission relies on demonstrating similarity to already approved devices.
However, I can extract information related to the performance data mentioned and the basis for determining substantial equivalence.
Here's an analysis based on the provided text, addressing your points as much as possible:
1. Table of acceptance criteria and the reported device performance:
The document states that the new device has been shown to be "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the new device's performance is comparable to the predicate devices across various characteristics. The "Comparison of Characteristics with the Predicate Device" table serves as the primary evidence for this.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Acuity 200™ with Tangible® Hydra PEG®) |
|---|---|---|
| Material | fluoroxyfocon A (matching predicate K201194, K203571) | fluoroxyfocon A |
| Production Method | Lathe Cut (matching predicate devices) | Lathe Cut |
| UV Blocking | Yes (matching predicate devices) | Yes |
| Base Curves | 4.0 mm to 11.5 mm (matching predicate K201194, K203571, within range of K161100) | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm (matching predicate devices) | 6.0 mm to 6.5 mm |
| Design | Standard geometry with anterior aspheric surface (matching predicate K201194, K203571) | Standard geometry with anterior aspheric surface |
| Diameters | 7.0-21.0 mm (matching predicate K201194, K203571, within range of K161100) | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D (matching predicate devices) | -20.00D to +20.00D |
| Astigmatism Range | Up to 9.00 D (matching predicate K201194, K203571, comparable to K161100's up to 10.00 D) | Up to 9.00 D |
| Add Powers | +1.00 D to +4.00 D (matching predicate devices) | +1.00 D to +4.00 D |
| Indications for Use | Must be for daily wear for correction of refractive error (myopia, hyperopia, presbyopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes, and for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-keratoplasty/LASIK surgery). Must also be compatible with chemical disinfection. (Matching and expanding on predicates) | Matches and expands on previous predicates. |
| Refractive Index | 1.430 (matching predicate K201194, K203571, comparable to K161100's 1.4406) | 1.430 |
| Oxygen Permeability | 200 (matching predicate K201194, K203571, superior to K161100's 65) | 200 |
| Specific Gravity | 1.18 (matching predicate K201194, K203571, comparable to K161100's 1.27) | 1.18 |
| Hardness (Shore D) | 78 (matching predicate K201194, K203571) | 78 |
| Modulus (MPa) | 1194 (matching predicate K201194, K203571) | 1194 |
| Tint | Visibility Tints (various as specified) (matching predicate devices) | Visibility Tints (various as specified) |
| Water Content |
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(123 days)
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased 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) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Acuity 200™ (fluoroxyfocon 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) |
| ± 0.18 (5 to = 10.0D) | ||
| ± 0.25 (10 to = 15D) | ||
| ± 0.37 (15 to = 20D) | ||
| ± 0.50 (over 20D) | ||
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D) |
| ± 0.37 (2 to = 4D) | ||
| ± 0.50 (over 4D) | ||
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surface | |
| defect |
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability | |
| (Dk) | 200 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |
This document describes the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and its substantial equivalence to predicate devices, focusing on its expanded indications for use.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission for a medical device (contact lens) and not an AI/software device. The primary "acceptance criteria" for such a device effectively revolve around demonstrating substantial equivalence to legally marketed predicate devices and proving its safety and effectiveness for its intended use and expanded indications.
The reported device performance is primarily qualitative and based on the outcomes of a retrospective clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Original Indications | Demonstrated through previous 510(k) clearances. Substantial equivalence to predicate for its original indications (correction of refractive error in non-diseased eyes). |
| Safety and Effectiveness for Expanded Indications | In a retrospective clinical study (41 patients, 66 eyes), "irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses." No serious adverse reactions reported over 13,760 total days of wear. This demonstrates safety and effectiveness for management of irregular corneal conditions. |
| Physical and Chemical Properties Equivalence | Refractive Index, Modulus, Hardness, Specific Gravity, and Oxygen Permeability (Dk) are provided for the Acuity 200 and are comparable to predicate devices in terms of material group. |
| Manufacturing and Design Equivalence | Lathe-cut production method, daily wear intended use, |
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(127 days)
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear.
The Acuity 200™ (fluoroxyfocon 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- . in the power range of -20.00 to +20.00 diopters for spheres
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm ●
- with diameters of 7.0 to 21.0 mm ●
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.
The provided text describes the acceptance criteria and study proving the performance of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.
Here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for an AI device (e.g., target accuracy, sensitivity, specificity thresholds). Instead, the study aims to demonstrate substantial equivalence to a predicate device (Acuity 100). The "acceptance criteria" are implied by the comparison to the predicate device in terms of safety and effectiveness endpoints.
| Metric / Endpoint | Acceptance Criteria (Implicit for Substantial Equivalence to Acuity 100) | Reported Device Performance (Acuity 200™) |
|---|---|---|
| Effectiveness - Visual Acuity | Substantially equivalent to Control lenses (Acuity 100) | Test and control lenses performed similarly with respect to contact lens corrected visual acuity results. |
| Safety - Objective Findings (Slit lamp: staining, edema, vascularization, hyperemia, infiltrates, other complications) | No severity worse than Grade 2 (except for isolated instances permitted in predicate) | None of the completed or discontinued eyes in the test arm reported a severity worse than Grade 2 for these findings. |
| Safety - Subjective Symptoms (Discomfort, Dryness, Irritation) | Incidence and severity similar to Control lenses (Acuity 100) | Test and control lenses performed similarly with respect to subject reported symptoms. Symptoms reported with highest frequency (discomfort, dryness, irritation) showed no clinical difference in incidence between test and control arms. |
| Safety - Adverse Events | Incidence and severity similar to Control lenses (Acuity 100) | Adverse events that occurred in the study were similar in both arms, in terms of incidence and severity. |
| Safety - Vision Safety Measures (Keratometry changes, Refractive changes, Best corrected visual acuity) | No clinically relevant differences or negative trends compared to Control lenses (Acuity 100) | The test and control lenses performed equally well with regards to vision safety measures. Trend analysis shows no emerging trends for test and control lenses for the duration of the study. |
| Biocompatibility | Meets ISO 10993-1:2018 standards for biological evaluation. | Evaluation conducted according to ISO 10993-1:2018. Tests performed include Cytotoxicity, Systemic Toxicity, Ocular Irritation, and Skin Sensitization. Device found to show biocompatibility for a surface device, limited contact. |
| Performance Testing (Lens/solution compatibility, Manufacturing verification, Extractable testing, Contact angle, Dry shelf life, Lens stability testing) | Meets required performance standards for safety and intended function. | These tests were performed to establish the performance of the device. The non-clinical data demonstrates the safety of the device and demonstrates that the device should perform as intended. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 74 subjects (148 eyes) were enrolled.
- 50 subjects (100 eyes) were in the test group (Acuity 200™).
- 24 subjects (48 eyes) were in the control group (Acuity 100).
- 58 subjects completed the scheduled visits (40 in test group, 18 in control group).
- Data Provenance:
- Country of origin: United States. Subjects were evaluated at four independent clinical sites across the United States.
- Retrospective or Prospective: Prospective. The study design is described as an "open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes a clinical study for a contact lens, not an AI/ML device relying on expert-annotated ground truth for image analysis. Therefore, the concept of "experts used to establish ground truth" in the AI sense (e.g., radiologists marking images) does not directly apply here.
The "ground truth" for this study is derived from:
- Objective clinical measurements: Slit lamp observations (staining, edema, vascularization, hyperemia, infiltrates), keratometry, refractive changes, best corrected visual acuity, adverse event reporting. These are direct measurements/observations by licensed healthcare professionals at the clinical sites.
- Subjective patient reporting: Symptoms (discomfort, dryness, irritation), problems, and complaints.
The qualifications of the clinicians performing these assessments are not explicitly stated beyond them being affiliated with "four independent clinical sites."
4. Adjudication method for the test set:
Not applicable in the typical AI/ML context of image interpretation. The study is a clinical trial with observational and measurement endpoints. Data was collected by clinicians at study sites. There's no mention of an independent adjudication panel reviewing discrepancies in diagnoses or measurements in the way one would for an AI ground truth dataset.
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 clinical trial for a physical medical device (contact lens), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device; there is no "algorithm only" performance.
7. The type of ground truth used:
As explained in point 3, the "ground truth" for this clinical study consists of:
- Objective Clinical Findings: Slit lamp observations, keratometry, refractive changes, visual acuity measurements.
- Subjective Patient Outcomes/Symptoms: Self-reported discomfort, dryness, irritation, problems, and complaints.
- Adverse Event Data: Documented adverse events.
This is fundamentally an outcomes data and expert clinical observation driven ground truth, rather than pathology or image-based consensus in an AI context.
8. The sample size for the training set:
Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning model development. The "training" for such a device would refer to its manufacturing process development and quality control, which is implied by the non-clinical performance testing.
9. How the ground truth for the training set was established:
Not applicable, as there is no machine learning training set in this submission. The non-clinical performance data (biocompatibility, lens/solution compatibility, manufacturing verification, extractable testing, contact angle, dry shelf life, lens stability testing) are established through standard laboratory and manufacturing evaluation processes.
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(89 days)
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable
Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid
Gas Permeable Contact Lens
The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
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.
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
- cannot be adequately corrected with spectacle lenses
- requires a rigid gas permeable contact lens surface to improve vision
- 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 marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren'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 Boston Scleral Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.
The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
The provided document is a 510(k) Premarket Notification for Bausch & Lomb's Boston ES®, Boston EO®, Boston XO®, and Boston XO2® Rigid Gas Permeable Contact Lenses with a new Tangible™ Hydra-PEG surface coating. This document details the company's claim of substantial equivalence to previously cleared predicate devices, rather than presenting a study for a novel AI/software as a medical device (SaMD).
Therefore, the information requested for acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device proving AI/software performance is not present in this document.
This submission focuses on demonstrating the safety and effectiveness of a modified contact lens product by comparing its technological characteristics and performance (primarily wettability and biocompatibility) to already cleared devices. The "performance data" sections refer to non-clinical (toxicology, biocompatibility, stability) and clinical (based on predicate device history) testing relevant to contact lenses, not AI model performance.
The only "acceptance criteria" explicitly mentioned and met are related to quality control for the contact lenses:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bioburden levels |
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(41 days)
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are lathe cut from one of the following hydrophobic. FDA Group #3 fluoro-silicone acrylate materials: hexafocon A, hexafocon B, or oprifocon A-with the following properties: Refractive Index, Water Content, Specific Gravity, Wetting Angle, Oxygen Permeability (Dk) ISO/FATT Method (cm2/sec) (ml O2/ml x mm Hg @ 35°C), Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power, Aspheric Lens Eccentricity.
This document is a 510(k) Premarket Notification for the eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K.
The provided text does not describe a study that uses AI or machine learning models to meet acceptance criteria, but rather focuses on substantial equivalence to existing predicate devices for rigid gas permeable contact lenses. Therefore, I cannot extract information related to AI/ML model acceptance criteria, performance, sample sizes for test/training sets, expert adjudication, or MRMC studies from this document.
The document primarily covers:
- Device Description: Materials, properties, and available parameters of the contact lenses.
- Intended Use/Indications for Use: Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia), management of irregular corneal conditions, and temporary reduction of myopia for Ortho-K.
- Predicate Devices: Lists several "Boston" brand contact lenses as predicate devices.
- Substantial Equivalence: Argues that the eLens is substantially equivalent to the predicate devices based on common classification, product code, FDA Group #, USAN, production method (lathe-cut), actions, intended use, and indications for use.
- Performance Data: States that non-clinical and clinical performance data have been addressed by reference to the predicate devices and in previous applications.
Therefore, I cannot fulfill the request to discuss acceptance criteria and study proving the device meets those criteria, as the document does not contain information about an AI/ML-based study.
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