Search Results
Found 11 results
510(k) Data Aggregation
(80 days)
Acuity Polymers, Inc.
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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(29 days)
Acuity Polymers, Inc.
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 Polymers, Inc.
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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(52 days)
Acuity Polymers, Inc.
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 Polymers, Inc.
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 Polymers, Inc.
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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(53 days)
Acuity Polymers, Inc.
The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon 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 lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. 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. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.
The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose solution.
The provided text describes the regulatory clearance of "The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses." However, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies is not found in the provided document.
The document explicitly states: "Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated."
Instead, the submission relies on:
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a legally marketed predicate device (BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution, K073184).
- Prior Clearances for Materials and Solutions: The gas permeable lens materials themselves (Acuity 100, Acuity 18, Acuity 85, Acuity 58) were previously cleared under separate 510(k)s. The multi-action solutions (BOSTON SIMPLUS and Menicon Unique pH) were also previously cleared. The current submission bundles these cleared components.
- Biocompatibility Testing: The materials have been tested and found to meet biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009).
- Solution Compatibility Studies: Previous 510(k)s for the individual RGP lens materials included solution compatibility studies demonstrating stable lens parameters when using the specified solutions.
- Microbiological Methods (Bioburden Studies): Bioburden studies (in accordance with ISO 11737-1) were conducted to monitor lens manufacturing. These were extended to evaluate wet storage and shipping for up to 30 days, finding "no CFUs were found at any test point during the 30-day period." This represents a specific "performance" aspect, but not in the context of clinical efficacy.
- Conformance to Standards: The quality system conforms to ISO Standard 13485 (2003).
In summary, the document argues that the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device and by referencing prior clearances and standard-based testing for its constituent materials and solutions, rather than presenting a new, dedicated study with specific performance acceptance criteria.
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(150 days)
Acuity Polymers, Inc.
The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, bresbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D for daily wear. 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.
The Acuity 85™ (oprifocon 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 sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (oprifocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material.
The provided document is a 510(k) Summary for the Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, which seeks to establish substantial equivalence to a predicate device. As such, it does not detail a study involving AI or human readers, or clinical trials with acceptance criteria for device performance in the way a new medical device would typically be evaluated for accuracy or diagnostic capability.
Instead, the "acceptance criteria" here refers to demonstrating that the new device's material properties and design are substantially equivalent to a legally marketed predicate device, as per FDA guidelines for daily wear contact lenses. The "study" mentioned is primarily non-clinical testing of the material properties.
Here's a breakdown based on the information provided, framed to address your specific questions where applicable, and noting where information is not relevant to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the properties of the predicate device (Boston Equalens II) and the "performance" is the new device's (Acuity 85) equivalent properties. The goal is to show the new device meets or is comparable to the predicate's established properties.
| Characteristic | Acceptance Criteria (Predicate: Boston Equalens II) | Reported Device Performance (Acuity 85) |
|---|---|---|
| Lens Characteristics | ||
| Material | oprifocon A | oprifocon A |
| Production method | Lathe Cut | Lathe Cut |
| UV Blocking | Yes | Yes |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D |
| Add Powers (for multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Indications for Use | See detailed description in document | See detailed description in document |
| Refractive Index (RGP) | 1.423 | 1.422 ± 0.002 |
| Oxygen Permeability (RGP Center) | 85 | 115 ± 24 |
| Specific Gravity (RGP) | 1.24 | 1.23 ± 0.02 |
| Hardness (Shore D) | 80 | 81 |
| Modulus (MPa) | 1300 | 1378 |
| Tint | Visibility Tints – various | Visibility Tints – various |
| Water Content |
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(148 days)
Acuity Polymers, Inc.
The Acuity 58™ (en:flufocon B) 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 nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. 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.
The Acuity 58™ (enflufocon B) 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 sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.
Here's an attempt to extract the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Acuity 58™ enflufocon B) |
|---|---|---|
| Material | enflufocon B | enflufocon B (identical) |
| Production Method | Lathe Cut | Lathe Cut (identical) |
| UV Blocking | Yes | Yes (identical) |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm (identical) |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm (identical) |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface (identical) |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm (identical) |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D (identical) |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D (identical) |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D (identical) |
| Indications for Use | Effectively identical scope (myopia, hyperopia, presbyopia, astigmatism in aphakic/non-aphakic non-diseased eyes, irregular corneal conditions) | Effectively identical scope as predicate |
| Refractive Index | 1.429 | 1.429 (identical) |
| Oxygen Permeability | 58 | 58 (identical) |
| Specific Gravity | 1.23 | 1.24 (very close) |
| Hardness | 114 (Rockwell R) | 81 (Shore D) (Note: Different scales, not directly comparable without conversion. The document states "materials values meet minimum values required for use.") |
| Modulus | 1500 MPa | 1568 MPa (very close) |
| Tint | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) (identical) |
| Water Content |
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(58 days)
Acuity Polymers, Inc.
The Acuity 1800 (enflufocon 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 nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. 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.
The Acuity 18TM (enflufocon 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 sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm ●
- . with diameter of 7.0 to 21.0 mm
The lens material enflufocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston ES (AKA Boston 7-30) Material and Contact Lenses (enflufocon A) described K943177 and K053124.
The provided text describes a 510(k) premarket notification for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert review.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and adjudication methods for a study proving the device meets acceptance criteria is not explicitly available in this document in the typical sense of a diagnostic or AI-driven device.
Instead, the submission relies on the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a "Side-by-Side Comparison" of the new device (Acuity 18) and its predicate device (Boston ES (enflufocon A) RGP Lens). The "acceptance criteria" here are implicitly the characteristics and values of the predicate device, which the new device aims to match or be substantially equivalent to.
| Characteristic | New Lens (Acuity 18™ enflufocon A) | Predicate Lens (Boston ES enflufocon A) |
|---|---|---|
| Manufacturer | Acuity Polymers, Inc. | Bausch + Lomb |
| Material | enflufocon A | enflufocon A |
| Production method | Lathe Cut | Lathe Cut |
| UV Blocking | Yes | Yes |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Indications for Use | Identical | Identical |
| Refractive Index (RGP) | 1.445 | 1.443 |
| Oxygen Permeability (RGP Center) | 21 | 18 |
| Specific Gravity (RGP) | 1.22 | 1.22 |
| Hardness (Shore D) | 84 | 85 |
| Modulus (MPa) | 1739 | 1900 |
| Tint | Visibility Tints - various (D&C Green #6, D&C Violet #2, D&C Yellow #18) | Visibility Tints - various (D&C Green #6, D&C Violet #2, D&C Yellow #18) |
| Water Content (Soft Skirt) |
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