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510(k) Data Aggregation
(29 days)
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable
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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(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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