(50 days)
The Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
The device described is the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens. This document assesses its substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria directly. However, based on the provided information, we can infer acceptance criteria from the performed tests and the comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing (Manufacturing Verification) | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. | All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance. |
| Bioburden Testing | Colony forming units (CFU) per lens less than 100. | Colony forming units (CFU) per lens was less than 1. |
| Substantial Equivalence (General) | No significant differences from predicate devices in terms of safety and effectiveness. Does not raise different questions of safety and effectiveness. | Testing demonstrates no significant differences from the predicate devices, supporting the substantial equivalence claim. No new questions of safety and effectiveness are raised. |
| Components/Materials/Formulation | Equivalent to predicate devices (roflufocon D & E contact lens materials, and potentially others as per prednisone). | Uses roflufocon D & E contact lens materials, matching predicate devices. |
| FDA Classification & Group Number | Class II, Group #3 Fluoro Silicone Acrylate. | Class II, Group #3 Fluoro Silicone Acrylate. |
| Lathe Cut Manufacturing Process | Utilizes lathe-cut manufacturing. | Utilizes lathe-cut manufacturing process. |
| Large Diameter (Scleral) Design | Has a large diameter scleral design. | Has a large diameter (scleral) design. |
| Actions and Intended Use | Actions and intended use are equivalent to predicate devices. | Actions and intended use are equivalent to predicate devices, extending indications based on clinical case reports. |
| Therapeutic Indications for Use | Therapeutic indications for use are equivalent or justified compared to predicate devices. | Therapeutic indications for use include conditions like keratoconus, dystrophies, post-surgery, and ocular surface diseases, supported by clinical case reports and compared to predicates. |
| Physical Properties | (Implicit/Explicit from predicate and material specifications): Refractive Index, Light Transmission, Water Content, Dynamic Contact Angle, Specific Gravity, Modulus, Shore D Hardness, Oxygen Permeability (Dk), UV Light Blocking. | Roflufocon D: Refractive Index 1.4333, Light Transmission >97% (clear), >90% (tinted), Water Content 98% UVB, >95% UVA. |
| Roflufocon E: Refractive Index 1.4332, Light Transmission >97% (clear), >90% (tinted), Water Content 98% UVB, >95% UVA. | ||
| Lens Parameters | (Implicit/Explicit from predicate and manufacturing capabilities): Chord Diameter, Center Thickness, Base Curve, Spherical Powers. | Chord Diameter: 14.8 mm to 17.8 mm, Center Thickness: 0.20 mm to 0.40 mm, Base Curve: 6.6 mm to 11.0 mm, Spherical Powers: -30.00 D to +30.00 D (0.125 D steps). |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify a separate "test set" sample size for bench testing. It indicates "All lenses were manufactured..." suggesting testing was conducted on a representative sample or a substantial portion of manufactured lenses to verify production capabilities. The provenance of this data is internal to Valley Contax, Inc. (manufacturer), and is prospective in relation to the manufacturing verification.
- Bioburden Testing: The sample size is not explicitly stated, but bioburden testing was conducted on "rigid gas permeable lenses manufactured at Valley Contax, Inc." The data provenance is internal to Valley Contax, Inc. and is prospective from the manufacturing process.
- Clinical Studies: The document refers to "a series of clinical case reports" for performance demonstration. The specific sample size for these case reports is not given, nor is the country of origin. These are likely retrospective case reports from practitioners fitting the lenses.
- Reference to Predicate Devices: For the bulk of safety and effectiveness, the device relies on existing data from predicate devices (K033594 - Optimum GP and K161461 - BostonSight PD). The sample sizes and provenance for those original approvals are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on a de novo clinical trial with extensive ground truth establishment by external experts for a new device's performance.
- For the internal bench and bioburden testing, the "ground truth" is defined by established specifications (ANSI Z80.20 tolerance for manufacturing, less than 100 CFU for bioburden), which are likely set by industry standards and potentially internal quality assurance experts. No specific number or qualifications of "experts" are provided.
- For the "series of clinical case reports," the implicit "experts" are the eye care practitioners who prescribed and managed the patients. Their qualifications are not specified but would typically be optometrists or ophthalmologists.
- For the safety and effectiveness data derived from predicate devices, the "ground truth" and expert involvement would have been established during the approval process of those predicate devices, but this information is not included in the current document.
4. Adjudication Method for the Test Set:
- Bench Testing & Bioburden Testing: No explicit adjudication method is mentioned beyond compliance with pre-defined acceptance criteria (e.g., ANSI standards, CFU limits). This suggests direct measurement and comparison to thresholds rather than a multi-reader review process.
- Clinical Case Reports: Given they are "case reports," it's unlikely a formal adjudication method (like 2+1, 3+1 consensus) was used. Case reports typically document individual patient outcomes as observed and reported by a single practitioner or clinical team.
- Predicate Device Data: No information on adjudication methods for the predicate device studies.
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:
No MRMC comparative effectiveness study was mentioned, nor is there any indication of AI involvement in this device. This is a contact lens, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone (algorithm only) performance was evaluated, as this device is a physical contact lens and does not involve an algorithm.
7. The Type of Ground Truth Used:
- Bench Testing: Ground truth is based on engineering and manufacturing specifications (e.g., ANSI Z80.20 tolerance for lens parameters).
- Bioburden Testing: Ground truth is based on microbiological safety standards (CFU count).
- Clinical Case Reports: Ground truth is based on observed clinical outcomes and practitioner assessments of patient response to the lens (e.g., comfort, visual acuity, ocular health).
- Predicate Device Data: Ground truth would have been established during the original predicate approvals, likely through clinical trials and performance testing against objective measures and clinical endpoints.
8. The Sample Size for the Training Set:
This is a physical medical device (contact lens), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.