(75 days)
The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased 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 surgery.
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 BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, 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.
Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion 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). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.
Eye care practitioners may prescribe the lenses for 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.
The BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A. The lenses fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG coating. The lenses fabricated from oprifocon A are not available with Tangible® Hydra-PEG. The lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. When shipped "wet", the lenses are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution.
The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the BostonSight® Specialty Lenses to existing predicate devices. It does not present a study proving the device meets specific acceptance criteria based on performance data. Instead, it relies on the predicate pathway, meaning the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market.
Therefore, many of the requested elements for a study proving the device meets acceptance criteria (such as sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of regulatory submission.
However, based on the information provided, here's what can be inferred or stated regarding "acceptance criteria" through the lens of substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" in this context are primarily the material properties and physical parameters that establish similarity to predicate devices already cleared by the FDA. The performance is assessed by demonstrating these properties are within acceptable ranges, consistent with the predicates.
| Acceptance Criteria (Based on Predicate Equivalence) | Reported Device Performance (BostonSight® Specialty Lenses) |
|---|---|
| Intended Use | Daily Wear, Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons with non-diseased eyes, and therapeutic use for irregular corneal conditions/ocular surface disorders. |
| Classification | Class II, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code | HQD |
| FDA Material Group | Group #3 Fluoro Silicone Acrylate |
| USAN Materials | roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A |
| Production Method | Lathe Cut |
| Water Content | 97% (roflufocon D, E), >95% (hexafocon B, oprifocon A) - Consistent with predicate materials. |
| Light Transmission (tinted) | >90% (roflufocon D, E, oprifocon A), >91% (tisilfocon A), >83% (hexafocon B), >87% (fluoroxyfocon A) - Consistent with predicate materials. |
| Dynamic Receding Contact Angle | Varies by material (e.g., roflufocon D: 3°, hexafocon B: 40°, oprifocon A: 56°) - Consistent with predicate materials. |
| Tangible® Hydra-PEG Availability | Yes (for all materials except oprifocon A) |
| Base Curve Range | 5.00mm to 11.5mm |
| Center Thickness Range | 0.05mm to 0.75mm |
| Chord Diameter Range | 7.00mm to 26.00mm |
| Spherical Power Range | -25.00 D to +35.00 D |
| Cylindrical Power Range | Up to -10.00 D |
| Cylindrical Axis Range | 1° to 180° |
| Multifocal Power Range | +1.00 D to 4.00 D |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on "Non-Clinical Studies" and "Clinical Studies" sections where it explicitly states that the safety and effectiveness have been "addressed by reference to previous 510(k) clearances." No new specific test set or clinical study data is presented for this particular submission.
- Data Provenance: The underlying data for the predicate devices would have come from their respective clearance processes. This document does not provide details on the provenance (country of origin, retrospective/prospective) of those original predicate studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no new test set data is presented. The "ground truth" for the predicate pathway is essentially the FDA's prior determination of safety and effectiveness for the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no new test set data is presented.
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 not an AI-assisted device. Also, this is a substantial equivalence submission, not a new clinical trial comparing performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k) submission, the "ground truth" is the established safety and effectiveness of the identified predicate devices, as previously determined by the FDA. The manufacturer is asserting that their new device is fundamentally similar in materials, design, and intended use, and therefore shares that established safety and effectiveness profile.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical 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.