(86 days)
The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed 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. The lens may be disinfected using a chemical disinfection system.
The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts. The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens. The lens material attributes and lens parameters are found in the package insert.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria for the Dyna Intra-Limbal Lens. Instead, it relies on the concept of "substantial equivalence" to predicate devices (Boston ES and Boston XO RGP lenses) and the demonstration of efficacy through a small clinical study for its new indication.
Therefore, the "acceptance criteria" can be inferred as:
- Safety profile equivalent to predicate devices.
- Manufacturing adherence to specified standards (ANSI Z80.20-1998) and cGMP.
- Clinical data supporting the efficacy of the new indication.
Since specific quantitative acceptance metrics are not provided, I cannot populate a table with "reported device performance" against them in the traditional sense. The document states:
| Implicit Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Profile | Equivalent to predicate devices (Boston ES/XO RGP lenses) based on pre-clinical toxicology and manufacturing/chemistry data. |
| Manufacturing Standards | Manufactured according to ANSI Z80.20-1998 and cGMP quality assurance program. |
| Efficacy for New Indication | Supported by clinical data from 20 randomly selected patients with various corneal conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 20 patients.
- Data Provenance: The document does not specify the country of origin. It is a "clinical data presented" which implies a prospective study, though this is not explicitly stated. The nature of the device (contact lens) and the typical regulatory pathway for such devices often involve prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical data. It simply mentions "clinical data," implying a clinical trial where patient outcomes and observations by eye care professionals would serve as the basis for efficacy.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done or reported. The study described is a direct clinical evaluation of the device's performance in patients, not a comparison of human readers with and without AI assistance. The device itself is a contact lens, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a contact lens, not an AI algorithm. No standalone algorithm performance study was mentioned.
7. The Type of Ground Truth Used
The ground truth used for evaluating the efficacy of the Dyna Intra-Limbal Lens in the clinical study was likely patient outcomes and clinical observations by eye care professionals. This would include metrics like visual acuity improvements, comfort, fit, and successful management of irregular corneal conditions, as assessed by the prescribing and follow-up clinicians. The document refers to "efficacy of the Dyna Intra-Limbal Lens" supported by "clinical data."
8. The Sample Size for the Training Set
This question is not applicable. The Dyna Intra-Limbal Lens is a medical device (contact lens), not an AI algorithm that requires a training set. The "training" in this context would refer to the historical data and experience used to design the device, which is not quantified in terms of a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8. No ground truth for a "training set" of an AI algorithm was established. The "ground truth" for the device's design would stem from established ophthalmic knowledge, contact lens science, and the performance of predicate devices.
§ 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.