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The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.

The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 36% water by weight.

This document doesn't contain a study that demonstrates the device meets acceptance criteria. Instead, it's a 510(k) summary for a medical device (AL-47 Toric contact lens) seeking FDA clearance based on substantial equivalence to previously marketed predicate devices, not on new clinical performance data.

Therefore, most of the information requested about acceptance criteria and a detailed study (like sample sizes, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is presented as equivalence to these predicate characteristics.

Regarding the study that proves the device meets acceptance criteria:

The document does not describe a new clinical study to establish performance against acceptance criteria for the AL-47 Toric lens. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" is effectively a comparison of characteristics and intended use.

2. Sample size used for the test set and the data provenance:

• Not applicable. No new test set data from human subjects is presented or analyzed to prove performance against specific clinical acceptance criteria. The submission relies on the established safety and effectiveness of predicate devices.
• The safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is stated to be "equivalent to AL-47 (spherical), PMA # P820078", which refers to prior data for a non-toric version of the lens. No specific sample sizes for this prior data are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring adjudication is described.

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 device is a contact lens, not an AI diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No new ground truth for performance is established for this submission. The "ground truth" for the device's acceptable safety and effectiveness is implicitly derived from the long-standing use and FDA clearance of the predicate devices and the original AL-47 spherical lens.

8. The sample size for the training set:

• Not applicable. This device's clearance is based on substantial equivalence to existing devices, not a machine learning model's training.

9. How the ground truth for the training set was established:

• Not applicable. No training set for a machine learning model is involved.

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The AL-47 (isofilcon) Soft Contact Lens for daily wear are indicated for the correction of visual acuty in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AL-47 (isofilcon) Hydrophilic Daily Wear Contact Lens (clear, lathe-cut, parametric release)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a contact lens. It does not contain the information requested in your prompt regarding acceptance criteria and study details for device performance. It simply states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device