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The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A), and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for the correction of refractive ametropia in aphakic and nonaphakic patients with keratoconus or following penetrating keratoplasty who may be disabled by conventional contact lenses or spectacles.

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This document is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a previously marketed predicate device.

Therefore, most of the requested information cannot be extracted from this document, as it describes a regulatory approval process for a contact lens based on equivalence, not a performance study against specific acceptance criteria.

Here's an attempt to address the points based on the available information, noting where data is absent:

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

   • Not Applicable. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent ... to legally marketed predicate devices." This means the device's performance is accepted because it is deemed to be as safe and effective as existing, legally marketed devices, not because it met specific, predefined quantitative performance metrics in a study. The document does not provide acceptance criteria or performance metrics for this specific device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. No test set or data provenance related to a performance study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. No ground truth establishment for a test set is mentioned.

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

   • Not Applicable. No test set or adjudication method is mentioned.

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 contact lens, not an AI/ML diagnostic or assistive device. No MRMC study or AI assistance is relevant here.

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

   • Not Applicable. This refers to a physical contact lens, not an algorithm.

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

   • Not Applicable. No ground truth for device performance as typically defined for diagnostic or AI devices is mentioned. The "ground truth" for this 510(k) clearance is the established performance and safety of its predicate devices.

8. The sample size for the training set

   • Not Applicable. No training set is mentioned as this is a physical device, not an AI/ML model.

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

   • Not Applicable. No training set or ground truth for it is mentioned.

In summary: This document is a regulatory approval based on the concept of "substantial equivalence" of a medical device (contact lens) to existing, legally marketed devices. It is not a report detailing a clinical performance study with specific acceptance criteria as you would typically find for a diagnostic device or an AI/ML product.

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