Search Results

The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA.

The device consists of the following main components and accessories: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly, a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator,

Here's a breakdown of the acceptance criteria and the study information for the CIBA Centurion SES™ Epikeratome, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive details of clinical trials with detailed statistical analysis and performance metrics in the way one might expect for a novel device requiring a PMA. Therefore, some of the requested information (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies with effect sizes) is not present in this document. The "study" described is primarily a bench testing equivalence study.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample size: Not explicitly stated. The "test set" here refers to the components and overall device undergoing bench testing. It's likely involved multiple units/components, but a specific number is not provided.
   • Data provenance: Bench testing results. Location of testing not specified, but the applicant (CIBA Vision Corporation) is based in Duluth, Georgia, USA. The study is retrospective in the sense that it's a comparison to an existing, cleared device (K031735).

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

   • Not applicable as this was primarily bench testing for functional equivalence, not a clinical study requiring expert diagnosis or assessment for ground truth. Device function was likely assessed against engineering specifications and pre-defined performance metrics through testing.

3. Adjudication method for the test set:

   • Not applicable. As noted above, this was a bench testing comparison, not a clinical trial with case adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (keratome) and does not involve "human readers" interpreting images or data where AI assistance would be relevant in the context of diagnostic improvement.

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

   • Not applicable. This device is a physical surgical instrument, not an algorithm. The "functional and electrical safety test results" can be considered a standalone performance assessment of the instrument.

6. The type of ground truth used:

   • For the bench testing, the "ground truth" was likely the technical specifications and established performance characteristics of the predicate device (Centurion SES Epikeratome cleared under K031735), along with engineering design specifications and safety standards for medical devices. The device's ability to "remove epithelium in a consistent and reproducible way" would be assessed against these engineering and functional standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable for the same reason as above.

Ask a specific question about this device