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The Norwood Abbey 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.

The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used 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: console, separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator. The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.

This submission, K051486, describes the Centurion SES™ Epikeratome, an AC-powered device for separating the corneal epithelium. The submission focuses on a new console for the device and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Bench testing" and "Functional test results." This implies a series of laboratory-based tests rather than studies involving human subjects or patient data.

• Sample Size: Not specified. Standard engineering and functional testing would likely involve testing multiple units of the device and observing performance over a range of operational parameters, but no specific count is given.
• Data Provenance: The testing appears to be prospective bench testing conducted by Norwood Abbey Limited in Australia. There is no mention of patient data, retrospective analysis, or specific country of origin for any human-derived data.

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

This type of information is not applicable to this submission. The device is for a surgical procedure (mechanical separation of epithelium), and its performance evaluation focused on its mechanical and functional equivalence to a predicate device, as demonstrated through bench testing. There is no mention of human-interpreted data (like medical images) that would require experts to establish ground truth.

4. Adjudication method for the test set

Not applicable. As the performance evaluation was based on functional and bench testing, there's no "ground truth" to adjudicate in the typical sense of expert review for diagnostic devices.

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

No. This is a mechanical surgical device, not a diagnostic imaging device with AI assistance. Therefore, an MRMC study is not relevant.

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

Yes, in spirit. The performance evaluation was entirely "standalone" in the sense that the device's functional characteristics were assessed directly through bench testing without human-in-the-loop performance testing in a clinical diagnostic context. The focus was on the machine's ability to perform its stated mechanical function.

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

The "ground truth" for this device's performance evaluation was defined by:

• Functional equivalence to the predicate device: The new console had to demonstrate it could perform the same functions as the predicate device.
• Consistency and reproducibility: The device had to consistently and reproducibly drive the separator assembly to remove epithelium.
• Lack of impact on safety or effectiveness: The modifications should not negatively affect the device's safety or its ability to perform its intended use.

These "ground truths" were assessed via a combination of engineering specifications, comparison to a predicate device's known performance, and functional testing to ensure consistent mechanical operation. It does not involve biological or clinical "ground truth" as you would find in diagnostic device submissions (e.g., pathology for a cancer detection device).

8. The sample size for the training set

Not applicable. This submission is for a mechanical surgical device without any machine learning or AI components that would require a "training set."

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

Not applicable. See point 8.

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