(78 days)
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 control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.
The provided 510(k) summary for the CIBA Centurion SES Epikeratome describes a medical device, but it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to predicate devices, supported by bench testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies. This information is typically found in more comprehensive clinical study reports, which are not part of this 510(k) summary.
However, based on the provided text, I can infer and state what was used to establish equivalence:
Acceptance Criteria and Study Summary (Based on Substantial Equivalence and Bench Testing):
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate devices (Biovision Visitome 20-10, Alcon Pallikaris Brush, Amoils Epithelial Scrubber) | Bench testing demonstrates functional equivalence, showing the Centurion SES device is functionally equivalent to the Visitome 20-10. Minor differences between Centurion SES and predicate devices do not affect safety and effectiveness. |
| Consistent and reproducible epithelium removal | Bench testing demonstrates that the Centurion SES separator removes epithelium in a consistent and reproducible way. |
| Biocompatibility of patient-contacting components | All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible. |
| Equivalence in intended use (separation of epithelium, making corneal flap) | Centurion SES is substantially equivalent to predicate devices with respect to intended use. |
| Equivalent technological characteristics | Centurion SES has equivalent technological characteristics to predicate devices. |
Detailed Study Information (Based on provided 510(k) Summary):
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A table of acceptance criteria and the reported device performance: See table above. These are inferred from the 510(k)'s focus on substantial equivalence and bench testing, rather than explicit numerical acceptance criteria.
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Sample sized used for the test set and the data provenance: Not specified. The document refers to "bench testing" but does not provide details on sample sizes, specific test protocols, or data provenance (e.g., country of origin, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for showing equivalence was based on functional performance in bench testing relative to predicate devices, not on expert consensus from human data.
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Adjudication method for the test set: Not applicable. No human adjudication process is described for performance evaluation; the assessment was based on bench testing.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an AC-powered surgical tool, not an algorithm. Its standalone performance was assessed through "functional and electrical" bench testing to demonstrate consistent and reproducible epithelium removal, and equivalence to predicate devices.
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The type of ground truth used: The "ground truth" for demonstrating the device's performance was the established functionality and performance of the predicate devices, against which the Centurion SES Epikeratome was quantitatively and qualitatively compared via bench testing. The biocompatibility of materials was also a "ground truth" based on historical use.
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The sample size for the training set: Not applicable. This device is a mechanical surgical tool, not an AI or algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.