(16 days)
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, 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 Norwood Abbey 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 (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.
The provided document describes the safety and effectiveness summary for the Norwood Abbey Centurion SES™ Epikeratome, specifically the 9.0mm suction ring. This submission is for a Class I device (regulated under 21 CFR 886.4370, Product Code 86 HNO, Keratome, AC - Powered) to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional Equivalence/Substantial Equivalence: | |
| Same intended use as predicate device. | The new 9.0mm Centurion SES Epikeratome suction ring has the "same intended use" as the predicate device (CIBA Vision/Norwood Abbey Centurion SES Epikeratome 10.0mm suction ring). The indications for use are identical: separation of epithelium from the cornea for subsequent surgical procedures, and making a corneal flap for LASIK or other lamellar resection. |
| Same basic scientific technology as predicate device. | Both devices utilize "suction to the cornea and oscillation principles to separate the epithelium from the cornea." |
| Functionally equivalent to predicate device. | "Bench testing has demonstrated that the new 9.0mm Centurion SES suction ring is functionally equivalent to the predicate Centurion SES 10.0mm suction ring." The device "removes epithelium in a consistent and reproducible way and is equivalent to the predicate device." |
| Minor differences between modified and predicate device do not affect safety or effectiveness. | "any minor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Biocompatibility: (for 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." |
| Consistency and Reproducibility: (of epithelium removal) | Functional test results demonstrate that the Centurion SES suction ring and separator assembly "removes epithelium in a consistent and reproducible way." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" and "Functional test results" but does not specify the sample size for these tests. It also does not directly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) summary for a Class I device and the focus is on "bench testing" and "functional equivalence" to a predicate, the testing would typically be conducted in a controlled lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth. The evaluation relied on demonstrable functional equivalence through bench testing.
4. Adjudication Method for the Test Set
Since no experts were used to establish ground truth (as per point 3), there was no adjudication method described or necessary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not mentioned or performed. The study focused on demonstrating functional equivalence through bench testing, not on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a mechanical epikeratome, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The "performance data" refers to the mechanical function of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this submission appears to be derived from the demonstrated functional characteristics and performance of the predicate device. The new device's performance was compared against the known and accepted performance of the predicate in terms of its ability to separate epithelium consistently and reproducibly. It is based on engineering/bench test results showing direct functional equivalence, rather than a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This device is a hardware product, not an AI model. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI model, the concept of a "training set" and establishing its ground truth is 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.