(128 days)
The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.
List of components
- Power unit and footswitch .
- Handpiece / submitted device motor .
- Head and blade separator .
- Suction rings .
a) Power unit and footswitch
The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor.
The front panel includes several displays and features:
- . Vacuum pressure gauge, Battery level indicator,
- . Battery charge indicator,
- Connector for the motorized handpiece of the submitted device .
- Vacuum outlet connector .
The back panel includes connectors for footswitches and battery charger
b) Handpiece / submitted device motor
The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).
c) Head and blade separator
The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:
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The metal part in low carbon steel, and
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The plastic holder of the blade separator, which is not in contact with the patient's eye.
d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:
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Reusable
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Disposable
The provided document is a 510(k) summary for the Moria Epi-K™ device, an epikeratome used for separating the epithelium from the cornea. It details the device, its intended use, and claims substantial equivalence to predicate devices, but does not specify numerical acceptance criteria or a dedicated study proving performance against acceptance criteria in the typical sense of a clinical trial with pre-defined endpoints and statistical analysis.
Instead, the submission relies on the concept of substantial equivalence to predicate devices that are already legally marketed. The "tests and results" section describes in-vitro and in-vivo studies to support the device's safety and efficacy, framing them in terms of their ability to perform the intended function similarly to established devices.
Here's an attempt to extract and frame the information requested, with necessary caveats due to the nature of the document:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
As explicit numerical acceptance criteria are not stated in this 510(k) summary, the "acceptance criteria" are inferred from the claims made about the predicate devices (which are legally marketed) and the stated purpose of the Epi-K™. The reported device performance is taken directly from the "Discussion of tests and results" section.
| Acceptance Criterion (Inferred from Predicate Devices & Intended Use) | Reported Device Performance (Epi-K™) |
|---|---|
| Ability to create an epithelial flap safely and effectively. | In-vitro studies on porcine eyes demonstrated: The safety and efficacy of the submitted device for creating an epithelial flap. The quality of the epithelium separation. |
| Ability to create a hinged circular epithelial flap of predetermined dimensions safely. | In-vivo studies on 77 human eyes showed: Epi-K™ is a safe device able to create a hinged circular epithelial flap of predetermined dimensions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for In-vitro Test Set: Not explicitly stated, but "porcine eyes" are mentioned.
- Sample Size for In-vivo Test Set: 77 human eyes.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The context suggests these were conducted by Moria S.A., a French company. The studies are described as "In-vitro" and "In-vivo," which implies prospective data collection for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies described are performance tests of the device itself rather than assessments requiring expert-established ground truth in the context of diagnostic accuracy. For the "quality of epithelium separation" or "safety" assessment, it's implied that trained professionals (e.g., ophthalmologists, pathologists) would have evaluated the outcomes, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the studies (device performance in creating a flap), a formal adjudication method for ground truth establishment (like 2+1 consensus) is less directly applicable than for diagnostic studies. Evaluations would likely involve direct observation and measurement by investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not mentioned. This type of study typically compares human readers' diagnostic performance with and without AI assistance. The Epi-K™ is a surgical device, not a diagnostic AI system, so this type of study would not be applicable.
6. Standalone (Algorithm Only) Performance Study
Not Applicable. The Epi-K™ is a mechanical surgical device with a motor, handpiece, and blade. It is not an algorithm or AI system, so a standalone algorithm-only performance study is irrelevant. The "performance" here refers to the device's ability to physically perform its intended function.
7. Type of Ground Truth Used
For the in-vitro porcine eye studies, the "ground truth" would be the direct observation and measurement of the "safety and efficacy" of flap creation and the "quality of epithelium separation" by qualified personnel.
For the in-vivo human eye studies, the "ground truth" for safety and ability to create a "hinged circular epithelial flap of predetermined dimensions" would be direct clinical observation and measurement during and after the procedure by the operating surgeon and clinical team. This could involve histological examination of the removed tissue, but specific details are not provided. Essentially, the "ground truth" is the observed physical outcome of the surgical procedure as performed by the device.
8. Sample Size for the Training Set
Not Applicable. The Epi-K™ is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the Epi-K™ device.
§ 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.