(51 days)
The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.
List of components
- Power unit
- Motor
- Suction rings
- Applanator lenses
- Footswitches
- Keratome head
- Keratome blade
a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & CARRIAZO BARRAQUER II Microkeratome (K002191) 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.
Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel.
The front panel has several displays and features:
- Vacuum pressure gauge,
- Gas pressure gauge,
- Battery level indicator,
- Battery charge indicator,
- Connectors:
DC motors outlets, Gas turbine outlet Gas outlet, Vacuum outlet
The back panel has several displays and features: - Connectors:
Gas inlet, Foot pedals, - Battery charger.
All connectors are of different types for preventing connection mistakes.
b) Keratome motor
The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome).
c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
Different heads are available in order to adjust the thickness of the cut.
d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the microkeratome heads.
e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.
f) Keratome blade
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.
The provided text describes the MORIA S.A. OneUse - Plus Microkeratome and its intended use, but it does not specify explicit acceptance criteria in a quantitative format. Instead, it mentions general performance characteristics demonstrated through studies.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not stated, the table below consolidates the qualitative performance mentioned in the "Discussion of tests and results" section.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Flap thickness consistency | Demonstrated in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device is able to create "circular lamellar resection of a predetermined diameter and thickness." |
| Safety of corneal resections | Demonstrated in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device is "a safe Keratome." |
| Quality of corneal resections (e.g., bed smoothness) | Demonstrated "good quality of corneal resections" in in-vitro studies on porcine eyes. In-vivo studies on 54 human eyes showed the device makes resections with "bed smoothness." |
| Equivalence to predicate device for creating lamellar resections | In-vivo studies on 54 human eyes showed the device is able to create, "equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness." (This implies a comparison and meeting the performance standards of the predicate device, but no specific metrics are given). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- In-vitro studies: Performed on "porcine eyes." The exact number of porcine eyes is not specified.
- In-vivo studies: 54 human eyes.
- Data Provenance:
- The document does not explicitly state the country of origin for the data for either the in-vitro or in-vivo studies.
- The studies were conducted as part of a premarket notification, implying they were prospective safety and performance assessments. However, the exact nature (e.g., fully prospective clinical trial, observational study) is not detailed beyond "in-vivo studies."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "in-vivo studies on 54 human eyes showed..." and "In-vitro studies on porcine eyes demonstrated...", suggesting clinical or laboratory assessments, but details on expert involvement in defining the "truth" for these assessments are absent.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size regarding human reader improvement with or without AI assistance. The device is a microkeratome, a surgical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable as the device is a mechanical surgical microkeratome, not an algorithm or AI system. Its performance is inherently tied to its use by a human surgeon.
7. Type of Ground Truth Used
The "ground truth" for the performance claims would be:
- In-vitro studies (porcine eyes): Direct measurements of flap thickness, assessment of corneal resection safety, and quality (bed smoothness) using laboratory techniques.
- In-vivo studies (human eyes): Clinical assessment of the quality of the corneal flap, its thickness, safety, and smoothness in a real-world surgical context. This would likely involve post-operative examinations and clinical measurements. The term "equivallently to the predicate device" suggests a comparative clinical outcome as a "ground truth" for equivalence.
8. Sample Size for the Training Set
No information is provided regarding a separate "training set" or its sample size. This is consistent with a mechanical device where performance is typically evaluated through direct testing rather than training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable in the context of this mechanical device, this information is not provided.
§ 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.