Search Results

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:

• The metal part in low carbon steel, and

• 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:

• Reusable

• 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.

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.

Ask a specific question about this device

The M3 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 cornea.

List of components

• Power unit .
• Motor ●
• Suction rings .
• Applanator lenses .
• Footswitches .
• Keratome head 1
• Keratome blade .

This document describes a 510(k) premarket notification for the MORIA M3 microkeratome, a device used to create corneal flaps for LASIK surgery. The submission claims substantial equivalence to previously marketed devices.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state formal "acceptance criteria" with numerical thresholds typically seen in studies for AI/software devices. Instead, it reports on the performance characteristics demonstrated by in-vitro and in-vivo studies in the context of establishing substantial equivalence to predicate devices.

   Performance Characteristic	Reported Device Performance (M3 Microkeratome)
   Flap thickness consistency	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Safety of corneal resections	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Quality of corneal resections	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Circular lamellar resection	Able to create circular lamellar resection (demonstrated in-vivo on human eyes).
   Uniform thickness	Able to create uniform thickness (demonstrated in-vivo on human eyes).
   Bed smoothness	Able to create bed smoothness (demonstrated in-vivo on human eyes).
   Equivalence to predicate device	Shown to be a "safe Keratome able to create, equivalently to the predicate device" in in-vivo human studies.

2. Sample Size Used for the Test Set and Data Provenance:

   • Test Set (In-vivo study): 100 human eyes.
   • Data Provenance: The document does not explicitly state the country of origin. The study was prospective in nature, as it involved performing resections on human eyes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   The document does not provide information on the number or qualifications of experts used to establish a "ground truth" in the traditional sense for these studies. The assessment of performance characteristics such as flap thickness, safety, quality, circularity, uniformity, and bed smoothness would typically be evaluated by ophthalmologists or surgeons using established clinical and imaging techniques, but specific details are not provided.

4. Adjudication Method for the Test Set:

   The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The M3 microkeratome is a surgical device, not an AI/diagnostic imaging tool that would typically involve human readers. The studies focus on the device's physical performance.
   • Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the studies performed (both in-vitro and in-vivo) represent the standalone performance of the device (microkeratome) itself, without a human-in-the-loop performance component in the context of an AI algorithm. The device performs the corneal resection.
   • However, it's important to clarify that "standalone" in this context refers to the device's function, not an AI algorithm. The device is operated by a human surgeon.

7. Type of Ground Truth Used:

   The "ground truth" for the in-vivo study on human eyes would be based on:

   • Clinical observation and measurement: Assessment of the resected corneal flap characteristics (thickness, circularity, smoothness of the bed) by ophthalmologists using standard clinical methods, likely including pachymetry for thickness and visual inspection/microscopy for quality and smoothness.
   • Safety outcomes: Absence of adverse events attributable to the device.
   • Comparison to predicate device outcomes: Performance was deemed "equivalent" to the predicate device, implying clinical equivalence in measured outcomes.

8. Sample Size for the Training Set:

   This device is a mechanical surgical instrument, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's design and manufacturing process are informed by engineering principles, prior device iterations (like the M5 microkeratome and predicate devices), and the results of the in-vitro and human in-vivo studies.

9. How the Ground Truth for the Training Set Was Established:

   As there is no AI "training set," this question is not applicable. The "ground truth" for the device's development would be established through engineering specifications, performance requirements derived from clinical needs, and iterative design and testing processes informed by mechanical and optical principles relevant to corneal surgery.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

List of components
a) Power unit
b) Motor
c) Suction rings
d) Applanator lenses
e) Footswitches
f) Keratome head with pre-inserted Keratome blade

The M2 SINGLE USE microkeratome is intended for use in creating a corneal flap for LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the M2 SINGLE USE microkeratome. Instead, it relies on demonstrating equivalence to predicate devices and qualitative performance. The reported performance is based on in-vivo and in-vitro studies:

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • In-vitro: Not specified, but stated as "in-vitro studies on porcine eyes."
  • In-vivo: 72 human eyes.
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter's location (MORIA S.A. in France), it is plausible the studies were conducted in Europe, but this is not confirmed. The studies are implicitly prospective for the M2 SINGLE USE microkeratome as they are conducted to demonstrate its performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts or their qualifications used to establish ground truth for either the in-vitro or in-vivo studies. The "Discussion of tests and results" section simply states what was "demonstrated" by the studies.

4. Adjudication Method

The document does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study compares the M2 SINGLE USE microkeratome to predicate devices, but there is no indication of human readers improving with or without AI assistance, as AI is not a component of this device.

6. Standalone Performance

Yes, the studies described are for the standalone performance of the M2 SINGLE USE microkeratome, as it is a physical device and not an AI algorithm requiring human-in-the-loop interaction. The performance metrics listed describe the device's inherent ability to create corneal flaps.

7. Type of Ground Truth Used

• In-vitro studies (porcine eyes): The ground truth for flap thickness consistency, safety, and quality of corneal resections would likely be based on direct measurements, microscopic examination, and qualitative assessment by trained surgical or pathology personnel.
• In-vivo studies (human eyes): The ground truth for safety, ability to create circular lamellar resection, predetermined diameter and thickness, and bed smoothness would be assessed directly by the operating surgeon and through post-operative clinical evaluations, possibly including imaging techniques for flap dimensions and quality. This primarily relies on expert assessment/clinical observation.

8. Sample Size for the Training Set

This information is not applicable as the M2 SINGLE USE microkeratome is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reason stated above (it's not an AI/machine learning device).

Ask a specific question about this device