(29 days)
The Epi-K is intended for use in the separation of the cornea in preparation for subsequent surgical procedures on denuded cornea.
The Evolution 3E Console includes pumps for producing vacuum for use with a keratome in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea. The Evolution 3E Console power unit has been designed to operate the keratome by means of electric motor or turbine.
The provided document describes a 510(k) premarket notification for the "EPI K Console" (also referred to as "Evolution 3E Console" and "Moria Evolution 3E Console"). This submission is for modifications to an existing device, the "Epi-K", which was cleared under K043183. The key changes are a transition from a purely battery-powered device to a mains-powered device with battery backup, and minor software revisions.
The document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets them in the context of diagnostic performance or clinical effectiveness. This is because the device, a keratome power unit, is a surgical instrument. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing of performance specifications, electrical safety, EMC, and software verification/validation, rather than clinical efficacy as would be required for a diagnostic or therapeutic device with a clinical endpoint.
However, I can extract the available information and highlight what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Testing | |
| Back-up battery performance | Verified, predetermined acceptance criteria met |
| Transformer power supply | Verified, predetermined acceptance criteria met |
| Vacuum/turbine performance | Verified, predetermined acceptance criteria met |
| Connection performance | Verified, predetermined acceptance criteria met |
| Performance with accessory components of keratome systems | Verified, predetermined acceptance criteria met |
| Software verification and validation | Verified to perform as intended, predetermined acceptance criteria met |
| Electrical Safety | |
| Conformance to IEC 60601-1:2012 (Medical electrical equipment - part 1: general requirements for basic safety and essential performance) | Device demonstrates conformity |
| Electromagnetic Compatibility (EMC) | |
| Conformance to IEC 60601-1-2:2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Device demonstrates conformity |
| Clinical Outcomes | |
| Clinical outcomes (Epi-K Console vs. predicate) | "The Evo3E Console will produce the same clinical outcomes as the predicate device." (This is a claim based on the fundamental operating principle being unchanged, not reported performance from a specific study in this document.) |
Explanation: The document states that "The verification and validation activities, as identified by the risk analysis... were conducted to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met." However, it does not provide the specific quantitative or qualitative acceptance criteria for each test (e.g., minimum battery life, vacuum pressure range) nor the specific numerical results obtained for these tests. It only states that the acceptance criteria were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. This document only refers to engineering verification and validation testing, not a clinical study on a patient sample.
- Data Provenance: Not applicable, as it's not a clinical data set. The testing was conducted internally by the manufacturer (MORIA S.A., France).
- Retrospective/Prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device (keratome power unit) would be based on engineering specifications and physical measurements, rather than clinical expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This testing involves engineering verification and validation, not a diagnostic assessment requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical instrument (keratome power unit), not an AI-powered diagnostic tool used by human readers for interpretation. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established by:
- Engineering Specifications: Defined acceptable ranges for vacuum pressure, motor speed, battery performance, electrical parameters, etc.
- International Standards: Conformance to standards like IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
- Functional Testing: Verifying that the device components and software perform their intended functions as designed (e.g., pumping, vacuum generation, power conversion).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. 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.