(535 days)
The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment.
The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure. With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge. The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters. The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechik GmbH. The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium. The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator. The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum. The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.
Here's a breakdown of the acceptance criteria and study information for the Gebauer EpiVision™ SL System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) Premarket Notification Summary) does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, the rationale for substantial equivalence focuses on functional similarity and safety compared to predicate devices.
However, the "Non-Clinical Performance Data" section mentions: "The effectiveness of the device was confirmed during bench testing which was designed to evaluate the functional ability of the Gebauer EpiVision™ SL System to create highly precise epithelial incisions with constant cut thickness."
While not quantitative, the implied acceptance criteria are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional ability to create highly precise epithelial incisions | Confirmed during bench testing |
| Functional ability to create incisions with constant cut thickness | Confirmed during bench testing |
| Compliance with electrical standards (UL 2601-1, IEC 60601-1, IEC 601-1-1, IEC 601-1-2) | Passed inspection by independent testing houses (UL-Germany and others) |
| Operational safety features (vacuum level gauge, low suction LED, audible tone indicators, automatic cutting stop, foot pedal controls) | Designed into the device |
| Intended Uses | Same as predicate devices |
| Operating & Cutting Principles | Same as predicate devices |
| Operational Features | Same/comparable to predicate devices |
| Safety Features | Same, similar, or better than predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document states "bench testing" was performed for effectiveness but does not specify sample size (e.g., number of cuts, number of eyes/models).
- Data Provenance: The testing appears to be "in-vitro non-clinical performance data" (bench testing), implying the data was generated in a lab setting rather than from human patients. No country of origin is explicitly stated, but the company is Gebauer Medizintechnik GmbH (German), and testing was conducted by "UL-Germany" and "independent testing house." This suggests European or international lab conditions. The study is retrospective in the sense that it's bench testing and not a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's performance was evaluated through bench testing against established engineering and functional parameters, not via expert interpretation of diagnostic output that would require a "ground truth" established by medical experts for a diagnostic task.
4. Adjudication Method for the Test Set
Not applicable, as this was functional bench testing against engineering specifications, not an assessment requiring adjudication by multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical performance data has been submitted." The safety and effectiveness were solely assessed through non-clinical bench testing and comparison to predicate devices, not through studies involving human readers or patient outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "effectiveness" mentioned refers to the device's inherent functional performance (creating precise incisions with constant thickness) in a standalone, automated manner. There is no "human-in-the-loop" aspect to its primary function of creating a corneal flap.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing was based on engineering specifications and measurable physical parameters (e.g., precision of incision, constancy of cut thickness) derived from the device's design and intent to perform functions comparable to predicate devices. It was not based on expert consensus, pathology, or outcomes data in a medical diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set." Its function is mechanical and automated.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.