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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:

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.

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The epiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The EpiTome System is a fully automated, AC powered ophthalmic keratome system designed for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea. The EpiTome Control Console is comprised of a Vacuum System, Software, and Controls that allow the System User to set the procedure specific cutting parameters. The motorized handpiece contains two motors controlling the oscillation and translation of the cutting blade across the epithelium. The EPI-Head assembly includes a base, an applanation part, and blade unit that fits securely onto the handpiece. The precisely machined EPI-Separator controls the depth of the delamination. The EpiTome System includes a choice of suction rings to allow the System User to select the appropriate ring on an individual patient basis. The EpiTome 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 an analysis of the provided text regarding the acceptance criteria and study for the Gebauer EpiTome System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) premarket notification summary for the Gebauer EpiTome System (K041206) does not explicitly state specific pass/fail acceptance criteria in a quantifiable manner (e.g., minimum accuracy percentages, specific tolerance ranges for cut thickness, etc.) within the provided text.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (CIBA Centurion SES™ Epikeratome, K032978) based on:

The "device performance" in this context is the assertion that it meets these substantial equivalence points, supported by non-clinical (in-vitro) data and compliance with electrical safety standards.

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

• Sample Size for Test Set: The document mentions "in-vitro testing" was performed to confirm the effectiveness of the device (creating precise epithelial incisions with constant cut thickness). However, the specific sample size (e.g., number of corneas, number of cuts, etc.) for this in-vitro test set is not provided in the given text.
• Data Provenance: The data is described as "In-Vitro non-clinical performance data." The country of origin for this data is not explicitly stated, but the sponsor is Gebauer Medizintechnik GmbH in Germany, suggesting the testing likely occurred in Germany or was overseen by the German entity. The testing is retrospective in the sense that it was conducted prior to this 510(k) submission.

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

There is no mention of experts being used to establish ground truth for the in-vitro testing described. The evaluation of functional ability to create precise epithelial incisions and constant cut thickness would likely rely on objective measurements rather than expert consensus on a subjective interpretation.

4. Adjudication Method for the Test Set

Since there is no mention of experts establishing a subjective ground truth, there is no adjudication method described for a test set in the provided text. The in-vitro testing would presumably rely on direct measurement and objective assessment of cut characteristics.

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." Therefore, an MRMC comparative effectiveness study was not performed or submitted for this 510(k) premarket notification.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described is a medical instrument (keratome system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance, as typically understood in AI/software validations, does not apply to this device. The in-vitro testing assessed the standalone performance of the device itself.

7. The Type of Ground Truth Used

For the in-vitro testing, the type of ground truth used would be objective measurements of physical properties. The text states the testing "was designed to evaluate the functional ability of the Gebauer EpiTome System to create highly precise epithelial incisions with constant cut thickness." This implies direct measurement of incision characteristics (e.g., depth, uniformity, smoothness) as the ground truth.

8. The Sample Size for the Training Set

The EpiTome System is a mechanical device, not a machine learning or AI algorithm in the context of "training data." Therefore, the concept of a "training set" for an algorithm does not apply to this submission.

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

As established above, the concept of a "training set" for an AI algorithm is not applicable to this device.

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