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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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