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The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).

The provided 510(k) summary for the Visitome 20-10 Microkeratome offers limited details regarding formal acceptance criteria or a comprehensive study demonstrating adherence to such criteria in the way modern AI/software as a medical device (SaMD) submissions do. Instead, it focuses on substantial equivalence to predicate devices and performance testing related to basic functionality.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "The new blade size has undergone performance evaluation testing in pig eyes."

• Sample Size for Test Set: Not specified, only that "pig eyes" were used. The number of eyes is not mentioned.
• Data Provenance: In vitro (or ex vivo) testing on pig eyes. The country of origin for the data is not mentioned, but the applicant is based in Switzerland, and the testing was likely conducted by or for them. This would be considered prospective data generation for the purpose of this submission, as the testing was performed specifically to evaluate the new blade size and device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely that veterinary ophthalmologists or ocular surgeons were involved in assessing the corneal flaps created on pig eyes, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The document does not describe any human review or adjudication process for the outcomes of the pig eye testing. Performance was likely assessed based on measurable physical characteristics of the created flaps (e.g., thickness, diameter, smoothness), rather than subjective expert consensus.

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

• Was an MRMC study done? No. This device is a surgical instrument, not an AI/SaMD diagnostic or assistive tool where human readers would typically be involved in evaluating performance data. Therefore, an MRMC study and the concept of "improving human readers with AI vs. without AI assistance" are not relevant to this type of device submission.

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

• Was a standalone study done? Yes, in a sense. The performance evaluation on pig eyes for the device (a mechanical instrument) without human intervention in the data collection/assessment process beyond operating the device and measuring outcomes. The device itself is standalone in its function of creating a corneal flap. However, this is not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the pig eye performance testing would have been objective measurements of the corneal flaps created, such as:

  • Flap thickness
  • Flap diameter
  • Quality/smoothness of the cut (e.g., microscopic evaluation of the stromal bed)
  • Absence of perforations or irregular cuts.

  This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device. It's based on physical and measurable characteristics of the device's output.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of an AI model. Device "training" would refer to its design, engineering, and iterative improvement processes, not data input for algorithm learning.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI algorithm. The design and validation of mechanical devices like this involve engineering specifications, material testing, prototyping, and bench testing, but not a data-driven training process with ground truth labels for an algorithm.

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The Visitome 20-10 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.

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, tubing kit (accessory), and a fluid collection container (accessory).

The Visitome 20-10 Microkeratome contains a positioning ring which allows the cornea to protrude through the ring. The cornea is restrained by an applanation shoe surface, which may be pivoted away. A stainless steel blade is suspended from the end of the positioning ring by a blade support (holder) which is driven by a drive mechanism, so that the blade moves along a forward path between the positioning ring and the applanation shoe while oscillating laterally. Drive control and vacuum for the positioning ring are provided by user command via the control unit and foot pedal.

Acceptance Criteria and Study for VISITOME 20-10 MICROKERATOME

Based on the provided 510(k) summary for the VISITOME 20-10 Microkeratome (K014000), here's an analysis of the acceptance criteria and the study performed:

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily relies on demonstrating substantial equivalence to a predicate device (Hansatome Microkeratome, K010260) rather than presenting a formal table of explicit acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied by the claim of equivalence in technological characteristics, safety, and effectiveness. The performance evaluation focuses on whether the device meets all performance specification requirements to be considered equivalent.

The comparison table outlines the technological characteristics of both devices, which serve as the basis for demonstrating equivalence in performance.

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

• Sample Size: The document explicitly states "The device underwent performance evaluation testing in pig eyes." It does not specify the number of pig eyes used.
• Data Provenance: The testing was conducted in "pig eyes," indicating an in vitro or ex vivo animal model study. This is prospective testing performed for the device. The country of origin of the data is not specified, but the applicant company is Biovision AG from Bern, Switzerland.

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

The summary does not mention the use of experts to establish ground truth for the performance evaluation testing in pig eyes. The assessment of whether the device "meets all performance specification requirements" would likely be based on objective measurements (e.g., flap thickness, diameter, smoothness) rather than expert opinion on clinical outcome, as it's an animal model.

4. Adjudication Method for the Test Set

Not applicable. The performance evaluation described is technical testing in an animal model, not interpretative assessment by experts requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The VISITOME 20-10 Microkeratome is a surgical instrument, and its evaluation focuses on mechanical performance and safety, not diagnostic interpretive accuracy.

6. Standalone (Algorithm Only) Performance

Not applicable. As a surgical microkeratome, the device does not have an "algorithm only" performance component in the sense of an AI diagnostic tool. Its performance is entirely mechanical and involves human operation.

7. Type of Ground Truth Used for the Test Set

The ground truth for the performance evaluation testing in pig eyes would be objective measurements of the corneal flaps created, such as:

• Flap thickness
• Flap diameter
• Flap morphology/smoothness
• Integrity of the corneal bed
• Blade performance (e.g., sharpness after use)

This is a form of objective measurement against pre-defined specifications, rather than expert consensus, pathology, or outcomes data in humans.

8. Sample Size for the Training Set

Not applicable. The VISITOME 20-10 Microkeratome is a mechanical surgical device and does not involve machine learning or an "algorithm" in the sense that would require a training set. The device's design and engineering principles are based on established biomechanical and optical principles, not data-driven learning.

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

Not applicable, as there is no training set for this type of mechanical device.

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