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510(k) Data Aggregation
(105 days)
MODIFICATION TO VISITOME 20-10 MICROKERATOME
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
| Acceptance Criteria (Implied/Generalized from text) | Reported Device Performance (Implied/Generalized from text) |
|---|---|
| Device meets all performance specification requirements for lamellar resection. | Bench testing (on pig eyes) demonstrates the device meets all performance specification requirements. |
| Device is substantially equivalent to predicate devices regarding safety and effectiveness. | "Bench testing demonstrates that the Visitome 20-10 Microkeratome is equivalent to the predicate devices, and that any differences do not affect safety or effectiveness." |
| Device is safe and effective for making a corneal flap. | Demonstrated through substantial equivalence to predicate devices. |
| Device is in accordance with applicable electrical safety standards. | "The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards." |
| New blade size performs adequately. | "The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements." |
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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