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510(k) Data Aggregation
(97 days)
VISTITOME 20-10 MICROKERATOME
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.
| Characteristic | Predicate Device (Hansatome Microkeratome) | VISITOME 20-10 Microkeratome (Reported Performance) | Implied Acceptance Criteria (for equivalence) |
|---|---|---|---|
| Indications For Use | Making a corneal flap for LASIK/lamellar resection | Making a corneal flap for LASIK/lamellar resection | Same indications for use. |
| Operating Principle | Electrically driven oscillating blade, gear rack, footswitch control | Electrically driven oscillating blade, gear rack, 3-pedal footswitch control | Electrically driven oscillating blade, similar mechanism for advancement and control. |
| Type of Hinge or Flap | Nasal and Superior | Nasal and Superior | Capability to create Nasal and Superior hinges/flaps. |
| Manual or Automatic Blade Advancement | Automatic | Automatic | Automatic blade advancement. |
| Blade Advancement Rate | Unknown | 1 to 10 mm/sec | Functionally appropriate range for corneal flap creation. (No direct comparison is made due to "Unknown" for predicate) |
| Oscillation Rate | Unknown | 0 to 12,000 rpm | Functionally appropriate range for corneal flap creation. (No direct comparison is made due to "Unknown" for predicate) |
| Flap Diameter Resection | 8.5 & 9.5 mm; accuracy unknown | Range of 7.5 to 10.5 mm | Capability to resect flaps within a clinically acceptable diameter range. |
| Thickness of Resection | 160 & 180 microns | 120, 160 & 180 microns | Capability to resect flaps at clinically relevant thicknesses. (VISITOME offers more options) |
| Eye Fixation Method | Suction Ring (sizes 8.5 & 9.5 mm) | Suction Ring (sizes 10.5, 11.5, & 12.0 mm) | Use of a suction ring for eye fixation. (VISITOME offers different sizes) |
| Disposable Blade with Fixed Holder? | Yes | Yes | Disposable blade with fixed holder. |
| Blade Angle | 25 degrees | 32 degrees | Clinically effective blade angle for corneal incision. (Difference accepted as not affecting safety/effectiveness) |
| Keratome Blade Material | Stainless Steel | Stainless Steel | Stainless Steel blade material. |
| Handpiece Material | Stainless Steel | Titanium | Biocompatible and durable material for the handpiece. (Difference accepted as not affecting safety/effectiveness) |
| Components That Contact the Patient | Blade, Keratome Head, Suction Ring | Blade, Suction Ring | Biocompatible and properly sterilized components in contact with patient. |
| Safety Features | 1. Internal diagnostics, 2. Vacuum check before cut, 3. Cut stops if vacuum drops. | 1. Internal diagnostics, 2. Vacuum check before cut, 3. Alarm/cut stops if vacuum lost. | Comparable safety features to prevent adverse events. |
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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