(118 days)
The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use:
· In the creation of a corneal flap in patients undergoing LASIK surgery or treatment reguiring initial lamellar resection of the cornea.
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
· In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.
· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea.
· In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.
The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.
The provided text is a 510(k) summary for the WaveLight FS200 Laser System, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices for new indications for use related to arcuate and pocket cuts/incisions in the cornea. It is not a study proving device meeting specific acceptance criteria in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested categories for a study proving device acceptance criteria (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. This document describes a traditional medical device's non-clinical performance and a comparison to predicate devices, not an AI/ML device study.
However, I can extract the relevant information regarding performance testing and a high-level "acceptance criteria" through the lens of what this document does provide.
Here's the breakdown based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy, precision, and quality of arcuate corneal cuts/incisions | "The results of these tests showed that the achieved performance is consistent with the requirements for these indications." (Specific numerical values for accuracy, precision, or quality are NOT provided in this summary.) |
| Accuracy, precision, and quality of corneal pocket cuts/incisions | "The results of these tests showed that the achieved performance is consistent with the requirements for these indications." (Specific numerical values for accuracy, precision, or quality are NOT provided in this summary.) |
| Safety Standards Compliance | "The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards." |
| Substantial Equivalence to Predicate Devices | The technology, design principle, and mode of operation of the WaveLight® FS200 were found to be "fundamentally the same as the cleared predicate devices" regarding laser radiation (wavelength, duration, femtosecond pulses for photo disruption) and patient contact portion fixation (sterile, disposable suction rings and patient interfaces). The new indications (arcuate and pocket cuts) were also deemed "very similar" to cleared predicate indications. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states "Performance testing on pig eyes." It does not specify the number of pig eyes used.
- Data Provenance: The data is from "pig eyes," indicating an ex vivo or in vivo animal study, not human data. The country of origin is not specified. It is a non-clinical study, presumably prospective in design for the purpose of testing the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts: Not applicable. This document describes non-clinical performance testing on animal tissue (pig eyes) to demonstrate the physical properties of the cuts. The "ground truth" would be objective measurements of the cuts themselves, not expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. As this is non-clinical testing of physical device output on animal tissue, an adjudication method for human interpretation is not relevant.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC study was not done. This device is an ophthalmic surgical laser, not an AI/ML-powered diagnostic or assistive tool for human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The device is a standalone surgical laser. Its performance (accuracy, precision, quality of cuts) was assessed directly from its physical output.
7. The type of ground truth used:
- Ground Truth: For the non-clinical performance testing, the ground truth would be objective measurements of the arcuate and pocket cuts/incisions (e.g., dimensions, morphology, depth, width, curvature) produced by the laser on the pig eyes. The document states "accuracy, precision, and quality" were addressed, implying quantitative measurement of these physical parameters.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This summary describes a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is "trained" through its engineering design and manufacturing processes.
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable. As there is no AI/ML algorithm involved, there is no training set and therefore no ground truth establishment for a training set.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.