(192 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 other surgery or treatment requiring 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.
The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.
The provided text describes the WaveLight® FS200 Laser System and its clearance through the 510(k) pathway. However, the document does not contain a detailed study design with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way one would typically expect for a modern AI/ML device submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance in creating corneal cuts. The information provided is characteristic of a traditional medical device submission rather than one for an AI/ML diagnostic tool.
Here's an attempt to answer your questions based only on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for precise numerical metrics like accuracy, sensitivity, or specificity. Instead, it refers to "performance tests" that establish "equivalence" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance of cuts is equivalent to predicate laser systems and microkeratomes for various corneal procedures. | The WaveLight® FS200 Laser System and accessory Patient Interface were found to perform equivalently to the predicate laser and microkeratome and their patient interfaces for the creation of corneal cuts. |
| Compliance with applicable safety standards. | The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards. |
2. Sample size used for the test set and the data provenance
The document states: "Performance tests according to the FDA Guidance 'Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System."
- Test Set Sample Size: Not specified. The document does not provide a number for the test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. The "ground truth" here would relate to direct measurements of the physical cuts, not expert interpretation of outputs. The document does not mention the use of experts in this context.
4. Adjudication method for the test set
Not applicable/Not specified. Given the nature of a laser system creating physical cuts, an adjudication method for expert consensus on images is not relevant to the described performance tests.
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
Not applicable. This is not an AI/ML device that assists human readers. It's a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone surgical laser system. Its performance evaluation focuses on the quality of the cuts it creates.
7. The type of ground truth used
The "ground truth" would be objective measurements of the physical characteristics (accuracy, precision, quality) of the corneal cuts themselves, likely performed using metrology or other analytical techniques directly on the cut tissue, as described in the referenced FDA Guidance. The document doesn't explicitly detail the methodology, but for a keratom, ground truth typically involves physical measurements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary Limitations:
The provided 510(k) summary is for a traditional surgical laser system, not an AI/ML driven device. Therefore, many of the questions related to AI/ML specific evaluation criteria (like training sets, expert consensus, MRMC studies, etc.) are not addressed in the document and are likely not relevant to its regulatory clearance. The performance testing for this device would have focused on engineering specifications, safety, and the physical outcomes of the laser's operation compared to known predicate devices or established standards.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.