(60 days)
The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
The IntraLase Fusion Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase Fusion Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
The provided text describes a 510(k) summary for the IntraLase Fusion Laser, claiming substantial equivalence to a predicate device (IntraLase FS Laser, K060372). The document focuses on regulatory approval rather than a detailed study evaluating the device's performance against specific acceptance criteria.
Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be found in the provided text.
Here is an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: | The IntraLase Fusion Laser and the accessory IntraLase Fusion Patient Interface were found to perform equivalently to the predicate laser and patient interface for the creation of corneal resections. |
| Compliance with applicable safety standards. | The IntraLase Fusion Laser has undergone testing and is in compliance with applicable safety standards. |
Explanation: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" reported is that the device "perform[s] equivalently" to the predicate for its intended use. Safety compliance is also mentioned as met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "nonclinical tests" but does not detail the methodology, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As a substantial equivalence submission for a surgical laser, ground truth typically would involve physical and operational testing rather than expert-derived ground truth for diagnostic image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This device is a surgical laser, not an AI-powered diagnostic tool. The document describes non-clinical testing for equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided related to "algorithm only" performance. The product is a physical laser device, not a standalone algorithm. The non-clinical tests would have evaluated the device's physical performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily refers to "nonclinical tests and results" which assessed whether the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections" and its compliance with "applicable safety standards." The "ground truth" here would likely be objective measurements and observations of the physical characteristics and cutting performance of the laser, compared against the known characteristics and performance of the predicate device, rather than a diagnostic "ground truth" like pathology or expert consensus on an image.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is usually applicable to machine learning models, which is not the primary focus of this device's approval process based on the provided text.
9. How the ground truth for the training set was established
This information is not provided in the document, as the device is not an AI/ML product for which a training set and its ground truth establishment would be discussed in this context.
§ 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.