(87 days)
The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
The IntraLase 600C Laser Keratome is a precision ophthalmic surgical laser designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing anterior lamellar corneal resections. The materials, basic scientific concepts and physical properties of the IntraLase 600C are similar to those of the ISL OC2000, while the indication for use and the intended use are identical to those of the Hansatome microkeratome.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the IntraLase 600C Laser Keratome:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K993153) does not explicitly list quantifiable acceptance criteria in a table format. Instead, it claims substantial equivalence to a predicate device based on performance in "extensive ex vivo and in vivo studies."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable criteria. The overarching acceptance criterion appears to be substantial equivalence to the predicate device (Hansatome Microkeratome) in creating corneal resections. | "The IntraLase 600C was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies." |
| "The technological changes in the IntraLase 600C Laser Keratome do not raise any new issues of safety, effectiveness or performance of the product." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document uses the term "extensive ex vivo and in vivo studies" but does not specify the numerical sample size for either.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market clinical investigations. Given the context, they are likely to be prospective studies conducted by the manufacturer to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The filing focuses on the device's technical characteristics and equivalence to predicate devices rather than a detailed clinical study with expert-adjudicated ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. This type of study (MRMC) is typically associated with AI/CAD systems where human readers interpret medical images with and without AI assistance. The IntraLase 600C Laser Keratome is a surgical device, not an AI/CAD system.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was it done? Not applicable in the context of an AI algorithm. If "standalone" refers to the device operating independently in the studies, the text implies that the device's performance in creating corneal resections was evaluated, presumably without a human "in the loop" for the creation process itself, but rather human oversight and evaluation of the results. However, this isn't an AI-specific standalone performance evaluation.
7. Type of Ground Truth Used:
The document implicitly uses the "performance...with respect to the creation of corneal resections" as the ground truth. This would likely involve:
- Measurements: Direct measurements of the thickness and diameter of the corneal resections created by the device.
- Visual Inspection/Histopathology: Evaluation of the quality, smoothness, and uniformity of the resections.
- Comparison to Predicate: The ultimate "ground truth" for the submission is the performance of the legally marketed predicate device (Hansatome Microkeratome).
8. Sample Size for the Training Set:
This information is not applicable as the IntraLase 600C Laser Keratome is a physical surgical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
§ 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.