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The Da Vinci™ Femtosecond Surgical 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.

Device Description

The Da Vinci™ Femtosecond Surgical Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Da Vinci™ Femtosecond Surgical Laser is achieved through nonlinear absorption of infrared laser light and subsequent disintegration of tissue, created by focused ultrashort pulses which are delivered through a lens while fixating the eye under a vacuum. The complete Da Vinci™ Femtosecond Surgical Laser system consists of the following functional units: 1. Base Station (BS), integrating the Laser Unit, Fast Scan Unit (FS), and Fixed Mirror Articulating Arm (FMAA) 2. Handpiece (HP), integrating the Slow Scan Unit (SS) and the Cutting Lens 3. Accessories, comprising Suction Ring, Distance Foil, Vacuum Tube with Strainer and Handpiece Cover. The Da Vinci™ Femtosecond Surgical Laser is movable on four rollers. Two rollers can be locked by a mechanical brake. For movement inside the clinic, HP and FMAA can be locked in a secured transport position.

AI/ML Overview

Here's an analysis of the provided text regarding the Da Vinci™ Femtosecond Surgical Laser, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) summary, which is a premarket notification for showing substantial equivalence to a legally marketed predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a predicate, rather than presenting extensive de novo clinical trial data with formal acceptance criteria and independent study designs as might be seen for a PMA. Therefore, some of the requested information (like specific effect sizes of human readers with/without AI, or details on ground truth for training data) is typically not present in a 510(k) summary focused on substantial equivalence.

Based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" in terms of specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device's main function (corneal flap creation) that were then met by a study. Instead, it focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.

However, some implied performance and safety parameters are mentioned:

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Premarket Acceptance: Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to the Pulsion FS Laser (K013941) for technical characteristics and the Amadeus Microkeratome (K993190) for intended use.
Compliance with FDA Standards: Performance Standard for Light-emitting Products	"The Da Vinci™ Femtosecond Surgical Laser is in full compliance with FDA's Performance Standard for Light-emitting Products; 21 CFR §1040.10 and 1040.11."
Corneal Flap Creation: Precision of focal point depth	`maximum by vepth of the focal point is at 250 µm ± 5 µm minus the thickness of the distance foil` (This defines a specification rather than a measured outcome of a specific study in the document).
System Safety: Residual net force of Fixed Mirror Articulating Arm (FMAA)	`

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