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510(k) Data Aggregation
(84 days)
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.
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.
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) | < ±2N (This is a design specification for minimizing stress on the eye). |
| System Safety: Force required to remove FMAA from clamp | <5N |
| System Safety: Vertical support of FMAA from clamp for transport | about 50N |
| System Safety: Watchdog system response time | If critical software task does not respond in < 1 second, system shuts down critical components. |
2. Sample Size for Test Set and Data Provenance
The document does not describe a specific "test set" and corresponding sample size in the context of clinical performance evaluation with patient data. Its primary focus is on engineering specifications, safety features, and comparison to predicate devices, rather than a clinical study establishing the device's performance on a specific dataset.
3. Number of Experts and Qualifications for Ground Truth
This information is not present in the document. No information is provided about expert consensus, ground truth establishment, or clinical studies involving experts.
4. Adjudication Method
This information is not present in the document. As there's no described clinical study or test set requiring expert ground truth or adjudication, this detail is omitted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or implied. The document focuses on the technical aspects and regulatory equivalence of the laser device itself, not on differences in human reader performance with or without the device.
6. Standalone Performance Study (Algorithm Only)
The device is a surgical laser system, not an AI algorithm in the contemporary sense. Therefore, a "standalone algorithm only" performance study is not applicable and not discussed. The document details the functional components and their operational specifications.
7. Type of Ground Truth Used
The document does not describe ground truth in the context of clinical outcomes or diagnostic accuracy. The "truth" or validation in this 510(k) submission relates to:
- Engineering specifications and testing (e.g., laser parameters, mechanical forces, safety shutdowns).
- Compliance with regulatory standards (e.g., 21 CFR §1040.10 and 1040.11).
- Substantial equivalence to predicate devices for intended use and technical characteristics.
8. Sample Size for the Training Set
This is not applicable and not present. The device is a surgical instrument, not a machine learning model that requires a training set of data.
9. How Ground Truth for Training Set Was Established
This is not applicable and not present for the same reasons as #8.
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