(151 days)
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multiplane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.
The LLS-fs 3D is a laser system designed for non-invasive treatment of the crystalline lens by photo-disruptive laser cutting of the lens tissue. The LLS-fs 3D may replace the conventional manual capsulorrhexis procedure with an automated. laser assisted capsulotomy procedure and laser phaco fragmentation.
A key function in the LLS-fs 3D is the Augmented Reality™ Imaging System, which uses precise biometric data collected at multiple angles and optical ray-tracing technology to form a 3-D model of each individual patient's eve. Accurate biometric measurements are required to ensure accurate placement of the femtosecond laser pulses used for various surgical procedures. The Augmented Reality " Imaging System uses enhanced depth of field of ocular structures and super luminescent diode (SLD) illumination to generate an in-focus image from the anterior cornea to the posterior lens capsule. The SLD is a continuous wave (cw) device with a beam emitting from the same aperture as the treatment laser. Variable-rate scanning ensures optical contrast to capture all ocular structures within the anterior segment of the eye. Using the biometric data collected, the LLS-fs 3D has the ability to detect even the smallest amount of lens tilt from the optical axis.
The LLS-fs 3D operates in the following manner: After dilation of the pupil, the laser is "docked" to the eye, and the eye is then optically scanned to determine the location, size, and shape of the crystalline lens and the cornea. The treatment parameters are entered by the user, and with the information from the scan. the control system computes a custom treatment pattern of photodisruptive laser pulses tailored to the individual eye.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values for the Lensar Laser System - fs 3D. Instead, it states that "All criteria were met" for specific features. However, we can infer the acceptance criteria from the descriptions of the performance evaluations.
| Feature Evaluated | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ANSI/AAMI/ISO 10993-1, 10993-5, 10993-10 standards. Sterility Assurance Level (SAL) of $10^{-6}$ for PID Kit. Cleaning validation for PID Interface Arm per AAMI TIR30:2011. | All standards and criteria were met. |
| Electrical Safety & EMC | Compliance with UL 60601-1, EN 60601-1, EN 60601-1-2, and IEC 60601-1-2007 (3rd Edition for EMC) requirements. | System met or exceeded all requirements. |
| Eye Safety Analysis | Compliance with ISO 15004-2:2007 for the Super Luminescent Diode (SLD). | SLD was determined to be safe using the described methods. |
| Software Verification & Validation | Compliance with specifications and requirements, as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "major" level of concern. | All cited changes and updates since prior clearance were verified and validated. Documentation provided. |
| Iris Registration Feature | Device performance complies with identified specifications and requirements for iris registration. | All criteria were met; results demonstrate the feature meets all performance specifications and requirements. |
| Cataract Density Imaging Feature | Device performance complies with identified specifications and requirements for cataract density imaging. | All criteria were met; results demonstrate the feature meets all performance specifications and requirements. |
| Beam Delivery & Placement (Ex vivo) | Confirmation of capsule clearance (anterior and posterior), corneal incisions for fixed/proportional depth for arcuate incisions, and selected proportional depth of clear corneal incisions. | Verification demonstrated compliance with requirements. |
| Residual Stroma Override (Ex vivo) | Demonstration of the safety feature's ability to override fixed depth selection to maintain a user-specified minimum residual stromal bed. | Performance demonstrated. |
2. Sample Size for the Test Set and Data Provenance:
- Biocompatibility Testing: Not specified in terms of number of samples, but materials coming in contact with patient fluid path were tested.
- Electrical Safety and EMC: Not specified, but involved testing of the LLS-fs 3D system.
- Eye Safety Analysis: Not specified, but involved evaluation of the Super Luminescent Diode (SLD).
- Software Verification and Validation Testing: Not specified for individual test cases, but covered all cited changes and updates.
- Performance Evaluation of Iris Registration Feature: Not specified.
- Performance Evaluation of Cataract Density Imaging Feature: Not specified.
- Animal Study (Ex vivo): "Porcine eyes" were used, but the specific number is not provided. This is retrospective as the tissue is already excised.
- Clinical Studies: No clinical evaluations were performed for this submission as the additional features and software updates did not change the Indications for Use.
The document does not explicitly state the country of origin for the data, but the company (LENSAR, Inc.) is based in Orlando, Florida, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not explicitly state the number or qualifications of experts used for establishing ground truth for the device's technical performance evaluations. However, given the nature of the tests (biocompatibility, electrical safety, eye safety, software validation, ex vivo animal studies), the ground truth for these would typically be based on established scientific principles, engineering specifications, and regulatory standards, rather than expert consensus on individual cases. For the ex vivo animal studies, qualified personnel would have performed the evaluations based on anatomical and surgical standards.
4. Adjudication Method for the Test Set:
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or data by multiple readers. Since this submission did not involve clinical studies with human readers, and the performance evaluations were primarily technical or ex vivo, no such adjudication method was mentioned or appears to have been applied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "These additional features and software updates do not change the Indication for Use. Thus no clinical evaluations are required as part of this submission." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Yes, the performance evaluations described, particularly for the "Iris Registration Feature" and "Cataract Density Imaging Feature," assess the device's capabilities and "compliance with specifications and requirements." This suggests an evaluation of the algorithm's direct output or performance against predefined metrics, independent of human interaction during the measurement process itself. The "Beam Delivery and Placement" and "Residual Stroma Override" features in the ex vivo animal studies also represent standalone performance evaluations of the laser system's mechanics and software logic.
7. Type of Ground Truth Used:
The types of ground truth used primarily include:
- Regulatory Standards and Specifications: For biocompatibility (ISO 10993 series), electrical safety and EMC (UL, EN, IEC 60601 standards), and eye safety (ISO 15004-2:2007).
- Internal Specifications and Requirements: For software verification and validation, Iris Registration, and Cataract Density Imaging features.
- Anatomical and Surgical Principles: For evaluations in ex vivo porcine eyes (capsule clearance, corneal incision depth, residual stroma override).
- Predefined Acceptance Criteria: For all the evaluated features, the "criteria were met per the specified criteria."
8. Sample Size for the Training Set:
The document does not mention any "training set" or explicit machine learning model training in the context of this 510(k) submission. The performance evaluations described are for the validation and verification of the device's features and overall safety/effectiveness, not for the training of an AI algorithm. The device includes an "Augmented Reality™ Imaging System" which uses biometric data and optical ray-tracing to form a 3-D model, but the specifics of any training data for such a system are not provided in this document.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, information on how its ground truth was established is not applicable or provided in this document.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.