Search Results

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 are 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) with Streamline™ 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 multi-plane 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 fragment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions. The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline" includes the integration with preop analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal and capsule marking for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LENSAR Laser System - fs 3D (LLS-fs 3D) with the Capsular IntelliAxis feature:

It's important to note that the provided document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with extensive statistical data. As such, some of the requested information (especially quantitative data like effect size in MRMC studies or large sample sizes for training sets) is not explicitly present.

Acceptance Criteria and Reported Device Performance

The document describes the verification and validation (V&V) testing for the Capsular IntelliAxis feature. The acceptance criteria are implicitly tied to the performance specifications and requirements identified for this feature. The reported device performance is that these criteria were met.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document mentions "a study using porcine eyes." It does not specify the exact number of porcine eyes used for this study.
   • Data Provenance: Porcine eye study. This indicates the data is from an animal model, not human clinical data, and is prospective experimentation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number or qualifications of experts involved in the porcine eye study. The evaluation likely involved technical personnel and potentially ophthalmologists, but this is not detailed.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. Given this was a technical/biomechanical study on porcine eyes, it's less likely to involve a complex expert adjudication process typically seen in image interpretation or clinical outcomes.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The document states: "Clinical performance data to demonstrate substantial equivalence was not required for this product change." The study described is a technical and biomechanical evaluation using porcine eyes for the Capsular IntelliAxis feature, not an evaluation of human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The "Performance Evaluation of the Capsular IntelliAxis Feature" involved "unit testing and system testing" to verify the software performance against specifications. The biomechanical testing on porcine eyes also evaluated the device's direct output (capsulotomy strength) rather than human interpretation. While a surgeon is "in the loop" for the overall procedure, the evaluation of the feature's effectiveness (mark visibility, capsulotomy strength) is akin to a standalone assessment of the device's functional output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For effectiveness and ease of use: The ground truth for "effectiveness and ease of use" (i.e., visibility of marks intraoperatively and ability to align Toric IOLs) was likely observational by surgeons during the porcine eye study.
   • For biomechanical strength: The ground truth was established through tensile testing (force required to tear and elongation before tearing) to objectively measure biomechanical properties of the capsular rim.

7. The sample size for the training set:

   • The document does not provide details on a separate "training set" sample size. The description of the device is that it "allows for a modification to the current capsulotomy procedure" and uses "standard pre-operative data" or data "entered by the surgeon." This suggests the algorithm is rules-based or relies on existing pre-operative data sources, rather than being a deep learning model requiring a large training dataset. The verification and validation are described as software testing and a porcine eye study.

8. How the ground truth for the training set was established:

   • Given the absence of a described "training set" for a machine learning model, this question is not directly applicable. If the system uses established pre-operative data and surgeon input, the "ground truth" for its operation is inherent in those inputs and the validated surgical parameters that the device is programmed to execute.

Ask a specific question about this device

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.

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.

Ask a specific question about this device