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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

• in the creation of an anterior capsulotomy;
• in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
• in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
• in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
• in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

The 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. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts.

The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

Acceptance Criteria and Study for LENSAR Laser System - fs 3D (LLS-fs 3D)

The information provided describes the performance evaluation conducted for the LENSAR Laser System - fs 3D (LLS-fs 3D) to support its substantial equivalence, particularly concerning new indications for use related to corneal ring segments and radial incisions.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of eyes, but the studies were conducted on porcine ex vivo eye models.
• Data Provenance: The data is from pre-clinical testing on porcine ex vivo eye models. This indicates an in vitro or ex vivo setting, not human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• For the assessment of incision quality (corneal tunnel and radial incisions), a "trained biomedical scientist" was used.
• No further details are provided regarding the number of scientists, their specific qualifications, or years of experience.

4. Adjudication Method for the Test Set

• Not explicitly stated. For the incision quality assessment, it mentions "A trained biomedical scientist... assessed the acceptability," implying a single assessor or a consensus not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The addition of the added indications for use and other minor changes... did not require clinical performance data to demonstrate substantial equivalence to the predicate device."
• Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The performance data presented focuses on the device's ability to create precise cuts and tunnels. While the device uses software and imaging for guidance (Iris Registration, IntelliAxis, CustomFrag), the performance evaluation described directly assesses the physical outcomes of the laser treatment on anatomical models. It does not describe a "standalone" algorithmic performance in the typical sense of an AI model making diagnostic or prescriptive decisions without human oversight or direct intervention. The device itself is a surgical tool controlled by a surgeon.

7. The Type of Ground Truth Used

• Instrumental measurements: For depth accuracy, an optical coherence tomographer was used.
• Expert assessment: For incision quality, a trained biomedical scientist performed the assessment.
• Biological assessment: Evaluation of endothelial cells of ex vivo eyes for cell density loss.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for any training set. The performance data presented is for verification and validation testing, which often refers to testing on a held-out set after development. There is no information provided about how the device's algorithms or parameters (e.g., for depth placement, cut patterns, image analysis) were internally trained or developed.

9. How the Ground Truth for the Training Set Was Established

• This information is not provided in the document. As no training set size is stated, the method for establishing its ground truth is also absent. The document focuses on the validation studies performed to demonstrate the device meets specifications, rather than the internal development or training processes of its embedded software/algorithms.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

· in the creation of an anterior capsulotomy;

• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• · in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and
• · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.

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. The device is also intended for use in the creation of pocket cuts/ incisions in the cornea in patients undergoing ophthalmic surgery, and in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, each of which may only be performed individually.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket and flap cuts.

The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™, an ophthalmic surgical laser. The submission is a 510(k) for changes to an already cleared device (K173346), specifically the introduction of a new elliptical-shaped Patient Interface Device (PID) Kit, a software change related to Limbus detection, and a change in manufacturing process for the PMMA contact lens of the Curved Contact PID.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• IOP Rise, Eye Stability, Corneal Folds: Tested in vitro using porcine eyes. The specific number of porcine eyes is not provided in the document.
• Iris Registration and Limbus Detection: Analysis incorporated images of eyes with the elliptical PID. The specific number of images or eyes is not provided.
• Biocompatibility (Molded PMMA): Testing was performed for cytotoxicity, irritation, and sensitization. The sample size or specific test protocols are not detailed.
• Software Verification and Validation: Conducted through unit and system testing, implying internal testing and validation against specifications. No specific "test set" size in terms of patient data is mentioned for this aspect.

The data provenance for the in vitro studies (porcine eyes) is not specified further than "porcine eyes." No human patient data is mentioned for testing these specific device modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not detail the use of external experts to establish ground truth for the test set.

• For the in vitro studies (IOP, stability, corneal folds), the assessment seems to be based on direct measurement or observation (e.g., OCT images for corneal folds) conducted by the manufacturer's testing personnel.
• For Iris Registration and Limbus Detection, "specifications...were achieved," suggesting internal verification against defined parameters.
• Hazard analysis was performed, likely by an internal risk management team.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The assessments appear to be based on internal testing and compliance with specifications.

5. 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

There is no mention of an MRMC comparative effectiveness study or any study involving human readers and AI assistance. This submission focuses on hardware and software changes to an existing laser system, not an AI diagnostic or assistive tool for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a surgical laser system; therefore, the concept of "standalone performance" for an algorithm in the typical sense (e.g., diagnostic AI) does not directly apply. The software performance described is integrated into the operation of the laser system (e.g., Limbus detection, Iris Registration). Its performance is evaluated within the context of the device's functional operation, not as a standalone interpretive algorithm.

7. The Type of Ground Truth Used

• For IOP, eye stability, and corneal folds, the ground truth is derived from direct physical measurements and observations on porcine eyes, compared against the performance of the predicate device's existing PID.
• For Iris Registration and Limbus Detection, the ground truth is adherence to pre-defined technical specifications for these functions.
• For biocompatibility, the ground truth is the results of standardized biocompatibility tests (cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This document does not describe the use of a "training set" in the context of machine learning or AI development. The software updates mentioned are likely modifications to existing algorithms or new implementations based on deterministic logic, rather than machine learning algorithms requiring large training datasets.

9. How the Ground Truth for the Training Set was Established

As no training set is described in the context of machine learning, this question is not applicable. The software changes are verified against internal specifications and by demonstrating that they do not compromise the safety and effectiveness of the existing system.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

• · in the creation of an anterior capsulotomy;
• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
• · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
• in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and
• · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.

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. The device is also intended for use in the creation of pocket cuts/ incisions in the cornea in patients undergoing ophthalmic surgery, and in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, each of which may only be performed individually.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket and flap cuts.

The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ includes the integration with pre-op 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.

This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) and its performance data in support of its 510(k) submission (K173346) for new indications: creation of corneal pockets and corneal flaps.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The study primarily utilized a porcine ex vivo eye model for most of the performance evaluations related to corneal pockets and flaps. Specific sample sizes for each test are not explicitly provided in the document.
Data provenance is retrospective as it refers to testing done in support of the submission. The origin of the porcine eyes is not specified. For some tests, human donor eyes were also used, but their provenance is not detailed either.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For the evaluation of incision quality and bed smoothness, the ground truth was established by:

• A board-certified ophthalmic surgeon.
  The document does not specify the number of years of experience of the surgeon, nor if multiple surgeons were involved for different assessments.

4. Adjudication Method for the Test Set:

For the human-graded assessments (incision quality and bed smoothness), the adjudication method appears to be none, as the decisions were based on the "judgement of the surgeon," implying a single expert opinion without a formal consensus or tie-breaking process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done to assess the improvement of human readers with AI vs. without AI assistance. The device is a surgical laser system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Yes, a standalone study was conducted as the performance data directly assesses the capabilities of the laser system itself (e.g., accuracy of depth, parallelism, incision quality) rather than its interaction with human interpretation or decision-making in a diagnostic context. This is a surgical device performing physical actions.

7. Type of Ground Truth Used:

The ground truth used was a combination of:

• Measurement against intended specifications: For objective metrics like depth accuracy, parallelism, and IOP rise.
• Expert subjective assessment: For qualitative metrics like incision quality (ease of opening, separation, smoothness) and bed smoothness, evaluated by a board-certified ophthalmic surgeon.
• Imaging (OCT): For assessing corneal folds.
• Biological effects: For endothelial cell density, based on previous studies.

8. Sample Size for the Training Set:

This information is not provided in the document. The document describes performance testing for new indications, not a machine learning model that would typically have a separate training set. The "software verification and validation testing" refers to the system's software, not an AI/ML algorithm that is trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned for an AI/ML model, this information is not applicable. The ground truth establishment described above pertains to the validation of the device's physical performance characteristics.

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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.

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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) 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 fragmentation treatment 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 marking for simple alignment of Toric IOLs as well as corneal treatment planning tools for precision guided laser treatments.

Here's an analysis of the provided text regarding the LENSAR Laser System - fs 3D (LLS-fs 3D), specifically focusing on the Iris Registration feature and its performance data:

The document describes performance data for the Iris Registration feature after an update that includes:

• Addition of Topcon Aladdin, OCULUS Pentacam® HR, and Pentacam® AXL topographers.
• An additional routine to the Iris Registration function to improve robustness to pupil center drift and gaze direction for cyclotorsion angle identification.
• Updated software for improved user interaction.

The study presented focuses only on the performance evaluation of the Iris Registration feature, not the overall device. Clinical performance data was not required for the changes described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics. The goal is for the algorithm to correctly determine the cyclotorsion angle and minimize cases where it cannot determine an angle or determines an incorrect one.

Note: The document states "All criteria were met" (page 5), implying these reported values meet the internal specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of images or patients) used for the test set for any of the topographers. It refers to "re-running the respective data sets," implying pre-existing datasets were used.

Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The method for establishing the "correct cyclotorsion angle" (ground truth) is not described.

4. Adjudication Method for the Test Set

The adjudication method is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The performance data specifically evaluate the algorithm's performance (standalone) for Iris Registration, comparing it to an "Original Algorithm" in some tables, but not involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study of the algorithm's performance was done. The tables clearly present the performance metrics of the algorithm itself in determining the cyclotorsion angle. The comparison tables for i-Optics Cassini and Nidek OPD Scan also show the performance of the "Original Algorithm" versus the "Modified Algorithm," indicating an algorithm-to-algorithm comparison.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. It can be inferred that it relates to the "Correct Cyclotorsion Angle," but how this "correct" angle was determined (e.g., by manual expert annotation, a different validated instrument, or pathology) is not described.

8. Sample Size for the Training Set

The sample size for the training set is not provided. The document details changes to an existing algorithm and its performance, but not its development or training details.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

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.

Here's an analysis of the acceptance criteria and study information for the LENSAR Laser System - fs 3D (LLS-fs 3D), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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