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510(k) Data Aggregation
(81 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Corneal Tunnel Depth Accuracy | Achieved depth was "well within the established requirements" for corneal tunnel depth. |
| Corneal Tunnel Incision Quality & Ease of Opening | Demonstrated "ease of opening and quality of incision quality that was acceptable." |
| Radial Incision Depth Accuracy (individual or with arcuate incisions) | Achieved depth was "well within the established requirements" for radial incision depth. |
| Radial Incision Quality & Ease of Opening (individual or with arcuate incisions) | Demonstrated "ease of opening and quality of incision quality that was acceptable." |
| Effect on Endothelial Cells from Partial Thickness Incisions | "No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained." |
| Hazard Analysis | All potential hazards have "acceptable levels of probability/severity characteristics." |
| Software Verification and Validation | All criteria were met, demonstrating the software meets all performance specifications and requirements. |
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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(69 days)
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
| Performance Metric | Acceptance Criteria (Implied/Derived) | Reported Device Performance |
|---|---|---|
| New elliptical PID Modification: | ||
| IOP Rise | Consistent with existing LENSAR PID (cleared in K173346). | The new proposed elliptical PID was consistent with LENSAR's existing PID regarding IOP pressure rise. |
| Eye Stability (during surgery) | Comparable minimum force necessary to detach the eye from the suction ring as existing LENSAR PID. | The minimum force necessary to detach the porcine eye from the suction ring was comparable to that of LENSAR's existing PID. |
| Corneal Folds | No visible corneal folds compared to existing LENSAR PID. | Using OCT images, no visible folds were noted. |
| Iris Registration and Limbus Detection | All specifications of Iris Registration and Limbus Detection functions achieved with elliptical PID. | The analysis incorporated images of eyes with the elliptical PID and showed that all specifications of the Iris Registration and the Limbus Detection functions were achieved. |
| Hazard Analysis | All potential hazards have acceptable levels of probability/severity characteristics with the proposed changes. | The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics. |
| General Performance (new elliptical PID) | Meets all performance specifications and requirements. | All criteria for unit/system verification testing were met, and the results demonstrate that the LENSAR System with the new elliptical PID meets all performance specifications and requirements. |
| Biocompatibility: | ||
| New elliptical PID (materials) | No new biocompatibility testing deemed necessary (due to no material changes from existing PID). | Biocompatibility risk evaluation indicated no new biocompatibility testing was necessary. |
| Molded PMMA contact lens | Materials used are biocompatible, passing cytotoxicity, irritation, and sensitization tests. | Based on testing (cytotoxicity, irritation, and sensitization), no issues were found, and all testing passed. |
| Software Verification and Validation: | ||
| All changes and updates | Complies with specifications and requirements, follows FDA guidance. | Complete software verification and validation testing was conducted covering all cited changes and updates, and documentation was provided as recommended by FDA guidance. The software was considered "major" level of concern. |
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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(128 days)
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:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of depth | Achieved depth within established requirements | Achieved depth well within established requirements for both pocket and flap. |
| Parallelism of bed | Achieved depth at multiple points (tangential/sagittal planes) within specification of measured depth | Achieved depth at several points of both tangential and sagittal planes (i.e., parallelism) was well within the specification of the measured depth for both the pocket and flap. |
| Effect on endothelial cells | No loss of endothelial cell density | No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained (from a previous study). |
| IOP rise | Consistent with commercially available applanating PIDs | Consistent with other commercially available applanating PIDs. |
| Eye stability during surgery | Minimum force to detach eye from suction ring for new PID higher or equivalent to existing PID | Minimum force necessary to detach the porcine eye from the suction ring was higher for the curved contact PID versus that of LENSAR's existing PID. |
| Retinal burn hazard | No increase in hazard | No increase in hazard following a retinal burn hazard analysis for the addition of corneal pockets and flaps. |
| Incision quality (Pocket/Flap) | Acceptable ease of opening, ease of separation, smoothness of bed surface | Judgement of a board-certified ophthalmic surgeon indicated "Yes" for acceptability for each factor, consistent with the predicate device. |
| Bed smoothness (Pocket/Flap) | Consistent with predicate device | Judgement of the same surgeon indicated bed smoothness was consistent with that of the predicate device using donor eyes. |
| Corneal folds | No visible folds | No visible folds noted in OCT images when compared to a commercially available applanating PID. |
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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(67 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) 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.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Modified Algorithm) |
|---|---|---|
| i-Optics Cassini Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.97% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.03% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| Nidek OPD Scan Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.52% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.48% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| Topcon Aladdin Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 97.17% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 2.83% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| OCULUS Pentacam® HR Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 97.50% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 2.50% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| OCULUS Pentacam® AXL Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.33% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.67% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
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.
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(48 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.
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:
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Nidek OPD Scan Topographer) |
|---|---|
| Algorithm determines the correct cyclotorsion angle | ≥ 99.26% |
| Algorithm cannot determine an angle | < 0.74% |
| Algorithm determines an incorrect cyclotorsion | ≤ 1.81 * 10-3 % |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "Verification and validation testing were completed," but the number of cases or images analyzed for the Iris Registration feature is not provided.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The method for establishing ground truth for the "correct cyclotorsion angle" is not described.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The study focused on the performance of the Iris Registration feature itself, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done for the Iris Registration feature. The reported device performance in the table above reflects the algorithm's performance without human intervention in determining the cyclotorsion angle.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. For the "correct cyclotorsion angle," it would typically involve a reference standard established by a highly accurate measurement technique or expert consensus, but the detail is missing.
8. Sample Size for the Training Set:
The document does not provide information about the sample size used for the training set. It refers to "Verification and validation testing," but no details on training data are given.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document.
Summary of the Study:
The provided 510(k) summary focuses on the LENSAR Laser System - fs 3D (LLS-fs 3D) and specifically addresses the validation of its Iris Registration feature with the Nidek OPD Scan Topographer. The study was a performance evaluation of this particular feature.
The key aspects of the study as reported are:
- Objective: To demonstrate that the Iris Registration feature, particularly with the Nidek OPD Scan Topographer, meets predefined specifications and requirements.
- Methodology: Verification and validation testing were conducted.
- Results: The Iris Registration algorithm demonstrated a high accuracy rate in determining the correct cyclotorsion angle (≥ 99.26%) when used with the Nidek OPD Scan Topographer. It also had a very low incidence of determining an incorrect angle (≤ 1.81 * 10-3 %).
- Conclusion: The company concluded that the Iris Registration feature meets all performance specifications and requirements, and that the LENSAR Laser System - fs 3D is substantially equivalent to its predicate device (K143010) with this additional validated feature.
- Clinical Studies: No clinical evaluations were deemed necessary for this specific submission because the additional feature did not change the device's indications for use.
Missing Information:
Crucially, the document lacks detailed information on the methodology of the validation study, including:
- The exact number of cases/samples in the test set.
- How the "correct cyclotorsion angle" (ground truth) was determined for these cases.
- Details about the dataset's origin (e.g., retrospective/prospective, demographics).
- Any information regarding the training dataset for the algorithm.
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