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The LenSx Laser system is indicated for use:

• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.

The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.

The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.

The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

N/A

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The LenSx Laser system is indicated for use:

• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.

The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.

The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.

The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Based on the provided FDA 510(k) Clearance Letter for the LenSx Laser System, this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new AI or novel diagnostic device.

The clearance is for a modified version of an existing device (LenSx Laser System) with software updates and an expanded indication for Implantable Collamer Lens (ICL) surgery. The general approach taken is to show that these modifications do not raise new questions of safety or efficacy and that the device remains substantially equivalent to its predicate. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/diagnostic device) is not explicitly detailed in this 510(k) summary.

However, I can extract the relevant information presented, acknowledging that it's framed within the context of demonstrating substantial equivalence for a modified device, rather than a de novo clearance for a completely new technology with novel performance claims.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable or not detailed in this type of submission:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) Summary)

The 510(k) summary indicates that the modifications to the LenSx Laser System are minor and do not introduce new safety or efficacy concerns. The "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating that the device continues to meet its intended design specifications and functional requirements, performing as intended and being equivalent to the predicate. There are no specific numerical performance metrics provided in the summary that would typically be seen for a new diagnostic or AI device (e.g., sensitivity, specificity, accuracy against a gold standard).

Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to an existing device, the "acceptance criteria" are generally about maintaining the performance and safety profiles of the predicate. The "reported device performance" refers to the successful completion of the tests.

Study Details (as applicable)

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

   • Test Set Sample Size: Not specified in terms of clinical cases or patient data, as no animal or clinical testing was deemed necessary for this submission. The "test set" primarily refers to bench testing, software verification/validation, and regulatory compliance checks.
   • Data Provenance: Not applicable as no clinical or animal data was collected for this submission. The data provenance for compliance testing is internal Alcon laboratories.

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

   • Not applicable as this 510(k) submission does not rely on expert-adjudicated ground truth from a clinical test set. The ground truth for engineering and software tests is based on design specifications, recognized standards, and regulatory guidance. For clinical ground truth, the submission relies on the established safety and efficacy of the predicate device and the assessment that the modifications do not alter this.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There was no clinical test set requiring expert adjudication.

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 MRMC study was performed or required. The device is a surgical laser, not an AI-assisted diagnostic tool that would typically involve human readers.

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

   • Not applicable in the context of an AI algorithm. However, the device itself, including its software, undergoes standalone functional and safety testing as part of the "Non-Clinical Testing" detailed in Section 7.1, such as "Software verification and validation testing" and "Performance Testing." These tests ensure the device (algorithm and hardware) performs its functions correctly according to specifications, independent of operator interaction after initial surgical planning.

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

   • For the non-clinical and software testing, the "ground truth" is defined by:
     • Engineering Specifications: The pre-defined technical and functional requirements for the laser system.
     • International and National Standards: Compliance with standards like IEC 60601 series, ANSI Z80.36-2021 for safety and performance.
     • FDA Guidance Documents: Compliance with FDA recommendations for software documentation and cybersecurity.
     • Predicate Device Performance: The established safety and effectiveness of the existing LenSx Laser System serves as the clinical benchmark.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the typical sense for a new diagnostic algorithm. The software modifications are deterministic or rule-based enhancements (e.g., embedded calculator, new cut patterns).

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

   • Not applicable for the same reason as above. If there were internal development/optimization processes for the new features (e.g., nomogram calculations), their accuracy and "ground truth" would be established through mathematical validation, simulation, and bench testing against known physical principles or desired outcomes, rather than a data-driven training set.

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The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

• Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
  • Similar intended use.
  • Similar indications for use.
  • Similar fundamental scientific technology.
  • No new harms or unacceptable risks.
• Study That Proves the Device Meets Acceptance Criteria:
  • Type of Study: Non-clinical studies were performed, including:
    • Bench testing.
    • Electromagnetic Compatibility (EMC) testing.
    • Software verification and validation testing.
    • Design verification and validation testing.
  • Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
  • Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
  • Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
    • Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
    • Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
    • Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

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The CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.

Catalys™ Precision Laser System ophthalmic surgical laser system Device Description: used in healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings. The System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys™ Precision Laser System (also referred to as the Catalys™ System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates 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 System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the threedimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys™ Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.

Here's an analysis of the acceptance criteria and study information for the CATALYS™ Precision Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and software changes.

The "reported device performance" is described qualitatively as "the System's ability to meet all intended design specifications related to the software design changes" and that "the System remains safe and effective for its intended use".

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "hardware and software bench tests" and "simulated use testing", but does not provide details on the number of tests or specific data samples used for these tests.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The testing involved "bench testing" and "simulated use testing", suggesting a controlled environment rather than real-world patient data.

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

This information is not provided in the document. The testing described primarily focuses on technical and software verification, not clinical performance based on expert review of outcomes.

4. Adjudication Method for the Test Set

This information is not provided as the type of testing described (bench and simulated use) does not typically involve expert adjudication in the way clinical studies or image-based AI studies do.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Data was deemed not necessary for the Catalys™ Precision Laser System."

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

The device itself is a laser system with integrated software, not purely an algorithm that provides a diagnostic output. The "standalone" performance in this context would refer to the laser system's ability to execute its functions (capsulotomy, phacofragmentation, corneal cuts) according to its design specifications.

The document states, "Software verification and validation testing in addition to bench testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects have been introduced due to the software change." This implies standalone testing of the software's functionality within the system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data appears to be based on engineering and design specifications. The software's ability to meet its "intended design specifications" was verified. For the laser's physical actions, the ground truth would be precise measurements of the cuts/fragmentation against pre-defined parameters.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a laser system, not an AI model trained on a large dataset in the conventional sense (e.g., for image analysis). The software updates are for workflow efficiency, astigmatism management, and iris registration, which are likely based on engineering development and calibration rather than machine learning training sets.

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

This information is not applicable/not provided for the same reasons as point 8.

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The ALLY™ Adaptive Cataract Treatment System 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.

The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and 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 provided text describes the LENSAR ALLY™ Adaptive Cataract Treatment System and its substantial equivalence to a predicate device, the LENSAR Laser System – fs 3D (LLS-fs 3D). However, it does not contain a specific study demonstrating performance against acceptance criteria in the way typically required for AI/ML device evaluations (e.g., diagnostic performance metrics like sensitivity, specificity, or AUC).

Instead, the document focuses on demonstrating that the ALLY™ System is substantially equivalent to its predicate device through non-clinical performance data, ensuring it meets safety and effectiveness requirements.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a specific task. Instead, it describes various non-clinical tests conducted to ensure the device's safety, effectiveness, and equivalence to the predicate. The "performance" here refers to meeting engineering and safety standards.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not applicable in the context of diagnostic performance studies. The "test set" here refers to various samples used for non-clinical engineering and safety testing (e.g., material samples for biocompatibility, packaging samples for integrity). Specific sample sizes for each non-clinical test are not detailed in this summary.
• Data Provenance: The nature of the non-clinical tests implies that the data was generated specifically for the ALLY™ device during its development and testing phases. There is no mention of external, retrospective, or prospective patient data sets for performance evaluation in the diagnostic sense. The testing was conducted by LENSAR, Inc., likely in the US, as suggested by the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission focuses on engineering and safety validation, not on diagnostic performance or interpretation by human experts.

4. Adjudication Method

Not applicable. There is no mention of expert adjudication for ground truth for diagnostic or interpretative tasks.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the document. The device is a surgical laser system, and the evaluation focuses on its technical performance and safety, not on improving human reader performance in interpreting medical images with AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone algorithm-only performance study (in the context of AI/ML diagnostic or interpretative algorithms) was not explicitly conducted or described. The document describes the performance of the integrated ALLY™ system itself through various engineering and safety tests. While the system uses "automated precision" and "treatment planning tools for precision-guided laser treatments," the evaluation presented is not a standalone AI algorithm performance study in the typical sense of measuring diagnostic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests would be the established engineering standards, safety regulations, and predetermined specifications that the device had to meet. For example:

• Eye Safety: ANSI Z-136.1:2014 standards.
• Biocompatibility: ISO 10993-1 standards.
• Sterile Device Packaging: ISTA 3A, ASTM F2096, ASTM F88 standards.
• EMC & Electrical Safety: ANSI/AAMI/IEC 60601-1-2:2014, ANSV/AAMI/ES 60601-1:2005 A1:2012 standards.
• Software: IEC 62304 standard and FDA guidance.

8. Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML model that would require a distinct "training set" of data for diagnostic or interpretative learning. The "automated precision" and "treatment planning tools" are likely based on deterministic algorithms and calibrated parameters from engineering design, not deep learning from a large training dataset.

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

Not applicable, as no AI/ML training set is described.

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The Catalys® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.

Catalys® Precision Laser System is an ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The Catalys® Precision Laser System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed.

The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates 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 System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

The Catalys® Precision Laser System laser classification per 21 CFR 1040.10 and 21 CFR 1040.11 is Class 4.

This document describes the CATALYS® Precision Laser System, specifically focusing on the acceptance criteria and study that proves the device meets those criteria for a modified Liquid Optics Interface (LOI).

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes bench testing performed to confirm the ability of the Gen3 LOI to meet its intended use. The acceptance criteria themselves are explicitly stated as "All acceptance criteria were met" for various tests, implying successful completion against predefined benchmarks. The document also states, "The acceptance criteria remain unchanged between Gen2 and Gen3 LOI." While specific quantitative criteria are not listed in a table format within the provided text, the document asserts that they were met. The reported performance is that the device did meet these (unspecified) criteria.

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

The document mentions "bench testing" and "performance testing conducted for the Gen3 LOI." It indicates testing was done at "baseline time point T=0 (before aging) and at T=24 (after accelerated aging equivalent to 24 months)." However, the exact sample size for any of these tests is not specified in the provided text. The data provenance is stated as from the manufacturer's own internal testing, specifically AMO Manufacturing USA, LLC, which is a retrospective evaluation of a new manufacturing process for an existing component.

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

The document does not describe the use of human experts to establish "ground truth" for the technical performance tests. These tests (sterilization, performance, biocompatibility) typically rely on standardized protocols and instrumental measurements against engineering specifications, rather than subjective expert assessment.

4. Adjudication Method for the Test Set

Not applicable, as the testing described focuses on objective technical performance criteria (e.g., sterilization assurance, mechanical integrity, biocompatibility) rather than subjective assessments requiring adjudication.

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 proposed device does not include any changes to the indications for use or intended use of the primary predicate device. It does not introduce any new harms or unacceptable risks, and therefore does not require clinical testing to assess safety and performance or to demonstrate equivalence."

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

This device is an ophthalmic laser system for cataract surgery with a modified patient-user interface. It is a physical medical device, not an AI or algorithm-only product. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The performance evaluated here is the physical and functional performance of the device's components.

7. The Type of Ground Truth Used

The ground truth for the evaluations conducted ("sterilization cycle validation," "performance testing," and "biocompatibility testing") would be established by:

• Sterilization Validation: Meeting a predefined Sterility Assurance Level (e.g., 10-6 SAL) through standard microbiological challenge tests as defined by ISO 11135 and AAMI TIR28.
• Performance Testing: Adherence to engineering specifications and design requirements for the Liquid Optics Interface (LOI), ensuring it functions correctly with the CATALYS® Precision Laser System.
• Biocompatibility Testing: Compliance with biocompatibility standards (e.g., ISO 10993) demonstrating no cytotoxic effects or leaching for the specified materials.

8. The Sample Size for the Training Set

Not applicable. This submission is for a modification to a physical medical device component, not for an AI/machine learning algorithm that requires a "training set." The changes involve manufacturing site, sterilization parameters, and a colorant change for a single-use interface.

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

Not applicable, as there is no training set for an AI/machine learning algorithm described in this document.

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The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser is a solid state femtosecond laser used in ophthalmology. It is used for producing cuts in ocular tissue and can be used in corneal and cataract surgery.

The Z8 produces femtosecond laser energy that is absorbed by the tissue, resulting in plasma formation. This plasma rapidly expands, creating a cavitation bubble separating the tissue. This process is known as photodisruption. Because of its very short pulse duration, femtosecond laser technology deploys low pulse energy that virtually eliminates damage peripheral to the incision site and can therefore be used to dissect tissue on a microscopic scale. Femtosecond laser systems may use closer spot spacing to overlap these cavitation regions, producing less tissue bridges.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser system consists of the following functional units:

• Base Station (BS), integrating the Laser Cavity, Fixed Mirror Articulated Arm (FMAA), Power -Supply, Computer, Touchscreen Monitor, Suction Unit, OCT Box, and Safety System
• Handpiece (HP) integrating the Cutting Lens and Topview Camera
• Disposable accessories

The provided document is a 510(k) Summary for the FEMTO LDV™ Z8 Femtosecond Surgical Laser, which is a medical device. This document does not describe a study involving an AI/Machine Learning component, nor does it provide acceptance criteria and performance metrics typically associated with such studies.

Specifically, the document focuses on demonstrating substantial equivalence of a modified version of an existing ophthalmic laser device to its predicate device. The changes are primarily hardware and minor software updates (bug fixes, not new algorithms with performance metrics).

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, etc.) because the document does not contain this type of data related to an AI/ML device study.

The document states: "The changes described in section IV did not require clinical performance data to demonstrate substantial equivalence to the predicate device." This indicates that no new clinical studies were performed to assess the performance of the modified device in terms of efficacy or diagnostic accuracy, which would be the typical context for the acceptance criteria and study details you've asked for. The studies mentioned are focused on safety, EMC, biocompatibility, sterilization, and software verification/validation, rather than a performance study of an AI algorithm.

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The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.

Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid OpticsTM Interface and optional Mobile Patient Bed.

The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arccuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid OpticsTM [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

The Catalys® Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.

This document is a 510(k) premarket notification for the CATALYS® Precision Laser System. It is a submission for a modified device, comparing it to a previously cleared predicate device (K200056). The core of this submission is to demonstrate that the modified device remains substantially equivalent to its predicate.

Based on the provided information, the focus is on non-clinical performance data because clinical data was deemed not necessary for this submission. The device modifications are related to the Mobile Patient Bed, not the primary laser system itself.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format for this specific submission. Instead, it relies on demonstrating that the modified device's performance is maintained and that the changes do not introduce new safety or efficacy concerns compared to the predicate device. The "acceptance criteria" in this context are implicitly that the modified Mobile Patient Bed performs its intended function safely and effectively within the CATALYS® System, consistent with the original cleared device.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a numerical sample size for the test set used in the design verification and validation testing. The testing refers to "subsystem level verification and regression testing, as well as system validation."
• Data Provenance: The data is internally generated by AMO Manufacturing USA, LLC, as part of their design verification and validation process for the device modifications. The geographic origin of the data is not specified, but it would typically be internal testing data from the manufacturer's facilities. It is retrospective in the sense that it's performed on the modified device before submission for clearance, but it's prospective in terms of testing the changes being proposed.

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

This section is not applicable as the study described is a non-clinical device verification and validation study, not a study involving expert-derived ground truth (e.g., image interpretation). The "ground truth" here is the expected functional and safety performance of the device components, which is defined by engineering specifications and regulatory standards.

4. Adjudication method for the test set

This section is not applicable for the same reasons as above. There isn't a need for adjudication in the context of verification and validation testing of device components.

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

An MRMC comparative effectiveness study was not done. This device is an ophthalmic laser system for cataract surgery, not an AI-powered diagnostic or assistive tool for human readers. The clinical performance data was deemed "not necessary."

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

This section is not applicable in the context of an "algorithm only" performance. The device is a physical laser system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the entire system's functionality and safety.

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

As this is a non-clinical validation of device modifications, the "ground truth" for the tests performed (subsystem verification, regression testing, system validation) would be based on:

• Engineering specifications and design requirements: The modified components (electronics, battery, firmware, mechanical parts of the Mobile Patient Bed) must meet pre-defined engineering and performance criteria.
• Regulatory standards: Compliance with relevant medical device safety and performance criteria (e.g., ISO 15004-2:2007 mentioned for output power) is an implicit ground truth.
• Equivalence to predicate: The ultimate "ground truth" for this submission is demonstrating that the changes do not negatively impact the substantial equivalence to the already cleared predicate device.

8. The sample size for the training set

This section is not applicable as there is no mention of machine learning or an "AI algorithm" requiring a training set in the context of this 510(k) submission. The changes are hardware and associated firmware modifications to a component of an existing laser system.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

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The VICTUS Femtosecond Laser Platform is indicated for use for:
· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.

The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.

The provided text focuses on the 510(k) premarket notification for the VICTUS Femtosecond Laser Platform, specifically regarding modifications to its Patient Interface. It primarily discusses the technological comparison and non-clinical performance data to establish substantial equivalence to a previously cleared device. Therefore, the information regarding in-depth acceptance criteria and a standard study that proves the device meets those criteria (especially in the context of AI/ML performance) is not available in the provided document.

However, based on the non-clinical performance data section, we can infer some aspects related to acceptance criteria and the study performed, even though it's not presented in a typical AI/ML study format.

Here's an attempt to structure the answer based on the available information, noting where specific details are absent:

Acceptance Criteria and Study for VICTUS Femtosecond Laser Platform (Modified Patient Interface)

This submission describes changes to the Patient Interface (PI) of the VICTUS Femtosecond Laser Platform. The study's primary goal was to demonstrate that these modifications do not negatively impact the device's performance compared to the previously cleared version, thus establishing substantial equivalence.

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 for each non-clinical test. The document mentions "All bench testing results" without detailing the number of tests performed or the quantities of PI kits/cuts analyzed for each criterion (fidelity, quality, docking behavior).
• Data Provenance: The studies are described as "Non-Clinical Performance Data" and "bench testing." This implies internal laboratory studies conducted by the manufacturer (Technolas Perfect Vision GmbH). The country of origin is not specified but is likely within the company's operational regions (e.g., Munich, Germany or San Francisco, CA where the contact person is located). It is retrospective in the sense that it evaluates a modified component against an existing, cleared component.

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

• Not Applicable / Not Mentioned: This type of information (number of experts, qualifications) is typically relevant for studies involving human interpretation or clinical endpoints, especially in AI/ML performance evaluation. The presented data is from bench testing, where "ground truth" would be established by objective measurements (e.g., precise measurements of cut parameters, biocompatibility assay results). Experts would be involved in interpreting the objective data, but not in establishing a subjective "ground truth" in the way radiologists might for medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Mentioned: Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies among multiple human readers. This was a non-clinical bench testing study comparing device performance metrics, not human expert assessments.

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

• No: No MRMC or human-in-the-loop study was done. This notification is for a hardware modification (Patient Interface) of a laser platform, not an AI/ML algorithm requiring human reader performance evaluation. The document explicitly states: "There was no clinical study performed to support substantial equivalence of this premarket notification." Additionally, "No new software testing was performed to support this premarket notification."

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

• No: This is not an AI/ML algorithm. The performance evaluation focuses on the mechanical and optical characteristics of a physical device component (Patient Interface).

7. The Type of Ground Truth Used

• The ground truth for the non-clinical performance data appears to be objective measurements and laboratory assays comparing the modified Patient Interface (PI) to the predicate PI. This includes:
  • Quantitative measurements of cut pattern fidelity and quality (e.g., dimensions, regularity).
  • Biocompatibility assay results (pass/fail criteria per ISO standards).
  • Endotoxin concentration measurements.
  • Measurements related to docking behavior outcomes (IOP, suction integrity).

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As there is no training set for an AI/ML algorithm involved, this question is not relevant.

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The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.

Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed.

The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates 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 System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

The information provided is about the CATALYS® Precision Laser System for cataract surgery, specifically a software update (K200056), and does not describe a device that uses AI or machine learning. Therefore, many of the requested categories related to AI performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable.

The document indicates that the device itself is a laser system used in ophthalmic surgery. The update discussed in this document relates to software revisions to improve workflow efficiency, advanced astigmatism management, and additional improvements to existing features, including the addition of software modules to support patient exam import and iris registration.

Here's an analysis of the provided text based on the questions, with "N/A" for criteria not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with corresponding reported performance metrics for the software updates. Instead, it states that "Software verification and validation testing in addition to bench testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects were introduced due to the software changes." and "The modified device employs additional tests to verify the performance of the laser’s ability to execute the intended trajectory."

The non-clinical performance data section effectively serves as the "study" that proves the device meets (implied) acceptance criteria, by demonstrating that the software changes do not negatively impact safety and efficacy.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document. The testing involved "hardware and software bench tests, in conjunction with simulated use testing."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing described as "bench testing" and "simulated use testing" implies a controlled, laboratory-type environment rather than patient data. The submission is from AMO Manufacturing USA, LLC, suggesting the testing was likely conducted in the US. The term "retrospective or prospective" is not applicable as this was bench and simulated use testing, not clinical data from patients.

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

Not applicable. "Ground truth" in the context of expert consensus is typically relevant for interpretative devices (like AI for image analysis). This document describes a surgical laser system with software updates, and the testing focuses on functional performance and adherence to design specifications through bench and simulated use testing, not on expert interpretation of output.

4. Adjudication method for the test set

Not applicable, as expert adjudication of results is not relevant for this type of technical device performance testing.

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

Not applicable. This device is a laser system for surgery, not an AI-powered diagnostic or interpretive tool where human readers would be assessing cases with or without AI assistance.

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

Not applicable. The software changes are part of a surgical laser system, which inherently involves a human operator (surgeon). The testing described focuses on the software's ability to control the laser and execute its functions as designed.

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

The concept of "ground truth" as typically defined for AI/diagnostic devices (e.g., pathology, clinical outcomes) is not directly applicable. For this device, the "ground truth" would be established by engineering specifications, validated measurements, and successful execution of intended laser trajectories and software functions during bench and simulated use testing. For example, "the performance of the laser's ability to execute the intended trajectory" would be verified against its programmed design.

8. The sample size for the training set

Not applicable. This document describes software updates for an existing medical device, not a machine learning model that requires a training set. The changes involve workflow improvements, astigmatism management, and patient data import/iris registration functionalities.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device requiring a training set.

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