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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 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 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.

• Maintain consistent motor output for Z-motors when lifting maximum weight.
• Proper battery and charging management.
• Diagnostic data logging capability (field service accessible).
• Functional and tactile mechanical interface (pendant buttons, armrest, headrest). | Electronics/Circuits:
• Z-Motors: "Consistent motor output between MPB's when lifting maximum weight."
• Battery/Charging: "Vendor provided battery management module" (implies proper functionality).
  Firmware/FPGA:
• "Diagnostic data logging (only field service accessible)."
  Mechanical:
• "Tactile membrane switches on pendant."
• "Armrest attached to seat near backrest."
• "Simpler headrest assembly with only one articulation points." |
  | System Integration and Safety:
• No adverse effects introduced by the changes to the Mobile Patient Bed.
• Maintains same intended use, indications for use, and fundamental/scientific technology as the predicate device.
• No new harms or unacceptable risks. | "Design verification and validation testing was performed to verify the ability of the modified Mobile Patient Bed to meet its intended use with the Catalys System and to ensure that no adverse effects have been introduced due to the changes."
  "The testings conducted and presented for the subject device, provides reasonable assurance that the System remains substantially equivalent for its intended use..."
  "It does not introduce any new harms or unacceptable risks..." |

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 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 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) is a femtosecond laser system intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, 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] Interface1). 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). In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys® Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.

The provided document is a 510(k) summary for the AMO Manufacturing USA, LLC's Catalys® Precision Laser System. This submission is for software revisions to an already cleared device (predicate device K172002). The core of the summary focuses on demonstrating substantial equivalence to the predicate device, especially considering the software changes.

Based on the provided text, we can extract the following information regarding acceptance criteria and study data:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the software changes. Instead, it outlines the scope of the software revisions and states that verification and validation testing was performed to ensure the software meets its intended use and introduces no adverse effects.

The "acceptance criteria" for this 510(k) are implicitly focused on demonstrating that the modified device's performance is maintained and that the software changes do not negatively impact its safety or effectiveness compared to the predicate. The performance aspects mentioned relate to maintaining the ability to deliver laser patterns for capsulotomy, phacofragmentation, and corneal incisions with corresponding accuracy and precision.

Here's how we can interpret and present the information given:

• Updates to hardware communication timing to reduce false positive alarms.
• Graphical user interface changes to support use of the Mobile Patient Bed in environments with multiple Catalys systems.
• A revision associated with trajectory timing offsets seen most evidently in the alignment verification function of the System.
  The modifications are stated to "employ additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
  | Continued ability to deliver various laser patterns (capsulotomy, phacofragmentation, corneal incisions) with accuracy and precision. | Bench testing of the predicate device (K172002) regarding the ability to deliver these patterns with accuracy and precision is directly applicable to the subject device because "there are no significant changes to the subject device other than the design changes resident in the software." The modified device reportedly "employs additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
  | System remains safe and effective for its intended use and is substantially equivalent to the predicate device. | Bench testing, coupled with software regression testing, verification, and validation, including regression testing, provides "reasonable assurance that the System remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device." The changes in software are stated not to "raise new questions of safety and efficacy." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing, software regression testing, verification, and validation testing. It does not mention a 'test set' in terms of patient data or clinical samples. The testing is hardware and software focused.

• Sample Size: Not applicable in the context of patient data. The "sample" would be the software builds and system configurations tested. No specific number of test cases or test runs is provided, only the types of testing.
• Data Provenance: Not applicable in the context of patient data. The testing appears to be internal engineering and software validation. No country of origin for data is stated as it's not a clinical study on patients.
• Retrospective/Prospective: Not applicable for this type of software/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The "ground truth" for this submission revolves around the correct functioning of the software and hardware according to design specifications, rather than expert interpretation of medical images or patient outcomes. The testing involves engineers and quality assurance personnel validating system performance against requirements.

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

Not applicable for this submission. Adjudication methods are typically employed in clinical studies involving multiple expert readers assessing medical data. This submission focuses on software and bench testing, where the "ground truth" is defined by the technical specifications and expected system behavior.

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 MRMC comparative effectiveness study was done or mentioned. This device is a laser system for cataract surgery, not an AI diagnostic or assistance tool for human readers of medical images. The submission pertains to software updates for the laser system's operational functionality.

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

The device is a physical laser system with integrated software. Its performance is inherently "standalone" in the sense that the laser performs the surgical actions. However, it's a human-operated device. The software changes are about the internal operation and control of the laser system, not an external algorithm processing data for human interpretation. The testing described is of the full device system.

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

The "ground truth" for the software revisions and the device's continued substantial equivalence is based on design specifications, pre-defined operational parameters, and expected system behavior for the laser's functions (capsulotomy, phacofragmentation, corneal incisions). This is primarily established through engineering validation, verification, and bench testing. There is no mention of expert clinical consensus, pathology, or outcomes data used as ground truth for these software changes. The original predicate device (K172002) would have had its own validation studies to support its initial clearance, but this submission specifically addresses the impact of software revisions.

8. The sample size for the training set

Not applicable. This submission is for software revisions to an existing medical device, not for an AI/machine learning algorithm that requires a "training set" of data. The software updates are described as modifying hardware communication timing, GUI, and trajectory timing offsets, which points to traditional software engineering rather than an AI model that learns from large datasets.

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

Not applicable, as there is no mention of a training set or AI/machine learning in this 510(k) summary.

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The OptiMedica® 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.

The Catalys Precision Laser System ("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).

This document describes a 510(k) premarket notification for the "Catalys Precision Laser System" (K172002). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K170322). The changes primarily involve an upgraded software version (cOS 5.0) and the addition of a Mobile Patient Bed.

Based on the provided text, the following information can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance metrics for an AI/algorithm-based device. Instead, it focuses on demonstrating that the updated "Catalys Precision Laser System" with cOS 5.0 and the Mobile Patient Bed continues to meet its intended design specifications and performs as intended.

The acceptance criteria are implicitly related to the device's ability to "deliver incisions as intended" and continue to provide the functions (anterior capsulotomy, phacofragmentation, corneal incisions) with appropriate accuracy and precision, as established during the clearance of the predicate device (K170322).

Reported Device Performance:

• "Bench testing demonstrated that subject device with cOS 5.0 continues to deliver incisions as intended."
• "Bench testing of the predicate device with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the software change and the use of the Mobile Patient Bed with the Catalys Precision Laser System."
• The system complies with laser classifications per 21 CFR 1040.10 and 1040.11, and Class 4 lasers per ANSI Z136.1-2007.
• Biocompatibility testing confirmed the Mobile Patient Bed upholstery meets ISO 10993-1 requirements.
• Electrical safety and EMC testing ensured compliance with electrical safety standards.

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

The document primarily describes bench testing and design validation. It does not mention clinical studies or test sets involving patient data (images, clinical records, etc.) in the context of an AI algorithm's performance on such data. The testing described is focused on the device's functional performance, hardware, and software.

• No specific sample size for a "test set" of patient data is provided, as the studies are not evaluating diagnostic or prognostic AI performance on patient data.
• The data provenance is from bench testing activities (e.g., software-specific bench testing, hardware-specific bench testing of the Mobile Patient Bed) rather than patient data. The country of origin of this testing is not explicitly stated, but the applicant (AMO Manufacturing USA, LLC) is based in Milpitas, CA, USA. The testing appears to be prospective in nature, conducted specifically for this submission.

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

As the studies described are bench tests of hardware and software functionality and safety, and not an evaluation of an AI algorithm on patient data, the concept of "ground truth" derived from experts' review of patient data is not applicable here. The "ground truth" for these tests would be the design specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of a test set involving human interpretation of data requiring adjudication.

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

No, an MRMC comparative effectiveness study is not mentioned. This submission is for a laser surgical system, not a diagnostic or decision-support AI intended to assist human readers in interpreting medical cases.

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

The device is a "Precision Laser System" that employs "femtosecond laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics." It has "system software" (cOS 5.0) that "recognizes ocular surfaces" and uses "a computerized scanning system" to direct the laser.

While the system has automated functions and software, the description does not position it as a standalone AI algorithm in the sense of a diagnostic or prognostic tool that processes data independently to produce an output for human review in a clinical decision-making pathway. It's an automated surgical device. The "standalone" performance described is the system's ability to fulfill its intended surgical actions (capsulotomy, phacofragmentation, corneal cuts) based on its programming, without direct human intervention in each laser pulse, but still under the supervision and operation of a surgeon.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by:

• Design specifications: The intended performance parameters and requirements of the device.
• Regulatory standards: Compliance with standards like 21 CFR 1040.10, 1040.11, ANSI Z136.1-2007, and ISO 10993-1.
• Predicate device performance: The previously cleared performance of the K170322 system serves as a baseline for "accuracy and precision" in delivering laser patterns.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The software (cOS 5.0) for this device is described as an "upgraded software version" to provide "compatibility" and ensure continued performance, rather than a learning algorithm trained on a dataset.

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

Not applicable, as a machine learning training set is not described. The "ground truth" for the software's functionality would be its adherence to engineering specifications and safe operation relative to the established performance of the predicate device.

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· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea

· In patients undergoing surgery or other trequiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments

· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

· In lamellar IEK and corneal harvesting

· 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 a lamellar cutresection of the cornea for lamellar IEK and for the creation of a penetrating cutincision for penetrating IEK

· In patients undergoing ophthalmic surgery or other treation of corneal channel for placement/ insertion of a corneal inlay device

The iFS Laser System is an ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use as follows:

• . In patients undergoing surgery or other 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
• . In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal
• In lamellar IEK and corneal harvesting
• 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 a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK
• In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channels for placement/insertion of a corneal inlay device

The iFS Laser System uses focused femtosecond laser pulses to create incisions and separate tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

Here's an analysis of the provided text regarding the iFS Laser System, focusing on acceptance criteria and supporting studies:

The provided documents describe the iFS Laser System and its clearance for creating corneal channels for corneal inlay devices. There is limited detailed information on specific acceptance criteria and a single, comprehensive study as might be found for a diagnostic AI device. Instead, the information points to a validation process that appears to be focused on demonstrating the new functionality and adherence to existing safety and performance standards for a surgical laser.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a surgical laser adding a new pattern), the "acceptance criteria" are implied through compliance with safety standards and a demonstrated ability to perform the new cut pattern effectively and precisely.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of "samples" in a clinical trial sense. The "test set" for the laboratory verification consisted of:
  • Glass microscope slides
  • Agarose gel
  • Porcine eyes
    The number of each material used is not specified.
• Data Provenance: The data is from laboratory verification bench studies. There is no mention of human clinical data or geographical provenance (e.g., country of origin) for these bench studies.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For the safety and electrical performance, compliance with standards would typically involve certified testing labs and engineers.
  • For the software validation, software engineers and quality assurance professionals would be involved.
  • For the new cut pattern performance, the text doesn't mention expert assessment of the "cut quality" in a formal ground-truthing process. It refers to "acceptable performance," implying a comparison against established standards or benchmarks, potentially assessed by the manufacturer's R&D personnel or quality control.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. These were bench studies, not a clinical study involving human assessment that would typically require adjudication. The performance was assessed against predefined metrics (channel widths, depths, and cut quality) and compliance with standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is measured. The iFS Laser System is a surgical instrument.

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

• Yes, in essence, standalone performance was evaluated. The "algorithm" (the laser's software-controlled cutting pattern) was tested independently on non-human biological and artificial substrates (glass, agarose gel, porcine eyes) to demonstrate its ability to create the specified corneal channels with acceptable widths, depths, and cut quality. The performance of the laser system itself was verified without direct human-in-the-loop interaction for the cutting process once the pattern was initiated.

7. The Type of Ground Truth Used

• The "ground truth" for the new cut pattern was predefined physical metrics and expectations of performance (e.g., specific channel widths and depths, and acceptable cut quality) derived from existing, cleared resection patterns and the requirements for corneal inlay device placement. This is a form of physical/benchmarking ground truth.
• For the safety and electrical performance, the ground truth was compliance with established international standards (IEC 60601 series).
• For software, the ground truth was fulfillment of functional and safety-critical requirements outlined in FDA guidance.

8. The Sample Size for the Training Set

• The iFS Laser System is a physical surgical device with software control. It is not an AI/machine learning model in the typical sense that would require a "training set" for model development. The software updates were to include a new pre-programmed pattern and associated GUI functionality, which would not involve a "training set" in the context of machine learning.

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

• As there is no mention of a machine learning component requiring a "training set," this question is not applicable in the context of the provided document. The ground truth for the development of the new cutting pattern would have been the engineering specifications and clinical requirements for creating an appropriate channel for corneal inlays, but this is distinct from an AI training set.

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