Search Results

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).

The provided document, a 510(k) summary for the Catalys Precision Laser System, focuses on demonstrating substantial equivalence to a predicate device (K141079) due to a software upgrade (cOS 3.90). It explicitly states that "there are no significant changes to the subject device other than the design changes resident in the software." As such, the document refers back to the testing performed for the predicate device to justify safety and effectiveness.

Because of this, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning the clinical performance of the device's therapeutic functions. Instead, it refers to prior submissions.

Here's an analysis of what is available and what is missing based on your request:

Information Present in the Document (or deducible):

• Device: Catalys Precision Laser System
• Purpose of current submission: Software upgrade (cOS 3.90) providing additional surveillance of vacuum pressure and LOI suction during docking, and video monitoring for fluid loss during treatment.
• Study type mentioned: "Software specific bench testing of the Catalys System was conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes." This is a purely standalone test of the software's functionality, not related to clinical outcomes or human performance.
• General assertion: "The bench, animal and clinical performance testing provided in K141079, when coupled with the software verification and validation testing presented for the subject device, provides reasonable assurance that the System is safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device." This indicates that detailed performance data would be in K141079.
• Ground Truth for software testing: For the software-specific bench testing, the "intended design specifications related to the software design changes" serve as the ground truth. This would involve comparing the software's output (e.g., reported vacuum pressure, fluid loss detection) against pre-defined correct operational parameters.
• Sample size for software testing: Not specified.
• Data provenance for software testing: Not specified, but generally, bench testing data would be internal development data.
• Training set: Not applicable for this type of software-specific bench testing as described. This is a validation of new software features, not a model requiring a training dataset.

Information NOT Present in the Document:

1. Table of acceptance criteria and reported device performance (for clinical outcomes): Not provided. The document references prior submissions for clinical performance.
2. Sample size used for the test set and data provenance (for clinical outcomes): Not provided; referenced in K141079.
3. Number of experts and their qualifications (for clinical outcomes ground truth): Not provided; referenced in K141079.
4. Adjudication method (for clinical outcomes): Not provided; referenced in K141079.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned for this submission. The device is a surgical laser system, not an AI diagnostic tool that assists human readers.
6. Standalone (algorithm only) performance (for clinical outcomes): While software bench testing was performed, clinical standalone performance data is not explicitly detailed in this document; referenced in K141079.
7. Type of ground truth used (for clinical outcomes): Not provided; referenced in K141079.
8. Sample size for the training set (if applicable for AI/ML): Not applicable for the described software update. This is a rule-based software design change, not an AI/ML system that would require a 'training set'.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document describes a 510(k) submission for a software upgrade (cOS 3.90) to an existing device, the Catalys Precision Laser System. The primary study described in this specific document is "Software specific bench testing" to verify the new software's ability to meet its intended design specifications related to vacuum pressure monitoring and fluid loss detection. This is a standalone test of the new software features.

For clinical efficacy and safety, the document explicitly states that the "bench, animal and clinical performance testing provided in K141079" (the predicate device's submission) is directly applicable due to "no significant changes to the subject device other than the design changes resident in the software." Therefore, details regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for clinical outcomes would need to be sought in the K141079 submission, not in the provided text.

Ask a specific question about this device

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.

OptiMedica's Catalys® Precision Laser System ("Catalys®System") is a Class II ophthalmic surgical laser system as defined by regulation number 21 CFR 886.4390. The Catalys® System is indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect 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] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. 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 as well as to ISO 15004-2:2007.

The provided text describes a 510(k) premarket notification for the Catalys® Precision Laser System. This device is an ophthalmic laser system intended for use in cataract surgery. However, the document does not contain information regarding an AI/ML-based device or a study involving human readers and AI assistance for diagnostic image interpretation. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI/ML device meets these criteria based on the provided text.

The "study" described in the document pertains to the performance and safety of the laser system itself for surgical procedures, not an AI/ML diagnostic aid. It refers to:

• Bench testing: Demonstrated the system's ability to deliver corneal incision patterns with accuracy and precision (±75um relative to intended cut dimensions).
• Animal testing: Demonstrated corneal safety by comparing laser-created incisions to standard manual surgical incisions histologically.
• Cadaver eye testing: Qualitatively demonstrated the laser's ability to effectively cut various tissue types using bracketed laser parameters.

To directly answer your request based only on the provided text, I must state that the information requested about acceptance criteria and a study to prove an AI/ML device meets those criteria is not present.

If you have a different document that describes an AI/ML device and its validation, please provide it.

Ask a specific question about this device

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 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] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OptiMedica Catalys Precision Laser System:

Acceptance Criteria and Device Performance Study for OptiMedica Catalys™ Precision Laser System

This document describes the bench and animal performance testing conducted to demonstrate the substantial equivalence of the OptiMedica Catalys™ Precision Laser System.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Bench Testing: "Multiple samples for a given test pattern were created in a test substrate." The exact number is not specified.
• Animal Testing: The exact number of animals or incisions is not specified.
• Cadaver Eye Testing: The exact number of cadaver eyes or incisions is not specified.
• Data Provenance: The studies appear to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but it's presumed to be the United States, given the FDA submission context.

3. Number of Experts and Qualifications for Ground Truth

• Bench Testing: The ground truth was established by "cross-sectioning and measured using a NIST-traceable reticule, under magnified digital image analysis." This implies technical experts performing measurements, but no specific number or qualifications are provided beyond the NIST traceability.
• Animal Testing: The comparison was against "standard manual surgical incisions histology." This implies veterinary pathologists or similar experts would have evaluated the histology, but no details on their number or qualifications are provided.
• Cadaver Eye Testing: The ground truth was based on "qualitative acceptance criteria." This would likely involve expert assessment of the incision quality, but no details on the number or qualifications of these experts are provided.

4. Adjudication Method for the Test Set

The reported studies do not describe a specific adjudication method like 2+1 or 3+1. The ground truth appears to be derived directly from measurements (bench testing) or comparative histological/qualitative assessments (animal and cadaver testing), implying single expert or consensual assessment rather than a multi-reader adjudication process with conflict resolution.

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

No information suggesting a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done is present in the provided text. The studies focus on the device's technical performance and safety, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device, the OptiMedica Catalys Precision Laser System, is an ophthalmic surgical laser system. Its "performance" refers to the accuracy, precision, and safety of the laser actions (capsulotomy, phacofragmentation, corneal incisions) it performs directly, not an AI algorithm that provides diagnostic or assistive outputs for a human. Therefore, a standalone algorithm performance study in the typical sense (e.g., for an imaging AI) is not applicable. The device itself is the "standalone" entity whose performance is being evaluated.

7. Type of Ground Truth Used

• Bench Testing: Metrology (NIST-traceable reticule measurements of physical cuts).
• Animal Testing: Histopathology (comparison of laser-created incisions to manual incisions).
• Cadaver Eye Testing: Qualitative expert assessment of incision effectiveness.

8. Sample Size for the Training Set

The document describes performance testing, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The system presumably relies on pre-programmed parameters and control algorithms rather than a learned model from a training set.

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

As stated above, this document does not describe a machine learning model, and thus, no training set or ground truth establishment method for a training set is applicable or provided.

Ask a specific question about this device

The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

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 phacofragmentation, thus facilitating efficient lens removal. 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 coregistered and provide for precise overlap between imaging and treatment beams. 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.

Here's a summary 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

• ±40μm for all thicknesses and diameters
• ±1% for all surface radii |
  | Laser Pattern Accuracy/Precision | Intended Cut Dimensions: ±100μm | All measured values met:
• ±100μm relative to the intended cut dimensions. (Validated for a variety of capsulotomy and phacofragmentation patterns within specified limits.) |
  | Capsulotomy Effectiveness | (Implied non-inferiority to CCC control) | Difference from Intended Diameter (Catalys™ System):
• Mean: 29 µm
• Standard Deviation: 26 µm
• Minimum: 1 µm
• Maximum: 132 µm
  Difference from Intended Diameter (Control - CCC):
• Mean: 339 µm
• Standard Deviation: 248 µm
• Minimum: 23 µm
• Maximum: 1013 µm
  Conclusion: Catalys™ System demonstrated significantly higher precision in capsulotomy diameter compared to the manual CCC control. |
  | Laser Phacofragmentation (CDE) | (Implied non-inferiority to traditional phacoemulsification) | Cumulative Dissipated Energy (CDE) Values:
• Catalys™ System: Mean 10.39, StDev 6.61, Min 0.91, Max 27.65
• Control: Mean 18.54, StDev 12.07, Min 5.23, Max 47.86
  Conclusion: Catalys™ System showed a lower mean CDE, indicating less ultrasound energy used, which is generally considered beneficial. |
  | Safety | (Implied comparable to control and mild/transitory device-related complications) | Non-device-related complications and adverse events: Comparable between the two cohorts.
  Device-related complications: Limited to petechiae (72%) and subconjunctival hemorrhage (5%). All were mild and transitory, resolving in less than 30 days without intervention. |

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

• OCT Subsystem Bench Testing: "Various test article substrates of known dimensions were measured multiple times." (Specific number of samples not provided)
• Laser Pattern Bench Testing: "Multiple samples for a given test pattern were created..." (Specific number of samples not provided)
• Clinical Study (Capsulotomy & Phacofragmentation): The study was a "prospective, randomized non-inferiority trial in which one eye was randomly assigned to receive treatment with the Catalys™ System, including capsulotomy and laser phacofragmentation, followed by standard ultrasound phacoemulsification as necessary. The subject's contralateral eye, serving as the study Control eye, was assigned treatment with the current 'gold standard' surgical technique of continuous curvilinear capsulorrhexis (CCC) and standard ultrasound phacoemulsification." The specific number of subjects/eyes is not provided, but it states "all subjects treated with the Catalys™ System" and "all subjects" for phacofragmentation.
• Data Provenance: The provenance is a prospective clinical study. The country of origin is not specified.

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

• The document does not mention the use of experts to establish ground truth for the bench or clinical test sets.
• For bench testing, NIST-traceable reticules and known dimensions were used for ground truth.
• For the clinical study, the "gold standard" surgical technique (CCC) in the contralateral eye served as a comparison point for capsulotomy effectiveness, and CDE values were objectively measured. Safety outcomes (complications/adverse events) were observed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method involving experts for any of the test sets. For the bench testing, measurements were performed directly. For the clinical study, outcomes (capsulotomy diameter, CDE, adverse events) were reported as measured.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical study compares device performance against a "gold standard" surgical technique, not against human readers' performance with and without AI assistance.

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

• Yes, the performance of the Catalys™ System for OCT measurements, laser pattern accuracy, capsulotomy, and phacofragmentation effectiveness, as well as safety, is presented as a standalone assessment of the device's capabilities. Human intervention still occurs in the overall surgical procedure, but the reported metrics specifically evaluate the device's physical outputs and their direct clinical outcomes compared to a control, without evaluating a human-in-the-loop diagnostic accuracy task.

7. The Type of Ground Truth Used

• OCT Subsystem Bench Testing: Known dimensions of test article substrates.
• Laser Pattern Bench Testing: NIST-traceable reticule under magnified digital image analysis of cross-sectioned samples from the laser patterns.
• Clinical Study (Capsulotomy): The actual diameter of the capsulotomy (measured) compared to the intended diameter, and compared to the diameter of the continuous curvilinear capsulorrhexis (CCC) performed as the "gold standard" in the control group.
• Clinical Study (Phacofragmentation): Cumulative Dissipated Energy (CDE) values reported at the conclusion of cataract surgery.
• Clinical Study (Safety): Tallying of subject complications and adverse events.

8. The Sample Size for the Training Set

• The document does not specify a training set sample size. The device is a physical laser system with integrated OCT, not an AI/ML algorithm that typically has a distinct "training set" in the traditional sense for diagnostic image analysis. While there would have been internal development and calibration data, it is not described here as a "training set" for an AI model.

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

• As a training set is not explicitly mentioned or applicable in the traditional AI/ML sense for this device, a method for establishing its ground truth is not provided. The "training" for such a system would involve engineering design, calibration, and verification against known physical standards.

Ask a specific question about this device

The PASCAL Streamline Photocoagulator indications for use are the following: Intended for use in the treatment of ocular pathology in the posterior segment. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy - macular edema - choroidal neovascularization - branch and central retinal vein occlusion - age-related macular degeneration - lattice degeneration - retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: - iridotomy - trabeculoplasty

The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

The PASCAL® Streamline™ Photocoagulator is designed for treating ocular pathology in both the posterior and anterior segments of the eye. Its indications for use include retinal photocoagulation, panretinal photocoagulation, focal photocoagulation, and grid photocoagulation for various vascular and structural abnormalities of the retina and choroid, such as proliferative and nonproliferative diabetic retinopathy, macular edema, choroidal neovascularization, branch and central retinal vein occlusion, age-related macular degeneration, lattice degeneration, and retinal tears and detachments. Additionally, it is indicated for use in the anterior segment for iridotomy and trabeculoplasty.

The document provided (K100019) is a 510(k) summary for the PASCAL® Streamline™ Photocoagulator, submitted by OptiMedica Corporation. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the PASCAL Streamline Photocoagulator (K092621), and not to conduct a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, the provided text does not contain information regarding
acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, standalone performance studies, types of ground truth, or details about the training set used in the development of the device.

Instead, the document focuses on demonstrating substantial equivalence based on function, intended use, and technological characteristics without raising new issues of safety or efficacy compared to the predicate device.

The document states:

• "All necessary bench testing was conducted on the modified PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device."

This indicates that internal bench testing was performed to justify the claim of substantial equivalence, but the specifics of these tests, including acceptance criteria and how they directly quantify "device performance" in the context of clinical outcomes or diagnostic accuracy, are not detailed.

Consequently, I cannot fill out the requested table or provide specific answers to questions 1-9 based on the provided text. The information needed to address those points, such as clinical study results, performance metrics like sensitivity/specificity, or details about AI algorithms and their validation studies, is not present in this 510(k) summary. This document is a regulatory submission for market clearance, not a report on a clinical trial or performance study against specific acceptance criteria.

Ask a specific question about this device

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• proliferative and nonproliferative diabetic retinopathy .
• macular edema .
• choroidal neovascularization .
• branch and central retinal vein occlusion .
• age-related macular degeneration .
• . lattice degeneration
• retinal tears and detachments .
• iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

The PASCAL Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

The proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) premarket notification for the PASCAL Photocoagulator, seeking substantial equivalence to a predicate device.

The relevant sections indicate:

• Intended Use and Product Description: The device is intended for use in the treatment of ocular pathology.
• Substantial Equivalence: The manufacturer asserts that the proposed PASCAL Photocoagulator is substantially equivalent to a predicate device (K043486) in terms of function, intended use, and physical characteristics.
• Testing in Support of Substantial Equivalence Determination: "All necessary bench testing was conducted on the proposed PASCAL Photocoagulator to support a determination of substantial equivalence to the predicate device."

This documentation focuses on establishing equivalence rather than demonstrating performance against specific clinical acceptance criteria through a dedicated study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, adjudication, or MRMC/standalone studies is not provided in the given text.

Ask a specific question about this device

The PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation.

When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• Proliferative and nonproliferative diabetic retinopathy
• Macular edema
• Choroidal neovascularization
• Branch and central retinal vein occlusion
• Age-related macular degeneration
• Lattice degeneration
• Retinal tears and detachments
• Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

The PASCAL Synthesis Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology of the PASCAL multi-spot photocoagulator (a predicate device) with other commercially available laser platforms. This offers existing commercially available laser platforms the ability to deliver a full spectrum of pattern scanning options. The PASCAL Synthesis Delivery System is intended for use by trained ophthalmologists for diagnosis and treatment of ocular pathology.

The PASCAL Synthesis Delivery System consists of the following system components:

• 1. Scanning laser delivery system integrated into an Optimedica slit lamp with LCD/Touchscreen GUI that can be positioned by the user for optimal access and viewing.
• 2. Scanner control module with scanner controls, power supply, electronics, optical fiber & electrical connections integrated into a slit lamp table.

The PASCAL Synthesis Delivery System is compatible with the following commercially available laser systems:

• Alcon Ophthalas 532 Eyelite Laser Photocoagulator
• Zeiss Visulas 532s

The provided text describes a medical device, the PASCAL Synthesis™ Delivery System, and its clearance process through a 510(k) submission. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy against specific acceptance criteria in the way a new drug or novel medical device might through a large-scale clinical trial.

Therefore, the study design and acceptance criteria outlined in the input request are not directly applicable to this type of regulatory submission. There isn't a traditional "study" in the sense of a clinical trial with human subjects, a defined test set with ground truth established by experts, or MRMC comparative effectiveness.

However, I can extract information related to performance verification and equivalence that serve a similar purpose within the context of a 510(k) submission.

Here's an interpretation based on the provided text:

Description of Acceptance Criteria and Device Performance:

The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices in terms of intended use and technological characteristics, and that its performance is equivalent to its predicate.

This is verified by demonstrating that the PASCAL Synthesis Delivery System performs functionally identically to the PASCAL Photocoagulator (its predicate device that incorporates the same delivery system) and that it allows for multi-spot photocoagulation similar to another predicate device (Infinitech Multi-Spot Slit Lamp Laser Adapter) when connected to compatible laser systems.

1. Table of "Acceptance Criteria" (Substantial Equivalence Metrics) and Reported Device Performance:

Detailed Information on the "Study" (Performance Verification Testing):

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or medical images, but rather involves testing the physical device's performance parameters. The testing involved connecting the PASCAL Synthesis Delivery System to two compatible commercially available laser systems: the Zeiss Visulas 532s and the Alcon Ophthalas 532 Eyelite Laser Photocoagulator.
• Data Provenance: The testing was performed at OptiMedica's facility in Santa Clara, CA, and at outside test facilities as required. This indicates prospective, in-house technical testing rather than retrospective patient data analysis.
• Nature of the "Test Set": The "test set" here refers to the device's operational parameters and functionalities (e.g., power delivered, pulse widths, scan patterns, spot size, beam uniformity) as measured under various conditions when integrated with the two specified laser systems.

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

• This type of expert-driven ground truth establishment is not applicable to a 510(k) performance verification. The "ground truth" for the device's technical specifications and performance metrics would be based on engineering specifications, industry standards, and the known performance of the predicate device. The "experts" would be the engineers and technicians conducting the verification tests, qualified in device design, testing, and metrology.

4. Adjudication Method for the Test Set:

• Not applicable in the context of this technical performance verification. Adjudication methods (like 2+1 or 3+1) are typically used for clinical endpoints or image interpretation where human judgment is being consolidated. Device performance parameters are measured objectively.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for substantial equivalence of a delivery system which enables a laser, not a diagnostic AI device or a decision support system for human readers. The focus is on the technical performance of the laser delivery.

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

• Yes, a form of standalone performance was assessed, though it's not an "algorithm" in the typical AI sense. The PASCAL Synthesis Delivery System itself (the "algorithm") was rigorously tested for its technical performance parameters (power, pulse widths, scan patterns, spot size, beam uniformity) "standalone" in the sense that its intrinsic, objective output was measured. The phrase "algorithm only" isn't quite fitting, as it's a hardware delivery system, but its performance was evaluated independent of clinical outcomes, focusing solely on its output capabilities.

7. Type of Ground Truth Used:

• The "ground truth" was based on defined engineering specifications, compliance with performance requirements, and objective measurements of physical parameters (e.g., laser power, spot size, pulse duration, pattern accuracy). The ultimate "ground truth" for substantial equivalence was the established performance and indications of the predicate device (OptiMedica PASCAL Photocoagulator).

8. Sample Size for the Training Set:

• Not applicable. This is a hardware device where "training" refers to engineering design and optimization processes, not a dataset used to train a machine learning model.

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

• Not applicable as explained above. The design and development of the PASCAL Synthesis Delivery System would have been guided by engineering principles, optical physics, safety standards, and lessons learned from previous iterations and existing devices (including the predicate).

Ask a specific question about this device

The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:

• . Diabetic retinopathy (panretinal photocoagulation)
• . Macular degeneration
• Peripheral neovascularization .
• ◆ Retinal breaks
• Retinal detachments
• . Retinal tears
• Lattice degeneration
• Pneumatic retinopexy reattachment procedures .
• . Segmental peripheral photocoagulation
• . Segmental photocoagulation
• . Cloudy vitreous cavities
• Pediatric retinal repairs (under general anesthesia) .
• . Delivery of laser energy through small pupils or to eyes with focal lens opacities

The OptiMedica Laser Indirect Ophthalmoscope (LIO) is intended for use in the diagnosis and treatment of ocular pathology. The LIO illuminates and magnifies the fundus image. When connected to the Pascal Retinal Photocoagulator, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.

Here's an analysis of the provided text regarding the OptiMedica Laser Indirect Ophthalmoscope (LIO) acceptance criteria and supporting study:

The provided document is a 510(k) summary for the OptiMedica Laser Indirect Ophthalmoscope (LIO). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily aimed at proving this equivalence, particularly in terms of technical characteristics and optical performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the technical specifications of the predicate devices. The reported device performance is compared against these predicate specifications.

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

The primary "test set" for this 510(k) submission appears to be a comparison of the OptiMedica LIO's physical and optical characteristics against those of predicate devices.

• Sample Size: The document does not refer to sample sizes in the traditional sense of patient data. Instead, it refers to a comparative analysis of the physical and optical properties of the OptiMedica LIO against a selection of predicate devices (Zeiss LIO, Lumenis Novus 3000, Lumenis Novus VARIA, Coherent Novus Verdi systems). The "sample" here would be the physical devices themselves.
• Data Provenance: The data is generated through performance testing of the OptiMedica LIO in a laboratory setting, specifically characterizing its optical performance. This is prospective data generation for the comparison. The specifications for the predicate devices would come from their own regulatory submissions or product specifications, which are retrospective for the purpose of this comparison. The country of origin for the data (testing lab) is not specified, but the applicant (OptiMedica Corporation) is based in the USA.

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

• Number of Experts: Not applicable in the traditional sense. The "ground truth" for this submission is based on the technical specifications and established performance of the predicate devices, which were themselves cleared by regulatory bodies (e.g., FDA) based on their own submissions. These specifications are taken as the benchmark.
• Qualifications of Experts: No external experts were used to establish "ground truth" for the test set of device characteristics. The "expertise" lies within the engineering and scientific teams that designed and tested the OptiMedica LIO, ensuring its compliance with the established technical parameters. The FDA's review process itself involves expert assessment of the submitted data.

4. Adjudication Method for the Test Set

Not applicable. There's no human adjudication process described for comparing the technical specifications. The comparison is objective, based on measured physical and optical parameters.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This submission is a 510(k), which focuses on substantial equivalence based on technical and performance characteristics, not on a direct comparison of diagnostic or treatment efficacy in a clinical setting with human readers. The document states: "Performance testing has been conducted with the OptiMedica LIO to establish the optical similarity of the OptiMedica LIO with respect to a predicate device, the Zeiss LIO, as a means to assess the relative clinical performance of the devices." This indicates a technical comparison, not a human reader study.

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

This is not applicable as the device is a laser indirect ophthalmoscope, a piece of hardware used by a human clinician for diagnosis and treatment. It is not an algorithm or an AI-powered system that would have a "standalone" mode in the context of image analysis or diagnostic predictions.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established technical specifications and validated performance characteristics of the predicate devices. The OptiMedica LIO aimed to demonstrate that its technical and optical performance aligns closely with these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument (hardware), not a machine learning algorithm. Therefore, there is no "training set" in the computational or AI sense.

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

Not applicable. As there is no training set mentioned or implied for an AI/ML algorithm, this question is not relevant to the described device.

Ask a specific question about this device