Search Results

The Navilas Laser System 577s is indicated for use:

• In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser). Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
• For the imaging (capture, display, storage and manipulation) of the retina of the eve, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
• In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

The Navilas Laser 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas 577s Laser System combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.

The Navilas Laser 577s is comprised of:

• A semiconductor laser source that operates at 577nm. The semiconductor laser . source for the Navilas 577s is identical to the laser source used with the Navilas 577+ cleared under K141851.
• An integrated delivery system that directs the laser beam through an ● ophthalmoscope using motorized mirrors.
• A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
• A software platform intended to be used to capture display, store and manipulate . images captured by the fundus camera.

The Navilas Laser System 577s supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:
Digital imaging as provided by a color image with white light, supporting mydratic and non-mydratic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored or discarded after viewing on the touch sensitive digital display.
Image Storage - Captured images can be digitally stored in the Navilas Laser System 577s database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.
Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.
Laser Treatment - Treatment options are also unchanged from the predicate device with Single Pulse Mode. Repeat Mode and Scanned Pattern Mode available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.
Report generation - Information collected in the database includes images obtained before, during and after treatment. This information may be used for the generation of patient reports for documentation purposes.

The provided text describes a 510(k) premarket notification for the "Navilas® Laser System 577s." This document primarily focuses on demonstrating substantial equivalence to a predicate device (Navilas Laser System 577+), rather than presenting a detailed independent study with specific acceptance criteria and performance data for a new AI/algorithm-driven device.

Therefore, many of the requested elements (e.g., acceptance criteria for a new clinical study, sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set details) are not present in this document because it is a submission for a device change that is functionally identical to the predicate with some hardware improvements and elimination of a feature. The "Performance Data" section discusses engineering and software testing, not clinical performance against specific metrics for diagnostic accuracy or efficacy.

However, I can extract and present the information that is available:

Summary of Device and Context:

• Device Name: Navilas® Laser System 577s
• Device Type: Laser photocoagulator with an integrated digital fundus camera.
• Purpose of Submission: 510(k) premarket notification to demonstrate substantial equivalence to the Navilas Laser System 577+ (K141851).
• Key Differences from Predicate: Elimination of fluorescein angiography imaging capability; hardware design improvements (new GUI, relocation of scanner controls, conversion to manual base height adjustment, designation of table as optional accessory, inclusion of combination objective element). The core laser and imaging technology are stated as the same.
• Indications for Use: (Identical to predicate, except for the removed angiography feature)
  • Retinal Photocoagulation for various conditions (Diabetic Macular Edema, Proliferative Diabetic Retinopathy, Sub-retinal Neovascularization, Retinal Vein Occlusion, Lattice Degeneration, Retinal Tears and Detachments).
  • Imaging (capture, display, storage, manipulation) of the retina (color, infrared) for aiding diagnosis and treatment of ocular pathology in the posterior segment.
  • Laser Trabeculoplasty for Primary Open Angle Glaucoma, and Iridotomy/Iridoplasty for Closed Angle Glaucoma.

Regarding the Requested Information:

Since this document describes a 510(k) submission for substantial equivalence based on functional identity and engineering testing rather than a new clinical performance study for an AI/algorithm, most of the specific questions about acceptance criteria for clinical performance, ground truth, expert consensus, and reader studies are not applicable or not detailed in this document.

Here's what can be inferred or directly stated from the provided text, with a clear note when information is absent:

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

   • Acceptance Criteria: For substantial equivalence, the primary acceptance criterion is that the new device (Navilas 577s) is as safe and effective as the predicate device (Navilas 577+). This is demonstrated through engineering and software verification and validation, showing that the minor changes do not negatively impact performance or safety. No specific quantitative clinical performance acceptance criteria (e.g., accuracy thresholds) are listed, as this isn't a de novo clinical study establishing such criteria. Instead, it's about meeting specifications and requirements.
   • Reported Device Performance: The document states: "All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the Navilas Laser 577s meets all performance specifications and requirements." This is a qualitative statement of success in the engineering and software tests.

   Criterion Type	Description / Test Performed	Reported Performance / Outcome
   Substantial Equivalence	Device maintains functional identity to predicate (Navilas 577+) with minor changes (no fluorescein angiography, hardware updates).	Determined to be substantially equivalent by FDA.
   Illumination Safety	ISO 15004-2 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection	Criteria met.
   Software Life Cycle Process	IEC 62304 Medical Device Software Software Life Cycle Process (Software LOC "Major")	Criteria met. (Implies adherence to process adequate for software with potential for serious injury/death)
   Human Factors & Usability	IEC 62366 (Usability Engineering), IEC 60601-1-6 (General requirements for basic safety and essential performance - Usability)	Criteria met.
   Laser Product Safety	IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (Therapeutic Laser Equipment), IEC 60825-1 (Laser classification)	Criteria met.
   Laser Bench Testing	Verify spot and pattern placement accuracy.	Criteria met.
   Software Verification & Validation	General V&V for the "Major" LOC software.	Criteria met.

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

   • Not Applicable / Not Provided: This document describes engineering and software testing ("bench testing") rather than a clinical study with a patient "test set". There is no mention of patient data (images or otherwise) used for testing in this summary.

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)

   • Not Applicable / Not Provided: No clinical test set or ground truth establishment by experts is described in this submission summary.

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

   • Not Applicable / Not Provided: No clinical test set or adjudication method is described.

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: This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is a laser system with imaging capability, not an AI diagnostic assistant.

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

   • Not Applicable: While the device has an imaging and software component ("aiding in the diagnosis"), the focus of this submission is on the laser safety, performance, and the integrated system's function, not a standalone diagnostic algorithm. No such standalone performance study is mentioned.

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

   • Not Applicable / Not Provided: For the engineering and software tests, "ground truth" would likely refer to established engineering specifications and requirements (e.g., laser power, spot size accuracy, software functionality conforming to design), rather than clinical ground truth like pathology or expert consensus on disease states.

8. The sample size for the training set

   • Not Applicable / Not Provided: This is not a submission for a machine learning or AI device that typically requires a distinctive "training set" for an algorithm. The software is described as a platform for image capture, display, storage, and manipulation, and planning tools, not a learning algorithm.

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

   • Not Applicable / Not Provided: As noted above, training sets and their associated ground truth methodology are not discussed in this substantial equivalence submission.

Ask a specific question about this device

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:

· In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).

· For the imaging (capture, display, storage and manipulation) of the eve, including via color. fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.

· In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods, providing the doctor with a system for image capture, display, storage and manipulation for treatment planning and documentation.

The primary components of the Navilas Laser System include:

• . One of three optional ophthalmic laser sources:

  • a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
  • an optically-pumped semiconductor laser source that also operates at the same -532nm, or
  • an optically-pumped semiconductor laser source that operates at 577nm -

• An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,

• A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).

Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).

The provided text is a 510(k) summary for the Navilas Laser System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than detailing a specific clinical study with acceptance criteria for device performance in terms of diagnostic or therapeutic accuracy.

Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt, particularly regarding a study that proves the device meets specific performance metrics for an AI/algorithm-driven application.

The sections that would contain such information (4.8 SUMMARY OF PERFORMANCE TEST RESULTS and 4.9 CONCLUSIONS) are very general. They state that "Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the Navilas Laser System" and "All criteria for this testing were met and results demonstrate that the Navilas Laser System meets all performance specifications and requirements." However, they do not provide the specific acceptance criteria or the study details (sample size, ground truth, expert qualifications, etc.) for any performance evaluation in the context of an AI-driven component.

To directly answer your prompt based only on the provided text, the information requested is largely absent.

Here's a breakdown of what is and isn't available based on your requested structure:

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

• Not available in the provided text. The document states that performance testing was completed and criteria were met, but it does not list the specific acceptance criteria or the quantitative results of the device's performance against those criteria.

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

• Not available in the provided text. There is no mention of a test set sample size or data provenance for any performance evaluation.

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)

• Not available in the provided text. The document does not describe the establishment of ground truth by experts, as it does not detail a study involving such a process.

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

• Not available in the provided text. No adjudication method is described.

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 available in the provided text. The document does not describe an MRMC study or the use of AI assistance for human readers. The Navilas Laser System, as described, is a surgical laser system with imaging, planning, and documentation capabilities, not an AI diagnostic assistant.

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

• Not available in the provided text. No standalone algorithm performance study is described.

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

• Not available in the provided text. As no study requiring ground truth is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

• Not available in the provided text. There is no mention of a training set, indicating that this submission is not about an AI/ML algorithm requiring such data.

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

• Not available in the provided text. As no training set is mentioned, the method for establishing its ground truth is not provided.

Conclusion: The provided 510(k) summary (K141851) for the Navilas Laser System is focused on establishing substantial equivalence based on indications for use, technological characteristics, and compliance with general safety and performance standards (like IEC and ISO). It does not present data from a clinical or performance study that would typically include acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested for an AI/algorithm-based device.

Ask a specific question about this device

The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.

The NAVILAS Laser System is a retinal laser photocoagulator with an integrated digital fundus camera. The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.

The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.

Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.

The provided 510(k) summary for the NAVILAS Laser System primarily focuses on demonstrating substantial equivalence to predicate devices and verifying that the device complies with specifications through internal testing. It does not present a clinical study with detailed acceptance criteria and reported device performance metrics typically found in AI/ML device submissions.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this device, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the document.

The document discusses "Performance Data" in a general sense:

Performance Data Summary (as per the document):
"Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements."

This statement indicates that internal engineering and bench testing was performed to ensure the device met its design specifications, but it does not detail specific acceptance criteria for a human-interpretable performance metric (like sensitivity, specificity, accuracy) derived from a clinical trial or expert review.

Here's what can be extracted based on the provided text, with many fields noted as "Not Applicable" or "Not Provided" due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not provided. The testing described appears to be internal engineering and bench testing, not a clinical study with a patient test set.
• Data Provenance: Not provided.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable/Not provided. The submission focuses on device engineering specifications and functionality, not diagnostic accuracy requiring expert ground truth in a clinical context.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for Test Set:

• Adjudication Method: Not applicable/Not provided.

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

• Was an MRMC study done? No.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable. (The NAVILAS Laser System is a photocoagulator and imaging system, not an AI-diagnostic assistant that would typically be evaluated in an MRMC study for reader improvement.)

6. Standalone (Algorithm Only) Performance Study:

• Was a standalone study done? Not in the sense of an algorithm's diagnostic performance. The document describes "software and hardware verification & validation testing, along with system level bench testing," which functions as a standalone performance evaluation of the device's operational specifications, but not its diagnostic or clinical efficacy in terms of specific performance metrics against a clinical ground truth.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable for a clinical performance evaluation. The "ground truth" for the verification and validation testing would be the engineering specifications and functional requirements of the device itself (e.g., laser power output accuracy, image resolution, software functionality).

8. Sample Size for Training Set:

• Sample Size: Not applicable/Not provided. This device is not described as involving machine learning or AI that would require a 'training set' in the modern sense.

9. How Ground Truth for Training Set was Established:

• How Ground Truth was Established: Not applicable/Not provided.

Ask a specific question about this device