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BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.

The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries.

Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes.

BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.

The provided FDA 510(k) summary (K240215) describes the Carl Zeiss Meditec AG BLUE 400 and BLUE 400 S accessories to surgical microscopes for fluorescent visualization of grade III and IV gliomas.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (BLUE 400, K211346) through technical and performance testing, rather than defining explicit clinical acceptance criteria in terms of sensitivity, specificity, or other diagnostic measures for identifying gliomas. The acceptance criteria used are in the form of "Passed" results for various technical and functional tests.

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

The document describes non-clinical performance testing (bench testing) using "ZEISS fluorescence target," "spatial test target," "photometric resolution test target," "test target with a circle," "white sheet of paper," and "ZEISS BLUE 400 test phantom."

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for bench validation of optical and system parameters. These are physical components being tested, not patient samples.
• Data Provenance: The tests are described as bench/non-clinical system testing. This indicates the data was generated in a lab setting by the manufacturer (Carl Zeiss Meditec AG, Germany, based on manufacturer details). It is not derived from patient data.
• Retrospective/Prospective: Not applicable as it's bench testing, not clinical studies.

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

• Not applicable. This submission relies on technical bench testing against predefined engineering specifications and comparison to a legally marketed predicate device. The "ground truth" for these tests is the physical measurement of optical properties and system functions, validated against engineering requirements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for establishing ground truth (e.g., determining disease presence in an image) based on multiple readers. This submission describes bench testing where the outcome is a "Passed" result based on meeting physical specifications.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical technical equivalence and performance of the device's optical and system functions. It does not evaluate human reader performance with or without AI assistance. The device itself (BLUE 400/BLUE 400 S) is a filter accessory, not an AI-powered diagnostic tool aiming to improve reader interpretation.

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

• No, a standalone algorithm performance study was not done. This device is an accessory to a surgical microscope. It enhances visualization for a human surgeon; it is not a standalone algorithm that provides diagnoses or interpretations. The software verification testing mentioned is for the device's control software, not a diagnostic algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing is engineering specifications and measurements of optical, electrical, and mechanical properties. For example, excitation wavelength range is validated against the known excitation peak of PpIX, and image properties (resolution, brightness, lack of deformation) are validated against defined standards for surgical microscopes. The comparison to the predicate device also serves as a benchmark for equivalence.

8. The Sample Size for the Training Set

• Not applicable. The BLUE 400 and BLUE 400 S are physical filter accessories for a surgical microscope, not an AI/machine learning device that requires a training set. The software mentioned is for the device's operation and control, not for image analysis or diagnostic inference that would necessitate a training set.

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

• Not applicable. As the device is not an AI/ML system requiring a training set, there is no ground truth established for such a set.

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The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source:

• Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery.
• The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.

The provided text describes the Myriad SPECTRA Light Source, an accessory for fluorescent visualization of grade III or IV gliomas during neurosurgery. The submission focuses on demonstrating substantial equivalence to a predicate device (Leica FL400) through performance testing.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists various tests conducted and states that the device "Passed" them or that the results were "acceptable" compared to the predicate. The "acceptance criteria" are implied by the nature of the tests and the "Passed" results.

For the purpose of this summary, I will infer the acceptance criteria from the context of "Passed" or "acceptable when compared to the predicate device" results.

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

The document provides very limited information regarding sample sizes for human-involved testing:

• Usability/Comparison Study: This study involved a usability/comparison study where users "consistently and accurately rank[ed] the level of fluorescence." No specific sample size (number of users or cases) is mentioned.
• Data Provenance: The document does not specify the country of origin of the data or whether any human user studies were retrospective or prospective. Given the nature of a 510(k) submission for a light source, most of the "testing" described is non-clinical (electrical, mechanical, optical properties) rather than clinical.

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. For the usability/comparison study where users ranked the level of fluorescence, there is no mention of experts establishing a "ground truth" for the fluorescence levels themselves, nor are the qualifications of the users participating in this study mentioned. The study focused on the user's ability to consistently and accurately rank the level of fluorescence, implying a comparison rather than an absolute ground truth establishment.

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

This information is not provided in the document.

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

• MRMC Study: There is no mention of an MRMC comparative effectiveness study in the provided text.
• AI Assistance: The device described, Myriad SPECTRA Light Source, is a light source for surgical visualization, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The usability/comparison study simply assessed the user's ability to rank fluorescence levels when using the device with a compatible surgical microscope, comparing it implicitly to the predicate.

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

The Myriad SPECTRA Light Source is a hardware device (a light source) used in conjunction with a surgical microscope and a fluorophore for human visualization. It is not an algorithm, and therefore, a "standalone algorithm only" performance study is not applicable and was not done.

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

For the non-clinical performance tests (illumination characteristics, general performance, environmental, electrical safety, etc.), the "ground truth" is based on established engineering specifications, industry standards (e.g., IEC/UL/EN 60601-1, ISO 10993), and comparisons to the predicate device's measured characteristics.

For the usability/comparison study, the "ground truth" for fluorescence levels is not explicitly defined as expert consensus or pathology. The study assesses the user's ability to consistently and accurately rank fluorescence, implying that the relative levels of fluorescence in the tested scenarios served as a de facto ground truth for comparative purposes.

8. The sample size for the training set

The device is a hardware light source, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable to this device.

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

As the device does not involve a training set for machine learning, this question is not applicable.

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BLUE 400 is an accessory of the surgical microscope and allows the fluorescence observation of fluorophores with an excitation peak between 400 mm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.

The ZEISS BLUE 400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 is an accessory to the Zeiss surgical microscopes (OPMI PENTERO 800, OPMI PENTERO 900, and KINEVO 900), intended to allow intraoperative viewing of malignant glioma tissue under fluorescence. The BLUE 400 accessory is entirely composed of optical filters: the "Excitation" filter and the "Emission" filters. The Excitation filter is designed to filter all light wavelengths except 400 - 470 nanometers and is optimized to pass light between 400 - 410 nanometers. The Emission filters are designed to filter all light wavelengths except 430 - 800 nanometers and is optimized to pass light between 620 - 710 nanometers.

When installed in the surgical microscopes (class I), the BLUE 400 introduces optical filters to the illumination and viewing optical paths. The BLUE 400 includes installation of a software license that facilitates use of the accessory. After the SW license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the BLUE 400 mode.

The BLUE 400 accessory, when installed in the surgical microscopes, is intended to be used in conjunction with an approved optical imaging agent that is excited mainly in the wavelength range of 400 – 410 nanometers and fluoresces in the wavelength range of 620 - 710 nanometers.

Here's a breakdown of the acceptance criteria and study information for the BLUE 400 device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., specific thresholds for irradiance or power). Instead, they are implied by the "Passed" result for each test, indicating that the device met the defined specifications for each performance parameter. The study is a bench performance test comparing the subject device (BLUE 400) to a predicate device (Leica FL400).

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

The document describes bench performance testing. Therefore, the "test set" in the traditional sense of patient data is not applicable. The testing involves:

• Test Sets: The devices themselves (subject device BLUE 400 and predicate device Leica FL400) and various optical components (filters, light sources, specialized targets/phantoms).
• Data Provenance: The tests were conducted internally by Carl Zeiss Meditec AG, as part of their 510(k) submission. This is a prospective bench study. No external data sources or patient data are mentioned.

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

Not applicable. This was a bench performance study assessing physical and optical properties, not a clinical study requiring expert interpretation of patient data to establish ground truth. The "ground truth" was established by the physical measurements and calculations against defined specifications.

4. Adjudication Method for the Test Set

Not applicable. This was a direct measurement and comparison bench study, not a clinical study requiring adjudication of expert readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an accessory (an optical filter) to a surgical microscope, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study for diagnostic accuracy or human performance improvement.

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

The device itself is an optical filter system for a surgical microscope. It does not have an "algorithm" in the sense of an AI or software that performs standalone interpretation. Its function is to modify light for improved visualization by a human surgeon. Therefore, standalone algorithm performance is not applicable. The document does mention Software verification testing was performed in accordance with FDA Guidance to demonstrate the software (for the license installation and mode switching) is performing as intended. This is analogous to a standalone performance check for the software component, but not for an interpretative algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench performance tests, the "ground truth" was established by:

• Physical measurements: Using calibrated instruments like spectrometers, power meters, and thermopiles to measure optical properties (irradiance spectrum, power, density, emission spectrum).
• Calculations: Such as calculating the 50% decrease edges of spectral peaks and optical path loss.
• Comparison to predefined specifications: The results were evaluated against specific technical requirements and specifications for each test.
• Comparison to a predicate device: For certain tests like maximum excitation power density and system sensitivity, the performance of the subject device was compared directly to the predicate device (Leica FL400).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set."

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

Not applicable. As above, there is no training set for this device.

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The Leica FL400 is a surgical microscope accessory filter set for viewing fluorescence of fluorophores comprising an excitation filter for blue spectral range 380 mm - 430 nm and an observation filter comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm.

The FL400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Leica FL400 is a fluorescence accessory that consists of an excitation (illumination) filter module and an emission (observation) filter module that are intended to be inserted into the optical beam path of compatible Leica surgical operating microscopes models M525 and M530. The excitation filter (380 nm - 430 nm), when placed into the light path, provides a fluorescence excitation light system for use in conjunction with an approved fluorophore selective for grade III or IV malignant gliomas.

The emission filter is a long pass filter allowing light wavelengths greater than 444 nm to pass. The fluorophore emits light at a longer wavelength than the excitation light. Once passed through the emission filter module, a camera adapted to the surgical microscope detects the fluorescence signal, allowing the user to visualize the fluorophore in the open neurosurgery field.

The Leica FL400 is supplied with a test phantom to confirm proper pre-operative fluorescence set-up. The Leica FL400 Test Phantom offers multiple levels of fluorescence intensity, which provides the clinician with a visual assessment of the FL400 pre-operative set-up. The clinician is advised to confirm the fluorescence spots are visible to confirm functionality prior to utilization.

Here's a breakdown of the acceptance criteria and the study that proves the Leica FL400 meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

• Maximum Power and Irradiance of the Illumination Source: The maximum output power and irradiance were measured with a power meter at the end of the microscope light guide prior to application of the excitation filter module. |
  | (ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope; | - Irradiance Spectrum of the Excitation Light and Spectral Response of the Excitation Filter: The irradiance spectrum (300 nm - 1100 nm) of the illumination light, following passage through the excitation filter module, was measured at working distances of 30 cm (M525) and 35 cm (M530) with a spectrometer. The spectral response of the excitation filter was derived by dividing this by the illumination source spectrum without the filter.
• Spectrum of the Emission Filter: The spectrum (300 nm – 1100 nm) of the emission filter when integrated in the surgical operating microscope was measured, including all coatings and optics. Transmission of the emission filter was calculated from white light remission spectra. |
  | (iii) Excitation power and power density; | - Maximum Excitation Power and Power Density: The maximum power (mW) and power density (mW/cm²) of the excitation light was measured with a thermopile and UV diode at multiple working distances and zoom settings. These measurements were compared to excitation power densities observed in clinical trials assessing fluorophore efficacy. |
  | (iv) Optical path loss from illumination source to objective lens or microscope camera; | - Optical Path Loss: Calculated by dividing the output signal measured at the microscope eyepiece (without emission filter) by the illumination signal measured at the microscope focal plane for the same zoom setting, using a reflection standard. |
  | (v) Homogeneity of the excitation light at the focal plane; | - Homogeneity of the Excitation Light at the Focal Point: The reflected signal from a white sheet of paper was imaged by the surgical operating microscope camera, and the intensity profile was calculated to demonstrate homogeneity. |
  | (vi) Fluorescence detection sensitivity; | - System Sensitivity: A diffusely reflecting and fluorescent silicone disc was positioned at 30 cm working distance. The device output spectrum was measured by a spectrometer at the microscope eyepiece for different zoom settings. The fluorescence/remission ratio was calculated. |
  | (vii) Verification of calibration or pre-operative procedures; | - Pre-Operative Phantom Test: This test demonstrated that the Leica FL400 test phantom is suitable for pre-operative checks. The phantom, with 4 dots of different fluorophore concentrations, was imaged by the camera and observed through eyepieces at different working distances and zoom settings. |
  | (viii) If camera-based, spectral sensitivity of the camera. | - Spectrum of Camera Filter: Measured to demonstrate that it can block near infrared and infrared leakage of excitation light to the camera. This implies the camera's filter sensitivity is appropriate for the system. |

Study Details

The provided document describes no clinical studies for the Leica FL400 itself. The special controls and the benefit-risk determination rely entirely on non-clinical/bench studies to demonstrate the device's technical performance and its compatibility with an existing, FDA-approved fluorophore (aminolevulinic acid hydrochloride - ALA HCl). The efficacy of ALA HCl was demonstrated in prior clinical studies for which the Leica FL400 effectively acts as a visualization system with compatible spectral characteristics.

Here's the information requested based on the provided text:

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

   • Test Set Sample Size: Not applicable. No clinical test sets were used for the Leica FL400 device performance. The bench tests involved various optical measurements and simulated scenarios (e.g., test phantom, white reflection standard).
   • Data Provenance: Not applicable for clinical data. The non-clinical/bench testing was performed by the manufacturer, Leica Microsystems (Schweiz) AG. The source of the clinical data for ALA HCl is referenced as FDA's Center for Drug Evaluation and Research (CDER) under NDA 208630, which would generally be multi-national and prospective, but this pertains to the fluorophore, not the device's clinical performance.

2. 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. As no clinical studies were performed for the Leica FL400, no experts were needed to establish ground truth for a clinical test set. The technical specifications and measurements from bench testing serve as the "ground truth" for the device's optical performance.

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

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

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC comparative effectiveness study was not done. The Leica FL400 is a hardware accessory (filter set), not an AI-assisted diagnostic tool.

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

   • Not applicable. The Leica FL400 is not an algorithm. It's a filter set that requires a human neurosurgeon to interpret the visualized fluorescence through a microscope.

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

   • For the Leica FL400, the "ground truth" for its performance is derived from physical measurements and engineering specifications obtained during bench testing. For example, measured spectra, power densities, and calculated optical path losses are compared to design specifications and relevant external data (e.g., fluorophore characteristics).
   • The clinical efficacy of the fluorophore (ALA HCl) that the FL400 is designed to visualize was established based on clinical studies with ground truth likely derived from histopathology (for positive predictive value) and potentially adjudicated clinical follow-up/outcomes (for negative predictive value limitations), as described in the summary stating "PPV ranged from 96% to 98%" and "NPV ranged from 19% to 24%." However, this is for the drug, not the device.

7. The sample size for the training set:

   • Not applicable. The Leica FL400 is a hardware device (filter set), not an AI algorithm. There is no training set in this context.

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

   • Not applicable. There is no training set.

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