(203 days)
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.
| Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Illumination Characteristics Testing | • Irradiance measured successfully. | |
| • Beam Profile measured successfully. | ||
| • Spectral Analysis measured successfully. | Passed. Key characteristics of light from the Myriad SPECTRA Light Source were successfully measured. (Details on specific values/ranges are not provided in this summary). | |
| General Performance Testing | • Device and Foot Pedal satisfy acceptance criteria related to physical characteristics (e.g., weights, dimensions). | |
| • Light management functions properly. | ||
| • Operating power is within acceptable limits. | ||
| • Noise levels are within acceptable limits. | Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria related to physical characteristics, light management, operating power and noise. | |
| Environmental Testing | • Device and Foot Pedal function properly when subjected to ranges of altitude, humidity, and temperature. | Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria when subjected to various environmental conditions. |
| Software Verification and Validation | • Hardware/system and software testing confirms ability to select desired wavelengths, switch between wavelengths, control light intensity, adjust LCD touchscreen brightness. | |
| • System warnings function correctly. | ||
| • Regression testing completed successfully. | Passed. Software and/or hardware for Myriad SPECTRA Light Source and Foot Pedal satisfied all acceptance criteria. Additionally, regression testing was successfully completed. | |
| Packaging Testing | • Packaged devices visually and functionally acceptable after ISTA 2A test procedure (simulation of transport). | Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all visual and functional acceptance criteria after being subjected to ISTA 2A test procedure. |
| Electrical Safety Testing | • Device and Foot Pedal meet electrical safety requirements of IEC/UL/EN 60601-1, CAN/CSA C2.2 No. 601.1, and IEC/UL/EN 60601-1-2. | Passed. Myriad SPECTRA Light Source and Foot Pedal satisfied all applicable requirements related to electrical safety. |
| Biocompatibility | • NICO Illumination Fiber and NICO Delivery Sleeve meet requirements of ISO 10993 and FDA biocompatibility guidance for external communicating devices with limited contact (≤ 24 hours). | Passed. Biocompatibility test results demonstrated that the NICO Illumination Fiber and NICO Delivery Sleeve meet the requirements from ISO 10993 and the FDA biocompatibility guidance. |
| Usability | • All applicable usability activities completed successfully in accordance with IEC 62366. | |
| • User can consistently and accurately rank the level of fluorescence when using the Myriad SPECTRA Light Source with a compatible surgical microscope (usability/comparison study). | Passed. All applicable usability activities were successfully completed for the Myriad SPECTRA Light Source and Foot Pedal. The usability/comparison study successfully demonstrated that the user can consistently and accurately rank the level of fluorescence when using the Myriad SPECTRA Light Source with a compatible surgical microscope. | |
| Spectrum and intensity of illumination | • Spectrum and intensity of white light are acceptable when compared to the predicate device. | Passed. The spectrum and intensity of white light produced by the Myriad SPECTRA Light Source were acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary). |
| Spectrum of excitation light | • Spectrum of excitation light is acceptable when compared to the predicate device. | Passed. The spectrum of excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary). |
| Excitation power and power density | • Power density of excitation light is acceptable when compared to the predicate device. | Passed. The power density of the excitation light produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary). |
| Homogeneity of excitation light | • Homogeneity of excitation light at the focal plane is acceptable when compared to the predicate device. | Passed. Homogeneity of the excitation light at the focal plane produced by the Myriad SPECTRA Light Source was acceptable when compared to the predicate device. (Details on what constitutes "acceptable" are not in this summary, but implied by beam profile measurements). |
| Verification of calibration | • Stability of light output is acceptable over a maximum number of hours. | Passed. Stability of light output produced by the Myriad SPECTRA Light Source was determined to be acceptable over a maximum number of hours. Stability must be confirmed prior to each surgical case. (The specific "maximum number of hours" is not stated in this summary). |
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.
§ 882.4950 Diagnostic neurosurgical microscope filter.
(a)
Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following:
(i) Spectrum and intensity of the illumination source;
(ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
(iii) Excitation power and power density;
(iv) Optical path loss from illumination source to objective lens or microscope camera;
(v) Homogeneity of the excitation light at the focal plane;
(vi) Fluorescence detection sensitivity;
(vii) Verification of calibration or preoperative procedures; and
(viii) If camera-based, spectral sensitivity of the camera.
(2) Labeling must include:
(i) Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
(A) Illumination spectrum and power density; and
(B) Excitation and emission filter spectra.
(ii) Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
(iii) Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
(iv) A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
(v) A warning that the device is not a standalone diagnostic.