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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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