(14 days)
The intended use of the "Infinia LightSpeed" system is to perform:
- General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
- General Head & Body computed tomography (CT) applications. ◆
- Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).
The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991841) and the "LightSpeed" 5 CT Scanner (K030420). In addition to providing CT and NM standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the NM images and to facilitate localization of the emission activity in the patient anatomy.
This document describes the Infinia LightSpeed system, a combination of a Nuclear Medicine (NM) scanner and a Computed Tomography (CT) scanner, primarily for performing SPECT/CT attenuation correction and functional/anatomical mapping.
Here's an analysis of the provided text regarding acceptance criteria and the study:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| Code of Federal Regulations Title 21 Subchapter J- Radiological Health - 21CFR1020.30, 21CFR 1020.33 | Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances, which would inherently include compliance with these regulations for radiological health. No specific performance metrics are provided in relation to these regulations. |
| NEMA NU 1-2001 | Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances. No specific performance metrics are provided against NEMA NU 1-2001. |
| IEC60601-1 and associated collateral and particular standards | Implied to be met, as the device is determined substantially equivalent to legally marketed devices based on similar intended use and system performances. No specific performance metrics are provided against IEC60601-1. |
| Attenuation Correction Capability | Phantom data shows that SPECT/CT attenuation-corrected images are more uniform than NM images without attenuation correction. |
| Localization Capabilities | The images (from phantom data) demonstrate the localization capabilities of the SPECT/CT. |
Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive new clinical study data with detailed acceptance criteria and standalone performance metrics. The performance criteria listed are general regulatory and industry standards, and the "reported device performance" is a high-level summary of phantom study results.
Study Information
The provided document refers to a "Summary of Studies" that relies on phantom data. It is a submission for substantial equivalence based on modifications to existing devices, rather than a de novo submission requiring extensive new clinical trials.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved "Phantom data," implying a controlled test using physical phantoms, not human subjects.
- Data Provenance: Not specified, but likely obtained in a controlled laboratory setting (prospective data from phantom experiments).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study utilized phantom data and objective measurements for uniformity and localization, which do not typically require expert consensus for ground truth establishment in the same way clinical image interpretation does.
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Adjudication method for the test set:
- Not applicable. As the study used phantom data and objective measurements, there was no adjudication of expert interpretations.
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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. The document describes a technical and performance evaluation using phantom data, not a multi-reader, multi-case clinical study involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "study" described is a standalone performance evaluation of the SPECT/CT system's capabilities using phantom data, focusing on image quality (uniformity) and localization. It evaluates the system's inherent ability to produce corrected and localized images.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the phantom study would be known physical properties and distributions within the phantom, along with objective measures of uniformity and spatial accuracy.
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The sample size for the training set:
- Not applicable. The document describes a medical device system, not an AI algorithm that would typically have a "training set." The system's algorithms for attenuation correction and image reconstruction are based on established physics and engineering principles, not machine learning from a large training dataset as understood in AI/ML contexts.
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How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 7.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.