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Terran NM-101 is a post-processing software medical device in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.

Terran NM-101 is also intended for automatic labeling, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 37 acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps.

When interpreted by a neuroradiologist. Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis.

Terran NM-101 must always be used in combination with a T1-weighted image MR acquisition.

Terran NM-101 is a fully automated post-acquisition software as a medical device (SaMD) that measures neuromelanin associated contrast to noise ratio (CNR) signal in the substantia nigra (SN) and locus coeruleus (LC) regions of non-contrast brain magnetic resonance imaging (MRI) images from Siemens 3 tesla (3T) MRI scanners. Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.

Acceptance Criteria and Study for Terran NM-101

Based on the provided FDA 510(k) summary for Terran NM-101, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific quantitative acceptance criteria for the device's performance metrics (e.g., accuracy, precision of volumetric quantification). It states that "All predefined acceptance criteria for the engineering (preclinical) performance testing were met." and "The results of the clinical performance reviews of the Terran NM-101 reports by neuroradiologists demonstrate that the Terran NM-101 clinical user needs and intended use requirements were fulfilled and all acceptance criteria were met."

Without further details on the specific "predefined acceptance criteria," a detailed quantitative table cannot be constructed. However, based on the device's intended use and the comparison to predicate devices, general performance categories implicitly covered would include:

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

The document does not explicitly state the specific sample size of the test set used for performance evaluation. However, it does mention that:

• Data Provenance: The input data is acquired from "Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE)." No specific country of origin is mentioned for the data, nor is it explicitly stated whether it was retrospective or prospective. Given the nature of a 510(k) submission and the focus on "preclinical" and "clinical performance reviews," it is highly likely that this involved retrospective data from existing MR scans.

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

The document states: "The results of the clinical performance reviews of the Terran NM-101 reports by neuroradiologists demonstrate that the Terran NM-101 clinical user needs and intended use requirements were fulfilled and all acceptance criteria were met."

• Number of Experts: The exact number of neuroradiologists is not specified. It uses the plural, "neuroradiologists," implying more than one.
• Qualifications of Experts: The experts are identified as "neuroradiologists." This indicates they are medical doctors specializing in radiology with subspecialty training and expertise in interpreting neuroimaging (brain, spine, head, and neck). No specific years of experience are provided, but their subspecialty qualification is stated.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It states "clinical performance reviews... by neuroradiologists," which implies expert assessment. However, without further detail, it's not possible to determine if a formal adjudication process was used to resolve discrepancies among multiple expert readers.

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

No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance is not mentioned as part of the evidence provided in this 510(k) summary. The document states: "The subject device of this premarket notification, Terran NM-101, did not require clinical studies to support substantial equivalence to the predicate devices." This suggests that the clinical evaluation was primarily a "performance review" by neuroradiologists to confirm the output's utility, rather than a comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device's core functionality (automatic labeling, quantification, and parametric map generation) is an algorithm-only function, the 510(k) summary emphasizes its "adjunctive use" and states: "Results must be reviewed by a neuroradiologist - adjunctive use indication." This strongly implies that the primary performance validation for regulatory clearance was in the context of human-in-the-loop use, where the neuroradiologist interprets the AI-generated images. The "preclinical" and "engineering" testing likely covered the standalone accuracy of the algorithm's outputs, but the "clinical performance reviews" integrated the human expert.

7. The Type of Ground Truth Used

The ground truth for the test set appears to be expert consensus/review by neuroradiologists. While the device performs "automatic labeling, volumetric quantification and contrast quantification," the ultimate assessment of its performance and clinical utility was based on the "clinical performance reviews of the Terran NM-101 reports by neuroradiologists." This suggests that the neuroradiologists' interpretations and judgments served as the reference standard for evaluating the device's output. There is no mention of pathology or outcomes data being used as ground truth for this submission.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size of the training set used for developing the Terran NM-101 algorithm. The focus of the 510(k) summary is on substantiating equivalence and demonstrating performance for the submission (test) dataset, not on the specifics of the training data.

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

The document does not provide any information on how the ground truth for the training set was established. This detail would typically be part of the technical documentation for the device's development but is not required for a 510(k) summary focused on demonstrating substantial equivalence to predicate devices and performance of the final product.

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