(277 days)
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.
The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only.
The EXPERT-XL Total Body Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD in g/cm), Lean Tissue Mass (g), and Fat Tissue Mass (g) for the Total Body and sub-regions.
The provided document describes the EXPERT-XL Total Body Acquisition and Analysis Software, an accessory option for estimating Bone Mineral Density (BMD), Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The core acceptance criteria for the EXPERT-XL Total Body Acquisition and Analysis Software are based on its correlation and precision compared to the predicate DPX series products.
| Acceptance Criteria (Predicate DPX Series Performance) | Reported Device Performance (EXPERT-XL Software) |
|---|---|
| High correlation for Total Body BMD estimations | Highly correlated (r=0.97) with DPX series |
| High correlation for Lean and Fat Tissue Mass estimations | Highly correlated (r=0.95) with DPX series |
| Short term precision (%CV) for BMD | 0.4% (comparable to DPX series) |
| Short term precision (%CV) for Lean Tissue Mass | 3.1% (comparable to DPX series) |
| Short term precision (%CV) for Fat Tissue Mass | 4.8% (comparable to DPX series) |
| Acceptable radiation exposure | 5 mrem (higher than DPX series, but still low compared to maximum permissible dose) |
Conclusion from document: The results are "Comparable to the DPX results with similar precision." And "No new safety and effectiveness concerns."
Study Information
The document does not detail a formal clinical study with a defined test set, ground truth, or expert involvement as might be expected for contemporary device submissions. Instead, it relies on a comparative study against a predicate device to establish substantial equivalence.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a test set. The evaluation is described in terms of "Scans of the Total Body on the EXPERT-XL densitometer" and comparison to "corresponding regions estimated with the DPX series of products." This suggests an internal validation against the predicate device's known performance.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
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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. The ground truth, in this context, is the performance of the legally marketed predicate device (DPX series). There's no mention of independent experts establishing a new "ground truth."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no mention of an adjudication process as there isn't an independent "ground truth" establishment by multiple readers.
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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 MRMC comparative effectiveness study was done. This device is an accessory software for a bone densitometer, performing quantitative measurements, not a diagnostic aid for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is effectively a standalone performance evaluation. The software directly calculates BMD, Lean Tissue Mass, and Fat Tissue Mass. Its performance is evaluated by comparing its output (correlation and precision) directly to the output of the predicate device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is the performance of the legally marketed predicate device (Lunar DPX series). The EXPERT-XL software's outputs (BMD, lean, fat mass) were compared for correlation and precision against the equivalent outputs from the DPX series. This is a comparison against an established, cleared technology rather than a biological "ground truth" like pathology.
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The sample size for the training set:
- The document does not mention a training set. This submission is for an accessory software that calculates established metrics, likely using known algorithms. It doesn't appear to involve machine learning that would require a distinct "training set."
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How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned or implied.
§ 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.