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510(k) Data Aggregation
(47 days)
The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns.
The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement:
"Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.
Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Total exposure dose (lower than predicate and safe) | Radiation exposure is <10 mrem, which is "lower than that for the predicate device" and "low compared to the maximum permissible dose for extremities." |
| Effectiveness: Correlation with predicate device results | BMD estimations correlate ~0.95 with results obtained on the predicate device (LUNAR PIXI). |
| Effectiveness: Short-term BMD precision (in vivo) | Short-term BMD precision (%CV) in vivo is <1.5%, described as "comparable to previously registered devices." |
| General Safety & Effectiveness (Implicit): Comparability | The device is stated to be "comparable to previously registered devices that demonstrate similar precision" and "No new safety and effectiveness questions are raised." The FDA's substantial equivalence determination implies that the device is as safe and effective as the predicate. |
| Exposure Time: | Requires a 4-second exposure. This is not explicitly an acceptance criterion but a technical characteristic that contributes to the safety profile (lower dose due to shorter exposure) and efficiency of the device, making it implicitly favorable. |
| Regulatory Compliance (Implicit): Prescription Use Only | "Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician." This indicates compliance with regulatory requirements for prescription devices, which is an implicit acceptance criterion for market clearance. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The information provided is a summary of technical characteristics and a statement of comparability, rather than a detailed study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for any test set. The study focuses on correlation and precision compared to a predicate device, not on expert-adjudicated ground truth.
4. Adjudication method
The document does not mention any adjudication method for a test set.
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
There is no indication that an MRMC comparative effectiveness study was conducted, nor is there any mention of AI assistance in this document. The device is a bone densitometer, an imaging hardware device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance. The device itself is a standalone system for measuring BMD, and its performance is assessed against a predicate device's output. There isn't an "algorithm only" component in the context of typical AI/software device studies.
7. The type of ground truth used
The "ground truth" in this context is established by the predicate device (LUNAR PIXI). The study assesses the ORCA-DX's ability to produce highly correlated and precise BMD estimations relative to the predicate device, implying the predicate's output serves as the reference standard for this substantial equivalence submission. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for a diagnostic algorithm.
8. The sample size for the training set
The document does not specify any training set size. This device is not described as involving machine learning or AI that would require a distinct training set. The performance is assessed based on direct comparison to the predicate and precision measurements.
9. How the ground truth for the training set was established
As there's no mention of a training set in the context of an AI/ML algorithm, there's no information on how ground truth for a training set was established. The "ground truth" for the performance evaluation itself is the predicate device's measurements.
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