(74 days)
The intended use of the Fracture Risk Option includes the World Health Organization's (WHO) definition of osteoporosis and osteopenia based on the T-score and provides an estimate of Fracture Risk assessment based on WHO classification. The physician uses the Fracture Risk report in conjunction with other risk factors to arrive at diagnostic and patient management decisions.
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR® X-Ray Bone Densitometers.
The Hologic QDR X-Ray Bone Densitometers with the added feature of estimation of Fracture Risk from BMD includes additional reports that provide an estimation of risk of fracture.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a device that estimates fracture risk from Bone Mineral Density (BMD). While it describes the device's intended use and substantial equivalence to a predicate device, it lacks the specific performance metrics, study design, and results typically found in a clinical study report.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis based on the available information:
- Device: Hologic® QDR® X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD.
- Added Feature: Provides an estimation of fracture risk based on WHO classification (T-score).
- Intended Use: The physician uses the Fracture Risk report in conjunction with other risk factors to arrive at diagnostic and patient management decisions.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document.
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)
- Number of Experts: Not specified in the document.
- Qualifications of Experts: Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified 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 Done?: No, this is not an AI-assisted diagnostic tool in the sense of image interpretation. It's an added feature to a bone densitometer that provides a calculation (estimation of fracture risk from BMD). The document does not describe an MRMC study or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study Done?: The device's "added feature" is an algorithm that estimates fracture risk directly from BMD measurements taken by the Hologic QDR densitometer. The document implicitly supports standalone performance in that the densitometer outputs a fracture risk estimation, which is then used by a physician. However, no specific "standalone study" results or performance metrics are detailed in the provided text. The output is a quantitative risk estimation based on BMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "added feature" relies on the World Health Organization's (WHO) definition of osteoporosis and osteopenia based on the T-score, and provides an Bestimation of Fracture Risk assessment based on WHO classification. Therefore, the ground truth for establishing the methodology of the risk estimation is based on established medical guidelines (WHO classification), not on a unique set of patient outcomes or expert consensus specifically for this device's validation.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device feature calculates risk based on a defined formula/classification (WHO T-score), rather than a machine learning model that would require a "training set" in the conventional sense. The "training" here would be the development of the WHO classification itself.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Established: Not applicable/Not specified. The "ground truth" for the basis of the fracture risk estimation is the World Health Organization's (WHO) definitions and classification schemes for osteoporosis, osteopenia, and fracture risk based on T-scores. This is a widely accepted medical standard, not something established for this specific device's 'training.'
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.