(90 days)
The Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization ("WHO") criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of calcium and vitamin D, and smoking); and (2) compare the BMD estimate with reference populations of young normals and age matched normals to compute T-scores and Z-scores, respectively.
The Pronosco X-posure System™ estimates BMD based on established principles of radiogrammetry. A standard x-ray is first scanned into the system. then analyzed by computer to assess cortical thickness and textural characteristics in the pre-defined region of interest, which consists of the radius, the ulna, and the second through fourth metacarpals. The BMD estimate may be compared to a reference database of young normals and age matched normals to compute T-scores and Z-scores, respectively.
Here's a breakdown of the acceptance criteria and study information for the Pronosco X-posure System™ based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating "substantial equivalence" to existing predicate devices. The performance is described in a qualitative manner, affirming safety and effectiveness based on clinical and performance testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Clinical testing and performance testing have demonstrated the safety and effectiveness of the Pronosco X-posure System™ for its intended use. |
| BMD Estimation Quality | Estimates BMD based on established principles of radiogrammetry, assessing cortical thickness and textural characteristics in predefined regions (radius, ulna, 2nd-4th metacarpals). |
| Fracture Risk Assessment | Assesses increased risk of osteoporotic fractures according to WHO criteria. |
| Comparison to Reference Data | Compares BMD estimates with reference populations of young normals and age-matched normals to compute T-scores and Z-scores. |
| Substantial Equivalence to Predicates | Substantially the same intended use and indications for use as predicate devices. Minor differences in technical characteristics (BMD estimation method, specific regions of interest) do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The 510(k) summary does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It generally states "clinical testing and performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The 510(k) summary does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication Method for the Test Set:
The 510(k) summary does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The 510(k) summary does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance:
The 510(k) summary describes the device as performing the analysis ("analyzed by computer to assess cortical thickness and textural characteristics"). This implies standalone algorithm performance as a core component of its operation. However, no specific standalone performance metrics (e.g., sensitivity, specificity) are explicitly stated without human intervention, other than the general statement of safety and effectiveness. The device's output (BMD estimate, T-scores, Z-scores) is intended to "assist the physician," suggesting it's not a fully autonomous diagnostic tool but rather an aid.
7. Type of Ground Truth Used:
The 510(k) summary does not explicitly state the type of ground truth used for validation. Given that the device estimates BMD and assesses fracture risk in comparison to WHO criteria and reference populations, it's highly probable that:
- Clinical diagnoses: For osteoporosis status.
- Established BMD measurement techniques: As a gold standard for comparison of BMD values.
- Epidemiological data/outcomes data: For validating fracture risk assessment against actual fracture occurrences, although this is more speculative based on the limited information.
8. Sample Size for the Training Set:
The 510(k) summary does not specify the sample size of the training set.
9. How Ground Truth for the Training Set Was Established:
The 510(k) summary does not provide details on how the ground truth for the training set was established.
§ 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.