(44 days)
The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.
The imaging protocols and acquisition software of the MXA-II software option are the same as the Hologic Vertebral Morphometry software program. Using the MXA-II option, the patient would be scanned as under the currently distributed vertebral morphometry option. In the MXA-II option, however, the vertebral deformities can be evaluated either quantitatively or visually.
Here's an analysis of the provided text regarding the Hologic MXA-II Software Option for X-Ray Bone Densitometers, structured according to your requested points:
The provided documents do not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training data. The documents are primarily the 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than directly detailing performance studies against specific acceptance criteria.
Therefore, for most of your requested points, the answer will be "Information not available in the provided text."
Here's a breakdown of what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Information not available in the provided text. | Information not available in the provided text. The 510(k) submission states the MXA-II option uses the "same imaging protocols and acquisition software" as the predicate Hologic Vertebral Morphometry software program and allows evaluation of vertebral deformities "either quantitatively or visually." This implies its performance is considered comparable to the predicate. |
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: Information not available in the provided text.
- Data provenance: Information not available in the provided text.
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: Information not available in the provided text.
- Qualifications of experts: Information not available in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Information not available in the provided text.
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: Information not available in the provided text. The submission focuses on substantial equivalence to existing devices rather than a comparative effectiveness study showing human improvement with the new software.
- Effect size: Information not available in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance study done: Information not available in the provided text. The device is a "software option for the Hologic x-ray bone densitometers, allowing the visual or quantitative assessment of vertebral body deformities," implying human involvement in the assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Information not available in the provided text. Given the device's function (assessment of vertebral body deformities), it's highly probable that expert radiographic interpretation or similar clinical assessment would form the basis of ground truth, but this is not explicitly stated.
8. The sample size for the training set
- Sample size for training set: Information not available in the provided text.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Information not available in the provided text.
Summary of Device and Approval Context from Provided Information:
- Device Name: Hologic® QDR® X-Ray Bone Densitometers MXA-II Software Option
- Intended Use: "The product is a software option for the Hologic x-ray bone densitometers, allowing the visual or quantitative assessment of vertebral body deformities."
- Predicate Devices: Hologic Vertebral Morphometry Software Option, LUNAR Spine Morphometry Software Option, Radiographic identification of Vertebral Deformities, CT Scout views.
- Key Aspect of Submission: The 510(k) submission highlights that the "imaging protocols and acquisition software of the MXA-II software option are the same as the Hologic Vertebral Morphometry software program." This emphasizes substantial equivalence through shared underlying technology and methodology, rather than extensive new performance studies demonstrating novel capabilities or improved metrics. The key change seems to be the added flexibility for "visual or quantitative" assessment.
- Approval Date: August 17, 1999 (Date Prepared for Submission), August 18, 1999 (Received by FDA), FDA Clearance letter dated September 1, 1999.
- Regulatory Class: II (21 CFR 892.1170/Procode: 90 KGI)
- Type of Submission: 510(k) Premarket Notification, indicating reliance on substantial equivalence to legally marketed predicate devices.
§ 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.