(57 days)
The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD) of the proximal femur using digital antero-posterior hip or pelvis radiographic images. This information may be used by the physician in the assessment of fracture risk in conjunction with the World Health Organization ("WHO") criteria and to compare the derived BMD estimate with reference populations of young (20 - 39) and age matched normals to compute T-scores and Z-scores respectively.
The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays. The program utilizes a quantitative bone structural algorithm that measures a composite of weighted cortical and trabecular parameters in proximal femur projection radiographs from which total hip bone mineral density (BMD) is mathematically derived. Image analysis can take place remotely or at the point of care.
The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score).
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance validation against predefined criteria.
However, based on the available information, I can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
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Acceptance Criteria: Not explicitly stated in the document. The document refers to "standard methods for evaluation of BMD estimates," implying that the device's performance was compared against established benchmarks or methods for BMD measurement.
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Reported Device Performance:
- The document states: "The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age."
- It also mentions: "Software validation was performed using standard techniques."
- The results are "expressed as gm/cm2" and "can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score)."
Table (Inferred Acceptance Criteria based on common BMD device evaluation and what's mentioned):
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of BMD Estimate (vs. a reference standard/method) | "The device design was evaluated using standard methods for evaluation of BMD estimates in patient populations..." (No specific quantitative results like mean difference, R-squared, or Bland-Altman agreement with a gold standard are provided in this summary.) |
| Reproducibility/Precision | Not explicitly mentioned but often part of "standard methods for evaluation of BMD estimates." |
| Ability to generate T-scores and Z-scores | "The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score)." Implies the system successfully computes these scores. |
| Robustness across patient age spectrum | "...evaluated using standard methods for evaluation of BMD estimates in patient populations including patients across the spectrum of age." (No specific results for different age groups are provided.) |
| Software Validation | "Software validation was performed using standard techniques." (This typically covers functionality, bugs, data integrity, and security, but specific criteria or outcomes of this validation are not detailed.) |
| The device is stated to be "substantially equivalent" to predicate devices, implying its performance meets a comparable standard, but the specific metrics are not detailed in this summary. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "patient populations including patients across the spectrum of age" but does not give a number.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be clinical data used for evaluation, but whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "standard methods for evaluation of BMD estimates," but does not detail how ground truth was established for the specific dataset used in their evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided 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:
- An MRMC comparative effectiveness study is not mentioned in the document. The device is a "stand-alone software" intended to provide an estimate of BMD, not explicitly an AI-assisted interpretation tool for human readers in the way an MRMC study typically evaluates. It processes images to derive BMD, which physicians then use in their assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the device is described as "stand-alone software" and "algorithm only" in its function of estimating BMD. The document states: "The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD)..." and "The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays." This confirms it's a standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The direct ground truth for BMD values would typically come from reference BMD measurements (e.g., from a DEXA scan, which is considered the gold standard for clinical BMD) or potentially from a very meticulously calibrated physical phantom. The text only mentions "standard methods for evaluation of BMD estimates," but does not specify the ground truth methodology used for their evaluation studies.
8. The sample size for the training set:
- The document does not mention the sample size for a training set. This summary describes an evaluation of the device as a whole, not the specifics of its development (like training data for an AI model, even though it uses an "algorithm").
9. How the ground truth for the training set was established:
- This information is not provided as the training set itself is not mentioned.
§ 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.