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The DXL Calscan™ Bone Densitometer estimated bone mineral density (BMD) (g/cm²) for the region of the heel (os calcis). By comparing estimated BMD to a (grim ) for the region of the Rose (a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk.

The DXL Calscan™ Bone Densitometer estimates Bone Mineral Density (BMD) of the Os Calcis. THE DAL Calstan - Bone Densitometor Societator Sectionetry (DEXA). Heel width, measured by a The lectificiously is based on Dual Enorgy Artay Arage in the effects from soft and adipose tissues.

Here's an analysis of the provided text regarding the DXL Calscan Bone Densitometer's acceptance criteria and study information:

Summary of Device Acceptance Criteria and Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

   • The provided text does not specify the sample sizes used for the in vitro or in vivo precision and accuracy studies.
   • Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The company is Swedish (Demetech AB, Solna, Sweden), so it's possible studies were conducted in Sweden, but this is not confirmed.

2. 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 or qualifications of experts used to establish ground truth for the in vivo studies.
   • For in vitro studies, the "actual hydroxyapatite content" likely serves as a direct reference, not requiring expert consensus in the same way.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe an adjudication method.

4. 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:

   • No MRMC comparative effectiveness study is mentioned. This device is a bone densitometer, which directly measures BMD and does not involve human interpretation of images per se that would typically require an MRMC study or AI assistance for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance metrics (accuracy, precision, CV%) are for the DXL Calscan™ Bone Densitometer itself, which is an automated device for measuring BMD. These are standalone performance metrics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the in vitro accuracy study, the ground truth was "actual hydroxyapatite content."
   • For the in vivo precision study, the ground truth for precision is typically the repeated measurement itself, a comparator for accuracy is not explicitly stated but would ideally be a gold standard BMD measurement technique.

7. The sample size for the training set:

   • The document does not specify a training set sample size. This is common for predicate-based 510(k) submissions, especially for a device performing direct physical measurements rather than learning complex patterns from a large dataset like an AI algorithm.

8. How the ground truth for the training set was established:

   • The document does not specify how a ground truth for a training set was established, nor does it indicate the use of a distinct "training set" in the context of machine learning. The studies described are performance validation studies.

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