Search Results

Not Found

The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm2) for the regions of the forearm and heel (os calcis).

The provided text is a 510(k) summary for the LUNAR PIXI Bone Densitometer. It discusses the device's technical characteristics and claims comparability to predicate devices. However, it does not include a study that defines explicit acceptance criteria and then presents results showing the device meets those criteria.

Instead, the document focuses on demonstrating that the PIXI device's performance metrics (BMD estimation correlation, in vitro precision, and in vivo precision) are "comparable" to previously cleared devices. It does not set a specific threshold or target value that the PIXI must meet to be considered acceptable.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study proving it meets acceptance criteria, because such information is not present in the provided text.

Here's what can be extracted based on the information given, highlighting the missing elements:

1. A table of acceptance criteria and the reported device performance

Missing Information:

• Explicit, quantitative acceptance criteria (e.g., "BMD correlation must be > 0.99", "In vivo precision must be < 1.0%"). The document only states "correlate highly" and "comparable to those shown on previously cleared devices."

Regarding the Study and Other Details:

The provided text does not describe a specific study designed to prove the device meets acceptance criteria in the way you've outlined. It presents technical specifications and performance metrics that are stated to be "comparable" to predicate devices. Therefore, I cannot answer questions 2 through 9 definitively as that level of detail about a specific study is not available in the given text.

However, based on the inference from the text, here's what we can deduce about how the performance was likely assessed, along with a clear statement of what is missing:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Missing: The text does not provide details on sample size, data provenance, or whether the study for these precision and correlation figures was retrospective or prospective.
• 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)
  • Missing: This information is not provided. The "ground truth" for BMD estimation correlation was "actual density of calcium hydroxyapatite pellets," which wouldn't involve human experts in the typical clinical assessment sense. For in vivo precision, the "ground truth" is typically the repeated measurements from the device itself on the same individual.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Missing: Not applicable as the data presented (correlation, precision) does not appear to involve an adjudication process as described.
• 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
  • Missing/Not Applicable: This is a bone densitometer, an imaging device that measures BMD, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study related to human reader improvement with AI is not relevant to this device's context.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Partially Applicable: The performance metrics (correlation, precision) are inherent to the device itself. While a human technologist operates it, the results presented are "standalone" in the sense that they reflect the device's measurement capabilities.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • For BMD estimation correlation: "actual density of calcium hydroxyapatite pellets." This is a phantom/calibration standard-based ground truth.
  • For In vitro/In vivo precision: The ground truth is the consistency of the device's own measurements on repeated scans.
• 8. The sample size for the training set
  • Missing: The text does not mention a "training set" as it would for a machine learning algorithm. This device is a densitometer, not a learning algorithm that requires training data in that sense.
• 9. How the ground truth for the training set was established
  • Missing/Not Applicable: As above, this concept doesn't directly apply to this type of device. The device's calibration and accuracy would be established through physical standards and known-density phantoms.

Ask a specific question about this device