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The Discovery Package for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.

The Discovery Package for QDR Bone Densitometers is a software system that integrates all of the previously cleared features of prior versions of the QDR Densitometers in a Microsoft Windows XP operating environment.

The provided text is a 510(k) summary for the "Discovery Package for Hologic QDR X-Ray Bone Densitometers." This document is a regulatory submission for a software system that integrates previously cleared features of bone densitometers into a new operating environment. As such, the study described focuses on software validation rather than a clinical performance study with acceptance criteria in the typical sense of measuring diagnostic accuracy.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available within this 510(k) summary.

Here's why and what information is available:

• Software System: The device is described as "a software system that integrates all of the previously cleared features of prior versions of the QDR Densitometers in a Microsoft Windows XP operating environment." This suggests that the primary validation would involve ensuring the software correctly performs the functions it's designed for, consistent with its predicate devices.
• Predicate Devices: The submission heavily relies on predicate devices (K992677, K992775, K983028, K963363, K941362, K943505, K913321, K894795, K883280, K001812). This typically means the new device is being shown to be "substantially equivalent" to these existing, legally marketed devices. Demonstrating substantial equivalence for a software update often involves comparing the new software's output to the predicate's output without necessarily needing extensive new clinical trials or diagnostic accuracy studies.
• Lack of Clinical Study Details: The summary does not contain any sections detailing a clinical study, performance metrics like sensitivity/specificity, or a comparison against a human expert baseline. The focus is on the integration of existing functionalities into a new operating system.

Therefore, I cannot populate the table or answer most of the questions as the information is not provided in the given text.

Information that can be extracted or inferred:

• Device Trade Name: Discovery Package for Hologic QDR X-Ray Bone Densitometers
• Intended Use: Estimation of bone mineral density (BMD), comparison of measured variables to a reference database, estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using Hologic QDR X-Ray Bone Densitometers.
• Device Description: A software system integrating previously cleared features of prior QDR Densitometer versions into a Microsoft Windows XP operating environment.

Without a detailed study report within this 510(k) summary focusing on specific performance metrics, it's impossible to describe acceptance criteria or the study proving the device meets them in the context of diagnostic accuracy.

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