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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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The accuDEXA is a dual-energy x-ray device indicated for use in measuring an index of the bone density of the middle finger of the nondominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. The measurement is compared to similar measurements from patients of the same gender and ethnicity to provide t-scores (number of standard deviations above or below the mean for a reference group of young healthy individuals) and z-scores (number of standard deviations above or below the mean for a cohort of the same age). A t-score or a z-score may be used by a physician as one factor, in conjunction with other clinical indicators, to diagnose osteoporosis and other bone disorders. When a normative database of the same ethnicity and gender is not available, the BMD value may still be used to compare to the patient's own baseline value, for example in following the patient's response to treatment for osteoporosis.

Below normal bone density can be associated with a variety of conditions or disorders of bone. For example, the Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications for measurement of a patient's bone mass: for patients with premenopausal oophorectomy, spontaneous menopause, or estrogen deficiency conditions; for treatment-related osteopenia; when the diagnosis of osteopenia is suggested or established by other means, such as x-ray; during long-term immobilization; for endocrinopathies known to be associated with osteopenia; for post-gastrectomy and other malabsorption states leading to osteopenia: during long-term corticosteroid therapy; for chronic renal disease, particularly in childhood or adolescence; and to monitor treatment programs for osteoporosis.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to calculate an index of bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The zscore is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.

Here's an analysis of the provided text regarding the Schick accuDEXA Bone Densitometer, focusing on acceptance criteria and the supporting study:

Schick accuDEXA Bone Densitometer Acceptance Criteria and Study

The provided document, a 510(k) Summary for the Schick accuDEXA Bone Densitometer, describes the device's performance characteristics through a study to demonstrate substantial equivalence to predicate devices. While explicit "acceptance criteria" in a numerical or threshold format are not directly stated, the document implies them through its claims of precision, accuracy, and correlation with predicate devices and ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are implied by the demonstration of performance that supports substantial equivalence to existing devices. The document highlights key performance characteristics rather than specific pass/fail values.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states the study was conducted "on cadavers" for precision and accuracy testing. It does not specify the exact number of cadavers or bone samples used in this study.
• Data Provenance: Retrospective, as it involves cadaveric tissue. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document does not mention the number or qualifications of experts used to establish ground truth. The ground truth (ashed bone weights) is an objective physical measurement, not an expert interpretation.

4. Adjudication Method for the Test Set

• None specified. For the "ashed bone weights" ground truth, adjudication by experts would not be applicable, as it's a direct physical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The study focuses on the device's intrinsic performance (precision and accuracy) and its correlation with predicate devices.

6. Standalone Performance Study

• Yes. The primary study described evaluates the "precision and accuracy of the accuDEXA device" and its correlation with ashed bone weights. This is a standalone assessment of the algorithmic performance in determining bone density.

7. Type of Ground Truth Used

• For the accuracy evaluation, the ground truth used was "ashed bone weights." This is an objective, quantitative physical measurement of true bone mineral content.

8. Sample Size for the Training Set

• The document mentions "A reference data base has been developed in a clinical study which allows the calculation of t-scores and z-scores for each patient." However, it does not specify the sample size of this clinical study that formed the normative database.

9. How the Ground Truth for the Training Set Was Established

• The ground truth for the "reference data base" (which acts as a training set for norm-based scoring) was established through "a clinical study." It is assumed that this clinical study involved measuring BMD in a population to derive mean and standard deviation values for different age, gender, and potentially ethnic groups, thereby establishing the normative data for t-scores and z-scores. The specific methods for establishing the "ground truth" (i.e., true bone density measurements in this clinical cohort) are not detailed beyond "measurements."

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