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The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects. The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP Spine, Hip and "Total" body bone densitometry reference data for male, white American children. This software is used in conjunction with previously existing software in the QDR Series Densitometers which calculates and reports results relative to sex, ethnicity and age-matched values. The reference database is used to expand the range of bone densitometry reference values to include age 3-20 years of age. The software provides a comparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values. Patient results for each analysis region can be compared to reference values both graphically and numerically to each category of the age dependent reference Bone Mineral Density (BMD) values. The sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in standard deviation units) the difference between the patient's estimated BMD and the mean population standard (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

The provided text describes a Pediatric Reference Database for Hologic QDR Series X-Ray Bone Densitometers, a software option that extends the existing reference databases to include ages 3-20 years.

Here's an analysis of the acceptance criteria and the study as per your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) with thresholds. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices. The study's reported "performance" is implicitly that the device functions as intended by providing a Z-score and comparison to age-matched values for pediatric populations, which is consistent with the function of the predicate devices.

Note: The document focuses on demonstrating substantial equivalence, which is a regulatory pathway. It does not provide a traditional performance study with explicit numerical metrics (e.g., accuracy, precision of the Z-score calculation itself, or clinical outcomes). The "study" here is the collection and presentation of reference data.

Detailed Study Information:

The provided text does not describe a traditional study in the sense of an experiment to test the performance of the device against a cohort. Instead, it describes a reference database that enhances an existing device's functionality. Therefore, many of the requested details about a "study" (like test sets, ground truth establishment for test sets, expert adjudication methods, MRMC studies, standalone performance, and training sets) are not directly applicable or are not explicitly stated in the provided text.

Based on the information given, here's what can be inferred or explicitly stated:

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

   • Test Set Sample Size: Not applicable in the context of a "test set" for performance evaluation, as this document is about establishing a reference database. The database itself comprises the reference data. The size of the population from which the reference data was collected is not stated.
   • Data Provenance: The reference data is for "male, white American children." This indicates the data origin is from the United States and is retrospective in the sense that it represents a collected population. It's not a prospective study to test a hypothesis about the device's performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly stated/Not applicable. The "ground truth" here is the reference data itself, representing a healthy pediatric population's BMD values. The process of collecting and validating this reference data (e.g., how the healthy population was defined, how measurements were ensured to be accurate) is not detailed. There's no mention of experts establishing a "ground truth" for individual cases in a test set.

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

   • Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication of results.

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, an MRMC study was not done. This device is a reference database, not an AI-assisted diagnostic tool.

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

   • Not applicable, but the device inherently functions "standalone" as a reference. The software provides Z-scores based on the input BMD measurement and patient demographics. It's a computational tool, not an AI algorithm that makes diagnostic interpretations. Its "performance" is its ability to correctly reference the input BMD against its stored database.

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

   • Reference Database Values derived from a healthy population. The "ground truth" is the established set of age-, sex-, and ethnicity-matched Bone Mineral Density values for healthy children. The methodology for establishing this healthy population baseline is not detailed in the provided text, but it would typically involve anthropometric measurements, medical history, and DEXA scans from a large, representative cohort of healthy children.

7. The sample size for the training set:

   • Not explicitly stated. The term "training set" is not used, as this is a reference database, not a machine learning model. The size of the population from which the "Pediatric Reference Database" data was derived is not provided.

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

   • Not explicitly stated, but implied as a collected reference population. The "ground truth" for this reference database would have been established through a systematic collection of Bone Mineral Density (BMD) measurements from a cohort of healthy male, white American children across the age range of 3-20 years, using validated DEXA scanning protocols. The process would involve defining inclusion/exclusion criteria for "healthy," performing scans, and statistically characterizing the BMD distribution to create age-specific means and standard deviations.

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The DXAVIEW™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk.

The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.

The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.

Here's a breakdown of the acceptance criteria and study information for the DXAView™ Hip and Spine device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" but rather describes the "Summary of Clinical Performance Data" and "Conclusions" from the validation studies, which implicitly serve as the criteria for deemed substantial equivalence.

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

• Test Set Sample Size: The document refers to "Patient validation studies" and "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip." However, the exact numerical sample size for these clinical studies (test set) is not specified.
• Data Provenance: Not explicitly stated. It refers to "clinical comparison studies," but neither the country of origin nor whether the data was retrospective or prospective is mentioned.

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

• This information is not provided in the document. The studies focused on comparing the DXAView™ software to DXA results, implying DXA itself served as a reference, but no mention of human experts establishing ground truth for the test set is given.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study is not mentioned. The document focuses on comparing the algorithm's output (DXAVIEW™) to a reference standard (DXA), not on how human readers' performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "Clinical Performance Data" and "Conclusions" describe the performance of the DXAVIEW™ software directly (e.g., its precision, correlation with DXA), without mentioning a human-in-the-loop component. The device itself is described as "software Options to the Image Analysis QCT-3D Plus product."

7. Type of Ground Truth Used

• The ground truth used was comparison to a predicate device (DXA). The document states, "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip showed correlation coefficients R of 0.93-0.94." It also mentions the new device provides "estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate DXA device." This implies DXA measurements served as the reference standard (ground truth) for the clinical validation.

8. Sample Size for the Training Set

• The document does not specify a separate training set sample size. It describes the validation studies. Since the device uses reference data (NHANES III) for T-Scores and Z-Scores, this reference data itself could be considered a form of "training" or foundational data, but its sample size is not stated in relation to the device's development.

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

• The document does not detail how a training set's ground truth was established, as it primarily focuses on the validation against DXA. It mentions that "NHANES III Standardized Reference Data are used to calculate T-Scores and Z-Scores." The ground truth for such standardized reference data like NHANES III would typically be established through large-scale, cross-sectional population studies using direct measurements (e.g., DXA) from a diverse cohort to establish population norms.

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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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