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The optional "Complete Pediaric" software option mineral content (BMC), bone nineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorpionery to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the software does not provide a reference population for comparative purposes for patients younger than 5 years of age.

Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).

enCORE software is used on GE Lunar DXA bone densitometers. Release 16 of the enCORE software (enCORE 16 or enCORE 16.xx) includes some feature enhancements. The software will now expand upon its previously cleared pediatric indication (K001812) by providing a "Complete Pediatric" software that can measure the bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software will also provide a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. The software will also expand its previously cleared orthopedic hip indication (K972517) to include estimates of the BMD of the knee before and after joint implant.

The GE Lunar DXA bone densitometers measure the bone mineral density (BMD), lean and fat tissue mass and calculate derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI).

GE Healthcare's enCORE version 16 software for Lunar DXA Bone Densitometers expands its pediatric indication to include patients from birth to 20 years of age and its orthopedic hip indication to include knee BMD estimates before and after joint implant.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for accuracy, precision, sensitivity, or specificity) or quantitative performance metrics for the enCORE version 16 software.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices through verification and validation testing, confirming that the new features (expanded pediatric age range and knee orthopedic analysis) do not introduce new safety concerns and perform as well as existing devices.

The "Conclusion" section indirectly serves as a high-level performance claim:
"It does not result in any new potential safety risks, has the same technological characteristics, and performs as well as the devices currently on the market."

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

The document states: "Bench testing was performed to verify the effectiveness of the expanded population range of the 'Complete Pediatric' software application from birth to 20 years as well as add the knee as an additional anatomic site for the orthopedic software application."

• Sample Size: The document does not specify the sample size for the bench testing performed.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The term "bench testing" suggests that patient data might not have been used in the traditional clinical trial sense for this specific verification, but rather phantoms or historical data.

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

The document does not mention the use of experts to establish ground truth for a test set. The verification approach was primarily "bench testing," which typically refers to technical and performance validation in a lab setting rather than expert human interpretation.

4. Adjudication Method for the Test Set

Since an expert-based ground truth establishment is not mentioned, an adjudication method is not applicable or described.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, enCORE version 16 Software Release for the GE Lunar DXA Bone Densitometers, did not require clinical studies to support substantial equivalence." This indicates that no studies comparing human reader performance with and without AI assistance were conducted or deemed necessary for this submission.

6. Standalone (Algorithm Only) Performance

The document does not separately report standalone (algorithm-only) performance metrics in terms of diagnostic accuracy that might typically be seen with CADe/CADx devices. The performance is described in the context of the device's expanded capabilities (measuring BMC, BMD, body composition, and estimating periprosthetic BMD) and its overall substantial equivalence to predicate devices. The "bench testing" described implies verification of the algorithm's output against expected technical performance rather than a clinical diagnostic accuracy trial.

7. Type of Ground Truth Used

For the bench testing, the type of "ground truth" would likely involve technical standards, phantom measurements, and comparisons against established predicate device performance. The document focuses on "effectiveness of the expanded population range" and adding a new anatomical site, implying that the ground truth related to accurate measurement of bone density, bone mineral content, and body composition within the defined age range and for the new anatomical site was validated. This would typically involve using known reference points or established measurement techniques.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This submission is for new software features (expanded pediatric range and knee analysis) for an existing device. It's possible that the core algorithms were developed or trained using data prior to this specific submission, but details are not provided here. The changes are presented as "feature enhancements" and expansions of previously cleared indications, suggesting modification rather than a completely new algorithm development needing a separate training set description.

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

As no training set is described, the method for establishing its ground truth is not provided.

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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 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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