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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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