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The proposed device: GE Lunar DXA Bone Densitometers with the enCORE version 18 software is intended for medical purposes to measure bone density, bone mineral content, and fat and lean tissue content by x-ray transmission measurements through the bone and adjacent tissues.

The changes proposed in this Premarket Notification will be used with the existing GEHC DXA Bone Densitometers, which utilize the enCORE software.

The GEHC DXA Bone Densitometers are composed of a scanner and a computer. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator.

GEHC DXA Bone Densitometers are used healthcare facilities and hospitals to measure bone mineral density (BMD) and body composition (%fat, fat mass, lean mass) using a technique called Dual-energy X-ray Absorptiometry or DXA. DXA measures the attenuation of x-rays of two different energy levels after they pass through the body of a subject. As bone, fat tissue, and lean tissue absorb the different energy x-rays at different rates, the relative attenuation of each x-ray energy is measured and used to calculate the composition of each pixel.

The provided text describes the GEHC DXA Bone Densitometers with enCORE version 18. This device is a bone densitometer that measures bone mineral density (BMD) and body composition using Dual-energy X-ray Absorptiometry (DXA). The submission is a 510(k) premarket notification, indicating that the device claims substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance. Instead, it describes various software features and states that bench performance testing confirmed that design outputs met design input requirements and that results are "comparable" or "precise and accurate."

Here's an attempt to structure the information into a table based on the provided text, recognizing that precise criteria are often implied rather than explicitly stated with quantifiable targets in this type of summary:

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

• DXAVision/Adult TBLH: The study involved a "heterogeneous sample of men and women with a diverse range of age, BMI, BMD, and body fat." No specific numerical sample size is provided.
• Integrated TBS iNsight: "internal engineering DXA data sets" were used. No specific numerical sample size.
• CoreScan: An "anthropomorphic phantom" was used. This is not human data.
• Small Body Composition ROIs: No specific sample size or provenance is mentioned for the verification results.
• Advanced Analytics: No specific sample size or provenance is mentioned.
• Software Verification and Validation: No specific sample size or provenance is mentioned besides "software verification and validation testing."

The provenance of human data, based on the description, is internal to GE Healthcare ("internal engineering DXA data sets"). It is implied to be retrospective, as it refers to existing data sets.

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

The document does not explicitly mention the number or qualifications of experts used to establish ground truth for any of the described tests. The studies focus on comparing the updated software features to previous cleared versions or literature, or phantom data, rather than independent expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any of the described tests. The evaluations appear to be based on comparisons to predicate technology, internal software testing, or phantom measurements.

5. 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 MRMC comparative effectiveness study is mentioned. The device's improvements are focused on streamlined workflow, integration of features, and accuracy/precision of measurements, not on direct human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are primarily standalone algorithmic performance evaluations. For example, the CoreScan bench testing used an anthropomorphic phantom, and the TBS iNsight validation compared algorithmic outputs. The DXAVision and Adult TBLH studies compare algorithm results to literature-reported precision, implying a standalone assessment of the algorithm's measurement precision.

7. The Type of Ground Truth Used

• DXAVision/Adult TBLH: The "ground truth" used for comparison appears to be the precision of "duplicate scans reported in the literature" for existing iDXA and Prodigy devices. This implies a comparison to established performance benchmarks rather than an independently adjudicated 'ground truth' for each case.
• Integrated TBS iNsight: The "ground truth" is the results from the "previously cleared TBS iNsight application."
• CoreScan: The "ground truth" is derived from the known characteristics of an "anthropomorphic phantom."
• Small Body Composition ROIs: "Accuracy of bone and body composition" is confirmed, suggesting comparison to a known standard or previously validated measurements, but the specific nature of this ground truth is not detailed.
• Advanced Analytics: No explicit ground truth is mentioned, as this feature is about user-defined equations using existing data.

8. The Sample Size for the Training Set

The document does not provide details about training sets for any of the software features. This submission is for updates to existing software (enCORE version 18) and integration of previously cleared applications, suggesting development was not based on a new, distinct training phase described in this summary.

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

Since no training set details are provided, the method for establishing ground truth for a training set is not described. The focus of this 510(k) submission is on changes and integrations based on verified algorithms and features, rather than the initial development of a new AI model requiring a training set.

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The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.

In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ).

The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

The seca mBCA 514 is a scale and impedance plethysmograph body composition analyzer for estimation of the body composition of individuals based on the Bioelectrical Impedance Analysis (BIA). The device measures bioelectrical impedance values by means of multi frequency, segmental measurements (right arm, trunk, right leg, left leg, right body side and left body side).

The seca mBCA 514 is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to estimate body composition. The device's performance was evaluated through bench and clinical testing to demonstrate its safety and effectiveness compared to a predicate device, the BioSpace InBody 720 (K052646), and other established methods for specific body composition parameters.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific thresholds (e.g., a certain percentage of agreement or a specific correlation coefficient). Instead, it states that the results of the testing "demonstrate that the seca mBCA 514 is as safe and effective as the predicate device" and that the "differences with the predicate devices and methods are sufficiently minor to establish substantial equivalence." This implies that the acceptance criteria were met by demonstrating comparable performance to established methods.

Here's a summary of the comparisons:

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

The document does not explicitly state the specific sample size used for the test set in the clinical trials, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only broadly refers to "clinical testing."

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth for different parameters was established using established scientific methods (e.g., deuterium oxide dilution, sodium bromide dilution, DXA, BOD POD), rather than solely expert consensus on interpretations of device outputs.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by reference methods, not by expert adjudication of device outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The study described is a comparison of the device's measurements against established methods and a predicate device, not a human reader study with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the studies described are standalone performance evaluations of the seca mBCA 514's ability to measure or estimate various body composition parameters compared to established reference methods and a predicate device. The device's output (measurements and estimations) is directly compared.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established using established scientific methods considered gold standards for body composition measurement:

• Deuterium oxide dilution method: For Total Body Water (TBW)
• Sodium bromide dilution method: For Extra Cellular Water (ECW)
• GE Lunar iDXA Bone Densitometer (K052581): For Lean Soft Tissue (LST)
• Four compartment model (incorporating GE Lunar iDXA, BOD POD Sonamet Body Composition Analyzer (K060848), and deuterium oxide dilution method): For Fat-Free Mass (FFM)
• Biospace InBody 720 (K052646): As a predicate device for Impedance raw data and Weight.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set size. Body composition analyzers typically use pre-developed algorithms and regression equations, which are often derived from large historical datasets, but no details are given here regarding the specific training set for seca's algorithms.

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

The document does not provide information on how the ground truth for any potential training set was established. It only describes the methods used for the comparative clinical testing to establish substantial equivalence.

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