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510(k) Data Aggregation
(120 days)
GE LUNAR CORP.
The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only.
The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
This document describes the equivalence study for the GE LUNAR DPX series Bravo, Duo Bone Densitometer.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate: LUNAR PRODIGY) | Reported Device Performance (DPX series Bravo, Duo) |
|---|---|
| In vivo BMD spine correlation with predicate: r > 0.983 | r > 0.983 (The actual reported value is ">0.983" for correlation with Prodigy, implying it met or exceeded this specific threshold) |
| In vivo average BMD values with predicate: Very similar | Very similar (Average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo) |
| In vitro short-term precision (%CV): Not explicitly stated, but 0.983) and the qualitative similarity of average BMD values. Other metrics are presented as being "comparable" to currently marketed devices, which implies the acceptance criterion was roughly "within the expected range for similar devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 45 subjects
- Data Provenance: In vivo data, implying it was collected from human participants. The country of origin is not specified in the provided text, but the manufacturer (GE LUNAR Corporation) is based in Madison, WI, USA. The study design is prospective as it involves collecting data for the purpose of comparing the new device to the predicate in subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a bone densitometer, the "ground truth" for BMD is typically the measurement from a reference device (the predicate in this case) rather than expert interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study directly compares numerical BMD measurements from two devices, not interpretations requiring adjudication.
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
An MRMC study was not done. This device is a bone densitometer, which provides quantitative measurements of BMD. It does not involve human readers interpreting images in a way that would typically be evaluated in an MRMC study with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this study is effectively a standalone (algorithm only) performance evaluation. The device generates a numerical BMD value without human intervention in the measurement process itself. The study evaluates the output of the new device (DPX series Bravo, Duo) against the output of the predicate device (Prodigy).
7. The Type of Ground Truth Used
The ground truth used for performance comparison is the measurements obtained from a legally marketed predicate device (LUNAR PRODIGY). In this context, the predicate device's measurements serve as the reference standard to establish substantial equivalence.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. In the context of a 510(k) for a device like a bone densitometer, there might not be an explicit "training set" in the machine learning sense. The device's calibration and underlying algorithms would have been developed prior to this equivalence study, likely using internal data and engineering principles, but details of that development are not part of this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no explicit mention of a training set or its ground truth establishment in this summary.
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(58 days)
GE LUNAR CORP.
Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).
The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The Dual-energy Vertebral Assessment View Software enables imaging of the spine for visual identification of vertebral deformities and estimation of vertebral heights (morphometry). Using this software, the patient is scanned as under the currently distributed product. The Dual-energy Vertebral Assessment View Option adds the ability to visually assess the image for identification of vertebral deformations.
The provided text describes a 510(k) summary for the GE Lunar Prodigy Dual-energy Vertebral Assessment View Software. However, it does not contain specific information about acceptance criteria or a detailed study proving the device meets acceptance criteria.
The document states:
- "The Prodigy Dual-energy Vertebral Assessment View Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Dual-energy Vertebral Assessment View Software application."
This indicates that the submission relies on demonstrating substantial equivalence to predicate devices (GE Lunar Lateral View software 510(k) K000826, LUNAR EXPERT Morphometry Software 510(k) K950611, Hologic Morphometry II option 510(k) K992775), rather than providing a detailed study with specific performance metrics against pre-defined acceptance criteria for the new software feature itself.
Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory compliance through substantial equivalence, not on a detailed performance study with acceptance criteria.
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(44 days)
GE LUNAR CORP.
Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females.
The Hip Morphometry Software, to be marketed as Advanced Hip Assessment Software, analyzes previously acquired dual-energy x-ray absorptiometry (DEXA) images of the proximal femur from the Prodigy bone densitometer for measurement of the hip axis length (HAL). The patient is scanned for bone density of the proximal femur with the currently distributed product, and puterit is bounded for official ware measures the HAL. A mean value of HAL for Caucasian females is included for comparison at the sole discretion of a physician.
The provided text unfortunately does not contain the detailed study information required to fill out the table and answer all the questions. The 510(k) summary focuses on establishing substantial equivalence to predicate devices for the "Advanced Hip Assessment Software Option" (Hip Morphometry Software) which measures Hip Axis Length (HAL) from DEXA images.
It states: "The Hip Morphometry Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Hip Morphometry Software application." This implies that extensive new studies proving performance against acceptance criteria beyond what was established for the predicate devices might not have been required for this specific filing.
Here's what can be inferred or stated as "not provided" based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hip Axis Length (HAL) Measurement Accuracy | Not provided | Not provided. The text only states the software "measures the HAL." |
| Reproducibility/Precision of HAL Measurement | Not provided | Not provided |
| Comparison to Gold Standard (if applicable for HAL) | Not provided | Not provided |
| Clinical Efficacy (e.g., impact on fracture risk prediction) | Not provided | Not provided |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not provided.
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
- MRMC Study: Not provided. Given the nature of the device (automated measurement of HAL), it is unlikely an MRMC study comparing human readers with and without AI assistance would be the primary validation method. The device automates a measurement, rather than assisting human interpretation of complex images.
- Effect Size of Improvement: Not applicable, as no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The text describes the software as analyzing images for measurement of HAL. This implies a standalone algorithm's performance in generating the HAL value. However, the details of such a study (sample size, metrics, ground truth comparison) are not provided. The "conclusion" states substantial equivalence, suggesting direct performance metrics for this specific device might have been linked to those of the predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not provided. For HAL, a physical measurement on a phantom or cadaver, or established manual measurements by experts on DEXA images, would typically be used as ground truth, but this is not mentioned.
8. The sample size for the training set
- Sample Size (Training Set): Not provided.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not provided.
Summary of what is known from the document:
- Device: Advanced Hip Assessment Software Option (Hip Morphometry Software) for Prodigy bone densitometers.
- Function: Analyzes DEXA images of the proximal femur to measure Hip Axis Length (HAL).
- Comparison: Includes a mean HAL value for Caucasian females for physician comparison.
- Regulatory Context: 510(k) submission, granted substantial equivalence, indicating it is similar in safety and effectiveness to predicate devices (LUNAR EXPERT Morphometry Software K950611 and LUNAR EXPERT Spine Morphometry Reference Values K961007).
- Intended Use: Prescription use only.
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(25 days)
LUNAR CORP.
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(27 days)
LUNAR CORP.
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(31 days)
LUNAR CORP.
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(56 days)
LUNAR CORP.
The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.
The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.
Acceptance Criteria and Study for Prodigy Total Body Software:
This device is a bone densitometer software, and its primary function is to provide estimations of Bone Mineral Density (BMD), lean tissue mass, and fat tissue mass. The acceptance criteria and supporting study focus on the correlation and precision of these measurements compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (LUNAR DPX) for BMD estimations. | r > 0.98 with the DPX. |
| Similarity of average BMD, lean, and fat tissue mass values compared to predicate device. | Very similar to the results obtained on a DPX in 46 subjects. |
| Short-term precision (%CV) in vivo for total body BMD. |
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(47 days)
LUNAR CORP.
The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of
The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.
Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Total exposure dose (lower than predicate and safe) | **Radiation exposure is |
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(62 days)
LUNAR CORP.
The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for PIXI is restricted to prescription use only.
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
This document is a 510(k) premarket notification for a software feature called "Fracture Risk option for EXPERT-XL Bone Densitometer," which assesses fracture risk based on a patient's bone mineral density T-score. The submission aims to establish substantial equivalence to a predicate device.
Here's an analysis of the provided text regarding acceptance criteria and the study:
Key Takeaways:
- No specific acceptance criteria or performance study is reported in this document. The submission relies on establishing substantial equivalence to a predicate device (Norland-Cameron Model 178 Bone Mineral Analyzer) rather than providing a new performance study with explicit acceptance criteria.
- The core argument is that the new software option does not introduce new safety or effectiveness concerns and does not change scan parameters or results produced by the bone densitometer.
Given this, I will answer the questions based on the absence of this information in the provided document, where applicable.
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not stated. Not stated. Explanation: The document does not provide specific acceptance criteria (e.g., target accuracy, sensitivity, specificity) for the Fracture Risk option, nor does it report any performance metrics against such criteria. The submission's focus is on substantial equivalence, implying that its performance is implicitly considered equivalent to the predicate device because it doesn't alter diagnostic output.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No test set or performance study is described.
- Data Provenance: Not applicable. No data or study is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set and no adjudication method are described.
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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
- Was an MRMC study done? No. The document does not describe any MRMC comparative effectiveness study.
- Effect size of improvement: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The document does not describe a standalone performance study. The device is a "software accessory to aid the physician," implying human-in-the-loop use. However, no performance data for this aid is provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth is described as part of a performance study for this submission. The device provides "assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO)." This implies that the 'ground truth' for its classification logic is based on established WHO guidelines, not a newly gathered dataset with independent ground truthing.
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The sample size for the training set
- Not applicable. The document does not describe a training set as part of a machine learning or AI algorithm development process. The "Fracture Risk option" appears to be a rule-based software feature applying WHO criteria to existing bone density T-scores.
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How the ground truth for the training set was established
- Not applicable. No training set is described. The "ground truth" for the device's function is the established WHO categories for fracture risk based on T-scores.
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(62 days)
LUNAR CORP.
The Fracture Risk option is used with the LUNAR EXPERT-XL bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for EXPERT-XL is restricted to prescription use only.
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
The Fracture Risk option for EXPERT-XL is a software accessory to aid the physician in assessing fracture risk from the results of an EXPERT-XL bone density examination. The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced.
The provided text does NOT include details about acceptance criteria, device performance, study design, or ground truth establishment. This specific 510(k) summary focuses on establishing substantial equivalence for a software feature (Fracture Risk option for EXPERT-XL Bone Densitometer) to a pre-amendment predicate device (Norland-Cameron Model 178 Bone Mineral Analyzer).
The summary explicitly states: "The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced." and "The Fracture Risk option for EXPERT-XL poses no new safety or efficacy concerns."
Essentially, the manufacturer is arguing that because the new software feature only processes existing bone mineral density T-scores into WHO-defined categories of fracture risk, and does not alter how the bone densitometer collects data or produces the primary T-score, no new performance studies are required to demonstrate safety or effectiveness beyond the existing predicate device.
Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria, study details, human reader performance, or ground truth from the provided text.
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