Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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 <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns.
The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement:
"Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

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

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The information provided is a summary of technical characteristics and a statement of comparability, rather than a detailed study report.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for any test set. The study focuses on correlation and precision compared to a predicate device, not on expert-adjudicated ground truth.

4. Adjudication method

The document does not mention any adjudication method for a test set.

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

There is no indication that an MRMC comparative effectiveness study was conducted, nor is there any mention of AI assistance in this document. The device is a bone densitometer, an imaging hardware device, not an AI-powered diagnostic tool.

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

The document does not describe a standalone algorithm performance. The device itself is a standalone system for measuring BMD, and its performance is assessed against a predicate device's output. There isn't an "algorithm only" component in the context of typical AI/software device studies.

7. The type of ground truth used

The "ground truth" in this context is established by the predicate device (LUNAR PIXI). The study assesses the ORCA-DX's ability to produce highly correlated and precise BMD estimations relative to the predicate device, implying the predicate's output serves as the reference standard for this substantial equivalence submission. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for a diagnostic algorithm.

8. The sample size for the training set

The document does not specify any training set size. This device is not described as involving machine learning or AI that would require a distinct training set. The performance is assessed based on direct comparison to the predicate and precision measurements.

9. How the ground truth for the training set was established

As there's no mention of a training set in the context of an AI/ML algorithm, there's no information on how ground truth for a training set was established. The "ground truth" for the performance evaluation itself is the predicate device's measurements.

Ask a specific question about this device

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:

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

• Sample Size: 46 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary, it is generally assumed that these studies are typically prospective clinical performance studies conducted in a controlled environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This type of device (bone densitometer software) uses physical measurements rather than subjective interpretation by experts for its primary output (BMD, lean/fat tissue mass). Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not directly apply here.
• The "ground truth" for the test set is established by the measurements obtained from the predicate device (LUNAR DPX Total Body Software), which is itself a validated bone densitometer. The comparison is between the new device's readings and the predicate device's readings. The predicate device's performance would have been established through prior clinical validation.

4. Adjudication Method for the Test Set:

• Not applicable. The study involves direct comparison of quantitative measurements (BMD, mass) between two devices on the same subjects, not expert adjudication of subjective interpretations.

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

• No, an MRMC comparative effectiveness study was not done. This device is an automated measurement system and does not involve human readers interpreting images. The study focuses on the agreement between the device's measurements and those of a predicate device.

6. Standalone Performance Study (Algorithm Only):

• Yes, the study described is a standalone performance study in the sense that it evaluates the algorithm's (software's) output by comparing its quantitative measurements directly against those of a predicate device. There is no human-in-the-loop performance evaluated in this summary.

7. Type of Ground Truth Used:

• Instrumental/Comparative Ground Truth: The ground truth is established by the measurements obtained from a legally marketed and presumably validated predicate device, the LUNAR DPX Total Body Software. The new device's measurements are compared to the predicate device's measurements.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for a training set. For a bone densitometer software, development often involves extensive internal testing and calibration using phantoms and potentially a large retrospective dataset for algorithm refinement, but this information is not typically included in a 510(k) summary as a distinct "training set" size. The 46 subjects mentioned are for the validation/test set.

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

• As the training set sample size and its specific details are not provided, the method for establishing ground truth for a hypothetical or implied training set is also not detailed. However, generally for such devices, ground truth for algorithm development and calibration would involve:
  • Phantom Studies: Using known, precisely measured physical phantoms with established BMD and composition.
  • Comparison to Reference Methods: Potentially comparative studies against DEXA gold standards or other validated technologies if available during early development.
  • Clinical Data with Predicate Device Correlation: Using data where the predicate device's measurements serve as the reference.

Ask a specific question about this device

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.

1. 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.

2. 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.

3. 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.

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

   • Not applicable. No test set and no adjudication method are described.

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

   • Was an MRMC study done? No. The document does not describe any MRMC comparative effectiveness study.
   • Effect size of improvement: Not applicable.

6. 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.

7. 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.

8. 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.

9. 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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Fracture Risk option is used with the LUNAR DPX Series of bone densitometer systems. 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 DPX Series is restricted to prescription use only.

The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.

The Fracture Risk option for DPX Series is a software accessory to aid the physician in assessing fracture risk from the results of a DPX Series 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 contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the format requested.

Here's an analysis of what is available based on the provided text, and what is missing:

What is present in the document:

• This is a 510(k) Pre-market Notification for the "Fracture Risk option for DPX Series Bone Densitometers."
• The device is a software accessory that provides fracture risk assessment based on a patient's bone mineral density T-score.
• It does not involve a comparative effectiveness study with human readers or standalone algorithm performance. Instead, it relies on substantiating equivalency to a predicate device.
• The ground truth for the device's assessment is stated to be "the categories of fracture risk defined by the World Health Organization (WHO)" using the patient's T-score value. This indicates a reliance on established medical guidelines rather than a new empirical study for establishing fracture risk.
• The submission document is a summary of safety and effectiveness, and the FDA's clearance letter. It concludes that "No new safety and effectiveness questions are raised" because the device is substantially equivalent to a pre-amendment device (Norland-Cameron Model 178 Bone Mineral Analyzer).

Missing Information (not found in the provided text):

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, precision). The document states no new safety or efficacy concerns and relies on substantial equivalence.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on standalone (algorithm-only) performance.
• Sample size for the training set.
• How ground truth for the training set was established (beyond reliance on WHO guidelines for T-score interpretation).

Summary of available information:

1. Table of acceptance criteria and reported device performance: Not applicable in the context of this 510(k) submission, as it focuses on substantial equivalence rather than new performance claims from an analytical study. The "performance" is implicitly tied to compliance with WHO guidelines for T-score interpretation.

2. Sample size used for the test set and data provenance: No test set is described. The device leverages existing interpretations of T-scores based on WHO guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as reliance is on WHO-defined categories of fracture risk, not a specific expert interpretation for a test set.

4. Adjudication method for the test set: Not applicable.

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 study was mentioned or performed as part of this submission. The device is a software accessory providing information based on existing measurements.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No specific standalone performance study is described. The device's function is to apply established WHO criteria to T-scores, which are generated by the bone densitometer.

7. The type of ground truth used: World Health Organization (WHO) definitions and categories of fracture risk based on T-score values. This is a form of established clinical guideline or consensus.

8. The sample size for the training set: Not applicable. This device is not described as using a machine learning model that requires a training set. It applies a rule-based algorithm (T-score to WHO fracture risk category).

9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

In essence, this device's regulatory review focused on its classification and the absence of new safety or efficacy concerns given its function as a software accessory applying established medical guidelines to existing data (bone density T-scores). It was determined to be "substantially equivalent" to a predicate device, meaning it did not require novel performance studies against specific acceptance criteria for a new clinical claim.

Ask a specific question about this device

The DPX-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The use of the DPX-RX Bone Densitometer is restricted to prescription use only.

The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

   • Sample Size: 50 subjects in vivo.
   • Data Provenance: Not explicitly stated, but based on the contact information (Madison, WI, USA) and the nature of medical device submissions to the FDA, it is highly likely that the data was collected in the USA.
   • Retrospective or Prospective: Not explicitly stated. Given that it's a submission for a new device claiming substantial equivalence, it's generally prospective for the new device testing itself, but could involve retrospective analysis of existing DPX-L data for comparison.

3. Number of Experts and Qualifications: Not applicable. The study is a technical comparison of device measurements, not a diagnostic accuracy study requiring expert human interpretation for ground truth.

4. Adjudication Method: Not applicable, as there's no human interpretation being adjudicated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. The study compares the performance of the new device to a predicate device, not human readers with and without AI assistance.

6. Standalone Performance: Yes, the study describes the standalone performance of the DPX-RX Bone Densitometer in terms of its BMD estimation, correlation with a predicate device, and precision.

7. Type of Ground Truth Used:
   The "ground truth" here is the measurement obtained from the predicate device, the LUNAR DPX-L, and established precision metrics (e.g., %CV) from previously validated methods. It's a comparison against an existing gold standard device, rather than a biological "ground truth" like pathology.

8. Sample Size for Training Set: Not applicable. This document describes a performance evaluation of a device, not the development of an AI algorithm with a training set.

9. How Ground Truth for Training Set was Established: Not applicable.

Ask a specific question about this device

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD), in g/cm2, of the lumbar spine vertebrae in the lateral view provided for the EXPERT-XL Bone Densitometer with a reference population for comparative purposes.

This device, the EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software, is an accessory for the EXPERT-XL Bone Densitometer. It is designed to estimate Bone Mineral Density (BMD) of the lumbar spine in the lateral view.

Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the in vitro and in vivo precision and correlation tests.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of Experts for Ground Truth and Qualifications

• The document does not provide information on the number of experts used to establish ground truth or their qualifications. The "known phantoms" for in vitro testing would inherently have an established ground truth, but the in vivo data's ground truth establishment method is not detailed.

4. Adjudication Method

• The document does not describe any adjudication method.

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

• A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on device performance metrics rather than human reader improvement with AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was implicitly done. The "reported device performance" noted in the table above refers to the algorithmic performance of the software itself in measuring BMD. This includes in vitro correlation and precision, as well as in vivo precision, without explicit mention of human interpretation influencing these results.

7. Type of Ground Truth Used

• For in vitro testing: "Known phantoms" imply a precisely measured or known BMD value, serving as an objective ground truth.
• For in vivo testing: The ground truth for the "average short term precision (CV) in vivo" is based on repeat measurements on human subjects. This is a measure of reproducibility, where the "ground truth" for a given subject at a given time is essentially the value obtained by the device itself, and the precision metric assesses the variability around this. It does not explicitly state an independent "gold standard" for the absolute BMD values in vivo.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. It's likely that the software's algorithms were developed and refined (trained) using a dataset, but this information is not provided.

9. How Ground Truth for the Training Set Was Established

• The document does not specify how the ground truth for any training set was established. Given the nature of a bone densitometer, training would likely involve a combination of phantom data (with known BMD) and clinical data where BMD might be established through various means (e.g., other densitometry methods, or clinically accepted values). However, this is not detailed here.

Ask a specific question about this device