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The bone density estimates from the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.

The Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone Densitometer (SXA 3000TM) can be used whenever it is desirable to do a bone assessment of the os calcis (heel). Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynecology, etc. The SXA 3000TM scans the heel using the industry standard SXA pencil beam technology and provides BMC, Area, BMD, T-Score, and Z-Score values. A scan takes about three minutes and the patient dose is less than 1.5 mRem. The SXA 3000TM provides fracture risk assessment based on the World Health Organization (WHO) criteria for relating the bone density test to fracture risk assessment and disease diagnosis. In general, this assessment states that patients with T-Scores from +1 to -1 are considered to be normal; T-Scores from -1 to -2.5 are considered to have low bone mass and an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic with a high risk of fracture.

The provided text describes a 510(k) summary for a "Fracture Risk Assessment Capability for the Norland SXA 3000™ Bone Densitometer." However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods. Instead, it focuses on the device's description, classification, and regulatory approval based on substantial equivalence to a predicate device.

The core of the document, the "510k Summary," primarily outlines the device's intended use and claim of "Safety and Effectiveness" by stating: "This Fracture Risk Assessment Capability for the SXA 3000™ is comparable to fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised with this capability." This indicates a reliance on the existing regulatory framework for bone densitometers and the predicate device (K973104), rather than a specific de novo study with acceptance criteria and performance metrics described in typical AI/ML device submissions.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify quantitative acceptance criteria or report specific performance metrics for the device. The claim for "Safety and Effectiveness" is based on comparability to predicate devices, not on meeting predefined performance thresholds in a distinct study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe a test set or any study involving patient data to validate the device's performance. The approval is based on substantial equivalence.

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)

• Cannot be provided. No test set or ground truth establishment process is described in the document.

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

• Cannot be provided. No test set or adjudication process is described in the document.

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

• Cannot be provided. This device is a bone densitometer providing quantitative measurements (T-Scores, Z-Scores), not an AI-assisted diagnostic tool that would typically involve human reader improvement studies. The document does not describe any MRMC study.

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

• The device itself is a standalone measurement device. The "Fracture Risk Assessment Capability" for the SXA 3000™ Bone Densitometer functions by providing T-Scores and Z-Scores based on bone density measurements, which are then interpreted by clinicians according to WHO criteria. It's an algorithm embedded in the device to calculate these scores, and its "performance" is implicitly tied to the accuracy and precision of the underlying bone density measurement, which is not detailed here in terms of a standalone study. However, it's not an AI algorithm in the contemporary sense that would have a "standalone performance" study against a human baseline for interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be explicitly provided from the document. The device outputs T-Scores and Z-Scores, which are compared against "estimates for people without bone related disease." The ground truth for these reference populations is implicitly established by epidemiological studies and clinical consensus, as reflected in the WHO criteria mentioned. However, the document does not detail how the ground truth was established for "testing" this specific device's fracture risk assessment capability.

8. The sample size for the training set

• Cannot be provided. The document does not describe a training set for an algorithm in the context of AI/ML. The device's calculations are based on established physical principles of X-ray attenuation and statistical models for T-Scores/Z-Scores derived from reference populations.

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

• Cannot be provided. As above, no training set is described in the context of AI/ML. The "ground truth" for the reference data used to define T-scores and Z-scores would be established through large-scale population studies that measure bone mineral density in healthy individuals, often with age, gender, and ethnicity stratification, as referenced by the mention of WHO criteria.

Essentially, this 510(k) summary is from 1998, predating much of the modern regulatory framework and expectations for AI/ML device submissions, which typically involve detailed performance studies. Its approval is based on substantial equivalence to an existing (predicate) device, making most of the requested performance-study-specific details inapplicable or not available within this document.

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The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

This fracture risk assessment capability provides information that aids the physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.

This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.

The provided text is a 510(k) summary for a "Fracture Risk Assessment Capability" for Norland X-Ray Bone Densitometers. This device is an interpretation capability that uses existing bone densitometer values (BMD and T-Score) and patient information (gender, age, ethnic background) to assess fracture risk based on World Health Organization (WHO) criteria.

The document states that the device "does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts" and "does not increase the scanning time, patient dose, or scatter radiation." It also asserts that "This Norland Fracture Risk Assessment Capability is comparable to fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised."

However, this document does not contain specific acceptance criteria, study details, or performance metrics for the device itself. It focuses on the substantial equivalence argument, stating that the device is comparable to existing predicate devices and does not raise new safety or effectiveness issues. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I detail specific study parameters for this particular device.

The FDA's letter (K980569) confirms that the device is substantially equivalent to a predicate device, meaning it doesn't require new clinical studies to prove safety and effectiveness if it meets the criteria of being essentially the same as a legally marketed device.

Based on the provided text, the following information is available or can be inferred, but many points requested in your prompt are explicitly not available:

Acceptance Criteria and Study Details (Based on available information in the document)

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to a predicate device and confirming that the new capability does not introduce new safety or effectiveness concerns. There are no quantitative performance metrics (e.g., sensitivity, specificity, AUC) detailed in this summary.

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

• Not provided. The document states the device interprets existing bone density test results but does not describe any specific test set or clinical study conducted for this 510(k) submission. The argument is based on substantial equivalence, implying that the underlying science of fracture risk assessment based on WHO criteria is already established.

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

• Not applicable. No specific test set with ground truth established by experts is described for this submission. The "ground truth" for the interpretation method itself is the established World Health Organization (WHO) criteria for T-Scores and their relation to fracture risk and osteoporosis diagnosis.

4. Adjudication method for the test set:

• Not applicable. No specific test set requiring adjudication is 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:

• No. The provided text does not describe an MRMC study or any study involving human readers' improvement with or without AI assistance. The device is described as an "interpretation capability" that presents information, not as an AI-assisted diagnostic tool for readers.

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

• Yes, implicitly. The device itself is an "interpretation capability" that processes bone densitometer values and patient information to generate a fracture risk assessment based on predefined WHO criteria. This operates in a standalone manner to generate its output, which is then presented to a physician. No human interpretation is built into the algorithm's output generation. However, this is not a diagnostic device in itself, but an aid to the physician.

7. The type of ground truth used:

• Expert Consensus / Clinical Guidelines: The ground truth for the fracture risk assessment interpretation is based on the World Health Organization's (WHO) criteria for relating bone density (T-Scores) to the risk of fracture and diagnosis of osteoporosis.

8. The sample size for the training set:

• Not applicable / Not provided. The device is not described as an AI/ML model that undergoes a "training" phase in the conventional sense. It applies established WHO criteria. The WHO criteria themselves were developed based on extensive medical and scientific research, but that's foundational knowledge, not a training set for this specific device.

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

• Not applicable. As described above, there's no "training set" in the context of an AI/ML algorithm. The underlying "ground truth" (WHO criteria) was established through scientific consensus and epidemiological studies in the medical community.

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The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.

The Norland Apollo™ Bone Densitometer (Apollo™) scans the os calcis (heel) using the industry standard DXA pencil beam technology to assess bone density. A water bath is not required and the scan takes less than 30 seconds. Patient dose is less than 0.5 mRem and scatter radiation is less than 0.1 mRem/hour at 3 feet.

Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo™ BMD scan results to healthy young adults aged 20 to 42. The results of the comparison is given in terms of T-Score (the number of standard deviations from the healthy young adult value), % Young Reference (the percentage relative to the healthy young adult value), and in graphical form.

The Apollo™ Reference Population capability also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.

Other reference data sets will be available in the future.

Here's an analysis of the provided text regarding the Norland Apollo™ Bone Densitometer's reference population capability, structured according to your requested information.

It's important to note that the provided 510(k) summary primarily focuses on establishing substantial equivalence for a reference population capability rather than a device with a specific performance metric like accuracy or sensitivity/specificity against a ground truth. The "device" in this context refers to the software feature that allows the Apollo™ densitometer to compare BMD results against a healthy young adult population. Therefore, typical acceptance criteria that you might expect for a diagnostic algorithm (e.g., AUC, sensitivity, specificity) are not present here. Instead, the "acceptance criteria" are implied by the successful establishment of this reference population.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this 510(k) is for a reference population capability, not an algorithm that produces a diagnostic output with typical performance metrics. The "device performance" here relates to the establishment and utilization of reference data.

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

The 510(k) summary does not explicitly describe a "test set" or a study designed to evaluate the performance of an algorithm against a specific gold standard using such a set. The document refers to "reference sets" which are effectively population normative data.

• Sample Size: Not specified for the reference sets of young normal Caucasians.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is described as "young normal Caucasian men and women."

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

This information is not provided in the 510(k) summary. Given that the submission is for a reference population capability and not a diagnostic algorithm, the concept of "experts establishing ground truth for a test set" in the traditional sense of evaluating an algorithm's output doesn't directly apply. The "ground truth" would be the derivation of the normative reference values, which typically involves statistical analysis of a healthy population, not individual expert adjudication of cases.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set that underwent adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. The context is not an AI-assisted interpretation but rather the provision of normative reference data for bone density measurements.

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

The "device" here is the software capability to provide reference population comparison, T-Scores, and fracture risk assessment based on WHO criteria. This is a standalone computational function of the densitometer; it doesn't involve human-in-the-loop performance for its core operation. The densitometer measures BMD, and the software then applies these reference data and algorithms to present results. However, it's not a standalone diagnostic AI algorithm in the contemporary sense.

7. The Type of Ground Truth Used

For the reference population, the "ground truth" is implicitly derived from statistical analysis of a defined "healthy young adult" population. This isn't pathology, outcomes data, or expert consensus on individual cases, but rather population-level normative data representing ideal bone mineral density for healthy young adults.

8. The Sample Size for the Training Set

The 510(k) summary does not specify the sample size for the "reference sets" (which serve as the basis for the device's capability, akin to a training set for normative data).

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

The document states: "Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo™ BMD scan results to healthy young adults aged 20 to 42."

The method for establishing these "reference sets" (the "ground truth" for normative data) is not detailed in this summary. Typically, such reference populations are established through:

• Careful selection of individuals meeting specific health criteria (e.g., no known conditions affecting bone metabolism, within a specific age range, ethnicity).
• Measurement of their bone mineral density using the densitometer.
• Statistical analysis of this data to derive mean BMD values and standard deviations for different age groups within the defined population.

The predicates mentioned (K931996 for pDEXA™ Reference Population and K973104 for Fracture Risk Assessment) imply that established methodologies for creating and using reference populations for bone densitometers were followed for the Apollo™ system.

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The Norland Body Composition Option (body composition) assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values.

These body composition estimates are useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment, can affect the relative amounts of patient fat and lean tissue. The Norland Body Composition Option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which lean and fat tissue estimates are useful are chronic renal failure, Anorexia Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is also a convenient alternative to hydrostatic weighing and skin fold measurements.

The Norland Body Composition Option (body composition) is used with Norland DEXA bone densitometers to estimate the relative amounts of lean and fat tissue in the scan area. Body composition does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans. In most cases, existing scans can be re-analyzed to provide the body composition values. Although body composition is most useful for whole body scans, it is compatible with all scan modes for Norland DEXA bone densitometers. Body composition values for whole body scans were compared to underwater weighing (UWW) values in clinical studies involving hundreds of subjects. The UWW values were determined using both the Siri and Brozek equations. Based on this study, the Norland body composition provides the Siri and Brozek equivalent values for the Whole Body scans.

The provided text describes the Norland Body Composition Option, a software addition to DEXA bone densitometers. The information available focuses on the device's intended use, safety, and regulatory clearance via 510(k) summary, rather than a detailed scientific study with explicit acceptance criteria.

However, based on the text, we can infer some details about the study and acceptance criteria related to its substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Body composition values for whole body scans were compared to underwater weighing (UWW) values in clinical studies involving hundreds of subjects. The UWW values were determined using both the Siri and Brozek equations. Based on this study, the Norland body composition provides the Siri and Brozek equivalent values for the Whole Body scans."

While specific numerical acceptance criteria (e.g., a specific correlation coefficient or percentage agreement) are not provided, the implicit acceptance criterion is that the Norland Body Composition Option's values "provide the Siri and Brozek equivalent values." This suggests that the device's output was considered sufficiently close to the UWW measurements (calculated via Siri and Brozek equations) to be deemed equivalent and acceptable.

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

• Sample Size: "clinical studies involving hundreds of subjects."
• Data Provenance: The document does not specify the country of origin. It does not explicitly state whether the data was retrospective or prospective, but "clinical studies" typically imply prospective data collection for such comparisons.

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

This information is not provided in the document. Underwater weighing (UWW) is a direct measurement method for body density, from which body composition is calculated using established equations (Siri and Brozek). Therefore, human expert "ground truthing" in the sense of image interpretation is not directly applicable to the UWW measurements themselves. The expertise would lie in correctly performing UWW and applying the equations, which is assumed.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth (UWW) is a direct measurement, not an expert-driven assessment requiring adjudication.

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

No, an MRMC study was not done. The study described compares the device's output to a physical measurement (UWW), not to human readers' interpretations with and without AI assistance.

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

Yes, the study described is a standalone performance assessment. The Norland Body Composition Option, a software feature, generates body composition values, which were then directly compared to UWW values. There's no mention of a human-in-the-loop component in this comparison.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / physical measurement, specifically Underwater Weighing (UWW), from which body composition values were derived using the Siri and Brozek equations. This is considered a gold standard for body composition assessment.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the clinical study appears to refer to the validation of the device's output against UWW. Given the nature of this 510(k) summary for a software option, it's possible the core algorithms for converting DEXA data to body composition were developed and validated independently prior to this specific submission, or the "clinical studies involving hundreds of subjects" served as the primary validation set for the software's performance against a gold standard.

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

This information is not provided, as a distinct training set and its ground truth establishment are not discussed in the document. If the "clinical studies involving hundreds of subjects" served as the primary validation, then the ground truth for this validation was established via Underwater Weighing (UWW) as described in point 7.

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The bone density estimates from the Norland pDEXA™ Bone Densitometer can be used as an aid to the physician in determining fracture risk.

The Fracture Risk Option consists of updated software which adds the fracture risk features to the screens and printed reports for the pDEXA. It also includes a supplement to the pDEXA Operator's Guide which explains how to interpret the pDEXA bone density values to aid in the assessment of fracture risk and the diagnosis of osteoporosis.

The provided document for K973104, "Fracture Risk Assessment Option for the Norland pDEXA™ Bone Densitometer," is a 510(k) summary submitted to the FDA in 1997. This submission focuses on establishing substantial equivalence to a pre-amendment device (Norland-Cameron Model 178 Bone Mineral Analyzer) rather than presenting a performance study with detailed acceptance criteria and reported device performance. As such, many of the requested details about a specific study testing the device against performance criteria are not available in this document.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not describe specific numerical acceptance criteria or present data from a performance study of the "Fracture Risk Assessment Option." Its primary argument is substantial equivalence to an existing device's intended use and function.

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

Not available. There is no mention of a test set, sample size, or data provenance (country of origin, retrospective/prospective) for evaluating the "Fracture Risk Assessment Option."

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

Not available. Since no specific performance study is detailed, there's no information about experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not available. No test set or adjudication method is described.

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

No. The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a software option for a bone densitometer, and the focus is on its output's relationship to existing diagnostic guidelines, not its impact on human reader performance in an MRMC setting.

6. Standalone Performance Study (Algorithm Only)

Not performed or reported in this document. The submission is for a "Fracture Risk Assessment Option" which is an update to existing software. The focus is on the substantial equivalence of its output (T-Scores and fracture risk categorization based on WHO definitions) to a predicate device's method, not on new standalone performance metrics. The document states: "The Fracture Risk Option provides an assessment of relative fracture risk based on the T-Score value. It presents the World Health Organization's (WHO) definition of osteoporosis and osteopenia; and makes the same diagnostic recommendations originally made by the pre-amendment Model 178." This implies the performance is tied to the established science behind T-Scores and WHO definitions, not a new algorithm requiring a standalone study in this context.

7. Type of Ground Truth Used

The ground truth implicitly used for the "Fracture Risk Assessment Option" is based on:

• Expert Consensus and Established Medical Guidelines: Specifically, the World Health Organization's (WHO) definition of osteoporosis and osteopenia, which is based on T-scores (standard deviations below the young adult mean).
• Predicate Device's Methodology: The comparison to the "pre-amendment Model 178" implies that its established approach of assessing bone density relative to a reference population and assigning fracture risk based on deviations from the mean served as a form of "ground truth" for equivalence. The "Interpretation of Fracture Index Charts; E. Smith and J. R. Cameron" (Smith-Cameron charts) is referenced as proof for the predicate device's claims.

8. Sample Size for the Training Set

Not available. As a software update applying WHO definitions and T-scores to data from an existing bone densitometer, it is highly unlikely there was a "training set" in the modern machine learning sense. The device's "training" (establishment of reference populations) would have occurred during the development of the original pDEXA™ Bone Densitometer device and the predicate Model 178. The document mentions "reference population (device specific)" for comparison, but not sample sizes for this reference population.

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

Not available for this specific submission. For the underlying bone densitometry, the "ground truth" for establishing reference populations would typically involve:

• Large Cohorts of Healthy Individuals: To establish normal bone mineral density (BMD) values across different age groups and genders.
• Clinical Studies and Epidemiological Data: To correlate BMD values with fracture incidence, leading to the establishment of thresholds like the WHO T-score criteria.

The document refers to the "reference population (device specific)" and states that the "Fracture Risk Option" and the Model 178 "both compare this bone density assessment to a reference population in terms of the number of standard deviations the value is below the mean." The ground truth for these reference populations was established through previous scientific and clinical work, much of which predates this 510(k) submission. The exact methods for the specific Norland devices' reference populations are not detailed here beyond mentioning the "Smith-Cameron charts."

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The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.

Apollo™ is a low cost, portable, easy-to-use bone densitometer which uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.

Here's an analysis of the provided text regarding the Norland Apollo™ Bone Densitometer, outlining the acceptance criteria and study information:

Norland Apollo™ Bone Densitometer Performance Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the Apollo™ to predicate devices rather than explicit, pre-defined acceptance criteria with quantifiable targets. However, based on the comparative table and descriptive text, we can infer the performance metrics considered important and the device's reported capabilities. This resembles how substantial equivalence is often demonstrated with respect to performance relative to established devices.

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