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UltraScan 650 can be used to determine BMDus Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.

The BMDus Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMD 15 Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual.

The UltraScan 650, with a user-supplied laptop, is designed for the estimation of bone mineral density (BMD in g/cm²) of the radius at the 1/3 location. The UltraScan 650 outputs a BMD is Index an estimate of the BMD that would be measured by dual-energy X-ray absorptiometry (DXA) at the same anatomical location, that is, an estimate of BMDDXA, at the 1/3 radius. The UltraScan 650 also outputs the T-score in standard deviations (SD) and Z-score in SD as well. The precision of the measurement is 2.1%, when expressed as a coefficient of variation. The range of the output of the UltraScan 650, depends on the subjects that are measured. However, based on the normative (reference) data, we can calculate the range that will include 99.85% of all subjects.

Here's an analysis of the acceptance criteria and study information for the UltraScan 650, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, quantifiable list. However, based on the performance comparisons made to establish substantial equivalence, we can infer the key performance metrics and the reported results for the UltraScan 650. The primary goal is to correlate with DXA measurements and demonstrate comparable precision.

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

The document provides limited detail on specific sample sizes for each clinical test. It mentions a "broader population" for patient population discussions and multiple "data sets."

• Sample Size for Test Set: Not explicitly stated as a single number.
• Data Provenance: The document generally refers to "Clinical Data" without specifying country of origin or whether it's retrospective or prospective. Given the FDA submission, it's likely the data were gathered for this submission. The reference database used is "Hologic 1/3 radius adult white females and males, K023398 / K103265," which suggests a US-centric or internationally recognized normative database.

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 document. The ground truth relies on DXA measurements, which are considered the "gold standard," but no details are given about the experts who performed or interpreted these DXA scans or established the ground truth.

4. Adjudication Method for the Test Set

This information is not provided 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

This device, the UltraScan 650, is a bone sonometer and not an AI-assisted diagnostic imaging interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human reader improvement with or without AI assistance is not applicable and was not performed. The device provides a direct measurement (BMDus Index) rather than assisting human interpretation of complex images.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the very nature of the UltraScan 650 is a standalone device. It's an "ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius." It outputs a BMDus Index, T-score, and Z-score directly. There is no mention of a human-in-the-loop component for its primary function of generating these measurements.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth used for comparison and validation of the UltraScan 650 is Dual-energy X-ray Absorptiometry (DXA) measurements of BMD, specifically at the 1/3 radius. DXA is referred to as the "gold standard" for measuring BMD. The device's "BMD us Index" is described as an "estimate of the BMD that would be measured by DXA."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This type of device relies on a "normative x-ray absorptiometry reference database" (Hologic 1/3 radius adult white females and males, K023398 / K103265) for T- and z-score derivations. The "clinical data" mentioned are for "Estimation of BMD," "Reproducibility," "Fracture Risk," "Reference Data Base," and "Dominant vs Non-Dominant Arm," but specific sample sizes for these studies are not detailed.

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

Since an explicit "training set" for an AI algorithm isn't detailed for this device, the concept of "ground truth for the training set" doesn't directly apply in the same way it would for AI-based image classification.

However, the device's T- and z-scores are "derived from comparison to a normative x-ray absorptiometry reference database." This means the ground truth for establishing these normative values would have been a large dataset of DXA measurements from a reference population (in this case, "Hologic 1/3 radius adult white females and males"). The establishment of this normative database itself would have involved numerous DXA scans performed according to established medical protocols to define normal bone density ranges across different age groups and genders.

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Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.

The proposed Hologic ® Single Energy (SE) Femur scan allows for the visualization of bone deformities of the femur, specifically focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.

The provided text does not contain detailed information about specific acceptance criteria and a study demonstrating the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.

However, based on the context, we can infer the implicit acceptance criteria and how the study "proves" the device meets them through that substantial equivalence.

Here's an attempt to structure the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing".

• Test Set Sample Size: Not explicitly stated. The submission relies on the established performance of the identical IVA-HD scan used in the predicate device (K060111). No new clinical data or specific test set for the SE Femur Exam is detailed.
• Data Provenance: Not explicitly stated for a new test set. The submission focuses on the technological equivalence to an existing, cleared device (IVA-HD). Therefore, the "data" effectively comes from the prior clearance of the IVA-HD technology, which was already deemed safe and effective.

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

Not applicable. This submission does not describe a new clinical study involving expert interpretation of a test set to establish ground truth for this specific device. The justification is based on technical equivalence to an already cleared device.

4. Adjudication Method for the Test Set

Not applicable. As no new clinical test set with expert ground truth establishment is described, an adjudication method is not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on technological equivalence rather than comparative effectiveness with human readers.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study is not described for the SE Femur Exam. The device is a software option that produces images for visual assessment by a clinician. Its "standalone performance" is implicitly tied to the image quality and characteristics, which are asserted to be identical to the IVA-HD scan already cleared.

7. Type of Ground Truth Used

Not applicable for a new study. The "ground truth" for the device's capability to visualize bone deformities is based on the prior clearance and established performance of the IVA-HD technology, which this device uses. The device's function is to visualize features, not to provide an automated diagnosis requiring an independent ground truth for accuracy metrics.

8. Sample Size for the Training Set

Not applicable. This device is a software option that uses an existing imaging technology (IVA-HD scan) on an existing bone densitometer. It does not describe a new AI algorithm that undergoes a training phase with a specific dataset. The software itself is largely the same as the predicate's IVA-HD acquisition software; only the intended anatomical region for imaging has changed.

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

Not applicable, as there is no specific "training set" for a new AI algorithm described in this submission.

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The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

The provided text is a 510(k) summary for the Hologic Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Densitometers. While it details the device's intended use and substantial equivalence to predicate devices, it does not contain information on specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with such studies (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The "Conclusion" section (H.4) states that the device is "substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option." This strongly suggests that the regulatory submission relied on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for this specific device.

Therefore, most of the requested information cannot be extracted from the provided 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

• Not Available: The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy thresholds for CSA, CSMI, Z, or Buckling Ratio). It only states the device "allows the physician to estimate structural properties."

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

• Not Available: The document does not mention any specific test set, its sample size, or the provenance of the data used for any testing.

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 Available: Since no specific test set or ground truth establishment process is described, information about the number or qualifications of experts is not present.

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

• Not Available: No adjudication method is mentioned as no specific test set evaluation process is detailed.

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

• Not Available: The document does not describe any MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a software option for bone densitometers, providing measurements of structural properties, not necessarily an AI-assisted diagnostic tool that would typically undergo MRMC studies in this context.

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

• Implied Standalone (but no performance metrics): The software itself is the algorithm, providing measurements. Therefore, its performance would inherently be "standalone" in generating these structural properties. However, there are no reported performance metrics for this standalone operation. The "Intended Use" states it "allows the physician to estimate structural properties," implying the software provides data to the physician, rather than fully automating a diagnostic conclusion.

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

• Not Available: No ground truth type is specified, as no detailed performance study or validation against a ground truth is described.

8. The sample size for the training set

• Not Available: The document does not mention a training set or its size.

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

• Not Available: No information is provided regarding the establishment of ground truth for a training set.

Summary Table of Available Information:

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The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC, in grams), bone mineral density (BMD, in grams/cm²), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary.

The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC. in grams), bone mineral density (BMD, in grams/cm²), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary. The Infant Whole Body software option adds an optional scan type to the QDR XP Scan Module, and an optional analysis type to the QDR XP Analysis Module of the QDR for Windows software operating system. The only differences between the Infant Whole Body software option and the adult Whole Body Software Option are: A modification to the Scan Module (data acquisition module) to enable a smaller region of interest (due to smaller subject size), thinner x-ray beam and slower scan speed to improve spatial resolution and bone edge detection, and A modification to the Analysis Module (data analysis module) include an algorithm that employs lower bone and soft tissue detection thresholds suitable for detecting and evaluating low bone densities and low soft tissue masses found in human infants.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Hologic Infant Whole Body Software Option for QDR Densitometers, dated October 29, 2004. It describes the device and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.

The document focuses on comparing the new device's features and intended use to existing, legally marketed predicate devices (K023398 Discovery Package and K961787 Body Composition Analysis Software). The primary argument for substantial equivalence is that the Infant Whole Body software performs the same functions with minor modifications to optimize for infants (smaller region of interest, thinner x-ray beam, slower scan speed, and lower bone/soft tissue detection thresholds). This is a regulatory filing for premarket notification, not a clinical trial report.

Therefore, many of the requested details are not present in this document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., specific accuracy thresholds for BMC, BMD, or body composition measurements) or numerical device performance results from a validation study. The comparison table (F.8) lists attributes of the devices but does not quantify performance.

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

This information is not provided in the document. No specific test set or clinical study data is reported.

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

This information is not provided in the document, as no specific test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study is not mentioned or described in the document. This type of study would compare human reader performance with and without AI assistance, which is not the focus of this 510(k) filing.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm itself (demonstrating its accuracy in measuring BMC, BMD, and body composition in infants) is not explicitly detailed or referenced in terms of specific metrics or a study. The document states that the software provides "estimates" and relies on its similarity to predicate devices, which are already cleared for measuring these parameters. The modifications are described as improving spatial resolution and bone edge detection and employing suitable detection thresholds for infants, but no quantitative performance improvement or validation is provided.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. For bone densitometry, "ground truth" would typically involve precise physical measurements, possibly validated by phantoms or alternative highly accurate methods, but no such details are furnished.

8. Sample Size for the Training Set

This information is not provided in the document. The filing describes the product as a "software option," implying algorithmic changes rather than a deep learning model that would typically require a training set in the modern sense. Given the 2004 date, it's more likely referring to adjustments in established algorithms rather than training a machine learning model on a dataset.

9. How Ground Truth for the Training Set Was Established

This information is not provided in the document.

Summary of Document's Content Regarding Performance/Validation:

The document asserts that the Infant Whole Body Software Option is substantially equivalent to predicate devices. It achieves this by:

• Modifying the Scan Module: To enable a smaller region of interest, thinner x-ray beam, and slower scan speed to improve spatial resolution and bone edge detection for smaller subjects.
• Modifying the Analysis Module: To include an algorithm that employs lower bone and soft tissue detection thresholds suitable for infants.

The basis for regulatory clearance (510(k)) is this claim of substantial equivalence, meaning it performs the same essential functions as previously cleared devices, with modifications appropriate for its specific user population (infants), and without raising new issues of safety or effectiveness. The filing does not include a new clinical study to establish specific performance metrics or acceptance criteria for the new software option. It relies on the established safety and effectiveness of the predicate devices and the design modifications tailored for infants.

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The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects. The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP Spine, Hip and "Total" body bone densitometry reference data for male, white American children. This software is used in conjunction with previously existing software in the QDR Series Densitometers which calculates and reports results relative to sex, ethnicity and age-matched values. The reference database is used to expand the range of bone densitometry reference values to include age 3-20 years of age. The software provides a comparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values. Patient results for each analysis region can be compared to reference values both graphically and numerically to each category of the age dependent reference Bone Mineral Density (BMD) values. The sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in standard deviation units) the difference between the patient's estimated BMD and the mean population standard (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

The provided text describes a Pediatric Reference Database for Hologic QDR Series X-Ray Bone Densitometers, a software option that extends the existing reference databases to include ages 3-20 years.

Here's an analysis of the acceptance criteria and the study as per your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) with thresholds. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices. The study's reported "performance" is implicitly that the device functions as intended by providing a Z-score and comparison to age-matched values for pediatric populations, which is consistent with the function of the predicate devices.

Note: The document focuses on demonstrating substantial equivalence, which is a regulatory pathway. It does not provide a traditional performance study with explicit numerical metrics (e.g., accuracy, precision of the Z-score calculation itself, or clinical outcomes). The "study" here is the collection and presentation of reference data.

Detailed Study Information:

The provided text does not describe a traditional study in the sense of an experiment to test the performance of the device against a cohort. Instead, it describes a reference database that enhances an existing device's functionality. Therefore, many of the requested details about a "study" (like test sets, ground truth establishment for test sets, expert adjudication methods, MRMC studies, standalone performance, and training sets) are not directly applicable or are not explicitly stated in the provided text.

Based on the information given, here's what can be inferred or explicitly stated:

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

   • Test Set Sample Size: Not applicable in the context of a "test set" for performance evaluation, as this document is about establishing a reference database. The database itself comprises the reference data. The size of the population from which the reference data was collected is not stated.
   • Data Provenance: The reference data is for "male, white American children." This indicates the data origin is from the United States and is retrospective in the sense that it represents a collected population. It's not a prospective study to test a hypothesis about the device's performance.

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

   • Not explicitly stated/Not applicable. The "ground truth" here is the reference data itself, representing a healthy pediatric population's BMD values. The process of collecting and validating this reference data (e.g., how the healthy population was defined, how measurements were ensured to be accurate) is not detailed. There's no mention of experts establishing a "ground truth" for individual cases in a test set.

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

   • Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication of results.

4. 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, an MRMC study was not done. This device is a reference database, not an AI-assisted diagnostic tool.

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

   • Not applicable, but the device inherently functions "standalone" as a reference. The software provides Z-scores based on the input BMD measurement and patient demographics. It's a computational tool, not an AI algorithm that makes diagnostic interpretations. Its "performance" is its ability to correctly reference the input BMD against its stored database.

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

   • Reference Database Values derived from a healthy population. The "ground truth" is the established set of age-, sex-, and ethnicity-matched Bone Mineral Density values for healthy children. The methodology for establishing this healthy population baseline is not detailed in the provided text, but it would typically involve anthropometric measurements, medical history, and DEXA scans from a large, representative cohort of healthy children.

7. The sample size for the training set:

   • Not explicitly stated. The term "training set" is not used, as this is a reference database, not a machine learning model. The size of the population from which the "Pediatric Reference Database" data was derived is not provided.

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

   • Not explicitly stated, but implied as a collected reference population. The "ground truth" for this reference database would have been established through a systematic collection of Bone Mineral Density (BMD) measurements from a cohort of healthy male, white American children across the age range of 3-20 years, using validated DEXA scanning protocols. The process would involve defining inclusion/exclusion criteria for "healthy," performing scans, and statistically characterizing the BMD distribution to create age-specific means and standard deviations.

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