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Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.

The associated accessories include:

• . Measurement stick
• Ultrasound gel (optional)

The Bindex BI-2 device underwent performance testing to demonstrate its safety and effectiveness, especially concerning its use in a home healthcare environment and its applicability to Hispanic individuals.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• EMC/Environmental/Biocompatibility/Electrical/Software/Mechanical/Acoustic Testing: The specific sample sizes for these engineering tests are not explicitly stated in the provided text. They typically involve a small number of devices or components representing the product. The data provenance is from internal testing conducted by the manufacturer or certified labs.
• Clinical Performance (Hispanic Population Study):
  • Sample Size: 293 postmenopausal women (153 Caucasian, 140 Hispanic).
  • Data Provenance: Prospective clinical trial conducted in Albuquerque, New Mexico, USA.

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

This document does not specify the number or qualifications of experts used to establish ground truth for the engineering tests (EMC, environmental, etc.).

For the clinical performance study aiming to validate DI thresholds in Hispanic populations:

• The ground truth for osteoporosis diagnosis was established using DXA (Dual-energy X-ray Absorptiometry) measurements of total hip or femoral neck T-score

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1. EchoS Family is a non-invasive ultrasound (US) bone sonometer. EchoS Family works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDus, T-score, and Z-score). The BMDus Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD of the same anatomical location as provided by DXA (BMDDXA), with a standard error of the estimate of 0.044grams/cm^2 for lumbar spine and 0.038 grams/cm^2 for femoral neck measurements.

BMDus Index is expressed in grams/cm^2 and as a T- and Z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women and men.

2. The EchoStudio software includes an optional tool called Fragility Score, which is intended to provide an assessment of 5-year fracture risk. The optional tool Fragility Score provides an estimate of 5-year probability of hip fracture and 5-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate takes into account the patient's age, sex, ethnicity, height, and the vertebraffemur neck ultrasound spectra and is computed using a proprietary algorithm. The tool has been validated for men and women between 30 and 90 years old.

The output is provided in a separate screen display and report that can be viewed or exported to an optional physician report generator tool. The results can be used by a physician, in conjunction with other clinical risk factors, as an aid in the diagnosis of osteoporosis and medical conditions leading to increased bone fragility, and ultimately in the assessment of fracture risk.

3. EchoS Family, when used with the optional Body Composition module of EchoStudio software, is indicated to estimate total body fat percentage (%BF). EchoS Family, together with Body Composition software module, is intended to be used only on generally healthy adults and is not for disease or condition. Body Composition software is indicated for the calculation of the Body Mass Index (BMI) and the Basal Metabolic Rate (BMR). Body Composition software module generates a report which displays the calculated values of Body FAT, BMR, and Body Mass Index (BMI).

The EchoS Family is an ultrasound device intended primarily for the diagnosis of osteoporosis. EchoS, through the ultrasound scan of the lumbar or femoral site of interest, picks up the ultrasound signal (RF) and performs an estimate of the bone mineral density (BMD).

The device therefore allows not only the visualization of ultrasound images, but also the real-time sampling of the RF signal and its appropriate treatment to make it usable for diagnostic algorithms.

The EchoS Family consists in two different configurations: EchoS (portable version) and the EchoStation (cart version). Each version consists of two main parts: the equipment device (EchoS and EchoStation) with its own probe and the software EchoStudio.

EchoStudio is a biomedical software that, used in combination with EchoS Family, allows the evaluation of bone mineral density (BMD) by means of the proprietary method REMS (Radiofrequency Echographic Multi Spectrometry) densitometry.

By using EchoStudio, it is possible to assess the key diagnostic parameters directly on the anatomical sites with increased fracture risk, such as lumbar spine and proximal femur.

EchoStudio analyzes the ultrasound signals and echographic images in order to compute the diagnostic parameters (BMD, T-score, and Z-score) and to estimate the fracture risk by means of the Echolight diagnostic algorithms and non-ionizing technique.

The provided FDA 510(k) summary for the EchoS Family device describes clinical performance studies related to its three Indications for Use (IFUs):

IFU 1: Diagnostic parameters (BMDus, T-score, and Z-score)
This IFU relates to the device's ability to compute diagnostic parameters based on ultrasound signals from the lumbar spine or femoral neck, correlating with DXA BMD.

IFU 2: Fragility Score for 5-year fracture risk assessment
This IFU relates to an optional tool that provides an estimate of 5-year probability of hip fracture and major osteoporotic fracture.

IFU 3: Body Composition module for total body fat percentage (%BF), BMI, and BMR
This IFU relates to an optional module for estimating body fat percentage, and calculating Body Mass Index (BMI) and Basal Metabolic Rate (BMR).

However, the summary does not provide a table of and does not explicitly state numerical acceptance criteria for each IFU, nor does it present the reported device performance in a direct comparative table. Instead, it describes general claims of correlation and mentions clinical trial reports.

Here's a breakdown of the available information based on your requested categories, acknowledging the limitations from the provided text:

Acceptance Criteria and Reported Device Performance

As noted, the document does not contain a specific table of acceptance criteria with numerical targets. However, the descriptions of the clinical studies imply the intended performance.

Study Details

The document mentions several clinical studies but often refers to "Performance Evaluation Protocol" and "Data Evaluation Report" documents rather than providing the detailed study results within the 510(k) summary itself. Therefore, specific details for all your requested points are limited or not available in the provided text.

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

• IFU 1 (Diagnostic parameters):

  • One study produced a publication "Radiofrequency echographic multi spectrometry for the prediction of incident fragility fractures: A 5-year follow-up study."
  • A second study produced a "Performance Evaluation Protocol" and a "Data Evaluation Report" titled "ECHOLIGHT: Comparative Performance Evaluation Report Echos System Vs. DXA in a male population aged 30-90 years".
  • Sample Size: Not explicitly stated for either study in this document.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the publication title "5-year follow-up study" suggests a prospective or longitudinal study in some capacity for the first study mentioned. The second study compared to DXA, implying live patient data.

• IFU 2 (Fragility Score):

  • "a dedicated clinical study was conducted."
  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated.

• IFU 3 (Body Composition):

  • Three clinical studies were conducted for %BF, BMR, and BMI respectively.
  • Sample Size: Not explicitly stated for any of these three studies.
  • Data Provenance: Not explicitly stated. The comparison to BIA and pocket calculator suggests live patient data.

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

• Not explicitly stated in the provided text for any of the studies.
• For IFU 1, DXA is used as the reference/ground truth, which is a widely accepted diagnostic method, implying established medical standards rather than expert consensus on images.
• For IFU 3, Bioelectrical Impedance Analysis (BIA) and a pocket calculator (for BMI) are used as references, which are also established methods, not typically requiring expert image review.

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

• Not explicitly stated in the provided text for any of the studies. Given the nature of the ground truth (DXA, BIA), expert adjudication of images or diagnoses might not have been the primary method.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:

• No MRMC comparative effectiveness study involving human readers with/without AI assistance is mentioned. The device appears to be a diagnostic tool providing objective measurements, not an AI assisting human interpretation of complex images.

5. Standalone (i.e., algorithm only without human-in-the-loop performance) study:

• Yes, the performance data presented is for the algorithm/device itself. The device computes diagnostic parameters, fracture risk estimates, and body composition values. This implies standalone performance, where the output is directly generated by the EchoS Family and EchoStudio software.

6. Type of ground truth used:

• IFU 1 (Diagnostic parameters): DXA (Dual-energy X-ray Absorptiometry) for BMD, which is a clinical gold standard for bone mineral density measurement.
• IFU 2 (Fragility Score): Clinical outcomes (incident fragility fractures within 5 years).
• IFU 3 (Body Composition): Bioelectrical Impedance Analysis (BIA) for %BF and BMR; results from a pocket calculator for BMI.

7. Sample size for the training set:

• Not explicitly stated in the provided text for any of the algorithms (BMD, Fragility Score, Body Composition).

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

• Not explicitly stated in the provided text. However, it can be inferred that for algorithms correlating with DXA or BIA, similar methods to the test set ground truth would have been used for training. For the Fragility Score, based on its purpose, the training likely used historical patient data with documented fracture outcomes and associated clinical/ultrasound data.

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EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMD13, T-sore, and Z-sore) and to assess fracture risk through the integrated FRAX® software.

The BMDgs Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD as provided by DXA at the same anatomical location (BMDnxA), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDris Index is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.

The subject device, EchoS, consists of two main parts: the equipment EchoS device with its own probe and the software EchoStudio.

• The EchoS device consists of EchoS device together with its probe,
• . The software EchoStudio: user interface and algorithmic calculation software provided in installation disc.

The EchoS device is connected to the computer via the USB port, and it is controlled by the EchoStudio to send the transmitting parameters to the EchoS device and to acquire the ultrasound (US) signals from EchoS device in order to calculate the BMDus and the other diagnosis parameters.

The EchoS System is a PC-based device that employs an ultrasound probe to collect ultrasound (RF) signals for echographic applications. During the measurement, the ultrasound convex probe, connected by a standard connector to the EchoS device, is applied directly to the skin in correspondence of the lumbar vertebrae or proximal femur, applying a thin layer of ultrasound gel between the probe surface and the skin to facilitate acoustic coupling. The ultrasound waves emitted by the probe are reflected by the bone, and then detected by the same probe.

During the scan, the algorithm automatically detects the bone interfaces and calculates the region of interest (ROIs) for data analysis. The automatic data processing is performed through the following steps: a custom developed signal pre-processing chain performs filtering, amplification and A/D conversion operations on the RF signals that are then passed to the EchoStudio software.

EchoStudio includes RF signal analysis and spectral comparison with reference models for the calculation of diagnostic parameters (BMDus, T-score, Z-score), and generation of the final medical report. The relevant scan depth, focus position, and visualization parameter settings can be adjusted and set by the interface of the software - EchoStudio.

EchoStudio software provides BMDus (in g/cm²), T-score and Z-score. It also estimates the 10-year osteoporotic fracture risk calculated with the original FRAX® algorithm that is integrated in the device.

Here's a breakdown of the acceptance criteria and the study information for the EchoS device, based on the provided text:

EchoS Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EchoS device are primarily based on its correlation with DXA measurements, particularly the standard error of the estimate (SEE) for BMD.

Study Proving Device Meets Acceptance Criteria:

The key study for proving the device meets the acceptance criteria for BMD correlation is a clinical performance test comparing EchoS to DXA.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set used in the comparative performance test against DXA. It mentions "Clinical data has been collected by Echolight on the intended patient population for the subject device" and "real data from intended patient population are used to compare results of FRAX® original algorithm."
• Data Provenance: The data was collected prospectively by Echolight. The country of origin is not specified, but Echolight S.p.a. is based in Italy, suggesting the data may have been collected in Italy or Europe. The patient population described for the proprietary internal database is "adult white females and males."

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not specify the qualifications of the experts involved in establishing the ground truth.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth seems to be established by the reference device (DXA) itself, not through an expert consensus requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies described are comparing the device's output (BMD, T-score, Z-score) to a gold standard (DXA), and the FRAX® algorithm's output using EchoS data versus DXA data. There is no mention of human readers improving with AI assistance.

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

• Yes, a standalone performance assessment was done. The "comparative performance test of EchoS vs DXA" and the comparison of FRAX® using EchoS-estimated T-score against DXA-measured T-score are examples of standalone algorithm performance. The device analyzes ultrasound signals and computes diagnostic parameters independently.

7. The Type of Ground Truth Used:

• The primary ground truth used for the device's diagnostic parameters (BMDus, T-score, Z-score) is DXA measurements (X-ray Densitometry), which is referred to as "a recognized gold standard for bone densitometry applications."
• For the FRAX® algorithm comparison, the ground truth for comparison was the FRAX® original algorithm using DXA-measured femoral neck T-Score.

8. The Sample Size for the Training Set:

• The document does not explicitly state the numerical sample size for the training set. It mentions "Clinical data has been collected by Echolight on the intended patient population for the subject device, in order to create the proprietary internal database for the different ages and BMI."

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

• The ground truth for the training set (referred to as the "proprietary internal database") was established through clinical data collection by Echolight. This would involve measuring BMD using DXA (the gold standard) and correlating these measurements with the ultrasound variables collected by the EchoS device across a diverse patient population (adult white females and males of different ages and BMI). This process allows the algorithm to learn the relationship between ultrasound signals and DXA-derived BMD values.

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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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Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bensity at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.

The provided document is a 510(k) summary for the Bindex BI-2 device, which measures apparent cortical bone thickness. The device received substantial equivalence based on its similarity to a predicate device (Bindex BI-100). The document focuses on demonstrating substantial equivalence rather than presenting an exhaustive de novo clinical study with specific acceptance criteria and detailed device performance metrics against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for clinical accuracy in the traditional sense of a de novo study. Instead, it relies on demonstrating that the Bindex BI-2 (subject device) is substantially equivalent to the Bindex BI-100 (predicate device), for which previous clinical and pre-clinical data supports its safe and effective use.

The "acceptance criteria" here are implicitly related to the predicate device's established performance and the subject device's ability to demonstrate equivalence in technical and functional aspects. The performance data presented are primarily related to engineering and safety testing, not direct clinical diagnostic performance metrics (like sensitivity, specificity, accuracy against a gold standard for bone strength or fracture risk).

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Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

The Bindex system includes ultrasound pulser, transducer and software. Bindex is connected to the USB port of a computer and controlled with computer software. Bindex is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal (1/3 length) of tibia. Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with disinfective solution moistened cloth or tissue.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core of the device's effectiveness lies in its ability to aid in the diagnosis of osteoporosis and determination of fracture risk, performing comparably to the predicate device and being able to identify osteoporotic and non-osteoporotic subjects correctly with certain thresholds.

Device Study Details

2. Sample Sizes and Data Provenance

• In vitro and In vivo Proof of Concept:
  • Bovine cortical bone samples (n=6)
  • Human volunteers (n=20)
  • Provenance: Not explicitly stated for these initial proof-of-concept studies, but the reference to Karjalainen et al. 2008 suggests academic research.
• Clinical Studies:
  • Study 1 (Initial Clinical Testing): Sample size not explicitly given for the study that introduced DI (Karjalainen et al. Osteoporos Int 2012).
  • Study 2 (Finnish Population): 572 subjects.
    • Provenance: Finland; Karjalainen J. et al. Osteoporos Int 2016. This was a prospective study used to determine diagnostic thresholds.
  • Study 3 (U.S. Study): 560 subjects.
    • Provenance: United States; Schousboe et al. 2016. This study validated the thresholds developed in the Finnish study. It's likely prospective given the validation nature.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test set. However, it heavily references DXA (Dual-energy X-ray Absorptiometry), which is the established gold standard for osteoporosis diagnosis. The criteria for osteoporosis classification (T-score threshold of -2.5) are based on World Health Organization (WHO) definitions and guidelines from the International Society of Clinical Densitometry (ISCD). This implies that ground truth was established by clinical diagnosis using DXA, interpreted by qualified medical professionals (e.g., radiologists, endocrinologists, or other specialists involved in bone health), rather than by individual experts marking images for AI.

4. Adjudication Method for the Test Set

Not applicable. The primary ground truth for clinical studies was established by DXA measurements and WHO/ISCD criteria for osteoporosis, not by human expert agreement on device output in a read-out session that would require adjudication.

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

No, a traditional MRMC study as understood in image interpretation (comparing human reader performance with/without AI assistance) was not performed. This device is a measurement tool (bone sonometer) that provides a quantitative output (Density Index) rather than creating images for human interpretation. Its effectiveness was evaluated by comparing its diagnostic capability (identifying osteoporotic patients, fracture risk prediction) to the DXA gold standard and to the predicate device.

The study aimed to show that the Bindex could reduce the need for DXA examinations by identifying a subset of patients who wouldn't need one (where Bindex's "yellow area" means they would). Approximately 30% of patients would still need a DXA. This indicates an effect on follow-up testing, but not a direct improvement in human reader performance on a given test.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the primary effectiveness endpoint evaluation describes the performance of the Bindex device (algorithm) itself in making classifications related to osteoporosis, in conjunction with DXA. While the phrase "in conjunction with other clinical risk factors or patient characteristics as an aid to the physician" implies physician involvement, the performance claims ("identify 90% of osteoporotic and non-osteoporotic subjects correctly," "similar fracture prediction capability") are attributed to the device's DI and Ct.Th. values, reflecting its standalone diagnostic potential within a clinical framework. The device is a "bone sonometer" providing a numerical output, not an AI interpreting complex images for human assistance.

7. Type of Ground Truth Used

• Clinical Studies: Clinical diagnosis of osteoporosis based on DXA measurements and World Health Organization (WHO) T-score criteria, as defined by the International Society of Clinical Densitometry (ISCD). This is the gold standard for osteoporosis diagnosis.
• In vitro and In vivo Proof of Concept:
  • In vitro: Caliper measurements of bovine bone samples.
  • In vivo: Peripheral Quantitative Computed Tomography (pQCT) measurements of human volunteers.

8. Sample Size for the Training Set

The document does not explicitly state the sample size of a "training set" for the device's algorithm. It describes clinical studies where thresholds were determined and validated.

• The Finnish study (n=572) was where the thresholds were "determined." This population effectively served as the development/training dataset for establishing the Density Index (DI) thresholds for osteoporosis classification.
• The U.S. study (n=560) was then used for validation of these predetermined thresholds.

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

For the "training" (threshold determination) set in the Finnish study (n=572), the ground truth for osteoporosis was established by conventional DXA measurements and the application of WHO/ISCD guidelines for osteoporosis diagnosis (T-score threshold of -2.5). This means patients in this cohort underwent DXA scans, and their osteoporosis status was determined based on the globally accepted clinical standard. The Bindex's DI and Ct.Th. values were then correlated with this established DXA-based ground truth to define clinical thresholds for the device.

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Achilles OsteoReportN is software used with the Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorptiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician. in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a software program running on PC to enter patient information, remote control and retrieve measurement results of GE ultrasonometer to help physicians to analysis the osteoporotic fracture risk and communicate with hospital information system.

Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a windows based application running on PC and will provide the following capabilities for Achilles series device:

• 1. A patient database
• 2. Customizable reporting
• 3. Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
• 4. Communication to the hospital/clinic information system

The objectives of this program including:

• Support Windows 7 (64 bit)/Windows XP(32bit) . operating system
• . Support merging the database with older version of Achilles product with the database used with the newer Achilles ultrasonometers, which is stored on the device.
• . Support remote control of EXPII's measurement and retrieve measurement results
• Support customized report printing .
• . Support DICOM

The provided text describes a 510(k) premarket notification submission for the "Achilles OsteoReportN" software. This software is intended to be used with Achilles ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems, ultimately assisting in the diagnosis of osteoporosis.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The submission documentation does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's performance in diagnosing osteoporosis. Instead, it focuses on the device's functional equivalence and technical characteristics relative to its predicate device.

The reported device performance emphasizes that:

• "The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip."
• "Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry."
• "The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes."
• "Achilles OsteoReportN employs the same fundamental scientific technology as its predicate devices."

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

The document explicitly states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

This indicates that there was no specific test set or clinical study conducted for this particular 510(k) submission. The device's substantial equivalence was based on its functional and technological similarity to a predicate device, Achilles EXP II.

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)

Since no clinical studies were conducted for this submission, there were no experts specifically utilized to establish ground truth for a test set related to Achilles OsteoReportN.

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

Not applicable, as no clinical studies were conducted.

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 applicable. The device is a software program designed to assist in analysis and reporting, not explicitly an "AI" for image interpretation, and no MRMC studies are mentioned.

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

Not applicable, as no clinical studies were conducted. The software itself is an analytical and reporting tool that operates "with the Achilles family of ultrasonometers."

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

For this specific submission, the "ground truth" for proving substantial equivalence was primarily the established performance and indications for use of the predicate device (Achilles EXP II), rather than a new clinical ground truth established for the Achilles OsteoReportN. The underlying scientific principle (Stiffness Index from os calcis ultrasound) had previously been shown to be comparable to BMD from X-ray absorptiometry.

8. The sample size for the training set

The document does not mention any training sets or machine learning model development for the Achilles OsteoReportN software itself. Its development focused on functionalities like database management, customizable reporting, remote control, and DICOM support, rather than learning from a dataset.

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

Not applicable, as no training set is mentioned in the provided text for the Achilles OsteoReportN software.

Summary of Device Acceptance and Study Detail:

The acceptance of Achilles OsteoReportN was based on a demonstration of substantial equivalence to a predicate device (Achilles EXP II), rather than new clinical performance trials for the software itself. The submission highlighted the software's functional capabilities (patient database, reporting, communication) and its reliance on the same fundamental scientific technology as the predicate device for generating the Stiffness Index measurements.

The submission specifically states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

Instead, the following quality assurance measures were applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

The provided information focuses on the software's functionality, compatibility, and its intended use in conjunction with existing Achilles ultrasonometers, assuming the clinical efficacy of the Stiffness Index measurements themselves, which were presumably established and accepted for the predicate devices.

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The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility.

The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.

Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture.

The SOS measured by MiniOmni has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).

The Sunlight MiniOmni Ultrasound Bone Sonometer is a noninvasive device that consists of:

• Main unit, which contains an ultrasound transmission / reception printed circuit board (1) (ultrasound PCB) and mechanical and electric elements for connecting the ultrasound probes
• (2) User interface and algorithmic calculation software provided in installation disc
• (3) Hand-held probes (choice from 3 ultrasonic probe types already PMA-approved, plus one new probe)
• Medical grade AC to DC power adaptor and cable (4)
• (5) USB Connection cable
• System quality verification (SQV) phantom; (6)
• Spring-loaded positioning gauge; (7)
• (8) Cushioned hand rest
• (a) User Guide
• Ultrasound gel (optional accessory)
• Skin marker pencil (optional accessory)
• Foot pedal (optional accessory) 12)
• Sterile disinfection towelettes (optional accessory) (13)
• Carrying case for easy mobility (optional accessory) (14)

The MiniOmni requires connection to a stand-alone computer and visual display unit provided by the user in order to operate as intended.

The provided 510(k) summary for the BeamMed MiniOmni Bone Sonometer focuses on demonstrating substantial equivalence to a predicate device (Sunlight Omnisense 7000S Bone Sonometer) rather than presenting a standalone study with acceptance criteria and performance data for this new device.

The document explicitly states: "The performance of the MiniOmni is identical to that of the predicate device." Therefore, the "reported device performance" and "study that proves the device meets the acceptance criteria" are based on the predicate device's existing approvals.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide information about a specific test set or sample size for a new study to prove the MiniOmni's performance. The basis for performance claims is the predicate device, the Sunlight Omnisense 7000S, which was approved under PMA P990035. Details regarding the original PMA study's sample size, data provenance, and study design are not included in this 510(k) summary.

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

This information is not available in the provided 510(k) summary, as it relies on the predicate device's prior approvals and does not describe a new ground truth establishment process for the MiniOmni.

4. Adjudication Method for the Test Set

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. The device is a bone sonometer, which measures physical properties, and the submission primarily focuses on hardware and software equivalency, not on AI-driven interpretation or human-in-the-loop performance improvement.

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

The document states: "The performance of the MiniOmni is identical to that of the predicate device." The predicate device's algorithms were "As described in PMA P990035." It can be inferred that the algorithms for calculating SOS, T-scores, and Z-scores operate in a "standalone" fashion (algorithm only) after the user acquires the ultrasound data. However, a specific standalone performance study for the MiniOmni itself is not detailed. The MiniOmni operates with software on a user-provided computer, meaning the algorithm is separate from the physical measurement unit but still requires human interaction for data acquisition and input.

7. Type of Ground Truth Used

For bone sonometers like the MiniOmni, the "ground truth" for bone health assessment typically involves comparison with established reference standards or correlation with other bone density measurement techniques (e.g., DXA, which is considered a gold standard for bone mineral density). However, the provided document does not specify the type of ground truth used for the predicate device's original PMA, nor for any new evaluation of the MiniOmni. The device provides "an estimate of skeletal fragility" and calculates T-scores and Z-scores based on embedded reference databases, rather than directly measuring pathology or relying solely on outcomes data.

8. Sample Size for the Training Set

This information is not available in the provided 510(k) summary. The device utilizes "an embedded reference database" for T-score and Z-score calculations, which likely represents a "training set" in a broad sense, but its sample size and characteristics are not detailed.

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

This information is not available in the provided 510(k) summary. For the "embedded reference database," the ground truth would have been established through a clinical study or compilation of data from a large healthy population and age-matched populations. Details of this process are not included.

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The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles EXPII measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptometry at the spine or hip.

GE Healthcare's Achilles EXPII Bone Sonometer measures ultrasound variables of the os calcis to provide a Stiffness Index. This index indicates the risk of osteoporotic fracture in postmenopausal women, comparable to bone mineral density (BMD) measured by X-ray absorptiometry at the spine or hip. The device's performance was compared to its predicate device, the Achilles Express.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document mentions "A clinical study GE3120 was performed". However, the sample size for this clinical study and the data provenance (e.g., country of origin, retrospective or prospective nature) are not provided in the provided text.

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

The provided text does not mention the use of experts or the establishment of ground truth in the context of radiologists or similar qualified professionals guiding the clinical study. The study focuses on comparing the device's output (Stiffness Index) with its predicate.

4. Adjudication method for the test set

The provided text does not describe any adjudication method like 2+1 or 3+1. The study appears to be a direct comparison of measurements between two devices.

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 is not an MRMC comparative effectiveness study in the context of human readers and AI assistance. The Achilles EXPII is a diagnostic device for measuring bone health, not an AI-assisted interpretation tool for human readers. Therefore, an effect size of human reader improvement with/without AI is not applicable and not mentioned.

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

This device functions as a standalone device (an ultrasonometer) that measures physical properties to calculate a Stiffness Index. Its performance, as described, is independent of human interpretation or input for the primary measurement itself, though physicians use its output in conjunction with other clinical factors. The comparison made in the study (device vs. predicate device) is a standalone performance comparison.

7. The type of ground truth used

The "ground truth" in this context is the Stiffness Index values obtained from the predicate device, the Achilles Express Ultrasonometer. The study aimed to demonstrate that the Achilles EXPII’s measurements are equivalent to those of the legally marketed predicate. The predicate device itself (Achilles Express) would have been validated against a clinical truth, likely Bone Mineral Density (BMD) as measured by X-ray absorptiometry, which is mentioned as the comparative standard for the Stiffness Index in general.

8. The sample size for the training set

The provided text does not mention a training set in the context of machine learning or AI models. The Achilles EXPII is a measurement device, not explicitly based on a machine learning model that requires a training set.

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

As there's no mention of a training set in the provided documentation, this question is not applicable.

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