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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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