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1. EchoSK and EchoSGyn Modules are additional software/hardware modules for EchoS Family devices and they are additions in terms of indication for use of the legally marketed EchoS Family.

2. EchoSK optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately trained professional in a clinical setting for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe.

3. EchoSGyn optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately-trained professional in a clinical setting for Fetal and OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures) applications. The EchoSCyn module can be used both with a convex or with an endocavitary probe.

EchoSK and EchoSGyn are optional modules for EchoS Family devices.

EchoSK is an optional module of the EchoStudio software that allows the operator to visualize echographic images for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe.

EchoSGyn is an optional module of EchoStudio that allows the operator to visualize echographic images for gynecological/obstetric applications. EchoSGyn module can be used both with a convex or with an endocavitary probe.

The provided FDA 510(k) summary (K212851) does not contain information regarding objective performance criteria that the device (EchoSK and EchoSGyn Modules for EchoS Family devices) meets through a specific clinical study with a test set, ground truth, and expert adjudication.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K202683 and K202514) based on:

• Intended Use: The new modules extend the existing EchoS Family devices to include musculoskeletal (EchoSK) and OB/GYN (EchoSGyn) applications, which are functions already performed by the primary predicate, the ACUSON Sequoia Diagnostic Ultrasound System.
• Technological Characteristics: The subject device shares similar hardware (EchoS and EchoStation) and software (EchoStudio) with the additional predicate device (EchoS Family K202514). It also operates similarly to the primary predicate in terms of transmitting, receiving, and displaying ultrasound echo data.
• Non-Clinical Performance Data: The summary lists non-clinical testing performed, including:
  • Biocompatibility (ISO 10993)
  • Electrical Safety and Electromagnetic Compatibility (EN 60601-1 and EN 60601-1-2)
  • Software Validation (ISO 62304)
  • Usability (IEC 62366-1:2015)

The document explicitly states "PERFORMANCE TESTING - CLINICAL: None" and "ANIMAL STUDIES: None". This indicates that the substantial equivalence determination for K212851 was not based on a clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with an AI-driven or diagnostic device.

Therefore, the requested information elements related to clinical performance criteria and studies cannot be extracted from this document. The device's acceptance is based on its similarity to legally marketed predicate devices, and the demonstration that any differences do not raise new questions of safety or effectiveness, as supported by the non-clinical testing mentioned above.

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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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