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Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.

When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:

• overriding artery
• septal defect at the cardiac crux
• abnormal relationship of the outflow tracts
• enlarged cardiothoracic ratio
• right ventricular to left ventricular size discrepancy
• tricuspid valve to mitral valve annular size discrepancy
• pulmonary valve to aortic valve annular size discrepancy
• cardiac axis deviation

Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.

Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.

Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for Fetal EchoScan v1.1:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents the performance metrics achieved by the device in both standalone and reader studies. The implication is that these performance levels were deemed acceptable for clearance.

Table 1. Standalone Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Table 2. Reader Study Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Note: The numerical acceptance criteria for "high sensitivity" and "high specificity" are not explicitly defined in the provided document, but the reported performance values surpassed what was considered acceptable by the FDA for substantial equivalence.

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

• Test Set Sample Size (Standalone Testing): 877 clinically acquired fetal ultrasound exams.
• Test Set Sample Size (Reader Study): 200 exams.
• Data Provenance:
  • Country of Origin: U.S.A. and France.
  • Retrospective or Prospective: The document doesn't explicitly state whether the data was retrospective or prospective, but it mentions "clinically acquired" exams, which often implies retrospective use of existing data.

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

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: Pediatric cardiologists. No further details on years of experience or board certification are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting among the three pediatric cardiologists.

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

• Was an MRMC study done? Yes.
• Effect Size of Human Readers' Improvement with AI vs. without AI assistance:
  • ROC AUC: Humans improved by +14.9% (from 0.825 unaided to 0.974 aided), with a p-value of 0.002.
  • Mean Sensitivity: Humans improved by +15.3% (from 0.782 unaided to 0.935 aided).
  • Mean Specificity: Humans improved by +21.1% (from 0.759 unaided to 0.970 aided).

6. Standalone Performance Study

• Was a standalone study done? Yes.
• Performance Metrics: Refer to Table 1 above. The AI system had a conclusive output rate of 98.8%. Sensitivity ranged from 0.977 to 0.987, and Specificity ranged from 0.963 to 0.977 for the detection of any suspicious findings, depending on how inconclusive outputs were treated.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, it was derived from a "truthing process in which three pediatric cardiologists assessed the presence or absence of each of the eight findings, and majority voting was used." This constitutes expert consensus.

8. Sample Size for the Training Set

• The document states: "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, the specific sample size for the training set is not provided in the clearance letter. It only mentions that the data used for standalone testing (877 exams) and the reader study (200 exams) were distinct from the training and validation data.

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

• The document states: "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, the methodology for establishing ground truth for the training set is not explicitly detailed in the provided text. It can be inferred that a similar expert review process would have been used, but no specific details are given.

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Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.

When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:

• overriding artery
• septal defect at the cardiac crux
• abnormal relationship of the outflow tracts
• enlarged cardiothoracic ratio
• right ventricular to left ventricular size discrepancy
• tricuspid valve to mitral valve annular size discrepancy
• pulmonary valve to aortic valve annular size discrepancy
• cardiac axis deviation

Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.

Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.

Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Here's a breakdown of the acceptance criteria and study details for the Fetal EchoScan device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, it presents the performance of the device in various metrics and then concludes that these results demonstrate substantial equivalence. For the purpose of this request, I will infer the implied acceptance criteria from the reported performance and the conclusion of substantial equivalence.

Inferred Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Standalone Test Set: 877 clinically acquired fetal ultrasound exams.
• Sample Size for MRMC Test Set: 200 exams.
• Data Provenance: The data was collected from 11 centers in the U.S.A. and France. It was retrospectively collected as it refers to "clinically acquired fetal ultrasound exams".

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: The document specifies "pediatric cardiologists" but does not provide details on their years of experience or other specific qualifications beyond their specialty.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting. This means that if at least two out of the three pediatric cardiologists agreed on the presence or absence of a finding, that was established as the ground truth.

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

• Was an MRMC study done? Yes.
• Effect size of human readers improvement with AI vs. without AI assistance:
  • ROC AUC for any suspicious finding: +14.9% increase (from 0.825 unaided to 0.974 aided, p=0.002).
  • Mean Sensitivity for any suspicious finding: +15.3% increase (from 0.782 unaided to 0.935 aided).
  • Mean Specificity for any suspicious finding: +21.1% increase (from 0.759 unaided to 0.970 aided).

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes.
• The results are presented in Table 1, showing sensitivity and specificity for "Any suspicious findings" and each individual finding, calculated under two scenarios for inconclusive outputs.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, it was derived from a truthing process by three pediatric cardiologists using majority voting.

8. Sample Size for the Training Set

• The document states that "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing," but it does not explicitly provide the sample size for the training set.

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

• The document states that the "ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, similar to the training set sample size, it does not explicitly describe how the ground truth for the training set was established. It only details the ground truth establishment for the test sets (standalone and MRMC).

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EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS).

When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis.

EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized AS clinical practice quidelines.

Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery

EchoSolv AS is a standalone, cloud-based decision support software which is intended to be used certified cardiologist to aid in the diagnosis of Severe Aortic Stenosis. EchoSolv AS analyzes basic patient demographic data and measurements obtained from a transthoracic echo examination to provide a categorical assessment as to whether the data are suggestive of a high, medium or low probability of Severe AS. EchoSolv AS is intended for patients who 18 years or older who have an echocardiogram performed as part of routine clinical care (i.e., for the evaluation of structural heart disease).

Patient demographic and echo measurement data is automatically processed through the artificial intelligence algorithm which provides an output regarding the probability of a Severe AS phenotype to aid in the clinical diagnosis of Severe AS during the review of the patient echo study and generation of the final study report, according to current clinical practice guidelines. The software provides an output on the following assessments:

1. Severe AS Phenotype Probability

Whether the patient has a high, medium, or low probability of exhibiting a Severe AS phenotype, based on analysis by the EchoSolv AS proprietary Al algorithm, that the determined predicted AVA is ≤1.0cm². The Al probability score requires a minimum set of data inputs to provide a valid output but is based on all available echocardiographic measurement data and does not rely on the traditional LVOT measurements used to in the continuity equation.

2. Severe AS Guideline Assessment

Whether the patient meets the definition for Severe AS based on direct evaluation of provided echocardiogram data measurements (AV Peak Velocity, AV Mean Gradient and AV Area) with current clinical practice guidelines (2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease).

EchoSolv AS is intended to be used by board-certified cardiologists who review echocardiograms during the evaluation and diagnosis of structural heart disease, namely aortic stenosis. EchoSolv AS is intended to be used in conjunction with current clinical practices and workflows to improve the identification of Severe AS cases.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the EchoSolv AS device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format. However, based on the performance data presented, the implicit acceptance criteria can be inferred from the reported performance and comparison to a predicate device. The performance metrics reported are AUROC, Sensitivity, Specificity, Diagnostic Likelihood Ratios (DLR), and improvement in reader AUROC and concordance in the MRMC study.

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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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The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow.

The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.

This document describes the Sonavex EchoSure Diagnostic Ultrasound System, which is intended for clinical examinations of blood vessels marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow and is intended for use by trained medical healthcare professionals in support of clinical diagnosis.

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

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with corresponding performance metrics as would typically be seen for a new device claiming improved performance. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K173265, WinProbe UltraVision 2 Diagnostic Ultrasound System) by outlining similar technical characteristics and adherence to relevant safety and performance standards.

The table below summarizes key comparisons between the EchoSure and its predicate, acting as implicit "acceptance criteria" through comparative equivalence:

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

The document states: "Clinical studies are not required to support equivalence for these conventional ultrasound systems." This implies that there was no specific clinical test set used for the EchoSure device itself to prove its performance in human subjects, beyond the non-clinical safety and performance data. The FDA clearance is based on substantial equivalence to a predicate device and adherence to recognized standards.

Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no clinical studies were performed for this specific submission.

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

As no clinical test set was required or performed for direct evaluation of the EchoSure device's performance in a clinical setting, there's no information about experts establishing ground truth for a test set. The submission relies on the established safety and performance of the predicate device and compliance with standards.

4. Adjudication Method for the Test Set:

Since a clinical test set was not used to evaluate device performance, an adjudication method for a test set is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No MRMC comparative effectiveness study was done, as confirmed by the statement "Clinical studies are not required."

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

The EchoSure is a diagnostic ultrasound system, not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The document emphasizes its use "by trained medical health care professionals."

7. The type of ground truth used:

Given the reliance on substantial equivalence and non-clinical testing, the "ground truth" for the EchoSure's clearance is primarily based on:

• Compliance with recognized electrical, mechanical, safety, EMC, acoustic output, and biocompatibility standards (e.g., ISO 10993, IEC 60601 series). These standards serve as the "ground truth" for ensuring the device meets fundamental safety and engineering performance requirements.
• Demonstrated performance specifications during bench testing. These tests confirm that risk controls were properly implemented, design outputs meet design inputs, and the device is suitable for its intended use within a laboratory/engineering context.

8. The sample size for the training set:

The EchoSure is a conventional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable.

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

As the device does not utilize a machine learning algorithm requiring a training set, this question is not applicable.

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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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The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.

The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.

The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.

The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.

The ON-Q* Echogenic Catheter is a closed tip catheter composed of polyamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist guide in a sterile Tyvek and polyester pouch.

ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is designed for the Regional Anesthesia market to deliver medication for regional anesthesia and pain management. The Kit contains multiple components; one being Halyard Health's new Echogenic Catheter. The Echogenic Catheter is a closed tip catheter composed of polvamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist quide in a sterile catheter sleeve composed of Tyvek and polyester.

Here's a breakdown of the acceptance criteria and study information, based on the provided document. It's important to note that this document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like sensitivity/specificity.

The provided documents describe two devices:

1. ON-Q EchoSpark Echogenic Catheter** (K161232)
2. ON-Q T-bloc Echogenic Continuous Nerve Block Kit** (K161232)

Both devices reuse part of the same summary. The information provided heavily emphasizes comparison to predicate devices and adherence to standards, rather than defining specific performance metrics against clinical ground truth.

For the ON-Q EchoSpark Echogenic Catheter (K161232):**

The acceptance criteria here are primarily about demonstrating substantial equivalence to the predicate device (ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set, K143164) and compliance with relevant performance standards and biocompatibility requirements. There are no explicit quantitative performance metrics like sensitivity/specificity for the echogenic catheter's visibility that are stated as acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.

The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.

This document describes the Echostar Comfort 1.5T MRI System, which is a modification of a previously cleared device (Echostar Spica 1.5T MR system). The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria directly related to clinical diagnostic accuracy.

Therefore, much of the requested information regarding clinical study design, sample sizes, expert adjudication, MRMC studies, and standalone performance for diagnostic tasks is not explicitly available within this 510(k) summary. The summary focuses on engineering and regulatory compliance, ensuring the modified device maintains the same safety and effectiveness as its predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for a specific condition) for the Echostar Comfort 1.5T MRI System. Instead, the acceptance criteria are based on technical and safety standards compliance and equivalence to the predicate device.

• AAMI ANSI ES 60601-1:2005/(R)2012
• IEC 60601-1-2:2007
• IEC 60601-2-33:2010
• NEMA MS-1 2008
• NEMA MS-2 2008
• NEMA MS-3 2008
• NEMA MS-4 2010
• NEMA MS-5 2010
• NEMA MS-6 2008
• NEMA MS-8 2008 |
  | Image Quality & Functionality | Sample phantom and clinical images, and test reports were presented to demonstrate conformance with standards and equivalent performance with the predicate device. The system can acquire 2D single slice, multi-slice and 3D volume images, and images reflect spatial distribution for hydrogen nuclei density, T1, T2, and flow. |
  | Safety | Nonclinical testing for safety was conducted. No new or additional safety concerns have been raised compared to the predicate device. |
  | RF Coils & System Components | Modifications include:
• Additional RF coils.
• Magnet modifications for a 70+ cm clear bore opening.
• RF transmit components specified for required RF transmit performance.
• Gradient subsystem specified for higher gradient strength and slew rate.
  These modifications are designed to maintain or improve performance while ensuring equivalence. |
  | Software Sequences & Applications | Includes the same software sequences and applications, modified for scan performance improvements. |

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

The document states: "Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device."

• Sample Size for Test Set: Not specified quantitatively. It mentions "sample phantom and clinical images," implying a limited set used for technical verification rather than a large-scale clinical trial to establish diagnostic accuracy against a ground truth.
• Data Provenance: Not explicitly stated (e.g., country of origin). It mentions "clinical images," suggesting real patient data, but whether it was retrospective or prospective is not detailed. Given the context of a 510(k) for a modified device, it's likely images were collected to demonstrate equivalence, possibly from a mix of retrospective and prospective technical validation scans.

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

This information is not provided. The assessment appears to be primarily technical validation (phantom images, engineering tests) and a comparison of image characteristics to the predicate device, rather than a clinical study requiring expert diagnosis against a clinical ground truth for the new device. The Indications for Use state, "When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis," implying that the interpretation relies on existing medical expertise once the image quality is deemed acceptable.

4. Adjudication Method for the Test Set

Since a formal clinical study with a diagnostic ground truth is not detailed, an adjudication method is not applicable or described in this summary. The assessment focuses on meeting technical standards and demonstrating image quality equivalence.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described. This submission is for an MRI system, not an AI-powered diagnostic algorithm alongside human interpretation.

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

No, a standalone performance study for an algorithm was not done or described. This device is an MRI hardware and basic software system, not an AI or standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the technical performance aspects, the "ground truth" would be established through:

• Physical Phantoms: Known physical properties and structures within phantoms are used to assess image quality metrics (signal-to-noise ratio, spatial resolution, contrast, uniformity, etc.) according to NEMA standards.
• Predicate Device Performance: The primary "ground truth" for the new device's performance is its substantial equivalence to the performance of the legally marketed predicate device (Echostar Spica 1.5T MR system), which itself would have demonstrated diagnostic capability in general use.
• Clinical Image Evaluation: As mentioned, "clinical images" were presented, which would implicitly be evaluated by qualified personnel for acceptable diagnostic quality, even if not against a specific pathological ground truth within this particular submission.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This document describes an MRI hardware system, not a device that relies on a trained algorithm or AI model. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable/Not mentioned. As there is no training set for an AI model, this question does not apply to this submission.

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EchoSoft™ is a software calculation package that is used with diagnostic ultrasound images to provide mechanical information about tendon-like tissues of interest that may be used by a physician, along with other medical data, to assist in clinical diagnosis. The software is intended to be used by trained professionals only.

The Echometrix, LLC software, EchoSoft, is an image processing algorithm that, when used with diagnostic ultrasound images, provides qualitative information about the mechanical characteristics of the deforming material by tracking motion, deformation, and ultrasonic echo magnitude change within a given region. This technology can be used by a physician to gather information about the mechanical and functional properties of soft tissues which, in conjunction with standard medical data, can be used to assist in clinical diagnosis.

The provided text does not contain detailed information about specific acceptance criteria, comprehensive device performance data, detailed study methodologies, or comparative effectiveness studies for EchoSoft™. However, based on the information provided, I can construct an answer with the available details and identify where information is missing.

Here's a breakdown of the acceptance criteria and study information, as much as can be gleaned from the text:

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

The document does not explicitly list quantitative acceptance criteria in a dedicated table format or specific performance metrics with target values. It broadly states that the software was evaluated to "verify the ability of the algorithm to distinguish between materials with different mechanical properties" and to "verify performance parameters such as resolution, sensitivity and precision." No actual numbers for these parameters are provided.

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

• Sample Size (Test Set): The exact sample size for the test set is not specified. The document mentions "multiple studies" including "laboratory measurements on phantoms," "several studies conducted on bovine tendons," and "sample clinical images." The number of phantoms, bovine tendons, or clinical images is not quantified.
• Data Provenance:
  • Phantoms: Laboratory measurements.
  • Bovine Tendons: Implies laboratory or research setting, likely not patient data.
  • Clinical Images: Described as "sample clinical images" with "previously diagnosed injuries." There is no indication of the country of origin.
  • Retrospective/Prospective: Not explicitly stated for any of the data types. "Previously diagnosed injuries" for clinical images suggests a retrospective collection, but this is not confirmed.

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)

This information is not provided in the document.

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

This information is not provided in the document. Given the nature of the studies (phantom, bovine tissue, and "sample clinical images"), formal expert adjudication methods commonly seen in human-in-the-loop clinical trials are unlikely to have been detailed in this regulatory submission.

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

There is no indication that an MRMC comparative effectiveness study involving human readers with and without AI assistance was performed or reported in this submission. The device is a software calculation package designed to provide "mechanical information," not primarily to improve human reader diagnostic accuracy in a comparative setting described for MRMC studies. The software is intended to "assist in clinical diagnosis," implying its output is used by a physician in conjunction with other data, but its effect on reader performance is not quantified.

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

Yes, the studies described are characteristic of standalone algorithm testing.

• "The EchoSoft 100 software was evaluated with multiple studies to verify the ability of the algorithm to distinguish between materials with different mechanical properties."
• "The studies consisted of laboratory measurements on phantoms containing materials with varying elastic properties to verify performance parameters such as resolution, sensitivity and precision."
• "Several studies were conducted on bovine tendons to demonstrate performance on tissue samples with known defects."
• "Sample clinical images were also provided to demonstrate performance of the software on tendons with previously diagnosed injuries."

These describe direct evaluations of the algorithm's output against known properties or diagnoses, without explicit human reader interaction within the performance metrics.

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

The ground truth used varied depending on the type of study:

• Phantoms: "Materials with varying elastic properties." The ground truth would be the known mechanical properties (e.g., stiffness/elasticity) of these engineered phantom materials.
• Bovine Tendons: "Tissue samples with known defects." The ground truth would be the known presence or absence and characteristics of these defects, likely established through direct inspection, mechanical testing, or other means.
• Clinical Images: "Tendons with previously diagnosed injuries." The ground truth was the existing clinical diagnosis for these injuries. The method of establishing this clinical diagnosis (e.g., expert clinical assessment, MRI, surgery, pathology) is not specified.

8. The sample size for the training set

This information is not provided in the document. The submission focuses on the evaluation (test) studies, with no mention of the training data used to develop the algorithm.

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

This information is not provided in the document, as the training set itself is not discussed.

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