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The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel, Lung and Dermatology.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index. which are both automatically displayed.

The provided text describes two AI-based features of the HM70 EVO Diagnostic Ultrasound System: UterineAssist and NerveTrack. The acceptance criteria and performance studies for each are detailed below.

UterineAssist

1. Table of Acceptance Criteria and Reported Device Performance

For UterineAssist, the document details performance for three areas: image segmentation, feature points extraction, and size measurement. While explicit acceptance criteria values (like a minimum percentage or maximum error) are not stated in a direct acceptance criteria table, the reported device performance serves as the evidence of meeting internal acceptance.

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

• Segmentation Test:

  • Sample Size: 450 sagittal uterus images and 150 transverse uterus images (total 600 images).
  • Data Provenance: Collected at three hospitals. Mix of retrospective and prospective data collection in clinical practice.
  • Country of Origin: All Koreans (implies South Korea).

• Feature Points Extraction Test & Size Measurement Test:

  • Sample Size: 45 sagittal and 41 transverse plane images of uterus (total 86 images).
  • Data Provenance: Collected at three hospitals. Mix of retrospective and prospective data collection in clinical practice.
  • Country of Origin: All Koreans (implies South Korea).

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

• Number of Experts: Three participating OB/GYN experts.
• Qualifications: Each had more than 10 years' experience.

4. Adjudication Method for the Test Set

• Method: The set of images (uterus and endometrium) were divided into 3 subsets. Each of the three OB/GYN experts drew the ground truths for one of the subsets. The ground truths drawn by one expert were then cross-checked by the other two experts. Any images not meeting inclusion/exclusion criteria were excluded. This can be described as a 1+2 cross-check adjudication method.

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

• No MRMC comparative effectiveness study is reported for UterineAssist, as this section only describes the standalone performance metrics.

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

• Yes, the reported performance metrics (Dice-score, error measurements) reflect the "standalone" performance of the algorithm.

7. The Type of Ground Truth Used

• The ground truth for both segmentation and feature points/size measurements was established by expert consensus/adjudication from three experienced OB/GYN experts.

8. The Sample Size for the Training Set

• The training data details (specific sample size) are not provided, but it is stated that it is independent of the test data.

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

• Not explicitly stated, but implicitly, similar expert labeling or other reliable methods would have been used, consistent with the independent test data approach. It is only mentioned that the training and test data sets are "completely separated" and there is "no overlap."

NerveTrack

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of Subjects: 18 (13 Females, 5 Males)
• Number of Images: 2,146
• Age Range: 22-68 years
• BMI Range: 16-31.5
• Data Provenance: Not explicitly stated as retrospective or prospective, but the description of gathering scan data and expert involvement suggests a prospective collection or a specifically designed retrospective collection process for validation.
• Country of Origin: All Koreans (implies South Korea).

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

• Number of Experts: Ten anesthesiologists and five sonographers (total 15 experts) for review and confirmation.
• Qualifications: All had more than 10 years of experience.
• Initial Ground Truth Drawing: One anesthesiologist who scanned the ultrasound directly drew the GT.

4. Adjudication Method for the Test Set

• Method: One anesthesiologist who directly scanned the ultrasound drew the initial ground truth (GT) for the nerve location. Then, "two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct." If any mistake was identified during the review, it was revised. This indicates a 1 + (2 or more) consensus/adjudication method.

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

• No, the document describes "standalone performance" validation of the NerveTrack algorithm, specifically focusing on accuracy and speed. It does not mention any MRMC study comparing human readers with and without AI assistance.

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

• Yes, the validation clearly states, "The standalone performance of NerveTrack was evaluated..." and provides performance metrics (accuracy and speed) for the algorithm itself.

7. The Type of Ground Truth Used

• The ground truth for the location of 10 different kinds of nerves was established by expert consensus/adjudication involving anesthesiologists and sonographers with significant experience.

8. The Sample Size for the Training Set

• The training data details (specific sample size) are not provided, but it is stated that it is independent of the test data.

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

• Not explicitly stated, but it is mentioned that the "training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm." This implies a separate, established ground truth for the training set, likely using similar expert labeling methods.

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The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode. CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) Premarket Notification for the HM70 EVO Diagnostic Ultrasound System. It describes the device, its intended use, and comparative information to predicates to demonstrate substantial equivalence. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, the document does not contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, or MRMC studies for AI-assisted performance.

The "Summary of Clinical Tests" section on page 5, point 12, clearly states:
"The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence."

Without a clinical study, none of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement can be extracted from this document. The provided text only discusses non-clinical tests related to safety standards, acoustic output, biocompatibility, software function, cleaning, disinfection, thermal, electrical, electromagnetic, and mechanical safety.

Ask a specific question about this device

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic). Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document pertains to the 510(k) Premarket Notification of the HM70 EVO Diagnostic Ultrasound System by Samsung Medison CO., LTD. As specified in section 12, "Summary of Clinical Tests: The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence."

Therefore, I cannot provide details regarding acceptance criteria for clinical performance or a study demonstrating device performance based on the provided text, as no clinical studies were deemed necessary for this submission. The submission relies solely on non-clinical tests to establish substantial equivalence to predicate devices.

Here's the breakdown of the information that can be extracted from the document regarding non-clinical acceptance criteria and their assessment:

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

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

Not applicable, as no clinical studies were performed or required for this 510(k) submission. The evaluation was based on non-clinical testing against established engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies were performed or required. Ground truth in this context refers to compliance with established technical specifications and safety standards, evaluated by qualified engineers and testers.

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

Not applicable, as no clinical studies were performed or required.

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 HM70 EVO is a diagnostic ultrasound system, and while it may incorporate advanced imaging techniques (e.g., ElastoScan), the provided document does not indicate the presence of AI assistance requiring an MRMC study. No clinical studies were required.

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

Not applicable. The HM70 EVO is a diagnostic ultrasound system and its performance is inherently tied to human operation and interpretation. The document does not describe any standalone algorithm performance separate from the device itself. No clinical studies were required.

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

For the non-clinical tests, the "ground truth" was compliance with established national and international recognized standards and FDA guidance documents for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004). This involves objective measurements and tests to verify specified performance and safety parameters.

8. The sample size for the training set

Not applicable, as no clinical studies or AI algorithm training are described or required for this submission.

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

Not applicable, as no clinical studies or AI algorithm training are described or required for this submission.

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