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The HS40 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 and Peripheral vessel.

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, 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 HS40 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 HS40 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 HS40 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 HS40 Diagnostic Ultrasound System: NerveTrack and UterineAssist. Here's a breakdown of their acceptance criteria and supporting studies:

1. Acceptance Criteria and Device Performance

NerveTrack

UterineAssist

2. Sample Sizes and Data Provenance

NerveTrack

• Test Set Sample Size:
  • Number of Subjects: 18 (13 females, 5 males)
  • Number of Images: 2,146 (1,168 from females, 978 from males)
• Data Provenance: All data were collected from Koreans. The study does not specify if the data was retrospective or prospective, but mentions "When collecting scan data, the speed of the probe varies..." which suggests prospective collection or at least data collected under specific scanning conditions.

UterineAssist

• Test Set Sample Size:
  • Segmentation Test: 450 sagittal uterus images and 150 transverse uterus images (total 600 images).
  • Feature Points Extraction & Size Measurement Tests: 45 sagittal and 41 transverse plane images of uterus (total 86 images).
• Data Provenance: Data collected at three hospitals. The ethnicity/country is All Koreans. It involved a mix of retrospective and prospective data collection in clinical practice.

3. Number and Qualifications of Experts for Test Set Ground Truth

NerveTrack

• Number of Experts: 10 anesthesiologists and 5 sonographers (total 15 experts).
• Qualifications: All experts had more than 10 years of experience.

UterineAssist

• Number of Experts: 3 OB/GYN experts.
• Qualifications: All experts had more than 10 years' experience.

4. Adjudication Method for the Test Set

NerveTrack

• Adjudication Method: "One anesthesiologist who scanned the ultrasound directly drew the GT of nerve location, and two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct. If there was any mistake during the review, it was revised again." This indicates an initial drawing by one expert with confirmation/review by at least two (or more) others, followed by revision if errors were found. This is a form of expert consensus with review and revision.

UterineAssist

• Adjudication Method: "The set of images (uterus and endometrium) were divided into 3 subsets and the three participating OB/GYN experts each drew the ground truths for one of the subsets. The ground truths drawn by an expert were cross-checked by the other two experts. Any images that do not meet the inclusion/exclusion criteria were excluded from the set of images." This is a cross-checking method where each expert's ground truth was reviewed by the other two, with exclusion of non-conforming images.

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

• The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to assess the improvement of human readers with AI assistance versus without. The studies described focus on the standalone performance of the AI algorithms.

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

• Yes, standalone performance was done for both algorithms.
  • NerveTrack: The acceptance criteria and reported performance (Accuracy, Speed) directly measure the algorithm's ability to detect nerves and its processing speed, without human intervention in the detection process.
  • UterineAssist: The segmentation accuracy (Dice-score) and error in feature point extraction and size measurement refer to the algorithm's direct output.

7. Type of Ground Truth Used

NerveTrack

• Type of Ground Truth: Expert Consensus. The ground truth for the location of 8 different kinds of nerves was established by a group of anesthesiologists and sonographers through a process of drawing, review, and confirmation.

UterineAssist

• Type of Ground Truth: Expert Consensus (Segmentation by experts). "Segmentation of the ground truth was generated by three participating OB/GYN experts with more than 10 years' experience."

8. Sample Size for the Training Set

NerveTrack

• The document states, "The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm," but it does not specify the sample size for the training set.

UterineAssist

• The document states, "Data used for test/training validation purpose are completely separated from the ones during training process and there is no overlap between the two," but it does not specify the sample size for the training set.

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

NerveTrack

• The document mentions that training data is independent of test data but does not describe how the ground truth for the training set was established.

UterineAssist

• The document implies that the ground truth for the training set would have been established similarly to the test set (i.e., by experts), as it only specifies the independence of the datasets. However, it does not explicitly describe the ground truth establishment method for the training set.

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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, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

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, private practices, clinics and similar care environment for clinical diagnosis of patients.

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

The RS85 / RS80 EVO are 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode, MV-Flow Mode or as a combination of these modes.

The RS85 / RS80 EVO also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. the RS85 / RS80 EVO have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document describes a 510(k) submission for the Samsung Medison RS85 and RS80 EVO Diagnostic Ultrasound Systems. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing.

Based on the provided text, a significant limitation is that no clinical studies were conducted to support the substantial equivalence of the RS85/RS80 EVO. The acceptance criteria and "device performance" described below are therefore derived from non-clinical tests and comparisons to the predicate device, not from human clinical data related to diagnostic accuracy or improved patient outcomes.

Therefore, the requested information about acceptance criteria and a study proving the device meets them will be based on the provided non-clinical testing and substantial equivalence claims. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done as no clinical efficacy studies were conducted. Similarly, no standalone (algorithm-only) performance was assessed as this is not an AI-driven diagnostic device beyond what is discussed in the software evaluation context.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since no clinical studies were performed, the "acceptance criteria" are based on compliance with regulatory standards and demonstrating comparable performance to the predicate device through non-clinical testing.

Study Proving Device Meets Acceptance Criteria

The study proving the device meets the acceptance criteria is a non-clinical test program designed to demonstrate compliance with recognized standards and substantial equivalence to a predicate device, rather than a clinical efficacy or performance study on human subjects.

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

   • Test Set Sample Size: Not applicable in the traditional sense of patient data. The "test set" consisted of the new RS85/RS80 EVO systems, their components (transducers, software), and their operational characteristics.
   • Data Provenance: The data is based on laboratory-based non-clinical testing performed by Samsung Medison Co., Ltd. in the Republic of Korea. The testing is retrospective in the sense that it relies on established standards and comparative analysis against known predicate device performance, not forward-looking clinical trials.

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

   • Not applicable. Ground truth for non-clinical testing is established by compliance with published engineering and safety standards (e.g., IEC, ANSI, ISO, NEMA) and comparison to the predicate device's established performance characteristics. No human experts are used to "read" or "adjudicate" test results in the clinical diagnostic sense for this type of submission.

3. Adjudication Method for the Test Set:

   • Not applicable. Non-clinical test results are typically evaluated against pre-defined quantitative thresholds set by the standards or against the established performance of the predicate device. There is no "adjudication" in the sense of multiple human readers resolving discrepancies.

4. 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:

   • No MRMC comparative effectiveness study was done. The submission states: "The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the prompt's context for MRMC studies. The software functionality evaluation focuses on maintaining image quality, not on improving human reader performance with AI.

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

   • No standalone algorithm performance study was done. The device itself is an ultrasound imaging system operated by a human, not a standalone AI algorithm producing diagnostic outputs without human interaction.

6. The Type of Ground Truth Used:

   • For non-clinical testing, the "ground truth" is established by:
     • Engineering Specifications and Performance Benchmarks: Adherence to established limits for acoustic output, electrical safety, EMC, and mechanical performance.
     • Regulatory Standards: Compliance with relevant ISO, IEC, ANSI, AAMI, and NEMA standards.
     • Predicate Device Performance: The established, cleared performance characteristics and functionality of the previously marketed predicate devices (K210959 and K211945).
     • Laboratory-based measurements and tests.

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/machine learning submission requiring a training set for model development. The software evaluation focuses on the migration of existing, cleared software functionality.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there was no training set for an AI/ML model.

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, 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.

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