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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 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, Trans-vaginal, 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 is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states:

"The subject of this premarket submission HS40. is not required clinical studies to support substantial equivalence." and "Summary of Clinical Tests: The subject of this premarket submission HS40. is not required clinical studies to support substantial equivalence."

Therefore, based on the provided document, there is no information available about acceptance criteria, the study that proves the device meets specific acceptance criteria, or any details related to human reader performance, expert involvement, or ground truth establishment relevant to the questions asked.

The document focuses on non-clinical tests (acoustic output, biocompatibility, software function, electrical/thermal/electromagnetic/mechanical safety, cleaning/disinfection) and demonstrating substantial equivalence to a predicate device based on similar intended use and technological features.

Because the document states that clinical studies were not required, it cannot provide the information requested in the prompt.

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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.

The HS40 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices.

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 document is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI algorithm or an analysis of human reader improvement with AI assistance. The document explicitly states:

• "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence." (Page 26, Section 12)

The main purpose of this submission is to demonstrate that the new HS40 system is as safe and effective as the predicate device (HS40 Diagnostic Ultrasound System K191055, and features migrated from HS50/HS60 Diagnostic Ultrasound System K192505), based on non-clinical tests and technological equivalence.

Here's a breakdown of why each requested point cannot be fully addressed by this document:

1. A table of acceptance criteria and the reported device performance: This document does not present quantitative acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for a particular disease detection) that would be proven by a clinical study. Instead, it relies on demonstrating equivalence in technical specifications, safety, and functionality to a previously cleared device.

   • However, it does list the clinical applications for the device and its various transducers. These implicitly represent the "performance" capabilities:
     • Clinical Applications (HS40 System - Page 3): 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.
     • Modes of Operation (HS40 System - Page 3): B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, and various combined modes. Also mentions S-Harmonic (Harmonic Imaging), Tissue Doppler Imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging, and ElastoScan Mode.
     • Added SW features (Page 25): S-Detect for Breast, 2D Follicle, LaborAssist, CrystalVue. These features, specifically S-Detect for Breast and 2D Follicle, hint at automated analysis or AI components, but no performance data for them is provided in this document.

2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical study or test set with patient data for diagnostic performance evaluation is detailed. The tests performed are non-clinical, related to safety and technical standards (e.g., acoustic output, electrical safety).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with ground truth established by experts is detailed.

4. Adjudication method for the test set: Not applicable, as no clinical study requiring adjudication is detailed.

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 document does not describe an MRMC study or AI assistance for human readers. While it mentions "S-Detect for Breast" as a new software feature, which typically implies AI-driven detection, the submission does not include any performance data or comparative studies for this feature.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. No standalone algorithm performance study is described.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical study with a ground truth is detailed.

8. The sample size for the training set: Not applicable. This document is a 510(k) for an ultrasound system, not an AI/ML device that would require explicit training set data for its submission. Even if the mentioned "S-Detect for Breast" feature utilizes AI, the details of its training are not part of this specific FDA submission as presented here.

9. How the ground truth for the training set was established: Not applicable for the reasons stated above.

In summary of what the document DOES provide regarding device meeting acceptance criteria:

The "acceptance criteria" here are generally understood as the regulatory requirements for demonstrating substantial equivalence to a predicate device. The study proves the device meets these criteria through:

• Comparison to Predicate (Section 10, Page 25): The document argues that the HS40 is substantially equivalent to its predicate (K191055 and K192505) in:
  • Intended use
  • Imaging capabilities
  • Technological characteristics
  • Safety and effectiveness
  • Specific examples include sharing imaging modes, modes of operation, and migrating certain software features and transducers from cleared devices.
• Summary of Non-Clinical Tests (Section 11, Page 26): The device has been evaluated and found to conform with applicable FDA guidance and medical device safety standards for:
  • Acoustic output
  • Biocompatibility
  • Software function (without detailing performance metrics for diagnostic features)
  • Cleaning and disinfection effectiveness
  • Thermal, electrical, electromagnetic, and mechanical safety
  • Specific standards cited: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004. These are the "acceptance criteria" in the context of this specific filing approach – adhering to recognized standards to ensure safety and performance equivalence.

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The HS40 ultrasound diagnostic 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, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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 is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a novel AI/ML algorithm.

Therefore, the document does not contain the acceptance criteria and the detailed study results as would be presented for a device demonstrating novel AI/ML performance. It focuses on showing the HS40 ultrasound system, including new software features and transducers, is equivalent to existing cleared ultrasound systems.

Here's an analysis based on the information provided, highlighting why the requested details are not present for an AI/ML algorithm in this specific document:

Missing Information (as expected for a 510(k) that is not for a novel AI/ML algorithm):

• Acceptance Criteria Table and Reported Device Performance: This document describes a general diagnostic ultrasound system. It outlines the intended clinical applications (Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel) and modes of operation (B-mode, M-mode, PWD, CWD, Color Doppler, etc.). There are no specific performance metrics (e.g., sensitivity, specificity, AUC) or acceptance criteria for an AI/ML algorithm.
• Sample Size for Test Set and Data Provenance: Not applicable, as no specific AI/ML performance test set is described.
• Number of Experts and Qualifications for Ground Truth Establishment (Test Set): Not applicable.
• Adjudication Method for Test Set: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence." This means a formal comparative effectiveness study like an MRMC study was not deemed necessary for this 510(k). The "summary of non-clinical tests" focuses on acoustic output, biocompatibility, software function, and safety standards.
• Standalone Performance (Algorithm Only): Not applicable. This is a system submission, not a standalone AI/ML algorithm. While the device mentions "added some of SW features (2DNT, BiometryAssist, E-Strain, NeedleMate, AutoIMT, etc.) that migrated from predicate HS50/60," it does not present performance data for these specific features in the way an AI/ML algorithm's performance would be evaluated. These features are likely automated measurement or image processing tools that were already cleared on other predicate devices.
• Type of Ground Truth Used: Not applicable, as there's no specific AI/ML performance outcome being measured against ground truth.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this document does not describe the development or training of a novel AI/ML algorithm. It describes a general ultrasound system and its equivalence to pre-existing cleared devices.

Information from the document that is tangentially related (but not what was asked for directly related to AI/ML acceptance criteria):

• Device Name: HS40 Diagnostic Ultrasound System.
• Intended Use: "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Clinical applications are listed above.
• Technology: "The HS40 employs the same fundamental scientific technology as its predicate device." This highlights the equivalence approach rather than novel technology.
• Predicate Devices: HS40 Diagnostic Ultrasound System (K180409) - Primary Predicate, HS50/60 Diagnostic Ultrasound System (K181336), SONOACE R7 Diagnostic Ultrasound System (K133505), HM70A Diagnostic Ultrasound System (K182894).
• Non-Clinical Tests: Evaluated for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable FDA guidance and medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-1, ISO14971, NEMA UD 2-2004, NEMA UD 3-2004). This speaks to the safety and fundamental performance of the ultrasound system itself, not the performance of an AI/ML algorithm.
• Regulatory Pathway: 510(k) Premarket Notification - Traditional. This pathway typically relies on substantial equivalence to a predicate, and for general ultrasound systems, does not usually require detailed clinical studies demonstrating AI/ML performance.

In summary, this 510(k) submission is for a general diagnostic ultrasound system and its associated transducers, demonstrating substantial equivalence to already-cleared predicate ultrasound systems. It does not provide the kind of performance data, acceptance criteria, or study details typically associated with the evaluation and clearance of novel AI/ML algorithms.

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The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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

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 is a 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System. It is a regulatory submission to the FDA demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML.

The document primarily focuses on:

• Indications for Use: Listing the various clinical applications and modes of operation for the ultrasound system and its different transducers.
• Device Description: Describing the HS40 as a general clinical diagnostic ultrasound system with standard imaging modes.
• Substantial Equivalence: Comparing the HS40 to existing predicate devices (e.g., HS40 (K172129), Sonoace R7 (K133505), LOGIQ S7 Expert (K160182)) based on intended use, imaging capabilities, technology, safety, and effectiveness.
• Non-Clinical Tests: Listing compliance with various safety and performance standards (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2-2004).
• Absence of Clinical Tests: Explicitly stating, under "Summary of Clinical Tests," that "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document pertains to a traditional diagnostic ultrasound system and explicitly states that clinical studies were not required for its substantial equivalence determination.

To answer your request, if this were an AI/ML device and the information was present, here's how the structure of the answer would typically look, but based on the provided text, the answer to most points would be "N/A" or "Not specified in this document":

Based on the provided 510(k) Premarket Notification for the Samsung Medison HS40 Diagnostic Ultrasound System, there is no information present regarding acceptance criteria or a study proving the device meets those criteria for an AI/ML-based device.

The document pertains to a traditional diagnostic ultrasound system and its transducers, demonstrating substantial equivalence to previously cleared devices. It explicitly states that clinical studies were not required for this submission. Therefore, most of the requested details about AI/ML device performance studies are not applicable or specified in this regulatory filing.

Here's a breakdown of the requested information based on the provided text:

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

   • N/A. This document does not describe performance metrics or acceptance criteria for an AI/ML component. It details the cleared indications for use and operational modes of a diagnostic ultrasound system.

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

   • N/A. No test set for an AI/ML algorithm is described. The document states "The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence."

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):

   • N/A. No ground truth establishment for an AI/ML algorithm is described.

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

   • N/A. No test set for an AI/ML algorithm is described.

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:

   • N/A. No MRMC study is mentioned. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image analysis.

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

   • N/A. This document does not describe an AI/ML algorithm.

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

   • N/A. No ground truth for an AI/ML algorithm is described.

8. The sample size for the training set:

   • N/A. No training set for an AI/ML algorithm is described.

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

   • N/A. No ground truth for an AI/ML algorithm is described.

Ask a specific question about this device

The HS40 diagnostic ultrasound system and probes were designed for obtaining ultrasound images and analyzing bodv fluid.

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

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 B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Freehand 3D mode, Dual mode, Dual live mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. 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 have 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 a 510(k) premarket notification for the Samsung Medison HS40 Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating acceptance criteria being met for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new device is not applicable or not provided in this specific filing.

However, based on the provided text, I can infer and extract some relevant information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating "substantial equivalence" to a legally marketed predicate device (HS50/HS60 Diagnostic Ultrasound System, K170493) in terms of safety, effectiveness, and functionality. The "reported device performance" is the assertion that the HS40 meets these criteria by having equivalent or similar functionality and adherence to safety standards.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS40, did not require clinical studies to support substantial equivalence." This indicates that there was no specific test set of patient data used for clinical evaluation of the HS40's performance against defined acceptance criteria because clinical studies were not required for this type of submission (510(k) for an ultrasound system). The equivalence is largely based on technical specifications and adherence to standards.

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

Not applicable, as no clinical test set requiring expert ground truth was performed for the HS40 in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed for the HS40 in this submission.

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

Not applicable. The filing explicitly states that no clinical studies were required or performed. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted for this device.

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

Not applicable. This is a diagnostic ultrasound system, not an AI-powered diagnostic algorithm in the typical sense that would undergo standalone performance evaluation. The device's performance is tied to its imaging capabilities, which are considered substantially equivalent to the predicate.

7. Type of Ground Truth Used

Not applicable, as no clinical studies with ground truth were conducted for this submission. The "ground truth" in a 510(k) context for an ultrasound system like this is primarily its adherence to safety standards and demonstration of equivalent technical and functional characteristics to a predicate, not clinical diagnostic accuracy against a reference standard.

8. Sample Size for the Training Set

Not applicable. This document describes a general-purpose diagnostic ultrasound system that acquires images, not an AI/ML algorithm that is trained on a specific dataset.

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

Not applicable, as there was no training set for an AI/ML algorithm for this device.

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