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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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The HS50 / HS60 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HS50 / HS60 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, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 and HS60 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 HS50 / HS60 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 is a 510(k) summary for the Samsung Medison HS50/HS60 Diagnostic Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly available in this document.

However, I can extract information related to the device's technical characteristics and the general safety and effectiveness assessments.

Summary of Device Features and Equivalence:

The HS50/HS60 Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data and displays it in various modes (B, M, Color M, Anatomical, Color Doppler, Pulsed Wave (PW) Spectral Doppler, Continuous Wave (CW) Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Doppler (PD), ElastoScan, 3D/4D/XI STIC imaging, Dual, Quad, Combined, Simultaneous, and Zoom modes). It also provides measurement and analysis packages for diagnostic purposes.

The device's substantial equivalence to predicate devices (H60 (K143264), RS80A (K162094), WS80A (K153529), HM70A (K153408), and HS70A (K163691)) is claimed based on safety, effectiveness, and functionality. All systems transmit ultrasonic energy into patients, process echoes for display of anatomic structures and fluid flow, and allow for measurements and calculations.

Here's the information formatted to the best of my ability based on the provided text, acknowledging that direct "acceptance criteria" and "study results" in the sense of a new clinical claim are not present for this type of submission:

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

The document does not specify quantitative acceptance criteria for a new clinical performance claim, as it is a 510(k) submission for substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent if the device meets all safety standards and performs its intended functions similarly to the predicate devices.

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

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size, data provenance, or details of a clinical study to report from this document.

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 for this 510(k) submission.

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

Not applicable, as no clinical studies were performed.

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. This is a 510(k) for a diagnostic ultrasound system, not an AI-based interpretation device claiming improved reader performance. The document explicitly states "Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence."

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

Not applicable. This is a diagnostic ultrasound system, which is a human-operated device, not a standalone algorithm.

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

Not applicable, as no clinical studies were performed for a new performance claim. The ground for substantial equivalence relies on comparison to predicate devices, which are already cleared for clinical use.

8. The sample size for the training set

Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set in the typical sense for machine learning.

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

Not applicable.

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