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The 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, Trans-esophageal(Cardiac) and Peripheral vessel.

The 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. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document is a 510(k) Premarket Notification for the Samsung Medison HS70A Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific quantitative acceptance criteria or a dedicated study with performance metrics against those criteria for the new device features. Instead, it states that the device was evaluated against existing standards and guidance, and that migrated software functionality was tested to ensure image quality was not compromised.

The comparison table in the document indicates that the HS70A (Under Review) is largely "Same to predicate" for various features, including:

• Intended Use and Clinical Applications: Identical to predicate devices (Fetal/Obstetrics, Abdominal, Gynecology, etc.).
• Fundamental Technology: Employs the same as predicate devices.
• Operating Modes: Identical (B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, S-Harmonic, 3D imaging, ElastoScan, Combined modes).
• Scanhead Types and Frequency: Identical.
• Acoustic Output Display & FDA Limits: Identical.
• Transmit/Receive Channels: Identical (192).
• System Characteristics: Mostly identical, with an addition of a 23.8-inch monitor option (predicate had 23-inch).
• Product Safety Certification: Conforms to IEC 60601-1, CSA C22.2 No.601.1, IEC 60601-2-37.
• EMC Compliance: Conforms to IEC60601-1-2: 2014(4th Edition).
• Acoustic Output Display Standard: Track 3.
• Biocompatibility Compliance: Conforms to ISO10993-1.
• Software Functionality: Many features are "Same to predicate" (e.g., Q Scan, ClearVision, MultiVision, Auto IMT+, Strain+, S-Detect for Breast/Thyroid, 3D Imaging features, HDVI, RealisticVue, CEUS+, 5D NT, 5D LB, 5D CNS, ElastoScan, E-Thyroid, E-Breast, ArterialAnalysis).

New Features and their Predicate Clearance:

The document highlights the addition of new software features and one new transducer, which are cleared based on their presence in the second predicate device (HERA W9/W10, K192319), indicating that these features themselves have undergone prior FDA review and clearance.

This implies that the acceptance criteria for these specific features were met in their previous 510(k) clearances.

Details of the Study (as described in the document):

The document explicitly states: "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence."

Instead, the submission relies on:

1. Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming with applicable medical device safety standards (e.g., ISO 14971, ANSI AAMI ES60601-1, IEC60601-1-2, ISO 10993-1, IEC60601-2-37, NEMA UD 2-2004).
2. Software Functionality Evaluation: "All migrated software functionality was evaluated using the same test criteria as the predicates for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality with respect to the intended use of each feature." This evaluation followed the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005."

Based on the provided text, the following information is not available or not applicable:

• Sample Size Used for the Test Set and Data Provenance: Not specified for performance of new features or overall substantial equivalence, as clinical studies were not required. The non-clinical evaluations likely used test equipment and phantom data.
• Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable, as expert-driven ground truth for performance studies is not described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not done.
• Standalone (algorithm only without human-in-the-loop performance) Study: Not explicitly described in terms of separate performance metrics, but the software functionality evaluation would implicitly be a standalone test for the algorithm's output.
• Type of Ground Truth Used: For non-clinical tests, physical measurements and engineering specifications would serve as ground truth (e.g., Acoustic Output, EMC, Electrical Safety). For the software functionality evaluation, the "same test criteria as the predicates" implies comparison against established performance levels or outputs of the predicate versions.
• Sample Size for the Training Set: Not applicable, as the submission focuses on substantial equivalence based on existing technology and non-clinical testing, not on developing a new AI/ML model that requires a distinct training set. The software is largely inherited or based on previously cleared modules.
• How the Ground Truth for the Training Set Was Established: Not applicable.

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The HS70A 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-rectal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document is a 510(k) Premarket Notification for the SAMSUNG MEDISON Co., Ltd. HS70A Diagnostic Ultrasound System. It details the device's intended use, technology, and comparison to predicate devices, but does not include acceptance criteria or the results of a study proving the device meets acceptance criteria related to diagnostic performance.

The document refers to non-clinical tests for safety and compliance with various standards but explicitly states: "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence." This means that no clinical performance study was conducted or reported in this submission to evaluate the diagnostic accuracy of the device.

Therefore, the requested information regarding acceptance criteria and the study proving device performance related to diagnostic accuracy cannot be extracted from the provided text.

Based on the provided text, here is what can be inferred about the criteria and tests performed for regulatory submission:

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

Since no clinical studies proving diagnostic performance were conducted or reported, no such table can be provided. The document focuses on regulatory compliance and safety standards.

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 test set for diagnostic performance was used or reported in this submission. The tests performed were non-clinical for safety and electrical compatibility.

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 ground truth was established or reported in this submission.

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

Not applicable as no clinical test set was used or reported in this 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:

Not applicable as implied by the statement "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence." The device is a diagnostic ultrasound system and not explicitly stated to include AI for diagnostic assistance. There is a mention of "E-Strain, S-Detect for Breast, and S-Detect for Thyroid" which are described as "same functionalities in the predicate RS80A," suggesting image processing features rather than a separate AI-driven diagnostic interpretation system that would typically warrant an MRMC study.

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

Not applicable as no diagnostic standalone algorithm performance study was reported.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the various safety and performance standards (e.g., IEC 60601-1, NEMA UD 2-2004).

8. The sample size for the training set:

Not applicable as no machine learning algorithm development training set is mentioned or implied for diagnostic performance.

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

Not applicable.

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The HS70A 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-reginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The HS70A 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, 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, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or performance studies with acceptance criteria in the way a performance study report typically would. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance metrics, and training set details) is not present in this document. The document explicitly states that clinical studies were "not applicable."

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, explicit, quantifiable acceptance criteria with corresponding device performance metrics for a specific algorithm or feature are not provided. The summary focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: The HS70A's clinical applications and modes of operation are equivalent to or expand upon those of the predicate devices.
• Technological Characteristics: The HS70A shares similar features and functionalities (e.g., imaging modes, scanhead types, frequency ranges, advanced features like 3D/4D imaging, elastography) with the predicate devices.
• Safety and EMC Compliance: The device conforms to various safety standards (UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, ISO14971).

Since this is a substantial equivalence submission for an ultrasound system, the "acceptance criteria" are implicitly met by demonstrating that the device performs as intended and is as safe and effective as the predicate devices, without introducing new questions of safety or effectiveness. No specific quantitative performance metrics comparing the subject device to a predefined threshold for a particular clinical task are mentioned.

2. Sample size 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. HS70A, did not require clinical studies to support substantial equivalence."

Therefore, there is no information provided regarding a test set sample size, data provenance, or whether data was retrospective or prospective, as no clinical studies were deemed necessary for this 510(k) submission.

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)

As stated in point 2, no clinical studies were performed, and thus, there is no information provided about experts establishing ground truth for a test set.

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

As stated in point 2, no clinical studies were performed, and thus, there is no information provided about an adjudication method.

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

The document explicitly states: "Summary of Clinical Tests: Not applicable."

Therefore, no MRMC comparative effectiveness study was performed or reported in this submission. The device is a diagnostic ultrasound system, not an AI-powered diagnostic aide (at least not in the context implied by this question). While it lists advanced features like "S-Detect" and "ElastoScan" which could involve machine learning or advanced image processing, the submission does not frame these as AI-assisted diagnostic tools requiring MRMC studies to demonstrate human reader improvement.

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

The document focuses on the ultrasound system and its transducers, which are operated by human users for diagnostic imaging. It is not an "algorithm only" device operating in a standalone capacity. The concept of "standalone performance" for an algorithm, as typically applied to AI/ML devices, is not relevant or addressed in this submission for a general diagnostic ultrasound system.

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

As no clinical studies were performed or reported to assess specific diagnostic performance metrics requiring ground truth, there is no information provided regarding the type of ground truth used.

8. The sample size for the training set

The document explicitly states: "Summary of Clinical Tests: Not applicable."
Furthermore, this document describes a diagnostic ultrasound system, not an AI/ML device that would typically have a "training set" for an algorithm, at least not in the sense of a data set for a performance study. Therefore, there is no information provided regarding a training set sample size.

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

As stated in point 8, there is no information provided regarding a training set, and therefore no information on how its ground truth might have been established.

In summary:

This 510(k) submission for the SAMSUNG MEDISON HS70A Diagnostic Ultrasound System is a demonstration of substantial equivalence to existing predicate devices. It relies on showing that the new device has similar intended uses, technological characteristics, and complies with relevant safety and performance standards. It explicitly states that no clinical studies were required or conducted for this submission. Therefore, the detailed information about acceptance criteria for particular performance metrics, test set details, expert involvement, and algorithm training specific to AI/ML device evaluations (as implied by many of your questions) is not present in this document.

Ask a specific question about this device

The HS70A 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-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HS70A 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, 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, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, based on the requirements you outlined.

It's important to note that the provided document is a 510(k) Premarket Notification from the FDA, specifically concerning the SAMSUNG MEDISON HS70A Diagnostic Ultrasound System. This type of submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than proving novel clinical efficacy or undertaking broad clinical trials typical for new therapeutic devices or high-risk diagnostics. Therefore, much of the requested information regarding detailed clinical study performance, ground truth establishment for a test set, and multi-reader multi-case studies will likely not be present as it falls outside the scope of a 510(k) for an ultrasound system of this class.

Acceptance Criteria and Device Performance Study for SAMSUNG MEDISON HS70A Diagnostic Ultrasound System (K152962)

The provided document describes the substantial equivalence determination for the HS70A Diagnostic Ultrasound System. For this type of device and submission, the "acceptance criteria" are primarily based on demonstrating equivalence to predicate devices across various technological characteristics and meeting established medical device safety standards, rather than specific performance metrics from a clinical study for a new intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to predicate devices and adherence to relevant standards. The performance is then demonstrated by showing that the HS70A meets or exceeds the capabilities of these predicate devices and complies with safety standards.

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

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission. HS70A, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set in the traditional sense of a clinical or retrospective imaging dataset used to evaluate diagnostic performance against a ground truth. The "proof" of performance relies on engineering verification and validation (bench testing, safety compliance) and comparison of technical specifications to legally marketed predicate devices, as detailed in the "Technological Characteristics Comparison Table" (pages 23-24).

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

Since no clinical test set was required or performed for diagnostic performance evaluation, this information is not applicable. The "ground truth" for a 510(k) submission of this nature refers to the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

As no clinical test set was used for diagnostic performance evaluation against an established ground truth, adjudication methods are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical studies were not required to support substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The HS70A is a diagnostic ultrasound system. While it incorporates advanced features/algorithms (like Tissue Harmonic Imaging, 3D imaging, MultiVision, Elastoscan), these are integrated functionalities of the device rather than standalone AI algorithms being submitted for independent performance claims. The performance is assessed as part of the overall system's technical specifications and safety profile, in comparison to predicates. Therefore, a "standalone algorithm performance" study as typically understood for AI/ML devices is not applicable in this context.

7. The Type of Ground Truth Used

The "ground truth" in this 510(k) pertains to the established safety, effectiveness, and performance of the predicate devices (WS80A, RS80A, A35, ACCUVIX XG). The HS70A demonstrates substantial equivalence by showing that its technological characteristics and performance meet or exceed those of these already cleared devices, and that it complies with all relevant safety standards. No new disease diagnosis performance metrics against an independent ground truth (e.g., pathology, outcomes data) were required or presented for this specific submission given its regulatory pathway.

8. The Sample Size for the Training Set

Since this is a diagnostic ultrasound system submission under the 510(k) pathway, and not a de novo AI/ML algorithm submission, there is no mention or requirement for a "training set" in the context of machine learning model development. The development of the device itself would involve internal engineering and design verification/validation, but not typically a "training set" for an explicit algorithm performance evaluation against clinical ground truth.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm, this information is not applicable. The "ground truth" for the predicate devices' safety and effectiveness was established through their own prior clearances and clinical use.

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