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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 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B mode, M mode, PW mode, CW mode, Color mode, Power/Dirpower mode, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The provided document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. to the FDA regarding their Resona 7 Diagnostic Ultrasound System. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily for proving novel clinical claims or improved clinical effectiveness through extensive clinical trials.

Therefore, the document does not contain information on acceptance criteria for an AI/CADe device's performance, nor does it detail a study proving such performance in the way a clinical study for a novel AI algorithm would. Instead, it focuses on demonstrating that a modified ultrasound system remains substantially equivalent to its predicate.

However, based on the structure of your request and assuming this was a document from which one hoped to extract such information about a theoretical AI/CADe device, I will explain why most of your requested points cannot be answered from this document and what information is relevant to the device's acceptance.

This document is for an ultrasound imaging system, not an AI/CADe device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to traditional ultrasound device performance and safety, not AI algorithm performance.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria for AI performance. The acceptance criteria for this ultrasound system are related to its safety, electrical performance, acoustic output, and imaging capabilities being equivalent to the predicate device. The performance is "proven" by compliance with recognized standards and comparison to the predicate.

• Acceptance Criteria (Implicit for a traditional ultrasound device K-submission):

  • Substantial equivalence to predicate device in terms of intended use, technology, safety, and effectiveness.
  • Compliance with recognized safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
  • Acoustic output levels below FDA limits.
  • Biocompatibility of patient-contacting materials (for new transducers/brackets).
  • Effective cleaning and disinfection.
  • Software lifecycle processes compliance (IEC 62304).
  • Risk management (ISO 14971).
  • Imaging modes and features perform similarly to predicate.

• Reported Device Performance: The document states that the device "has been found to conform with applicable medical safety standards" and "is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." It doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/CADe device, but rather confirms compliance with established engineering and safety benchmarks relevant to ultrasound systems.

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

This document is for a traditional ultrasound imaging system submission (510(k)), not an AI/CADe device. Therefore, it does not describe a "test set" or "data provenance" in the context of an AI algorithm being evaluated on a dataset of patient images.

The "testing" mentioned refers to engineering and safety tests on the physical device and its software, not performance on a clinical image dataset for diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/CADe device that requires expert-established ground truth for a test set. The "ground truth" for the device's function is its ability to produce images and measurements according to its specifications and to operate safely, which is verified through engineering tests and comparison to the predicate.

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

Not applicable, for the same reasons as point 3.

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 an ultrasound system, not an AI-assisted device. The "multi-reader multi-case" study design is typical for evaluating the impact of AI on human reader performance, which is not relevant to this submission.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its operation as an imaging system.

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

Not applicable for an AI/CADe device. The "ground truth" for this ultrasound system relates to its technical performance and safety, which are evaluated against engineering standards and comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device that has a "training set."

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

Not applicable. This is not an AI/CADe device that has a "training set."

Summary from the document's perspective:

The document describes a 510(k) submission for a Diagnostic Ultrasound System (Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB). The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (primarily K162267, Resona 7, and others like DC-8, ZS3).

The "acceptance criteria" and "study" are therefore focused on:

• Safety and Effectiveness: Ensuring the new/modified device is as safe and effective as the predicate.
• Compliance with Standards: A list of recognized consensus standards is provided (e.g., AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 60601-2-37 for ultrasonic equipment, ISO 14971 for risk management, ISO 10993 for biocompatibility, NEMA UD 2 for acoustic output). The "study" is the non-clinical testing performed to show compliance with these standards.
• Functional Equivalence: The device employs the same underlying technology (ultrasonic energy transmission and processing), has the same intended uses (e.g., fetal, abdominal, cardiac exams), and generally the same basic operating modes as its predicate. New transducers and features are added, but they are evaluated in the context of the device remaining substantially equivalent.

The document explicitly states under "8. Clinical Tests: Not Applicable," which further confirms that no clinical studies (like those evaluating AI diagnostic performance or human reader improvement with AI) were conducted or required for this particular 510(k) submission.

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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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