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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, Pediatric, 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 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Dopler 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 also gives 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 has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.

This document describes the validation of AI-based features for the Samsung Medison RS85 Diagnostic Ultrasound System, specifically focusing on NerveTrack's detection, segmentation, and EzNerveMeasure functionalities, as well as SonoSync.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Sizes and Data Provenance

2. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three participating experts.
• Qualifications of Experts:
  • One anesthesiologist with more than 10 years of experience in pain management performed the initial manual drawing of nerve areas.
  • Other doctors with more than 10 years of experience performed verification of the ground truth.

3. Adjudication Method for the Test Set

The adjudication method appears to be a 2+1 process:

1. Initial ground truth (GT) data was manually drawn by one anesthesiologist.
2. Other doctors (presumably at least two distinct individuals to form a consensus if needed, though the document only states "other doctors") with more than 10 years of experience checked every frame.
3. If discrepancies ("did not agree on nerve locations/contours") arose, necessary corrections were made to finalize the GT. This indicates a consensus-based approach for disagreement resolution, but the specific number for resolving disagreements is not explicitly 2+1; it just states "other doctors."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed according to the provided text. The studies focus on the standalone performance of the AI algorithms.

5. Standalone Performance Study

Yes, standalone (algorithm only without human-in-the-loop) performance studies were done for NerveTrack's detection, segmentation, and EzNerveMeasure functionalities. The reported results (accuracy, speed, Dice coefficient, Hausdorff distance, and error rates) are direct measurements of the algorithm's performance against established ground truth.

6. Type of Ground Truth Used

The ground truth used was expert consensus. It was established by manual delineation (drawing of nerve areas/contours) by an anesthesiologist with over 10 years of experience, followed by verification and correction (if needed) by other doctors also with over 10 years of experience.

7. Sample Size for the Training Set

The document explicitly states: "Data used for training, tuning and validation purpose are completely separated from the ones during training process, and there is no overlap among the three." However, the exact sample size for the training set is not provided in this document. It only gives the test set sizes.

8. How Ground Truth for the Training Set Was Established

While the exact size of the training set is not given, the method for establishing its ground truth is described similarly to the validation set:

• The GT data for training, tuning, and validation were built by three participating experts.
• Nerve areas were manually drawn by an anesthesiologist with more than 10 years of experience in pain management.
• The doctors who scanned the ultrasound were directly involved in the construction of GT data.
• For verification, other doctors with more than 10 years of experience checked every frame.
• If they did not agree on nerve locations/contours, necessary corrections were made to create the final GT.

This suggests that the ground truth for the training set was also established through expert consensus and manual delineation, following the same "Truthing" process as the test 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, 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 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.

The provided document, a 510(k) summary for the Samsung Medison RS85 / RS80 EVO Diagnostic Ultrasound System, does not contain the detailed acceptance criteria and performance study information typically required for an AI/ML-based medical device.

The document explicitly states in section 12: "The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device (RS85 Diagnostic Ultrasound System K192903) through non-clinical testing, rather than a performance study involving AI/ML components with specific acceptance criteria.

The information provided pertains to general ultrasound system functions, safety standards, and technological equivalence to a previous model, not to the performance of an AI-driven feature.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details for an AI component from this document.

To answer your request, if this were a document for an AI/ML-driven device, the following would typically be observed:

1. A table of acceptance criteria and the reported device performance: This would be found in a dedicated section detailing the clinical or technical validation of the AI feature. It would list performance metrics (e.g., sensitivity, specificity, AUC, accuracy) with pre-defined thresholds and the actual values achieved by the device.

2. Sample sized used for the test set and the data provenance: This information would be crucial for evaluating the robustness and generalizability of the AI model. It would include the number of cases/patients in the test set, their demographic breakdown, and where the data was collected (e.g., single-center, multi-center, specific countries), and whether it was collected retrospectively or prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For expert consensus ground truth, the number of readers, their specialty (e.g., board-certified radiologists), and years of experience would be detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: If multiple experts were used to establish ground truth, the method for resolving discrepancies (e.g., majority vote, senior expert arbitration) would be 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: This would be a specific section demonstrating the human-AI team performance, often comparing reader performance with and without AI assistance using metrics like AUC, sensitivity, or specificity, and reporting the statistically significant improvement (effect size).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Often, an AI model's standalone performance is evaluated first, before assessing its impact in a human-in-the-loop setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This would specify the "gold standard" against which the AI's performance was measured.

8. The sample size for the training set: The number of cases/patients used to train the AI model would be an important detail to understand the model's learning capacity.

9. How the ground truth for the training set was established: The method for labeling or annotating the data used for training the AI model would be described.

In summary, the provided document focuses on the substantial equivalence of a general diagnostic ultrasound system and its transducers, rather than the performance evaluation of an AI/ML-driven component within such a system.

Ask a specific question about this device

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

The RS85 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, 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 Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode, MV-Flow Mode or as a combination of these modes. The RS85 also gives 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 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 information for the Samsung Medison Co., Ltd. RS85 Diagnostic Ultrasound System.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices. Therefore, it primarily compares the new device to predicates rather than presenting de novo acceptance criteria and extensive clinical trial data as might be found in a PMA (Premarket Approval) submission for a novel device or an AI breakthrough.

The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." This means that acceptance criteria for the device's performance in a clinical setting (e.g., diagnostic accuracy) are not detailed within this particular submission. The "acceptance criteria" presented below are inferred from the substantial equivalence claim and the comparison to predicate devices, focusing on technical and functional equivalence rather than clinical performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" largely revolve around demonstrating the new device is functionally, technologically, and safely equivalent to existing cleared devices. The reported device performance is implicitly "meets or is similar to" the predicate devices.

• MI Output Display
• TI Output Display | Identical to predicate devices. |
  | Electrical Safety | Conform to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012 and IEC 60601-2-37 | RS85 evaluated per these standards. | Explicitly stated compliance. |
  | Electromagnetic Compatibility | Conform to IEC60601-1-2: 2014 (4th Edition) | IEC60601-1-2: 2014 (4th Edition) | Explicitly stated compliance. |
  | Biocompatibility | Conform to ISO 10993-1 Fourth edition 2009-10-15 | ISO 10993-1 Fourth edition 2009-10-15 | Explicitly stated compliance. |
  | Reprocessing Medical Devices | Conform to FDA Guidance issued March 17, 2015, revised June 9, 2017 | Evaluated per guidance | Explicitly stated compliance. |
  | Software/Firmware-driven Functionality | Evaluated using same criteria as predicate for image quality | Evaluated for migration into new system design. | "All migrated software functionality was evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality..." |
  | Ultrasound Safety (Acoustic Output Measurement) | Conform to IEC60601-2-37:2007 + A1:2015 and NEMA UD 2-2004 (R2009) | IEC60601-2-37:2007 + A1:2015, NEMA UD 2-2004 (R2009) | Explicitly stated compliance. |
  | System Characteristics (Channels, Monitor, Power) | Similar to predicate devices | 192 Transmit/Receive Channels, 23.8inch (new) / 23inch monitor, 256 gray shades, 100-240VAC, 1100VA, 50/60Hz | Comparison table shows equivalency or slight improvements (e.g., 23.8-inch monitor) that do not alter fundamental safety or effectiveness. |
  | Specific Software Features | Functionally equivalent to corresponding features on predicate/reference devices | New features (EzHRI, QUS, PureVision), predicate features (ShadowHDR, BiometryAssist, IOTA-ADNEX) added, improved features (ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging, HQ-Vision, Setup&Preference), and name changes (Panoramic -> Panoramic+, MV-Index -> Vascularity Index, NeedleMate -> NeedleMate+) | This implies the new/changed features were tested to ensure they function as intended and do not negatively impact safety or effectiveness compared to predicates they are similar to. |
  | Transducers | Functionally equivalent to previously cleared transducers | Various new (N) and previously cleared (P) transducers listed (e.g., LA2-14A, CA1-7S, PA1-5A, EV2-10A, EA2-11AR, EA2-11AV, EV2-10A) with specific indications. | Each transducer is compared to predicate transducers for substantial equivalence. "SE to predicates; refer to SE Analysis X" indicates supporting data. |
  | Biopsy Guides | Compatible and functionally equivalent to predicate devices | BP-KIT-029 etc. (various models) | Same or functionally equivalent to predicate devices. |

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

The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence."

Therefore:

• Sample size for test set: Not applicable (no clinical test set as part of this submission for substantial equivalence). The evaluation focused on engineering, software verification, and validation tests comparing the new system to already cleared devices.
• Data provenance: Not applicable for clinical data. The comparability data for components and technical specifications are likely derived from internal testing and validation processes by Samsung Medison (South Korea) against industry standards and predicate device specifications.

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

Given the statement that clinical studies were not required, there is no mention of external experts establishing a clinical "ground truth" for a test set in this submission. The "ground truth" for technical and functional validation would be against established engineering specifications, performance standards, and comparison with predicate device outputs. This would involve internal engineering and quality assurance teams.

4. Adjudication Method for the Test Set

Not applicable, as no external clinical test set requiring adjudication by experts is described 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

The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." Furthermore, while the device includes new software features like "EzHRI, QUS(TAI, TSI), PureVision" and improvements to "ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging", these are presented as enhancements or new capabilities whose safety and efficacy are demonstrated through technical equivalence to existing cleared features or algorithms, not through a comparative effectiveness study involving human readers and AI assistance. Therefore, no MRMC study or effect size for AI assistance is reported here.

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

The document doesn't provide specific details on standalone algorithm performance for features like EzHRI, QUS (TAI, TSI), PureVision, ElastoScan+, MV-Flow, S-Fusion, S-Shearwave Imaging, or BiometryAssist. The submission focuses on demonstrating that these software features (whether new or improved) are substantially equivalent to functions on predicate devices or previously cleared equivalents, or meet established performance criteria during internal testing. It implies that these features are integrated into the diagnostic ultrasound system, functioning as tools for a human operator, rather than performing as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" is primarily based on:

• Technical and functional specifications: Adherence to established engineering parameters, performance metrics, and compliance with national and international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2).
• Comparison to predicate devices: The functionality and safety characteristics of the RS85 (including its new and revised features) are demonstrated to be substantially equivalent to those of the predicate devices (RS85 K191115, HERA W10 K182595, HS50/HS60 K181336, and other reference devices like AIXPLORER K173021, Fibroscan K150949, AmCAD-US K162574). This means the performance of the predicate devices implicitly serves as a "ground truth" for what is acceptable.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data as a "ground truth" within this 510(k) summary, as it explicitly states no clinical studies were required.

8. The Sample Size for the Training Set

Not applicable. As no clinical studies were performed, there is no mention of a clinical training set for any AI/software features. If any internal machine learning models are used within the software features (e.g., BiometryAssist, S-Detect), the details of their training data are not provided in this 510(k) summary. The submission focuses on the output of these features being equivalent to predicate devices or meeting internal specifications.

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

Not applicable, as no clinical training set is described in this document.

Ask a specific question about this device

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The RS85 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, 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 or as a combination of these modes. The RS85 also gives 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 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) summary for the SAMSUNG MEDISON RS85 Diagnostic Ultrasound System. It mostly focuses on claiming substantial equivalence to a predicate device (RS85 Diagnostic Ultrasound System K182932) by demonstrating that the proposed device has the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based only on the provided document:

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

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it claims substantial equivalence to its predicate device (RS85 Diagnostic Ultrasound System K182932). The "device performance" reported is that the "proposed RS85 is same to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

The table provided lists comparisons between the proposed RS85 (version V1.05) and its predicate (K182932). This table indicates:

• Clinical Application: No addition (meaning identical to the predicate).
• Operation of modes: No addition (meaning identical to the predicate).
• Applied transducers: No addition (meaning identical to the predicate).
• SW Features: Improvement of cleared software (Setup&Preference, Patient Management, Measurement, ScanMode(CEUS+), S-Fusion).
• HW Features: No addition (meaning identical to the predicate).

Since no specific quantitative acceptance criteria or performance numbers are given for the device, a table of acceptance criteria vs. reported performance cannot be fully constructed in the traditional sense of numerical targets. The "acceptance criterion" appears to be equivalence to the predicate device's existing performance, which is implicitly considered acceptable.

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 states, "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." This indicates that no dedicated clinical test set with a specific sample size was used for this 510(k) submission. Instead, the submission relies on non-clinical tests and the established safety and effectiveness of its predicate device through technical comparison.

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)

Since no clinical studies were performed for this submission (as stated in section 11 "Summary of Clinical Tests"), there is no information provided on experts establishing ground truth for a test set. The substantial equivalence claim is based on non-clinical performance and a comparison to a previously cleared device.

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

As per item 2 and 3, no clinical test set was used, and therefore, no adjudication method is mentioned.

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, "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." Furthermore, the described improvements in "SW Features" (e.g., Setup&Preference, Patient Management, Measurement, ScanMode(CEUS+), S-Fusion) are functional enhancements to the ultrasound system itself, not features implying AI assistance for human image interpretation that would warrant an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with/without AI assistance is provided.

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

The device is an ultrasound system with software features, not a standalone algorithm. The "SW Features" listed are improvements to the existing cleared software. There is no indication of a standalone algorithm-only performance study.

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

As no clinical study was conducted for this submission, no information on the type of ground truth used is provided. The submission relies on non-clinical testing and comparison to the predicate device, K182932, whose ground truth establishment would have been part of its original clearance.

8. The sample size for the training set

The document does not describe any specific "training set" for an algorithm. The software features are described as "improvement of the cleared Software" for a diagnostic ultrasound system. This implies software updates or enhancements to an existing system, rather than the development of a new AI/ML algorithm that would undergo a distinct training phase. Therefore, no sample size for a training set is provided.

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

As no training set is mentioned in the context of an algorithm, no information is provided on how ground truth for a training set was established.

Ask a specific question about this device

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. 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.

The RS85 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. 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 or as a combination of these modes. The RS85 also gives 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 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 information:

Response:

Based on the provided 510(k) summary for the SAMSUNG MEDISON RS85 Diagnostic Ultrasound System (K182932), the device's acceptance criteria are primarily related to its substantial equivalence to a predicate device, K173204 (also an RS85 Diagnostic Ultrasound System). The submission did not involve clinical studies to demonstrate substantial equivalence, but rather relied on non-clinical tests and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical studies were performed, the "reported device performance" in the typical sense of metrics like accuracy, sensitivity, or specificity is not available for this submission. Instead, the acceptance criteria are based on equivalence to the predicate device in terms of features and conformity to relevant standards.

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

No test set of patient data (e.g., images) was used or described for performance evaluation in this 510(k) summary. The submission focuses on hardware and software equivalence to a previously cleared device. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective data) relating to clinical performance.

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

Not applicable, as no test set requiring ground truth establishment by experts was used.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." (page 32). There is no mention of AI integration or assessment of human reader improvement.

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

No standalone performance study of an algorithm was conducted or described, as this submission is for a diagnostic ultrasound system and not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with ground truth were conducted. The "ground truth" for this submission focuses on demonstrating that the device's technical specifications and intended uses are equivalent to a predicate device and that it complies with relevant safety and performance standards.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe the development or training of any machine learning or AI models. It pertains to a diagnostic ultrasound system.

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

Not applicable. This submission does not describe the development or training of any machine learning or AI models.

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The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The RS85 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, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS85 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 RS85 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 acceptance criteria and study information for the SAMSUNG MEDISON CO., LTD. RS85 Diagnostic Ultrasound System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the new device itself. As such, direct numerical acceptance criteria for performance (e.g., sensitivity, specificity) and a study proving the device meets those specific performance acceptance criteria are not explicitly stated in this document. Instead, the document relies on the equivalence of the RS85 to existing cleared devices and compliance with relevant standards.

Therefore, the tables below will reflect what is inferable from the document, which primarily focuses on demonstrating equivalence rather than establishing new performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document clearly states:

"The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence."

This indicates that no dedicated clinical study was performed with the RS85 device to prove specific performance acceptance criteria in human patients. Instead, the FDA clearance for this device, a 510(k), is based on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for substantial equivalence are based on:

• Similar intended uses.
• Similar technological characteristics.
• Similar imaging capabilities and modes (with new features shown to be equivalent to features in existing cleared devices).
• Compliance with recognized performance standards (acoustic output, biocompatibility, electrical safety, etc.).

Therefore, the following points address the questions based on this underlying premise of substantial equivalence, rather than a new performance study:

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable, as no dedicated clinical test set from human subjects was used for a performance study. Non-clinical testing would have involved engineering samples and simulated environments.
• Data Provenance: Not applicable for a clinical test set. The data presented relates to engineering and bench testing, and comparisons to legally marketed predicate devices (K171048, K171070, K132274, K163691).

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 test set requiring expert ground truth establishment for performance evaluation was conducted.

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

• Not applicable, as no clinical test set requiring adjudication was conducted.

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

• No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The device is a diagnostic ultrasound system, and while it may incorporate advanced features, it is presented as substantially equivalent to existing non-AI predicate devices in its fundamental technology and clinical applications. There is no mention of AI assistance for human readers or any associated effect sizes.

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

• Not applicable. The RS85 is a diagnostic ultrasound system, not an AI-driven algorithm intended for standalone performance evaluation without human-in-the-loop. Its performance is assessed through its output in imaging modes.

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

• For the non-clinical tests (acoustic output, biocompatibility, safety standards), the "ground truth" would be the specifications and requirements of the referenced standards (e.g., IEC 60601-1, NEMA UD 2-2004). For demonstrating substantial equivalence, the "ground truth" is established by the performance and safety profiles of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe the development or training of an AI algorithm necessitating a training set. The device is a traditional ultrasound system.

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

• Not applicable, as no training set for an AI algorithm is mentioned in this submission.

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