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The RS80A 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 Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The RS80A 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 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 RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: RS80A Diagnostic Ultrasound System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's equivalence to predicate devices, rather than explicit acceptance criteria with numerical targets. The "acceptance criteria" are implied by demonstrating substantial equivalence to existing cleared devices in terms of safety, effectiveness, and functionality.

The performance is implicitly demonstrated by showing that the new features (E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid) and improved features (S-Detect for Breast) perform comparably to their respective predicate features.

• Comparable sensitivity and AUC values to the predicate (clinical data).
• Accuracy value within the scope of the predicate (clinical data). | - Successfully demonstrated measuring two average strain values within two separate regions of interest using a phantom.
• Clinical data showed comparable sensitivity and AUC values to the predicate.
• Accuracy value was within the statistical scope of the predicate, despite a slightly lower specificity rate. |
  | S-3D Arterial Analysis | - Quantitative comparison of plaque volume value to the predicate (clinical data).
• Similar segmentation method and user interface to the predicate. | - Successfully compared plaque volume value quantitatively to the predicate using clinical data, demonstrating substantial equivalence.
• Functionality and user interface were similar to the predicate. |
  | S-Detect for Thyroid | - Measurement of lesion size using phantom as an essential and basic method.
• Workflow similar to the predicate.
• Lexicon classification method allows user selection and printing, comparable to the predicate for diagnostic decisions. | - Demonstrated measurement of lesion size using a phantom.
• Workflow was the same as the predicate.
• Lexicon classification, while items differ, uses the same method for user selection and printing for diagnostic decisions, demonstrating substantial equivalence. |
  | S-Detect for Breast | - Direct comparison of lesion size measurement to the predicate, showing substantial equivalence. | - Demonstrated substantial equivalent value in lesion size measurement through direct comparison to the predicate. |

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

• E-Strain:
  • Test Set Sample Size: Not explicitly stated, but "clinical data" was used. For the mechanical test, a "phantom" was used.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
• S-3D Arterial Analysis:
  • Test Set Sample Size: Not explicitly stated, but "clinical data" was used.
  • Data Provenance: Not explicitly stated.
• S-Detect for Thyroid:
  • Test Set Sample Size: Not explicitly stated. A "phantom" was used for lesion size measurement.
  • Data Provenance: Not explicitly stated.
• S-Detect for Breast:
  • Test Set Sample Size: Not explicitly stated, a "predicate" was used for direct comparison.
  • Data Provenance: Not explicitly stated.

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth for the test sets of E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid, or S-Detect for Breast.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test sets.

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

• The document states, "Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence."
• Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done and no effect size is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The studies described for E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid, and S-Detect for Breast appear to be evaluations of the software features themselves, not necessarily incorporating human-in-the-loop performance measurement.
• For E-Strain, it "Calculates the strain between the areas of the suspected lesion (ROI A) and reference tissue area (ROI B, reference) and displays the results." This sounds like an algorithmic output.
• For S-3D Arterial Analysis, it "display the highly comprehensible vessel structure through the 3D vessel and plaque analysis with the ultrasound equipment and help to diagnose cardiovascular by calculating clinically useful indicators." This also describes algorithmic functionality.
• For S-Detect for Thyroid, "It is a set of functionalities for conducting ultrasound thyroid exams. It assists the entire process of locating a lesion in an ultrasound image and making a diagnosis." This suggests the algorithm primarily assists or provides information, but the evaluation focuses on lesion measurement and lexicon classification, which are standalone functionalities.
• Therefore, the tests primarily focused on the standalone performance of specific software functionalities (e.g., measurement, analysis, classification display).

7. The Type of Ground Truth Used

• E-Strain: For the mechanical evaluation, a "phantom" was used. For quantitative comparison, "clinical data" was used, and the "accuracy value was within the scope of the predicate." This suggests the ground truth was derived from presumably established clinical assessments or measurements reflected in the predicate device's performance.
• S-3D Arterial Analysis: "Plaque volume value quantitatively to the predicate using clinical data." This implies the ground truth for plaque volume was established from clinical assessment, likely from the predicate device's output or other accepted clinical standards.
• S-Detect for Thyroid: "Measurement of lesion size using phantom" for essential measurement. "Lexicon classification is provided in the predicate [and] it is the same method for user to select item of best description to their diagnosis decision." This suggests ground truth for measurement comes from phantom characteristics, and for classification, it's aligned with established diagnostic lexicon criteria.
• S-Detect for Breast: "Direct comparison to the predicate" for lesion size measurement. Ground truth would be based on the established measurements from the predicate device that was already cleared.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for any of the described software features. This filing is for substantial equivalence to existing cleared devices, and it focuses on the performance of the new features.

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

• Since the sample size for the training set is not provided, the method for establishing its ground truth is also not elaborated upon in this document.

Ask a specific question about this device

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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

The RS80A 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 imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided document is a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study.

The document states:

• "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence."
• "Conclusion: Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the RS80A to be as safe, as effective, and performance is substantially equivalent to the predicate devices."

Therefore, the submission does not contain information about a study proving the device meets specific acceptance criteria in the manner usually associated with evaluating AI/ML-enabled devices (e.g., performance metrics compared against a predefined threshold). Instead, the substantial equivalence is established based on technological characteristics and compliance with recognized safety and performance standards.

However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the "device performance" as its declared characteristics and compliance.

Here's the information based on the provided text, structured to answer your questions where applicable. Please note that several points of your request pertain to clinical studies or AI/ML evaluations which are explicitly stated as "Not applicable" or not present in this type of submission for a diagnostic ultrasound system without a new AI component being evaluated for clinical accuracy.

1. Table of Acceptance Criteria (via Substantial Equivalence to Predicate Devices) and Reported Device Performance

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to predicate devices (RS80A K151663 and Prosound F75 K140639) across various technological characteristics and intended uses. The "reported device performance" refers to the capabilities and specifications of the RS80A.

Notes for above table:

• "P" in the original tables across pages 3-25 indicates "previously cleared by FDA K141620" for RS80A features (or K143089, K150478, K151663 for specific transducers). This essentially means the feature existed and was cleared in previous versions or related devices.
• The comparison specifically identifies "Arterial Analysis" as a new S/W feature for the RS80A (new in the subject device relative to K151663), but then states it's substantially equivalent to the "eTRACKING" of Hitachi's Prosound F75 (K140639) in regards to arterial analysis functionality. This feature "provides the user with vessel stiffness and strain information by measuring in vessel diameter."

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, RS80A, did not require clinical studies to support substantial equivalence."
• Therefore, no specific clinical test set, sample size, or data provenance information is provided for evaluation of medical efficacy to demonstrate performance against acceptance criteria in a clinical setting. The evaluation focused on engineering and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable due to the absence of clinical studies evaluating the device against a ground truth for clinical outcomes. The submission relies on technological equivalence and compliance with standards.

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

• Not applicable due to the absence of clinical studies.

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 submission is for a diagnostic ultrasound system (hardware and general software features), not specifically an AI/ML-enabled diagnostic algorithm that assists human readers and would typically require an MRMC study. The "Arterial Analysis" feature, while providing information, is not presented as an AI-driven interpretive tool that changes reader performance.

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

• Not applicable, as this is a medical device submission for an ultrasound system, not a standalone diagnostic algorithm.

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

• Not applicable in the context of clinical performance. The "ground truth" for this submission focuses on compliance with technical and safety standards (e.g., IEC, ISO, NEMA) and functional equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm submission where a training set size would be relevant for performance evaluation in the described context.

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

• Not applicable.

In summary, the provided document demonstrates substantial equivalence for the RS80A Diagnostic Ultrasound System based on a comparison of its technological characteristics, intended uses, and compliance with recognized safety and performance standards against two predicate devices (another RS80A model and Hitachi's Prosound F75). It explicitly states that clinical studies were not required for this submission. Therefore, detailed information on clinical acceptance criteria or a study proving clinical performance in the manner requested (e.g., using test sets, ground truth, expert adjudication, or MRMC studies) is not present in this 510(k) summary.

Ask a specific question about this device

The RS80A 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, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The RS80A 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 imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text describes a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through new clinical trials. Therefore, the document does not contain acceptance criteria, a study proving device meeting acceptance criteria, or information on AI/standalone performance.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not applicable to a 510(k) submission for this device:

Analysis of Acceptance Criteria and Study for RS80A Diagnostic Ultrasound System (K162094)

The provided document is a 510(k) Premarket Notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to establish new clinical effectiveness or safety based on acceptance criteria or a dedicated clinical performance study with human readers and AI assistance in the way a PMA (Premarket Approval) might require for novel devices.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, and clinical study designs (especially those involving AI-assisted human readers or standalone AI performance) are not applicable or not present in this type of submission for this particular device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable in a 510(k) for this device.
A 510(k) submission for an ultrasound system like the RS80A typically focuses on demonstrating that its technological characteristics, intended use, and safety/EMC performance are equivalent to predicate devices. It does not typically define specific clinical performance acceptance criteria (e.g., sensitivity, specificity for a particular pathology) that the device must meet, nor does it report device performance against such criteria. The "performance" demonstrated is primarily technical capability and compliance with safety standards.

The document states: "The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards." This is the primary "performance" being demonstrated for substantial equivalence in a 510(k).

Technological Characteristics Comparison Table (from pages 32-33):
This table compares features of the RS80A (V3.00) to its predicate devices, demonstrating equivalence in functionality, scanhead types, frequency ranges, and modes of operation. This acts as the "performance data" in the context of substantial equivalence, showing that the new device offers comparable features and safety.

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

Not Applicable for this specific 510(k) submission.
The document states "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used for an effectiveness study in the usual sense. The testing performed was primarily non-clinical (bench tests) for safety and performance against standards.

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

Not Applicable.
As no clinical effectiveness study was required, there was no ground truth for a test set established by experts in the context of clinical performance (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

Not Applicable.
Since no test set with expert ground truth was established for a clinical effectiveness study, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. without AI Assistance

Not Applicable.
The document does not mention any AI functionality in the context of diagnostic interpretation or a human-in-the-loop study comparing human readers with and without AI assistance. The features listed are image enhancement, processing, and visualization capabilities (e.g., HQ Vision, 3D imaging, ElastoScan, S-Fusion, S-Shearwave, S-Detect). While "S-Detect" might imply some level of automated detection, the submission does not describe it as an AI-driven diagnostic aid requiring an MRMC study or reporting an effect size on human readers. The purpose of this 510(k) filing is to demonstrate substantial equivalence, not superior effectiveness through such comparative studies.

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

Not Applicable.
There is no mention of a standalone algorithm performance evaluation in the provided document. The device is a diagnostic ultrasound system intended for use by a "competent health care professional."

7. The Type of Ground Truth Used

Not Applicable (for clinical effectiveness).
As no clinical effectiveness study requiring ground truth (e.g., pathology, outcomes data) was conducted for this 510(k) submission, this information is not available. The "truth" evaluated was compliance with safety standards and equivalence to predicate device specifications.

8. The Sample Size for the Training Set

Not Applicable.
Since this is not an AI/machine learning device undergoing a clinical performance study that would typically involve a "training set" for an algorithm to learn, this information is not relevant to this 510(k) submission.

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

Not Applicable.
As there was no training set for an algorithm, the method for establishing its ground truth is not relevant or provided.

Summary of what the K162094 510(k) demonstrates:

The 510(k) for the RS80A Diagnostic Ultrasound System (K162094) demonstrates substantial equivalence to previously cleared predicate devices (RS80A Diagnostic Ultrasound System (K151663), WS80A Diagnostic Ultrasound System (K153529), HM70A Diagnostic Ultrasound System (K153408), LOGIQ E9 Diagnostic Ultrasound System (K142160), Voluson E10 Diagnostic Ultrasound System (K131267), AmCAD-UT (K122536), QLAB (K121223)). This equivalence is based on:

• Identical Intended Uses: The RS80A and its transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications.
• Similar Technological Characteristics: The device utilizes standard ultrasound imaging modes (B-mode, M-mode, Doppler modes, harmonic imaging, 3D/4D imaging) and offers advanced features (e.g., Elastoscan, S-Detect, S-Fusion, HQ Vision) similar to or improved upon those in the predicate devices.
• Compliance with Recognized Standards: The device has been evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to international and national medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004).

The document explicitly states that clinical studies were not required to support substantial equivalence for this submission because it falls under the scope of demonstrating technical and safety equivalence to existing devices.

Ask a specific question about this device

The RS80A 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 RS80A 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 imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This is a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. The purpose of this document is to demonstrate "substantial equivalence" to previously cleared predicate devices, meaning that the new device is as safe and effective as the predicate devices and does not raise new questions of safety or effectiveness. As such, the document primarily focuses on comparing the new device's features and performance to those of predicate devices, rather than establishing acceptance criteria and proving the device meets them through a dedicated standalone study with defined ground truth and expert adjudication.

However, based on the provided text, I can infer information related to acceptance criteria through the comparison tables and the declaration of "substantial equivalence."

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RS80A Diagnostic Ultrasound System are implicitly met by demonstrating that its technical characteristics, intended uses, and safety compliance are "substantially equivalent" to predicate devices. This means the device's performance is expected to be on par with or better than the established performance of the cleared predicate devices.

Here's an inferred table of key "acceptance criteria" (represented by the features and standards the device claims to meet as being equivalent to predicate devices) and the "reported device performance" (which is the device possessing these features and meeting these standards):

Study Information:

The document describes a bench and non-clinical test approach rather than a specific clinical trial with a test set.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a distinct "test set" for performance evaluation in the described manner. The submission relies on "substantial equivalence" to predicate devices, implying that the performance of the RS80A is within acceptable ranges demonstrated by already cleared devices. The testing mentioned (acoustic output, biocompatibility effectiveness, thermal, electrical, electromagnetic, and mechanical safety) are likely internal engineering and quality assurance tests, not a clinical "test set" with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document does not describe a clinical study with a "ground truth" established by experts in the context of image interpretation or diagnosis. The "ground truth" for compliance testing is against engineering specifications and international standards.

3. Adjudication method for the test set: Not applicable. No clinical adjudication method is described.

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: Not applicable. This document is for a diagnostic ultrasound system and its transducers, not explicitly an AI-assisted diagnostic device requiring an MRMC study for improved human reader performance. The listed "SW Features" like S-Detect, E-Thyroid, E-Breast, and S-Fusion hint at advanced functionalities that might involve AI-like processing, but the document does not present them as standalone AI clinical decision support systems requiring MRMC studies to show reader improvement. Instead, they are presented as equivalent or improved features compared to predicates.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for the overall device clearance. The device is a diagnostic ultrasound system, intended for use with a human operator. Even advanced features like S-Detect for lesion analysis are presented as aids within the larger diagnostic system, not as standalone algorithms performing a diagnosis without human interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the safety and effectiveness mentioned, the "ground truth" would be the adherence to established international and national standards (e.g., IEC, NEMA, ISO standards) for medical devices. For functional comparisons, the "ground truth" is the established performance and features of the predicate devices. There is no mention of specific clinical ground truth (like pathology or outcomes data) being used for this 510(k) submission, as it relies on substantial equivalence.

7. The sample size for the training set: Not applicable. The document describes a general diagnostic ultrasound system and its transducers, not a machine learning model that would typically have a "training set." While "SW Features" like S-Detect might leverage machine learning, the details of their development (including training sets) are not provided in this 510(k) summary, which focuses on device safety and substantial equivalence rather than algorithm validation.

8. How the ground truth for the training set was established: Not applicable, as no training set is described. If features like S-Detect or E-Thyroid involve machine learning, their internal ground truth establishment would be part of their individual validation, but it's not detailed in this high-level regulatory summary.

Ask a specific question about this device

The RS80A 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, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The RS80A 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 imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided 510(k) summary for the RS80A Diagnostic Ultrasound System does not contain information related to acceptance criteria or a study proving the device meets specific acceptance criteria for AI/CAD performance. The document is a premarket notification for a general-purpose diagnostic ultrasound system and its various transducers.

The "study" discussed in this document is a demonstration of substantial equivalence to predicate devices. This is a regulatory pathway in the US for medical devices that are substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than a standalone clinical study to validate novel performance claims against specific acceptance criteria.

Therefore, the requested information cannot be fully provided from the given text. However, based on the document, here's what can be extracted and what is explicitly stated as not applicable:

Non-AI / Non-CAD Acceptance Criteria and Performance (Based on Substantial Equivalence)

The document asserts that the RS80A Diagnostic Ultrasound System is "substantially equivalent with respect to safety, effectiveness, and functionality" to several predicate ultrasound systems (UGEO WS80A, UGEO HM70A, ACCUVIX A30, ACCUVIX XG). This means that the device is deemed to meet the same implicit "acceptance criteria" through comparison.

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

The document does not specify quantitative acceptance criteria. Instead, it relies on a qualitative comparison to predicate devices, asserting equivalence across various features and functionalities. The "reported device performance" is implicitly represented by the "√" (check mark) indicating that the RS80A possesses the same features as the predicate devices.

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. The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." The evaluation was based on bench and non-clinical tests.

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. No clinical studies were conducted, thus no expert-established ground truth for a test set was required for this submission.

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

Not applicable.

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. No MRMC study was conducted. The "S-Detect" feature is mentioned as being substantially equivalent to "B-CAD (K050846)," which is likely a Computer-Aided Detection (CAD) system. However, the document does not include a comparative effectiveness study or report an effect size for human reader improvement with this feature.

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

Not applicable. The document does not describe standalone algorithm performance studies for any features. The comparison for "S-Detect" is to an existing CAD system, implying its functionality is similar, but no specific performance metrics are provided.

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

Not applicable. As no clinical studies or performance studies requiring ground truth were conducted for this substantial equivalence submission, no ground truth types are mentioned. The ground truth for proving safety and effectiveness primarily relies on meeting engineering and safety standards (e.g., IEC, UL, NEMA, ISO standards) and demonstrating functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe any specific training sets as no "AI" or "CAD" algorithms in the modern sense of requiring extensive training data are discussed in terms of their development or validation. The "S-Detect" feature is likely a rule-based or classic image processing CAD system from its predicate date (K050846), which typically would not involve machine learning training sets in the same way modern AI does.

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

Not applicable.

In summary: K141620 is a 510(k) submission based on substantial equivalence to predicate diagnostic ultrasound systems. It focuses on demonstrating that the RS80A Diagnostic Ultrasound System has similar intended uses, technological characteristics, and meets safety standards, thereby not requiring de novo clinical studies with specific acceptance criteria, test sets, or ground truth establishment for novel AI/CAD performance claims. The mention of "S-Detect" is a comparison to an existing CAD system (B-CAD K050846), but no performance data, either standalone or human-in-the-loop, is provided for this feature within this document.

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