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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-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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.

The provided text is a 510(k) Premarket Notification Submission for the GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a new clinical study with acceptance criteria and device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial for a novel device is not directly available in this document.

However, I can extract information related to the device's intended use, comparison to predicates, and the non-clinical tests performed.

Important Note: The acceptance criteria and performance data requested in the prompt typically refer to a clinical study demonstrating the efficacy and safety of a novel device. As this submission is for substantial equivalence to existing devices (K142160 GE LOGIQ E9, K131527 GE LOGIQ S8, K131514 GE Vivid E9), the "acceptance criteria" here are met by demonstrating that the new device shares the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness as the predicate devices, and complies with applicable safety standards. There is no new clinical study presented that would define novel acceptance criteria and then report performance against them.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, the "acceptance criteria" are implied by the features and performance of the predicate devices and compliance with relevant standards. The "reported device performance" is the demonstration that the LOGIQ E9, LOGIQ E9 XDclear 2.0 system performs equivalently to the predicates for its intended uses and complies with 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)

This document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." Therefore, there is no test set, sample size, or data provenance from a new clinical study provided in this submission for device performance evaluation. The substantial equivalence relies on demonstrating that the new device operates similarly and safely as the predicate devices, which were previously cleared.

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 new clinical study (and thus no "test set" and "ground truth" to establish) was required for this substantial equivalence submission.

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

Not applicable, as no new clinical study 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

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation. The "AutoEF and AFI" mentioned are software features but there's no MRMC study detailed here to show improved human reader performance.

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

Not applicable, as this is a diagnostic ultrasound imaging system, not a standalone algorithm.

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

Not applicable, as no new clinical study was required for this substantial equivalence submission. The "ground truth" for the predicate devices' clearance would have been established through methods appropriate for diagnostic ultrasound systems at the time of their original clearance (e.g., comparison to other imaging modalities, clinical correlation).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for an algorithm described in this submission.

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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, 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.

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The device is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document is a 510(k) Premarket Notification for the GE Vivid E80/E90/E95 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific study design details, and ground truth establishment is not explicitly available in this document.

However, I can extract the following information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the GE Vivid E80/E90/E95 system is substantially equivalent to its predicate devices concerning indications for use, imaging capabilities, technological characteristics, safety, and effectiveness. This "substantial equivalence" acts as the acceptance criterion. The reported device performance is that it meets this criterion by being comparable to 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)

The document primarily relies on comparisons to predicate devices and adherence to recognized standards. It explicitly states: "The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence."
Therefore, there is no specific test set or data provenance details relating to clinical performance provided in this document as new clinical studies were not deemed necessary for this 510(k) submission. The evidence is based on demonstrating the new device performs equivalently to existing cleared devices.

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 new clinical studies were not required, there is no information on experts establishing ground truth for a test set. The predicate devices would have undergone their own validation for their initial clearance.

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

Not applicable, as no new clinical test set was required.

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 diagnostic ultrasound system, and the submission is for showing substantial equivalence to predicate ultrasound systems, not for evaluating AI assistance or human reader improvement with AI.

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

Not applicable. This device is a diagnostic ultrasound system that functions with a human operator for image acquisition and interpretation.

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

Not applicable, as no new clinical studies requiring external ground truth were conducted for this 510(k). The "ground truth" for demonstrating substantial equivalence is the established performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as this is related to a new clinical study or AI development, neither of which were required for this 510(k) submission.

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

Not applicable, for the same reasons as above. The submission focuses on demonstrating the device's technical and functional equivalence to already cleared devices.

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