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The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.

The WS80A 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 Dopler 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 WS80A 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 WS80A 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 WS80A Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive study as one might see for novel AI/ML medical devices.

Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria (like performance metrics for an AI algorithm), nor does it provide a table of acceptance criteria with reported performance data in the context of an AI/ML-driven device.

Specifically, the document states: "The subject of this premarket submission, WS80A, did not require clinical studies to support substantial equivalence." This means there wasn't a clinical study to assess "device performance" in terms of algorithm accuracy, sensitivity, specificity, etc., as would be required for an AI/ML product.

However, I can extract the relevant information from the document regarding the device and its safety/effectiveness claims based on the provided text, while making it clear that it's for a traditional ultrasound system and not an AI/ML device in the sense of the detailed study requested.

Here's a breakdown based on the categories you provided, with explanations for why some information is absent:

Device: WS80A Diagnostic Ultrasound System
Type of Premarket Submission: 510(k) Premarket Notification - Traditional

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

This document does not provide a table of acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC) or reported performance data for an AI/ML model, because the WS80A is a traditional diagnostic ultrasound system. Its "performance" is demonstrated through its substantial equivalence to predicate devices, ensuring it meets safety and effectiveness standards for ultrasonic imaging.

The document discusses features and modes of operation:

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

Not applicable for this 510(k) submission. No "test set" in the context of validating an AI/ML algorithm's performance on clinical data was used or described. The validation is based on technological comparison and compliance with standards.

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

Not applicable. No ground truth establishment by experts for an AI/ML algorithm test set is described.

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. This is not an AI-assisted device.

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

Not applicable.

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

Not applicable. For a traditional ultrasound system, the "ground truth" for its operation often refers to physical and engineering principles, and its ability to accurately render anatomical structures and fluid flow. Substantial equivalence relies on the device performing equivalently to a legally marketed predicate, meaning it can acquire and display information that medical professionals interpret to reach a diagnosis.

8. The sample size for the training set

Not applicable. No AI/ML model training is described.

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

Not applicable.

Summary of Device Acceptance Approach in K173513:

The Samsung Medison WS80A Diagnostic Ultrasound System (K173513) gained FDA clearance through a 510(k) Traditional pathway. This means the approval was based on demonstrating substantial equivalence to already legally marketed predicate devices, specifically:

• WS80A Diagnostic Ultrasound System (K171070)
• RS80A Diagnostic Ultrasound System (K171048)
• Noblus™ Ultrasound Diagnostic System (K142368)

The manufacturer argues, and the FDA concurs, that the device is substantially equivalent in terms of:

• Intended use: Diagnostic ultrasound imaging and fluid analysis of the human body across various clinical applications (Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel).
• Imaging capabilities: It shares core imaging modes (B, M, Doppler, 3D/4D, Elastoscan, etc.) with its predicates. Specific features like E-Cervix, E-Strain, and S-Detect are stated to be substantially equivalent to those found in the predicate devices.
• Technological characteristics: Employs the "same fundamental scientific technology."
• Safety and Effectiveness:
  • No new hazards were identified.
  • Acoustic output and biocompatibility were evaluated.
  • Cleaning & disinfection effectiveness, electromagnetic compatibility, electrical, and mechanical safety were assessed and found compliant with applicable medical device safety standards.
  • The system includes real-time acoustic output display with Mechanical Index and Thermal Index.
  • The design, development, and quality process conform to 21 CFR 820 and ISO 13485.

Crucially, no new clinical studies were required for this submission because substantial equivalence was established through non-clinical testing and comparison to predicates. This indicates that the device's mechanism of action and expected performance were well-understood and similar to existing cleared devices, making detailed clinical performance studies unnecessary for this specific type of submission.

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The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The WS80A 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 WS80A 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 WS80A 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 WS80A Diagnostic Ultrasound System. It details an ultrasound system and its transducers, along with several software features.

Here's an analysis based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format (e.g., "accuracy must be > 90%"). Instead, it states that "Results of all conducted testing and assessments were found acceptable and did not raise any new issues of safety or effective." This implies the acceptance criteria were met by demonstrating functionality and safety equivalent to predicate devices.

The reported device performance is described qualitatively as "found acceptable" for the functionalities listed.

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

The document does not explicitly state the sample size used for the test set for the software features (IOTA-ADNEX, BiometryAssist, CrystalVue Flow, Needle Mate).

The data provenance is not explicitly mentioned as country of origin nor as retrospective or prospective data. The nature of the tests (bench and non-clinical) suggests controlled testing environment rather than clinical patient data for performance evaluation of new features in this submission.

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

The document does not provide information on the number of experts used to establish ground truth for the test set, nor their specific qualifications. For features like IOTA-ADNEX and BiometryAssist, which provide statistical information or aid in measurements, the "ground truth" would likely be established through comparison with established clinical methods or manual expert measurements. However, these details are not present.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The nature of "performance tests" and "image performance assessments" indicates an internal validation process, but details on how discrepancies or uncertainties were resolved are not provided.

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 states: "Not applicable. The subject of this submission, WS80A, did not require clinical studies to support substantial equivalence." This indicates that no MRMC comparative effectiveness study was done as part of this 510(k) submission. The evaluation focused on equivalence to predicate devices and adherence to safety standards.

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

The document describes "performance tests" for the functionality of "IOTA-ADNEX" and "BiometryAssist" and "image performance assessments" for "CrystalVue Flow" and "Needle Mate". While these tests evaluate the software features themselves, the document does not explicitly describe them as standalone algorithm-only performance studies independent of human interaction or interpretation steps. The phrasing "helps the user measure fetal growth indices" for BiometryAssist suggests a human-in-the-loop function. Given the lack of clinical study described, these were likely technical validations rather than full standalone clinical performance evaluations.

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

The document does not specify the type of ground truth used for the performance evaluation of the software features. For "IOTA-ADNEX" and "BiometryAssist," ground truth would typically refer to validated clinical diagnoses, pathological findings, or precise manual measurements, but these details are not provided. For "CrystalVue Flow" and "Needle Mate," ground truth would relate to objective image quality metrics or expert assessment of image features, also not detailed.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This is expected, as the document describes a 510(k) submission for an ultrasound system and its features, not a particular AI model that would typically have a distinct training set. The features listed (IOTA-ADNEX, BiometryAssist, CrystalVue Flow, Needle Mate) are likely algorithms or advanced processing techniques, but details about their development (e.g., training data) are not included in this regulatory document.

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

As no information is provided regarding a training set, the document does not describe how ground truth for a training set was established.

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The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The WS80A 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 WS80A 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 WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

I'm sorry but there is no acceptance criteria or study that describes how the device meets the acceptance criteria from the context you provided.

Ask a specific question about this device

The WS80A 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 WS80A 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 WS80A 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 WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This looks like a 510(k) summary for a diagnostic ultrasound system (WS80A) and its transducers. The document emphasizes that the device is substantially equivalent to previously cleared predicate devices and relies on non-clinical tests (bench testing, safety standards compliance) rather than a clinical study to demonstrate this.

Here’s a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a dedicated performance study with specific metrics like sensitivity, specificity, or accuracy. Instead, it demonstrates performance by asserting substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with recognized safety standards.

The closest equivalent to "acceptance criteria" is the comprehensive list of features and clinical applications provided for the WS80A and its various transducers, showing that they function similarly to the predicate devices. The "reported device performance" is implicitly that the WS80A performs safely and effectively in all its indicated modes and applications, matching or being equivalent to the listed predicate devices.

Here's a table based on the provided "Technological Characteristics Comparison Table" from the document (page 22), focusing on the parity claimed with existing devices.

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

The document explicitly states: "Not applicable. The subject of this submission. WS80A, did not require clinical studies to support substantial equivalence." Therefore, there is no "test set" in the context of clinical validation, and no information on sample size or data provenance from a performance study. The evaluation primarily relied on non-clinical (bench) tests and comparison to predicate devices against recognized standards.

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 study was conducted, there are no experts establishing ground truth for a test set. This information is not applicable and not provided in the document.

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

As no clinical study was performed, there was no test set requiring an adjudication method. This information is not applicable and not provided.

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 does not describe an MRMC comparative effectiveness study. It states that clinical studies were not required. The "5D" features (5D CNS, 5D Follicle, 5D Heart) are described as features that "assist with diagnosis," implying a potential benefit to users, but no study is presented to quantify this improvement or effect size.

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

This document describes a diagnostic ultrasound system and its transducers, which are inherently "human-in-the-loop" devices used by healthcare professionals. While it does mention "S/W Features" like "5D CNS," "5D Follicle," and "5D Heart" that "assist with diagnosis," it does not present a standalone algorithm-only performance study. These features are integrated into the system for use by an operator.

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

For the non-clinical tests (acoustic output, biocompatibility, electrical, electromagnetic, mechanical safety), the "ground truth" would be the specifications and requirements of the referenced international and national standards (e.g., IEC 60601-1, NEMA UD-2, ISO 10993-1). The device's performance was measured against these standards. For the functionality comparison, the "ground truth" is the established functionality and performance of the predicate devices.

8. The sample size for the training set

The document does not describe any machine learning or AI model development that would typically involve a "training set." The "5D" features are mentioned, but no details regarding their development, training data, or sample sizes are provided. Given the nature of a 510(k) for an ultrasound system, the focus is on hardware and software equivalence and safety rather than novel AI algorithm validation.

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

Since no training set is described, the method for establishing its ground truth is not provided.

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The UGEO WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel.

The UGEO WS80A 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 Dopler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO WS80A 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 UGEO WS80A 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) Premarket Notification for the UGEO WS80A Diagnostic Ultrasound System (K133329) does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or other quantitative measures) nor does it describe a study designed to prove the device meets such criteria.

Instead, this submission is a Premarket Notification focused on demonstrating substantial equivalence to existing legally marketed devices. As such, the "study" proving the device meets criteria is primarily a comparison of technological characteristics and intended uses to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria or performance metrics are provided in this regulatory submission. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various features and intended uses.

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, UGEO WS80A, did not require clinical studies to support substantial equivalence."

Therefore, there was no "test set" in the sense of clinical image data used for performance evaluation that would have a sample size or data provenance. The assessment was based on technical specifications and comparison to predicate 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 no clinical studies or test sets requiring expert-established ground truth were deemed necessary, this information is not applicable and not provided in the submission.

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

Not applicable, as no clinical 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

Not applicable. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies comparing human readers with and without AI assistance are typically conducted.

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

Not applicable. The UGEO WS80A is a diagnostic ultrasound system operated by a human, not a standalone algorithm. While it features some automated measurement and imaging functions (e.g., 5D Cine, 5D NT, Auto IMT+), these are features of the overall system, and their standalone "algorithm performance" is not separately reported in this regulatory documentation. The focus is on the substantial equivalence of the system as a whole.

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

Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for demonstrating substantial equivalence relied on technical specifications, functional comparisons, and adherence to recognized safety standards in comparison to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. Since no clinical studies were performed, there was no "training set" of data in the context of machine learning or AI development.

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

Not applicable, as no training set was used.

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