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Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp. Nuewa I9 Easi. Anesus I9, Anesus I9 Easi. Eagus I9 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).

The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text is a 510(k) summary for the Resona I9 series Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of features. It explicitly states that clinical studies were not required or performed for this submission.

Therefore, many of the requested elements regarding acceptance criteria and a study proving the device meets these criteria (especially those related to AI performance, human reader improvement, and ground truth establishment) cannot be found in this document. The device described is a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic tool, which further explains the absence of such information.

However, I can extract the general acceptance criteria for this type of device based on the non-clinical tests performed to demonstrate safety and effectiveness.

Here's a breakdown of the information available and the parts that are explicitly stated as "Not Applicable" or absent:

Acceptance Criteria and Device Performance

Since this is a 510(k) for a diagnostic ultrasound system and not an AI-driven device with specific performance metrics like sensitivity/specificity, the acceptance criteria are related to safety, electrical performance, acoustic output, and compatibility. The "reported device performance" is the manufacturer's claim that the device passed these tests and conforms to the standards.

While there isn't a table of specific numerical performance criteria (e.g., minimum diagnostic accuracy), the general acceptance is based on conformity to recognized medical device standards and comparability to predicate devices.

Study Details (Based on the Provided Document)

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided. The document states "Non-clinical Tests" were performed, but does not provide details on specific sample sizes for these tests (e.g., how many transducers were tested for acoustic output, or how many materials for biocompatibility). The document describes the system and its features, not a clinical trial or performance study based on patient data.
   • Data Provenance: Not specified, as it's not a clinical data study. Non-clinical tests are typically performed in a lab setting by the manufacturer.

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

   • Not Applicable. As this is a 510(k) based on non-clinical testing and comparison to a predicate device, there is no mention of expert-established ground truth for a test set in the context of diagnostic accuracy.

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

   • Not Applicable. No clinical test set with human assessment and adjudication is mentioned.

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. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies for AI performance improvement.

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

   • Not Applicable. This is a diagnostic ultrasound imaging system, not a standalone AI algorithm. While it mentions "new software and hardware options" and features like "Smart Scene 3D" or "High frame rate STE," these are described as "improvements or enhancement based on the cleared functions to facilitate users," implying integrated features within the ultrasound system, not a separate AI algorithm requiring standalone performance validation against a ground truth. None of these features are presented as standalone diagnostic algorithms.

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

   • Not Applicable. For the non-clinical tests, "ground truth" would be the established scientific/engineering standard for a given test (e.g., a calibrated device for acoustic output measurements, or a specified biochemical reaction for biocompatibility). There is no clinical ground truth (like pathology or outcomes data) mentioned, as no clinical studies were performed.

7. The sample size for the training set:

   • Not Applicable. The document does not discuss a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set is mentioned in the context of machine learning.

In summary, the provided 510(k) document is for a general diagnostic ultrasound system and asserts substantial equivalence via non-clinical testing and comparison to predicate devices, not through clinical performance studies involving a test set, expert readers, or AI algorithm validation against ground truth.

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Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.

This device is a general purpose diamostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.

However, I can extract information related to the device's broader regulatory and non-clinical testing.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."

However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.

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

Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards 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

Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or ground truth was established that would require adjudication.

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/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.

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

Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.

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

Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.

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

Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.

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The FibroScan® 630 is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.

FibroScan® 630 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).

The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

Shear wave speed and stiffness may be used as an aid in the clinical management of pediatric patients with liver disease.

FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.

FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and estimates of tissue stiffness. The probe containing a mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.

The focus of this submission is the new FibroScan® 630, available in two configurations: FibroScan® 630 'Prime' (FS630P) and FibroScan® 630 'Expert' (FS630E). Both FS630P and FS630E include improvements of the FibroScan appearance and user interface.

The FS630P version has the same indications as the previously cleared models and is only indicated for non-invasive measurement of 50 Hz shear wave speed in the liver and estimates of its stiffness, as well as determination of a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The FS630E includes an expansion of the intended use to include noninvasive measurement of shear wave speed at 100Hz in the spleen and estimates of its stiffness as well as an inclusion of a B-Mode ultrasound imaging system to help the user locate the liver or spleen.

Here's a breakdown of the acceptance criteria and the study details for the FibroScan® 630, based on the provided text:

Acceptance Criteria and Device Performance for FibroScan® 630

The acceptance criteria for the FibroScan® 630 are implicitly defined by its equivalence to the predicate device, FibroScan® 530 Compact, and the clinical support for its expanded indications. The reported device performance is presented as a comparison to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the FibroScan® 630 is considered "equivalent" to the predicate in terms of bias and precision. Therefore, the acceptance criteria are to perform comparably to the predicate device within a specified range, or to have a similar safety and effectiveness profile. Numerical acceptance criteria are given for the liver and spleen shear wave speed and CAP bias and precision, which must fall within a range similar to or better than the predicate devices.

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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.

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