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The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.

The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.

The provided text does not contain detailed acceptance criteria for a diagnostic ultrasound system's performance, nor does it describe a study specifically designed to prove the device meets such criteria. Instead, it is an FDA 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against specific acceptance criteria.

The document states that "No clinical testing was required" [7]. This means that the submission does not include data from a clinical trial demonstrating the device's performance in a real-world setting against specific clinical endpoints or acceptance criteria.

While the document lists various safety standards the device complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004, ISO 10993-1) [8], these are general safety and performance standards for medical electrical equipment and ultrasound devices, not specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., that would typically be evaluated in a clinical study.

Therefore, many of the requested details cannot be extracted from this document, as they are not present in a 510(k) summary that did not require clinical testing.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

This information is not provided in the document. The document lists general device specifications and modes of operation but does not specify quantitative acceptance criteria for diagnostic accuracy or image quality, nor does it present device performance against such criteria. The "Comparison to Predicate Device" table [8] lists features and controls, showing they are "Same" as the predicate, but this is not a performance comparison against acceptance criteria.

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

This information is not provided as no clinical testing was required for this 510(k) submission [7].

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)

This information is not provided as no clinical testing was required [7].

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

This information is not provided as no clinical testing was required [7].

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "No clinical testing was required" [7]. The device is a diagnostic ultrasound system, not an AI software, and the document makes no mention of AI assistance.

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

This concept is not applicable as the device is a diagnostic ultrasound system operated by a clinician, not an algorithm, and no standalone performance study was mentioned [7].

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

This information is not provided as no clinical testing was required [7].

8. The sample size for the training set

This information is not provided as no clinical testing was required [7]. The device is not described as an AI/ML algorithm that would typically have a "training set."

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

This information is not provided as no clinical testing was required [7].

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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

The SonoBook Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) the image Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

This document describes the SonoBook Series Diagnostic Ultrasound System and compares it to a predicate device (Q Series Diagnostic Ultrasound System K150851) to demonstrate substantial equivalence for FDA 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense, as this is a submission for a general diagnostic ultrasound system rather than an AI-enabled diagnostic algorithm. Instead, it demonstrates compliance with relevant medical device safety and performance standards and compares its features to a predicate device.

The "acceptance criteria" here implicitly refer to meeting established safety standards and having comparable functionality to the predicate device. "Reported device performance" is indicated by the system's features and compliance.

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

The document states "No clinical testing was required." (Section 7). The submission relies on non-clinical tests (lab tests) and comparison to a legally marketed predicate device. Therefore, there is no test set in the sense of patient data for evaluating diagnostic performance.

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 clinical testing was performed and no specific "ground truth" for a test set of patient data was established for diagnostic performance. The ground truth for functional and safety validation would be the compliance with recognized standards.

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

Not applicable, as no clinical testing was performed.

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 submission for a general diagnostic ultrasound system, not an AI-enabled diagnostic algorithm, and no clinical effectiveness studies of this nature were performed or required.

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, not an AI algorithm intended for standalone diagnostic performance.

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

The "ground truth" for this submission is implicitly defined by the adherence to recognized international and national consensus standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37), acoustic output (NEMA UD 2-2004, NEMA UD3:2004), and biocompatibility (ISO 10993-1). The comparison is primarily against the performance and features of the predicate device (Q Series Diagnostic Ultrasound System K150851).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. This is not an AI/ML device that requires a training set of data.

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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

I am sorry, but the provided text is a 510(k) Pre-Market Notification for a Diagnostic Ultrasound System and does not contain the specific details about acceptance criteria, device performance, study designs (sample sizes, provenance, ground truth, expert qualifications, adjudication methods), MRMC comparative effectiveness studies, or standalone algorithm performance that you requested.

The document primarily focuses on:

• Indications for Use: Listing the clinical applications for which the device is intended.
• Safety and Performance Standards: Stating that the device conforms to various IEC, NEMA, and ISO standards related to electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output.
• Comparison to Predicate Device: Highlighting similarities in features, operating controls, display modes, and safety compliance with a previously cleared device (Q Series Diagnostic Ultrasound System K153085).
• Conclusion: Asserting substantial equivalence to predicate devices based on safety and effectiveness.

It explicitly states: "No clinical testing was required." This means there wasn't a study of the type you are asking about, designed to assess the device's diagnostic performance against a ground truth or compared to human readers. The substantial equivalence was established based on engineering and safety testing, and comparison of technical specifications to a predicate device.

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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

The Q Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Q Series Diagnostic Ultrasound System

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

The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task. Instead, it focuses on demonstrating substantial equivalence to a predicate device (QBit Series Diagnostic Ultrasound System, K150861) by comparing technical and functional specifications. The "acceptance criteria" here implicitly refer to the device safely and effectively performing within the established parameters and indications for use, similar to the predicate device.

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

The document explicitly states: "No clinical testing was required." This indicates that there was no test set of patient data used for clinical performance evaluation. The substantiation of equivalence was primarily through non-clinical testing and comparison of technical specifications to the predicate device.

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

Not applicable, as no clinical testing with a test set and ground truth established by experts was performed or required.

4. Adjudication method for the test set:

Not applicable, as no clinical testing with a test set was performed or required.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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. No MRMC study or AI assistance evaluation was mentioned.

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

Not applicable. This is a hardware diagnostic imaging system; it does not explicitly refer to an "algorithm only" performance separate from the system's overall function. The performance is inherent to the integrated ultrasound system.

7. The type of ground truth used:

Not applicable, as no clinical testing requiring ground truth was performed. The evaluation relied on compliance with engineering standards and direct comparison of specifications to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. As this approval is for a traditional diagnostic ultrasound system and not an AI/ML-driven device, there would not typically be a "training set" in the sense of machine learning. The system's design and performance are based on established ultrasound physics and engineering principles, and its functionality is validated against industry standards and predicate devices.

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

Not applicable, for the same reasons as #8.

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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transectal, Transvaginal, Urology.

The QBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

The provided document is a 510(k) premarket notification for the CHISON Medical Imaging Co., Ltd. QBit Series Diagnostic Ultrasound System. This document asserts substantial equivalence to a predicate device and does not present an independent clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.

Instead, the document focuses on demonstrating that the QBit Series Diagnostic Ultrasound System has similar technological characteristics and performance to a legally marketed predicate device (DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, K132341), thereby concluding that it is as safe and effective.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for a de novo or novel device cannot be directly extracted from this type of regulatory submission in the typical sense. However, I can infer and extract information to the best of my ability based on the provided text, primarily from the "Comparison to Predicate Device" table.

Here's the breakdown of what can be gathered and what cannot:

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

The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical task. Instead, it relies on demonstrating that the "Submission Device" (QBit Series) is comparable to the "Predicate Device" in terms of indications for use, design, operating controls, safety compliance, patient contact materials, operation modes, display modes, display annotations, display monitor, measurements, transducer types & connectors, acoustic output, and power requirements.

The "reported device performance" is essentially the statement that the submission device is "Same" or "Substantially Equivalent" (SE) to the predicate across these many features.

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

• Sample Size for Test Set: This information is not applicable and not provided. The submission states, "No clinical testing was required." The comparison is based on technical specifications and regulatory compliance, not on clinical performance data gathered from a test set of patient cases.
• Data Provenance: Not applicable, as no clinical test data is presented.

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 clinical test data with expert-established ground truth is presented.

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

• Not applicable, as no clinical test data requiring adjudication is presented.

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 510(k) submission for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device for which MRMC studies are typically conducted to evaluate reader performance.

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

• Not applicable. This is a diagnostic ultrasound system, the performance of which is inherent to its image acquisition and processing capabilities, not a standalone algorithm.

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

• Not applicable, as no clinical test data with ground truth is presented. The "ground truth" for this regulatory submission is effectively the compliance with recognized standards (e.g., IEC, NEMA, ISO) and the technical specifications of the predicate device.

8. The sample size for the training set

• Not applicable. This document pertains to the regulatory clearance of a medical device based on substantial equivalence, not the development or training of an algorithm using a dataset.

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

• Not applicable.

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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

The Q6/Q8/Q9/Q10/i7/i8 /i9 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q6/Q8/Q9/Q10), or as a roll-around model on wheels (i7/i8/i9). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes.3D/4D.

The provided 510(k) submission for the CHISON Q Series & i7, i8, i9 Diagnostic Ultrasound System primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria are met in the way requested.

The submission claims substantial equivalence by showing that the proposed device has the same intended use, basic operating modes, and similar design principles as the predicate devices (GE Voluson E6/E8/E8 Expert K101236 and CHISON iVis60EXPERT, Q6/Q8, i7 K120801). The "Modifications and Newly Added Features" (new transducers and software options) are also claimed to be substantially equivalent.

No explicit acceptance criteria or a dedicated performance study against such criteria are presented in the document. Instead, the device's conformance to safety standards and comparison to predicate device specifications are used as the basis for demonstrating safety and effectiveness.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit acceptance criteria for individual performance metrics (e.g., sensitivity, specificity, accuracy for a specific diagnostic task) are defined or reported. The "acceptance criteria" in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant safety standards.

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

• No specific "test set" in the context of diagnostic performance (e.g., images for measuring sensitivity/specificity) is described. The conformity assessment for the device relies on laboratory testing against engineering specifications and safety standards, as well as a comparison to predicate devices.
• Data Provenance: Not applicable as no diagnostic performance test set is described.

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

• Not applicable. No diagnostic performance study involving expert-established ground truth is presented.

4. Adjudication Method for the Test Set

• Not applicable. No diagnostic performance test set requiring adjudication is described.

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

• No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence to pre-existing ultrasound systems based on technical specifications and safety standards, not on assessing the improvement in human reader performance with or without AI assistance. The new software options (Elastography, IMT, Curved Panoramic, Supper needle) are listed as features, but no clinical efficacy data for them is provided.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study was done. The device is a diagnostic ultrasound system, not an AI-only algorithm. The "newly added software options" are features of the ultrasound system, and their performance is subsumed under the general claim of substantial equivalence, without specific standalone performance metrics.

7. Type of Ground Truth Used

• Not applicable. For this type of 510(k) submission, "ground truth" related to diagnostic accuracy (e.g., pathology, outcomes data, expert consensus on disease presence) is not typically required or provided unless the device makes a new or significantly modified diagnostic claim that deviates from established predicate devices. The basis for safety and effectiveness is compliance with recognized standards and comparison to a legally marketed equivalent device.

8. Sample Size for the Training Set

• Not applicable. The submission does not describe an AI or machine learning component that would require a "training set" in the conventional sense for diagnostic performance.

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

• Not applicable. No training set is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is primarily a non-clinical performance evaluation and a substantial equivalence comparison to predicate devices.

• Non-Clinical Performance Evaluation: This involved laboratory testing to verify that the system (including new transducers) met all design specifications. This testing also confirmed conformity to various medical device safety standards:

  • IEC 60601-1: 2005 (General Requirements for Safety)
  • IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
  • IEC 60601-2-37: 2007 (Particular Requirements for Ultrasonic Equipment Safety)
  • NEMA UD 2-2004 (Acoustic Output Measurement)
  • NEMA UD3: 2004 (Real-time Display of Acoustic Output Indices)
  • ISO 10993-1 (Biological Evaluation of Medical Devices - Biocompatibility)

• Substantial Equivalence Comparison (to K101236 and K120801): The submission provides a detailed comparison table (Table 1) highlighting similarities in:

  • Indications for Use
  • Design principles (e.g., autocorrelation for color processing, FFT for Doppler)
  • Operating Controls (e.g., TGC 8 slider, Depth Range, shades of gray)
  • Safety Compliance (adherence to the same IEC/ISO standards)
  • Patient Contact Materials (Bio-compatible)
  • Scanning Modes (Electronic Sector, Convex, Linear, Mechanic Volume Sweep)
  • Operation Modes (B, M, PW, CFM, PD, TD, 3D/4D, etc., including newly added features like Elastography/Curved Panoramic)
  • Display characteristics and annotations
  • Monitor specifications
  • Measurement packages
  • Transducer Types & Connectors
  • Principle of Operation (high voltage burst to piezoelectric material, reflected echo detection)
  • Acoustic Output (matching the predicate's stated maximums for MI and Ispta)

The conclusion drawn from this comparison is that any differences are minor and do not affect the basic design, usage, effectiveness, or safety, thereby establishing substantial equivalence. No clinical testing was required or performed for this submission.

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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

The ECO Series Diagnostic Ultrasound Systems is a very compact and portable diagnostic ultrasound system having five variations: ECO6, ECO5, ECO3, ECO2, and ECO1, each with options and features suited for its market niche. It has an integrated keyboard, LED display and several interchangeable electronic-array transducers and provides digital acquisition, processing and display capability. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display.

This device is a Diagnostic Ultrasound System and therefore does not include acceptance criteria, as one would typically find for an AI/ML powered device. The document provided is primarily an FDA 510(k) summary for the "ECO Series Diagnostic Ultrasound System," submitted by Chison Medical Imaging Co., Ltd.

Instead of acceptance criteria and a study to prove performance, this document focuses on substantial equivalence to a predicate device, which is the standard regulatory pathway for many medical devices.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the context of an AI/ML device validating specific metrics (e.g., sensitivity, specificity, AUC). Instead, the document states:

• Acceptance Criteria (Implied): Substantial equivalence to the predicate device in terms of safety and effectiveness, and compliance with applicable safety standards.
• Reported Device Performance: The device performs general-purpose ultrasonic imaging and fluid flow analysis. Its capabilities are outlined by the clinical applications and modes of operation available for each transducer.

The device meets its implied acceptance criteria by being shown to be "substantially equivalent in safety and effectiveness to the predicate systems" (GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound (K102256)). The justification for this equivalence includes:

• Transmits ultrasonic energy into patients.
• Performs post-processing of received echoes to generate on-screen display of anatomic structures and fluid flow.
• Has the same intended uses and basic operating modes as the predicate device.
• Allows for specialized measurements of structures and flow, and calculations.
• Has the same gray-scale (presumably imaging capabilities).
• Acoustic output levels are below FDA limits.
• Designed to applicable electrical and physical safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).

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

Not applicable. This is not a study evaluating an AI/ML algorithm's performance on a test set. This is a premarket notification demonstrating substantial equivalence.

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

Not applicable. No ground truth was established for a test set in the context of an AI/ML algorithm.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document does not describe human reader performance or improvements with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a general-purpose ultrasound system, not an AI/ML algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no ground truth established for an algorithm. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the AI/ML sense.

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

Not applicable. No training set or associated ground truth was established.

Summary of the Study (Substantial Equivalence Justification):

The "study" in this context is the comparison to predicate device(s).

• Predicate Device: GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound (K102256).
• Methodology: The manufacturer presented information demonstrating that the ECO Series Diagnostic Ultrasound Systems share fundamental technological characteristics, intended uses, and operational modes with the legally marketed predicate devices. The comparison highlights similarities in how they transmit and process ultrasonic energy, display anatomical structures and fluid flow, and perform measurements and calculations. The manufacturer also asserts compliance with relevant safety standards and FDA acoustic output limits.
• Conclusion: Based on this comparison, the FDA determined that the ECO Series Models are "substantially equivalent in safety and effectiveness to the predicate systems." This allows the device to be marketed without requiring a more extensive premarket approval (PMA) pathway.

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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.

The provided document is a 510(k) summary for the SonoTouch Series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than performing new clinical effectiveness studies with specific acceptance criteria and detailed performance reporting. Therefore, much of the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes is not present in this document.

The document primarily states that the device is "substantially equivalent" to predicate devices (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound (K102256)) based on its intended use, operating modes, grayscale imaging, acoustic output levels, and adherence to safety standards.

Here's a breakdown of what can be extracted and what is not available:

1. Table of acceptance criteria and the reported device performance

No specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The basis for acceptance is "substantial equivalence" to the predicate device.

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

Not applicable for a 510(k) substantial equivalence submission, as it typically does not involve new clinical effectiveness studies with test sets in this manner. The comparison is based on the technical and functional characteristics of the device relative to the predicate.

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 a test set is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a hardware ultrasound system, not an algorithm.

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

Not applicable. No ground truth is mentioned. The comparison is against a predicate device's established performance and safety.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

Summary of the Study/Basis for Acceptance:

The "study" in this context is a technical and regulatory comparison against a legally marketed predicate device (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound, K102256).

• Basis for Acceptance: The device is considered "substantially equivalent" in safety and effectiveness to the predicate devices. This means that it has the same intended use, fundamental technological characteristics, and safety and performance characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
• Proof: The documentation submitted (which is summarized here) asserts that:
  • The SonoTouch Series has the same intended uses as the predicate devices (listed in detail across multiple pages for various transducers).
  • It utilizes comparable operating modes (B-Mode, M-Mode, Doppler modes, etc.).
  • It offers "the same gray-scale" imaging capabilities.
  • Its acoustic output levels are below FDA limits.
  • It adheres to relevant product safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).

This 510(k) summary does not contain information about clinical studies with specific performance metrics or statistical analyses typically found in PMAs or some de novo classifications. The acceptance is based on the regulatory pathway of substantial equivalence.

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The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for the evaluation of Fetal (Obstetrics), Abdomen, Cardiac (Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.

The CHISON Q6 / Q8 / iVis60 / iVis60 / EXPERT / i7 ultrasound system is an integrated preprogrammed color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q6/Q8), or as a roll-around model on wheels (iVis60 / iVis60 EXPERT/i7). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.

The provided document K120801 is a 510(k) premarket notification for the CHISON iVis & Q Series, i7 Diagnostic Ultrasound Systems. However, this type of submission is for establishing substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a study with ground truth.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor its data provenance.
3. The number of experts used to establish ground truth or their qualifications.
4. Adjudication methods for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size on human reader improvement with AI assistance.
6. Standalone (algorithm-only) performance results.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. The sample size for a training set.
9. How ground truth for a training set was established.

Instead, the submission focuses on demonstrating that the CHISON ultrasound systems are "substantially equivalent in safety and effectiveness to the predicate systems" (GE Voluson E8 Diagnostic Ultrasound System, K101236) based on having:

• Comparable type and intended uses.
• The same basic operating modes (B-Mode, M-Mode, Pulsed Doppler, Continuous Doppler, Color Doppler, Power Doppler, Directional Power Doppler).
• Similar specialized measurements and calculations.
• Acoustic output levels below FDA limits.
• Compliance with applicable electrical and physical safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).

The "Indications For Use" sections (pages 5-15) list the various clinical applications and operation modes for the main system and each specific transducer, indicating whether they are "N = new indication" (for the submitted device) or "P = previously cleared by FDA" (implying the predicate device covered these). This is a statement of intended use, not a performance metric from a study.

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The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parotid, submaxillary gland, testes and breast.). Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.

The CHISON iVis20/iVis30/i3/ Q1/Q2/Q3/Q5 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured as a roll-around model on wheels (iVis20/iVis30/i3/ Q1/Q2/Q3/Q5). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.

Acceptance Criteria and Study for CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems

This document describes the acceptance criteria and study information for the CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems, extracted from the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification summary. For medical devices seeking substantial equivalence, performance characteristics are typically compared against an existing "predicate device" rather than predefined numerical acceptance criteria in the same way as an AI/ML device. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate device, GE Voluson E6/E8/E8 Expert (K101236), across various imaging modes and clinical applications.

The reported device performance is that the CHISON iVis Models and Q Models and i3 are "substantially equivalent in safety and effectiveness" to the predicate. This equivalence is based on the systems having the "same intended uses and basic operating modes," "same gray-scale and Doppler capabilities," and acoustic output levels "below the applicable FDA limits."

The 510(k) summary itself does not contain specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic effectiveness, as would often be the case for AI/ML devices or novel technologies. Instead, the focus is on demonstrating that the new device meets the same safety and performance standards as the predicate device already on the market.

Table: Comparison to Predicate Device (Implied Acceptance Criteria)

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

The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective study design).

The submission is for a diagnostic ultrasound system aiming for substantial equivalence to a predicate device. This type of submission typically relies on device design specifications, performance testing (e.g., electrical safety, acoustic output, electromagnetic compatibility), and a comparison of technical features and intended uses to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or novel diagnostic algorithms.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since the 510(k) summary does not describe a clinical study with a test set requiring ground truth established by experts, there is no information provided regarding the number or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

As there is no mention of a clinical study or a test set requiring expert adjudication for ground truth, no adjudication method is described in the provided document.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide any effect size of human readers improving with or without AI assistance. The device is a diagnostic ultrasound system, not explicitly described as incorporating AI for interpretation.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone (algorithm only) performance study. The device is a complete ultrasound system, and its performance is evaluated in the context of its overall functionality and comparison to a predicate device, not as a standalone algorithm.

7. Type of Ground Truth Used

Given the nature of a 510(k) for a diagnostic ultrasound system (not an AI algorithm or a novel diagnostic modality), the concept of "ground truth" in the context of a clinical test set is not directly applicable or described. The submission focuses on demonstrating that the device's technical specifications, imaging capabilities (B-Mode, M-Mode, Doppler), and safety aspects are equivalent to those of a legally marketed predicate device.

8. Sample Size for the Training Set

The provided 510(k) summary does not contain any information about a training set or its sample size. This is consistent with a traditional medical device submission for substantial equivalence, which does not typically involve machine learning model training as a documented component of the submission.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied, there is no information on how ground truth for a training set was established.

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