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MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology exams.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify*), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify**), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Thoracic/Pleural (Specify****), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Other (Specify***)

*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, eSpacial Navi, Smart 3D mode, Strain Elastography, Contrast imaging (Contrast agent for Liver and LVO) or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

This document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. It does not describe an AI/ML-driven device, therefore, a detailed acceptance criteria table and study results for such a device are not present. However, I can extract the information related to the device's general performance and safety evaluations as presented in the document, which serves as a form of acceptance criteria for a medical device cleared via the 510(k) pathway.

The provided document describes the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System. This is a general-purpose ultrasound system and not an AI/ML device in the sense of providing automated diagnoses or assisting human readers with AI. The "acceptance criteria" for such a device primarily revolve around safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than AI performance metrics like sensitivity, specificity, or AUC.

Here's an analysis of the provided information concerning the device's acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative performance metrics as one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are met by demonstrating compliance with recognized medical device standards and showing substantial equivalence to predicate devices in terms of technology, intended use, and safety/effectiveness.

The reported "performance" is qualitative, focusing on whether the device meets regulatory and safety standards:

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

The document explicitly states "7. Clinical Tests: Not Applicable." This indicates that no clinical study involving human subjects or real patient data (test sets) was performed for this 510(k) submission to demonstrate performance in a clinical setting. The evaluation relied entirely on non-clinical tests (bench testing, engineering validation, adherence to standards).

Therefore, there is no sample size for a test set, nor specific data provenance (country of origin, retrospective/prospective) related to patient data. The "tests" mentioned are primarily engineering and compliance tests.

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

Since no clinical tests or human reader studies were conducted as part of this submission, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.

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

Not applicable. The device is a diagnostic ultrasound system (hardware and general software features), not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader improvement. The document does not mention any AI capabilities that assist human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device, not a standalone algorithm. The "performance" is inherent to the system's ability to acquire and display ultrasound images and perform basic measurements, which is evaluated through engineering and safety standards.

7. Type of Ground Truth Used:

For the evaluation described, the "ground truth" is established by:

• Compliance with recognized standards: The device's technical specifications and safety features are compared against established industry and regulatory standards (e.g., IEC, ISO).
• Substantial equivalence to predicate devices: The functionality, safety, and performance characteristics are determined to be similar enough to already-cleared devices, implying that if the predicate is safe and effective, so is the new device.
• Engineering validation and bench testing: Physical measurements and tests demonstrating that the device operates within specified parameters and does not pose undue risks (e.g., acoustic output, temperature, electrical safety).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device's "training" and validation are part of its design, manufacturing, and quality control processes to ensure it meets its specifications and regulatory requirements.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's development and validation relies on engineering principles, scientific understanding of ultrasound physics, and established medical device safety and performance standards.

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DC-60/DC-60S/DC-60 Exp/DC-55 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, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac. peripheral vessel and urology exam.

The DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, contrast imaging (contrast agent for LVO), iScape, Color M, TDI, 3D/4D mode, Elastography or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array, convex array, phased array.

This summary details the DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System, which is a general-purpose, software-controlled device. The information provided outlines the system's intended uses, various application modes, and different transducers. The document explicitly states that clinical studies were not required or conducted for this 510(k) submission to support substantial equivalence. Therefore, I cannot provide information on acceptance criteria based on clinical performance, a study to prove meeting acceptance criteria in a clinical context, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

However, the submission does refer to non-clinical tests and standards to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria for non-clinical performance are based on compliance with recognized FDA standards. The reported device performance is that the device conforms to these standards.

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

• Sample Size for Test Set: Not applicable for clinical performance based on the document. For non-clinical tests, the "sample size" refers to the tested device components and systems, which are assumed to be representative of the manufactured product. Specific quantities are not provided, but the testing would have been conducted on a sufficient number of units to demonstrate compliance with the referenced standards.
• Data Provenance: The tests are non-clinical and conducted by the manufacturer, Shenzhen Mindray Bio-medical Electronics Co., LTD, in Shenzhen, Guangdong, China. The data would be prospective, generated specifically for this submission.

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

Not applicable in the context of clinical performance, as no clinical studies were performed. For non-clinical engineering and safety tests, the "ground truth" is established by the validated methods outlined in the respective standards. The expertise would lie with the engineers and technicians performing the tests and validating the equipment according to these standards.

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

Not applicable for clinical performance. For non-clinical tests, adjudication methods like 2+1 or 3+1 are not typically used. Compliance is generally determined by whether the device meets the pass/fail criteria of the specified technical standards.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this submission... does not require clinical studies to support substantial equivalence."

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

Not applicable as an AI algorithm for clinical decision-making is not mentioned as a core component of this ultrasound system's substantial equivalence claim in the provided text. The device is described as an "ultrasonic diagnostic system" with software control and various imaging modes, not an AI for interpretation.

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

Not applicable for clinical performance. For non-clinical tests, the "ground truth" is typically the established physical or electrical properties measured against the specifications and limits defined by industry standards (e.g., acoustic output measurements, EMI limits, biocompatibility profiles).

8. The sample size for the training set:

Not applicable, as no AI/machine learning algorithm requiring a training set for clinical interpretation is described or validated in this submission for substantial equivalence.

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

Not applicable, as there is no mention of a training set or AI/machine learning algorithm for clinical interpretation.

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The Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

This FDA 510(k) K180862 document describes the Acclarix LX8 and Acclarix AX8 Diagnostic Ultrasound Systems, focusing on their intended use, clinical applications, and comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria" in the format of specific thresholds for quantitative performance metrics (e.g., sensitivity, specificity, accuracy) and then report actual device performance against those thresholds. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" can be inferred as meeting the safety and performance requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 for biocompatibility, as well as adherence to FDA guidelines for acoustic output (NEMA UD 2, UD3). The reported device performance is that it complies with these standards and has similar performance effectiveness and safety to the predicate devices.

We can synthesize the comparison tables (Table 2-1, 2-2, 2-3) to show how the device's characteristics meet or are similar to the predicate devices, which implies meeting the established performance and safety profiles.

Inferred "Acceptance Criteria" and Reported Performance:

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 does not specify any sample size for a test set in the context of clinical performance evaluation (e.g., number of patients/scans). This is because the submission primarily relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

Similarly, there is no information provided regarding data provenance (country of origin, retrospective or prospective) for clinical data, as formal clinical testing with patient data was not a required component of this 510(k) submission.

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):

As no "test set" in the sense of clinical cases evaluated for ground truth is described in the document, there is no information regarding the number or qualifications of experts used to establish ground truth.

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

Since there is no described test set or expert evaluation of clinical cases, there is no adjudication method mentioned in the document.

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 mention any MRMC comparative effectiveness study, nor does it discuss AI assistance or its effect size on human reader performance. The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool.

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

The device is a diagnostic ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not applicable and not mentioned.

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

As there were no clinical studies described, there is no mention of the type of ground truth used for performance evaluation. The "ground truth" for the non-clinical testing would be the engineering specifications and compliance with recognized standards.

8. The sample size for the training set:

The document describes a diagnostic ultrasound system, not an AI or machine learning algorithm that requires a training set. Therefore, there is no information regarding the sample size for a training set.

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

Since no training set for an algorithm is discussed, there is no information on how ground truth for a training set was established.

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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), cardiac(adult, pediatric) , peripheral vessel and urology exams.

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System. It details the device's intended use, classification, comparison to predicate devices, and non-clinical tests conducted. The document explicitly states "Not applicable" for clinical studies, meaning no patient data or expert evaluations were used to establish acceptance criteria or prove device performance through a clinical study as would be typical for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set sizes cannot be extracted from this document. This document pertains to a traditional medical device (ultrasound system) that relies on engineering verification and validation against recognized standards and comparison to predicate devices for substantial equivalence, rather than clinical performance metrics in the way AI/ML devices often do.

Based on the provided text, the device relies on substantial equivalence to predicate devices and adherence to recognized safety standards, not on clinical performance studies with acceptance criteria in the typical sense for AI/ML algorithms.

Here's a breakdown of why the requested information is absent:

• No AI/ML Component: The submission describes an ultrasound system, not an AI/ML-powered device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI performance (e.g., sensitivity, specificity, AUC) is not relevant here.
• Substantial Equivalence: The primary method for gaining clearance is demonstrating "substantial equivalence" to legally marketed predicate devices. This involves showing similar intended use, technology, safety, and effectiveness.
• Non-Clinical Tests: The "Non-clinical Tests" section lists compliance with various electrical, mechanical, acoustic, and biocompatibility standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 14971). These are engineering and safety standards, not performance metrics derived from clinical data in the context of an AI algorithm.
• Clinical Studies Not Applicable: The document explicitly states: "Not applicable. The subject of this submission, DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This directly confirms the absence of the type of study you are asking about.

Therefore, I cannot provide the requested table or bullet points as the information does not exist within the provided text for this specific device clearance. The regulatory pathway for this ultrasound system did not require the demonstration of performance metrics against clinical ground truth in the way your questions imply.

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The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.

M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a 510(k) summary provided by Mindray. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria through a clinical study.

The document details:

• Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
• Regulatory Classification: Class II, Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570).
• Intended Use: General diagnostic ultrasound imaging for various applications (fetal, abdominal, intra-operative, small organ, neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology exams) across different patient populations.
• Comparison to Predicate Devices: Lists several Mindray ultrasound systems (M7, M5, DC-70, DC-8, M9) and states that the new device has "the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
• Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and conformance with various medical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1).

It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance data.
7. Details on the type of ground truth used (expert consensus, pathology, outcomes data).
8. Information on how ground truth for training data was established.

This document serves as a regulatory clearance for a traditional medical device (ultrasound system), not an AI/ML-driven device that typically requires detailed clinical performance studies and acceptance criteria as outlined in your prompt.

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The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B mode, M mode, PW mode, CW mode, Color mode, Power/Dirpower mode, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The provided document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. to the FDA regarding their Resona 7 Diagnostic Ultrasound System. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily for proving novel clinical claims or improved clinical effectiveness through extensive clinical trials.

Therefore, the document does not contain information on acceptance criteria for an AI/CADe device's performance, nor does it detail a study proving such performance in the way a clinical study for a novel AI algorithm would. Instead, it focuses on demonstrating that a modified ultrasound system remains substantially equivalent to its predicate.

However, based on the structure of your request and assuming this was a document from which one hoped to extract such information about a theoretical AI/CADe device, I will explain why most of your requested points cannot be answered from this document and what information is relevant to the device's acceptance.

This document is for an ultrasound imaging system, not an AI/CADe device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to traditional ultrasound device performance and safety, not AI algorithm performance.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria for AI performance. The acceptance criteria for this ultrasound system are related to its safety, electrical performance, acoustic output, and imaging capabilities being equivalent to the predicate device. The performance is "proven" by compliance with recognized standards and comparison to the predicate.

• Acceptance Criteria (Implicit for a traditional ultrasound device K-submission):

  • Substantial equivalence to predicate device in terms of intended use, technology, safety, and effectiveness.
  • Compliance with recognized safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
  • Acoustic output levels below FDA limits.
  • Biocompatibility of patient-contacting materials (for new transducers/brackets).
  • Effective cleaning and disinfection.
  • Software lifecycle processes compliance (IEC 62304).
  • Risk management (ISO 14971).
  • Imaging modes and features perform similarly to predicate.

• Reported Device Performance: The document states that the device "has been found to conform with applicable medical safety standards" and "is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." It doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/CADe device, but rather confirms compliance with established engineering and safety benchmarks relevant to ultrasound systems.

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

This document is for a traditional ultrasound imaging system submission (510(k)), not an AI/CADe device. Therefore, it does not describe a "test set" or "data provenance" in the context of an AI algorithm being evaluated on a dataset of patient images.

The "testing" mentioned refers to engineering and safety tests on the physical device and its software, not performance on a clinical image dataset for diagnostic accuracy.

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

Not applicable. This is not an AI/CADe device that requires expert-established ground truth for a test set. The "ground truth" for the device's function is its ability to produce images and measurements according to its specifications and to operate safely, which is verified through engineering tests and comparison to the predicate.

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

Not applicable, for the same reasons as point 3.

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) for an ultrasound system, not an AI-assisted device. The "multi-reader multi-case" study design is typical for evaluating the impact of AI on human reader performance, which is not relevant to this submission.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its operation as an imaging system.

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

Not applicable for an AI/CADe device. The "ground truth" for this ultrasound system relates to its technical performance and safety, which are evaluated against engineering standards and comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device that has a "training set."

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

Not applicable. This is not an AI/CADe device that has a "training set."

Summary from the document's perspective:

The document describes a 510(k) submission for a Diagnostic Ultrasound System (Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB). The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (primarily K162267, Resona 7, and others like DC-8, ZS3).

The "acceptance criteria" and "study" are therefore focused on:

• Safety and Effectiveness: Ensuring the new/modified device is as safe and effective as the predicate.
• Compliance with Standards: A list of recognized consensus standards is provided (e.g., AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 60601-2-37 for ultrasonic equipment, ISO 14971 for risk management, ISO 10993 for biocompatibility, NEMA UD 2 for acoustic output). The "study" is the non-clinical testing performed to show compliance with these standards.
• Functional Equivalence: The device employs the same underlying technology (ultrasonic energy transmission and processing), has the same intended uses (e.g., fetal, abdominal, cardiac exams), and generally the same basic operating modes as its predicate. New transducers and features are added, but they are evaluated in the context of the device remaining substantially equivalent.

The document explicitly states under "8. Clinical Tests: Not Applicable," which further confirms that no clinical studies (like those evaluating AI diagnostic performance or human reader improvement with AI) were conducted or required for this particular 510(k) submission.

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