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The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode. B. M. PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/Color/PWD or CWD, B/Power/PWD.

The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.

The provided text is a 510(k) summary for the Qingdao Hisense Medical Equipment Co., Ltd's HD60 Series Ultrasound Diagnostic System. It outlines the device's technical specifications, indications for use, and a comparison with a predicate device to demonstrate substantial equivalence.

However, the document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

This means that the submission for the HD60 Series Ultrasound Diagnostic System does not contain information about acceptance criteria for device performance based on clinical studies, nor does it provide details of a study (clinical or otherwise with human data) that proves the device meets such criteria.

The basis for substantial equivalence is primarily through demonstrating that the new device has "the same intended use, and similar physical characteristics" and "employs the same fundamental scientific technology" as its predicate device. Any new functions or changes are argued to have "no impact on safety or effectiveness" because they are either:

• Equivalent to features found on other already-cleared reference devices.
• New, but their performance "meets the requirements" and does not raise new risks.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, because this specific 510(k) summary states that no clinical studies were required or conducted for this submission.

To directly answer your numbered points based only on the provided text's stated approach for this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe specific acceptance criteria for performance based on user studies or clinical trials, nor does it report device performance data from such studies. The acceptance is based on substantial equivalence to a predicate device and adherence to regulatory standards for safety and non-clinical performance (e.g., electrical, acoustic, biocompatibility).

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical or human-data based performance test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication 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 an ultrasound diagnostic system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a complete ultrasound system, not a standalone algorithm. Performance is assessed through compliance with general safety and performance standards for ultrasound equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as typically understood in performance studies for diagnostic accuracy is mentioned, as no such studies were required or presented.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that would undergo a training phase on a dataset.

9. How the ground truth for the training set was established: Not applicable. No training set is described.

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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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M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare 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, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, CW-Mode, CW-Mode, Color-Mode , Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

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

The provided document is a 510(k) Summary for a diagnostic ultrasound system. It outlines the device's features, intended use, and comparison to predicate devices, but it explicitly states that no clinical studies were performed.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance based on clinical studies.
• Sample size, data provenance, ground truth establishment, or expert details for a test set.
• Adjudication method or MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details (sample size, ground truth establishment).

The document explicitly states:

8. Clinical Studies

Not applicable. The subject of this submission, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

This indicates that the substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, and compliance with recognized standards) and a comparison of technical characteristics and intended uses with legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria for AI-assisted performance or human-in-the-loop improvements.

The "acceptance criteria" for this device, as implied by the document, are primarily related to safety and effectiveness being substantially equivalent to predicate devices through engineering and design validation, and adherence to relevant industry standards. There are no performance metrics provided that would typically be seen for an AI/ML-driven device requiring clinical validation against specific performance targets.

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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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