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The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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 cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, 3D/4D mode, Elastography 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 with a frequency range of approximately 3 MHz to 10.0 MHz.

This is a 510(k) premarket notification for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel claims through extensive clinical trials. Therefore, much of the information you requested about acceptance criteria and detailed study results for performance validation (like sample sizes, expert qualifications, and ground truth establishment) is not present in the provided text, as it's not typically required for this type of submission.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics in the format of a table. Instead, it attests to the device's compliance with established safety and performance standards, and its substantial equivalence to predicate devices.

Acceptance Criteria (Implied from the document):

• Compliance with recognized medical device safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, UD 2, UD 3, ISO 10993-1).
• Acoustic power levels below FDA limits.
• Biocompatibility of patient-contact materials (for new transducers).
• Effectiveness of cleaning and disinfection.
• Thermal, electrical, and mechanical safety.
• Software life cycle processes compliance (IEC 62304).
• Usability engineering application (IEC 62366 and IEC 60601-1-6).
• Application of risk management (ISO 14971).
• Identical intended uses and basic operating modes compared to predicate devices.

Reported Device Performance (Implied):
The device is stated to conform with all the above-mentioned applicable standards and to have identical intended uses and basic operating modes as the predicate devices. The modifications and newly added features (new transducers, software options, contrast imaging function) have been compared with predicate devices and found to be "substantially equivalent."

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

The document does not specify a sample size for a test set or data provenance from patient studies. The review is based on non-clinical testing and comparison to predicate devices.

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

Not applicable for this type of submission. Ground truth, in the context of clinical performance evaluation with expert readers, is not detailed as this submission relies on non-clinical testing and established equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with 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

An MRMC study was not conducted or mentioned, as this is a traditional ultrasound system and not an AI-assisted diagnostic device seeking to demonstrate improved 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, not an algorithm being submitted for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly established by compliance with recognized industry standards for acoustic output, electrical safety, biocompatibility, and software quality, as well as demonstrated equivalence to predicate devices which have already established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

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The DC-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 EXP 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 cephalic, adult cephalic, transvaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, 3D/4D mode, Elastography 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 with a frequency range of approximately 3 MHz to 10.0 MHz.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System:

Summary of Device and Regulatory Status:

• Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• 510(k) Number: K150080
• Regulatory Class: II
• Product Codes: IYN (Ultrasonic pulsed doppler imaging system), IYO (Ultrasonic pulsed echo imaging system), ITX (Diagnostic Ultrasound Transducer)
• Predicate Device: DC-8 (K132341) - Main predicate device. Other predicate devices mentioned: Mindray M9 (K141010), GE Voluson E8 (K132913).

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K132341) rather than defining specific numerical acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) derived from clinical studies. The "acceptance criteria" can be inferred as compliance with recognized safety and performance standards and showing that modifications do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a detailed clinical trial report, explicit numerical acceptance criteria and performance metrics (e.g., sensitivity, specificity, AUC) for the diagnostic performance of the device itself are not provided in the document. Instead, the "acceptance criteria" are based on:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing it has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Compliance with Standards: The device meets recognized safety and performance standards.

Here's a table summarizing the implicit "acceptance criteria" from the document and the reported device performance in relation to these:

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

The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set sample size and no data provenance as no clinical performance study was conducted to evaluate the diagnostic accuracy of the device on patient data. The evaluation relied on non-clinical tests to demonstrate substantial equivalence to an existing device.

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

Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set

Not applicable, as no clinical performance study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. The submission explicitly states "Clinical Tests: Not Applicable."

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

No, a standalone diagnostic performance study was not done. The submission explicitly states "Clinical Tests: Not Applicable." The document refers to the system as a "software controlled, ultrasound diagnostic system," implying human-in-the-loop operation, but its diagnostic performance was not evaluated in a clinical setting as part of this submission. The "newly added software options" and "other software modifications" (IVF, SCV+, iPage+, ART Flow) were compared for "identity" with predicate devices, suggesting functional equivalence rather than measuring independent diagnostic performance.

7. The type of ground truth used

Not applicable, as no clinical performance study was conducted. The "ground truth" for the non-clinical tests would be the established specifications and standards the device was tested against (e.g., specific acoustic power limits, material biocompatibility standards).

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for an ultrasound system, not an AI/ML algorithm that typically has a distinct training set. The "software modifications" mentioned (IVF, SCV+, iPage+, ART Flow) are integrated features of the ultrasound system and are stated to be "identical as the predicate devices," implying they leverage existing, cleared functionalities rather than being newly developed AI algorithms requiring dedicated training data for this submission.

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

Not applicable, as no training set (in the context of AI/ML) was described or used in this submission.

Ask a specific question about this device

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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 cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, 4D 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 with a frequency range of approximately 3 MHz to 10.0 MHz.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to medical safety standards rather than establishing new performance criteria through clinical studies.

Therefore, the document does NOT contain information regarding:

• Specific acceptance criteria framed as quantitative metrics (e.g., sensitivity, specificity, accuracy).
• Details of a study proving the device meets acceptance criteria in terms of clinical performance.
• Sample sizes used for test or training sets for an AI/algorithm.
• Data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth related to clinical performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
• Standalone algorithm performance studies.
• The type of ground truth used as it relates to clinical performance studies.
• The sample size for the training set or how ground truth was established for a training set.

The document primarily outlines the device's technical specifications, intended uses, and lists applicable safety and electrical standards it conforms to. It states that the device has been evaluated for "acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform with applicable medical safety standards.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in a regulatory context, which is demonstrating substantial equivalence to predicate devices and compliance with recognized standards.

Here's a breakdown of what can be extracted based on that understanding:

1. Table of "Acceptance Criteria" and "Reported Device Performance":

In the context of a 510(k) submission for a diagnostic ultrasound system like this, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity) but as conformance to established safety and performance standards, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is the statement of conformity.

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

The document does not detail specific clinical studies with test sets, sample sizes, or data provenance (country, retrospective/prospective) for proving diagnostic performance. The evaluations mentioned are primarily for safety, electrical, and mechanical conformity.

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

Not applicable, as no described clinical performance study with a test set requiring expert-established ground truth.

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

Not applicable.

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

Not applicable. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic algorithm aiding human readers.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

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

Not applicable in the context of clinical diagnostic performance. For technical evaluations, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., standard measures for acoustic output, material properties for biocompatibility testing).

8. The sample size for the training set:

Not applicable, as no described AI/algorithm training process.

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

Not applicable.

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