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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-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, CNV 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 510(k) summary regarding acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or quantitative device performance metrics for image quality or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards.

The "performance" is implicitly deemed acceptable because the device's modifications and new features are found to be "substantially equivalent" to predicate devices, and the system conforms to various medical safety standards.

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

The document states: "8. Clinical Tests: Not Applicable."

This indicates that no clinical performance study, and therefore no test set with a specific sample size or data provenance, was conducted or submitted as part of this 510(k) notification for the modified device. The claim of substantial equivalence is based on non-clinical tests and comparison to predicate devices.

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

Since no clinical tests were performed, there was no test set for which ground truth was established by experts.

4. Adjudication Method for the Test Set

As no clinical tests were performed, there was no test set requiring an adjudication method.

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

No MRMC comparative effectiveness study was done, as indicated by "Clinical Tests: Not Applicable." The submission relies on demonstrating substantial equivalence to predicate devices rather than a comparative study against human readers or other devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. The submission focuses on the safety and effectiveness of the system and its components, not an AI algorithm performing a standalone diagnostic task. Even if there were AI-powered features (like the 'Smart NT' or 'Smart Volume' features being newly added), the document does not detail any standalone performance evaluation for these features separate from the overall system.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Since no clinical tests were performed, there was no ground truth established for a test set. The substantial equivalence argument relies on the established safety and performance of predicate devices and general compliance with standards.

8. Sample Size for the Training Set

The document states: "8. Clinical Tests: Not Applicable."

This implies that there was no training set, as no clinical study was conducted. Even if some of the "newly added software options" (like Smart Volume, Smart NT, Tissue Tracking QA, UltraView) incorporate algorithms that would typically require training data, information regarding such training data (size, how ground truth was established, etc.) is not provided in this 510(k) summary. The submission focuses on the substantial equivalence of the overall system and its features to predicate devices, rather than detailing the internal validation of each new software component.

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

Since no specific training set is mentioned or implied to be part of the 510(k) submission, there is no information provided on how ground truth for a training set was established.

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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 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, 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 document describes a 510(k) premarket notification for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This type of submission is a statement to the FDA that the device is substantially equivalent to another legally marketed device, not a claim of superior performance or a detailed study of acceptance criteria against novel performance metrics.

Therefore, the provided text does not contain the acceptance criteria or a study proving the device meets those criteria in the context of specific performance metrics for diagnosis or improved human reader performance with AI assistance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards.

Here's an analysis of the provided information relative to your requested points:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with recognized safety and performance standards, rather than defining specific outcome-based acceptance criteria and reporting performance against them.

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 there is no clinical performance study detailed in this 510(k) summary. The document states "DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety." These are non-clinical hardware tests, not clinical performance studies involving a test set of patient data.

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 applicable/not provided. As no clinical performance study is detailed, there's no mention of a test set, ground truth establishment, or experts for that purpose.

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

This information is not applicable/not provided. No clinical performance study or 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

An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this document. The device is a general-purpose diagnostic ultrasound system, not explicitly an AI-powered diagnostic tool. The purpose of this 510(k) is to establish substantial equivalence, not to demonstrate improved human reader performance.

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

This information is not applicable/not provided. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.

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

This information is not applicable/not provided. Since no clinical performance study with a test set is detailed, there's no mention of the type of ground truth used.

8. The sample size for the training set

This information is not applicable/not provided. The device is an ultrasound system. There is no mention of a "training set" in the context of an algorithm or AI.

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

This information is not applicable/not provided. As there's no training set mentioned in the context of an algorithm or AI, there's no corresponding information on how ground truth would be established for it.

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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