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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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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.

DC-60/DC-60S/DC-60 EXP/DC-55 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI 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 and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.

I'm sorry, but this document does not contain the detailed information necessary to answer your request.

Here's why:

• No Acceptance Criteria or Performance Data: The document is a 510(k) premarket notification for an ultrasound system. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and performance data for a new AI/ML device. The tables provided list intended uses and modes of operation, not performance metrics.
• No Mention of AI/ML Study: There is no indication that this device incorporates AI or machine learning. The focus is on the hardware and software capabilities of a diagnostic ultrasound system, and its conformance to established safety and performance standards relevant to ultrasound technology, not AI algorithms.
• Focus on Substantial Equivalence: The primary goal of a 510(k) summary is to show that a new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves comparing intended use, technological characteristics, and safety and effectiveness, often through non-clinical bench testing and compliance with recognized standards. It does not typically include detailed studies on AI performance as you've requested.
• No Clinical Study Details: The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." Therefore, it would not contain information about sample sizes, data provenance, ground truth establishment, or expert adjudication for clinical studies, which are crucial for AI/ML performance evaluation.

To answer your request, I would need a document specifically detailing the development and validation of an AI/ML component of a medical device, including its predefined acceptance criteria and the results of a robust clinical or technical study.

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