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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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TE7/TE5 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 and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

TE7/TE5 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, LVO, Color M, Smart 3D, TDI 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 and phased array.

This document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD TE7/TE5 Diagnostic Ultrasound System (K180912) and its substantial equivalence to predicate devices. The information provided heavily references previously cleared devices and standards, indicating that no new clinical study was conducted for this specific submission to establish de novo acceptance criteria or device performance.

Therefore, the requested information elements related to a new study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set sample size, how training ground truth was established) are not applicable as they relate to newly conducted efficacy or performance studies. The submission relies on demonstrating equivalence to existing, cleared devices and compliance with recognized standards.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance study with specific criteria and results is outlined for this submission, the "acceptance criteria" are implied by compliance with safety standards and substantial equivalence to predicate devices. Device performance is considered equivalent to the predicate devices.

Study Proving Device Meets Acceptance Criteria:

The device meets its implied acceptance criteria by demonstrating substantial equivalence to existing legally marketed predicate devices and by compliance with recognized national and international safety and performance standards. The submission explicitly states: "Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Page 31)

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

Not applicable. No new clinical performance or efficacy studies were conducted for this 510(k) submission. The submission relies on non-clinical tests and equivalence to predicate devices.

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)

Not applicable. No new clinical performance or efficacy studies were conducted for this 510(k) submission that would require establishing ground truth from experts for a test set.

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

Not applicable. No new clinical performance or efficacy studies requiring adjudication were conducted for this 510(k) submission.

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 submission concerns a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was performed as confirmed by the statement "Clinical Studies: Not applicable. The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 32).

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, and no such performance study was conducted for this submission.

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

Not applicable. No specific ground truth establishment for a new performance study is mentioned in this 510(k) submission. The device's safety and effectiveness are established through compliance with existing standards and comparison to predicate devices, which would have had their performance and safety established previously.

8. The sample size for the training set

Not applicable. No new machine learning or AI algorithm development requiring a training set is described in this 510(k) submission.

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

Not applicable. As no new training set is indicated, this question is not relevant to the provided documentation.

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