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The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.

Device Description

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI 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 probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.

AI/ML Overview

The DC-7 Diagnostic Ultrasound System is a general purpose ultrasound system with various transducers and modes of operation. The provided text is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, and outlines its intended use, non-clinical tests, and technological characteristics. The document does not contain specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.

Instead, the document details the Indications for Use (IFU) for the DC-7 Diagnostic Ultrasound System and its various transducers across different clinical applications and modes of operation. The "acceptance criteria" here are implicitly that the new system and its transducers can perform these functions ("P" for previously cleared, "N" for new indications) safely and effectively, demonstrating substantial equivalence to the listed predicate devices.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the claimed capabilities and "study" as the information provided for regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) clearance for a general-purpose ultrasound system and not a specific AI/CADe algorithm with performance metrics like sensitivity/specificity, the "acceptance criteria" are the claimed modes of operation and clinical applications for each transducer. The "reported device performance" is that the system and transducers are capable of these indicated uses, demonstrating substantial equivalence to predicate devices.

The tables for each transducer (e.g., 3C5A, C5-2, V10-4, L12-4, P7-3, etc.) list the following "acceptance criteria" (indicated by 'P' for previously cleared or 'N' for new) and their reported performance (the presence of 'P' or 'N' in the table signifies the device meets these criteria for the given transducer):

Clinical Application	B Mode	M Mode	PWD	CWD	Color Doppler	Amplitude Doppler	Combined Mode	Other Features
Ophthalmic
Fetal	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,3,4,6,7
Abdominal	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,3,4,5,6,7
Intraoperative (includes abdominal, thoracic, vascular)	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,6,7
Pediatric	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,5,6,7
Small Organ (breast, testes, thyroid)	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,6,7
Neonatal Cephalic	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,5,6,7
Adult Cephalic	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,5,6,7
Trans-rectal	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,3,4,6,7
Trans-vaginal	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,3,4,6,7
Musculoskeletal Conventional	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,6,7
Musculoskeletal Superficial	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,6,7
Cardiac Adult	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,5,6,7
Cardiac Pediatric	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,5,6,7
Peripheral Vascular	P / N	P / N	P / N	P / N	P / N	P / N	P / N	Note 1,2,4,6,7
Other (Urology)	N	N	N	N	N	N	N	Note 1,2,4,6,7

Notes:

Tissue Harmonic Imaging: The feature does not use contrast agents.
Smart3D: (Likely a 3D imaging feature)
4D (Real-time 3D): (Real-time 3D imaging)
iScape: (Likely an extended field of view imaging feature)
TDI (Tissue Doppler Imaging): (Cardiac function assessment)
Color M: (Color M-mode)
Biopsy Guidance: (Assistance for biopsy procedures)

P = Previously cleared by FDA; N = New indication (for this specific K-number, it implies new to this device or transducer combination)
Entries are filled based on the collective information from all transducer tables where "P" or "N" is indicated for at least one transducer. Some specific cells might be blank for certain transducers, meaning that mode/application is not indicated for that specific transducer.

The "study" proving these criteria are met is the "Non-clinical Tests" and the demonstration of "Technological Characteristics" being substantially equivalent to predicate devices.

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

The 510(k) summary does not describe a specific "test set" in terms of patient data for a clinical study comparing performance metrics.
Instead, the submission relies on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and comparison of technological characteristics to predicate devices to establish substantial equivalence.
Data provenance: Not applicable in the context of a clinical test set from patient data. The provenance for the non-clinical tests would be internal laboratory testing by the manufacturer.

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

Not applicable. This is a clearance for a general diagnostic ultrasound system based on technological equivalence and safety standards, not an AI/CADe device requiring expert-established ground truth for a clinical performance study.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.

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 is not an AI/CADe device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used

Not applicable. The clearance is based on adherence to medical safety standards (IEC, ISO), acoustic output, biocompatibility, and demonstrated technological equivalence to legally marketed predicate devices, rather than comparison to a clinical ground truth like pathology or outcomes data for a specific diagnostic task.

8. The Sample Size for the Training Set

Not applicable. This is a hardware/software system, not an AI/CADe algorithm requiring a training set from patient data in the context of medical imaging.

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

Not applicable. As above, this is not an AI/CADe algorithm with a training set.

In summary: The provided 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System is for a general-purpose diagnostic imaging device, not an AI or CADe product. Therefore, the "acceptance criteria" and "study" described align with the requirements for establishing substantial equivalence for such a device, focusing on safety, performance, and technological similarity to already cleared predicate devices, rather than detailed performance metrics from clinical trials or AI algorithm validation.

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