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The device is intended for use by a qualified physician for ultrasound evaluation of gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, and musculoskeletal, perficial vascular, exams exams.

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. It function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, DirPower 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 2.0 MHz to 12.0 MHz.

The provided document is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and the reported device performance: The submission is for a general-purpose diagnostic ultrasound system, and its "performance" is demonstrated through its substantial equivalence to predicate devices, compliance with safety standards (e.g., acoustic output, electrical safety), and its ability to acquire and display various ultrasound modes. There are no specific quantitative performance metrics or acceptance criteria for a diagnostic algorithm provided.
• Sample size used for the test set and the data provenance: No specific test set data is described for algorithmic performance. The indications for use are established based on the capabilities of the ultrasound system and its transducers, and their equivalence to predicate devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic algorithm requiring ground truth establishment for a test set described.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as no AI model training is mentioned.
• How the ground truth for the training set was established: Not applicable.

However, based on the document, here's what can be extracted:

Acceptance Criteria (Implied by the 510(k) process for ultrasound systems):

The implied acceptance criteria for this diagnostic ultrasound system are focused on demonstrating substantial equivalence to existing legally marketed predicate devices, along with compliance with relevant safety and performance standards. While not explicitly stated in a table with performance targets, the document indicates that the device meets these criteria through:

• Technological Equivalence and Functionality: The device shares similar technologies and functionality with predicate devices.
• Intended Use Equivalence: The device has the same intended uses as the predicate devices across various clinical applications and modes of operation.
• Compliance with Safety Standards: Adherence to recognized medical device safety and acoustic output standards.

Study Proving Acceptance Criteria (General Description):

The "study" proving the device meets the acceptance criteria is the 510(k) premarket notification process itself, where the manufacturer (Shenzhen Mindray Bio-medical Electronics Co., LTD) demonstrates substantial equivalence. The summary states:

• "The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." (Page 2)

This demonstration of safety and effectiveness, leading to the FDA's substantial equivalence determination, relies on:

1. Comparison to Predicate Devices: The primary method is a direct comparison of the DC-3/DC-3T system's technological characteristics, intended use, and performance claims to those of its predicate devices:

   • Original DC-3/DC-3T Diagnostic Ultrasound System (K083505)
   • Mindray M5 (K080640)
   • Mindray DC-6 (K072164)
   • GE Voluson 730 (K041688)

2. Compliance with Recognized Standards:

   • Acoustic Output: Measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Standards, such as IEC 6004.
   • Medical Device Safety: Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Specific Information Found in the Document:

• Device Type: General purpose, mobile, software-controlled diagnostic ultrasound system.
• Operating Modes: B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, or combined modes (e.g., B/M Mode, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B).
• Probes: Linear array, convex array, and phased array.
• Frequency Range: Approximately 2.0 MHz to 12.0 MHz.
• Intended Use: Wide range of clinical applications including gynecology, obstetrics, abdominal, pediatric, small parts, neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal exams. The Indications for Use forms (pages 4-17) detail which transducers are indicated for which specific clinical applications and modes.

In summary, for this type of conventional diagnostic imaging device, the acceptance criteria are largely met by demonstrating adherence to established engineering, performance, and safety standards, and by showing that the device is equivalent in its intended use and fundamental technological characteristics to devices already on the market.

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The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc. ), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

The DC-3/DC-3T 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, Color mode, PW mode, CW mode, Power mode, DirPower 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 2.0 MHz to 12.0 MHz.

I am sorry, but the provided text describes a 510(k) premarket notification for a diagnostic ultrasound system and its transducers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the way a clinical study for a novel AI device would.

Therefore, the input does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document states: "The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." This is the general statement of meeting the "acceptance criteria" for a 510(k) submission, which is substantial equivalence. However, it does not provide specific performance metrics or study details typically associated with AI/ML device evaluations.

Ask a specific question about this device