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The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-31 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, PW 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.

The provided text is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. It is a declaration of substantial equivalence to previously cleared devices, rather than a study outlining acceptance criteria and device performance. As such, the input does not contain the information needed to directly answer all parts of your request.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission does not typically include a table of acceptance criteria or quantitative performance metrics from a specific study designed to prove the device meets these criteria. Instead, it asserts equivalence based on technological characteristics and adherence to safety standards.

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

No studies with a "test set" are described, nor is there information about sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) relies on comparison to existing predicate devices and compliance with recognized standards.

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

Since no specific study evaluating the device's diagnostic performance against a ground truth is described, there is no information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as no specific test set-based study is presented.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on establishing substantial equivalence based on technological characteristics and adherence to safety standards, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This device is a general-purpose diagnostic ultrasound system, not an AI-powered algorithm. Therefore, a standalone algorithm-only study is not applicable and not mentioned. The declaration is for the complete ultrasound system.

7. The Type of Ground Truth Used:

No ground truth is mentioned as no specific diagnostic performance study is presented. The "ground truth" in a 510(k) for a general ultrasound system is typically considered to be compliance with established safety and performance standards for diagnostic ultrasound and equivalence to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a traditional ultrasound system, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as (8).

Summary of available information from the document:

• Acceptance Criteria/Performance: The submission claims the device "has been found to conform with applicable medical safety standards" (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304) and is "substantially equivalent" to predicate devices (Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991)). This implies that the 'acceptance criteria' are primarily regulatory compliance and demonstration of equivalence to existing devices.
• Study Design: This is a 510(k) summary, which is a regulatory submission asserting substantial equivalence, not reporting a clinical study with detailed performance metrics. It does not describe a clinical study in the format one might expect for device performance evaluation against specific metrics.
• Intended Use: The device is broadly applicable for adults, pregnant women, pediatric patients, and neonates for various exams including gynecology, obstetrics, abdominal, cardiac, vascular, and small parts.
• Transducers: A list of compatible transducers (3C5A, 6C2, 7L5, 6CV1, 6LE7, 7LT4, 7L4A, 6LB7, D6-2, 7L6, 3C1, 10L4, 2P2) is provided, each with specific "Indications for Use" forms detailing the clinical applications and modes of operation they support. "P" indicates previously cleared by FDA for that application/mode.

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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.

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The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-3T is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.c. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a diagnostic ultrasound system (Mindray DC-3/DC-3T).

The document focuses on:

• Device Description: General purpose, mobile, software-controlled ultrasonic diagnostic system with various imaging modes (B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode, combined modes).
• Intended Use: Specifies applicable patient populations (adults, pregnant women, pediatric, neonates) and exam types (fetal-OB/GYN, abdominal, pediatric, small parts, neonatal cephalic, transvaginal, transrectal, peripheral vascular, musculoskeletal).
• Safety Considerations: Compliance with FDA guidance for Track 3 devices, acoustic output measurement standards (NEMA UD 2, NEMA UD 3), and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1).
• Substantial Equivalence: A statement that the device is as safe and effective as legally marketed predicate devices (Mindray M5, Mindray DC-6).
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence and lists the transducers included.
• Indications for Use Forms: Detail the specific clinical applications and modes of operation for the main system and each transducer (3C5A, 6CV1, 7L4A, 7L6, 10L4).

Missing Information:

The document does not provide the following information that would be necessary to answer the prompt:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution) or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No performance study data is presented, so no information on test set size or its origin.
3. Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described for a performance study.
4. Adjudication method for the test set: Not applicable as no performance study is detailed.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information: No such study is mentioned.
6. Standalone (algorithm only) performance study information: Not applicable as this is a complete ultrasound system, not an AI algorithm with standalone performance.
7. Type of ground truth used: Not applicable as no performance study is detailed.
8. Sample size for the training set: Not applicable as no data training is described for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence to existing devices through safety and intended use considerations, rather than reporting on a specific performance study with acceptance criteria.

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