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510(k) Data Aggregation
(20 days)
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
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.
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.
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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(34 days)
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
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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(16 days)
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
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, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.
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, PW 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.
The provided text is a 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing devices and details the device's features, intended use, and safety considerations. It does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or accuracy for diagnostic tasks.
Instead, the document primarily addresses:
- Manufacturing and Safety Standards: The device conforms to acoustic output standards (NEMA UD 2:2004, NEMA UD 3:2004) and medical device safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1). These are the "acceptance criteria" for the safety and basic functionality of the ultrasound system itself, not for a specific diagnostic performance.
- Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is the demonstration that the DC-7 is "as safe and effective as the legally marketed predicate devices" (Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688)). This is not a study measuring diagnostic accuracy but rather a comparison of technical characteristics and intended uses.
Therefore, many of the requested details about a performance study are not present in this type of regulatory submission. I will answer the questions based on the information available and explicitly state when information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system and not a specific diagnostic algorithm or AI, the "acceptance criteria" are related to safety, electrical, and acoustic performance, and functional equivalence to predicate devices, rather than diagnostic accuracy metrics. The document states that the device was tested to meet recognized international and national standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantially equivalent to legally marketed predicate devices. | "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." This is a general claim based on the entire submission, including comparisons of various characteristics (technical characteristics, new features/algorithms, and indications for use) to predicate devices. The listed predicate devices are: Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688). |
| Acoustic Output | Conforms to FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008), NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, and NEMA UD 3:2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. | "The acoustic output is measured and calculated per NEMA UD 2: 2004 (...) and NEMA UD 3: 2004 (...). The device conforms to applicable medical device safety standards..." |
| Medical Device Safety | Conforms to applicable medical device safety standards. | "The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1." |
| Functional Equivalence/Modes | The device should be capable of acquiring and displaying ultrasound images in specified modes (B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI mode, combined modes) and for the stated clinical applications with the listed transducers. | The comprehensive "Indications for Use" forms for the system and each transducer (pages 5-23 of the original document) list the specific modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) and clinical applications (e.g., Fetal, Abdominal, Cardiac, Small organ, Peripheral Vascular, etc.) for which the system and its associated transducers are intended and found to be substantially equivalent to predicate devices. |
Regarding diagnostic performance studies, the document contains no information on the following points:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No details on a specific diagnostic performance test set are provided. The "testing" mentioned refers to safety and functional compliance, and comparison to predicate devices, not clinical diagnostic accuracy of an algorithm.
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 as no diagnostic performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no diagnostic performance study is described.
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 device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm or an assist tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable as no diagnostic performance study is described.
8. The sample size for the training set
Not applicable. This device is a general-purpose ultrasound system. Any "new algorithm" mentioned in section 3 (page 1) would likely refer to internal signal processing or imaging algorithms, not a machine learning model trained on a large dataset for diagnostic output. No details about such training are provided.
9. How the ground truth for the training set was established
Not applicable as no training set for a diagnostic algorithm is mentioned.
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(43 days)
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. 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 2.0 MHz to 12.0 MHz.
This document refers to the Mindray DC-7 Diagnostic Ultrasound System (K092691).
Acceptance Criteria and Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific quantitative acceptance criteria for performance metrics. The core statement is that "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."
The "Indications for Use" section (pages 4-11 of the original document) lists the clinical applications and operating modes for the device and its various transducers. These serve as the functional requirements the device needs to meet.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety: Device conforms to applicable medical device safety standards. | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1. Acoustic output measured and calculated per NEMA UD 2: 2004 and NEMA UD 3: 2004. |
| Effectiveness: Capable of performing specified clinical applications across various modes and transducers, similar to predicate devices. | The device is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult) applications. Supports M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e., B/M Mode). Includes optional biopsy needle guides. |
| Substantial Equivalence: Features and performance are comparable to predicate devices. | Declared substantially equivalent to Mindray DC-3 (K#091491), Mindray DC-6 (K#072164), GE Vivid S6 (K#071985), Siemens X300 (K#090276), GE Logiq P5 (K#060993), GE Vivid 7 (K#060542). |
Study Information
The document describes the type of information typically provided for a 510(k) submission, which focuses more on substantial equivalence to existing devices rather than a standalone clinical trial with specific performance metrics. Therefore, detailed information about a dedicated study meeting the requested criteria is largely absent.
Here's an analysis based on the provided text:
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Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The submission is based on engineering tests and comparison to predicate devices, not data from a specific patient test set in the way an AI/CADe device would typically require. The data provenance would be internal engineering verification and validation data, not patient data in the context of clinical performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not explicitly stated. For a diagnostic ultrasound system, "ground truth" typically refers to the physical and functional performance of the device against engineering specifications and industry standards, rather than expert interpretation of images for a specific disease. The "ground truth" for compliance with standards would be established by internal engineering and quality control teams.
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Adjudication method for the test set: Not applicable or not explicitly stated. This concept (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation where discrepancies need to be resolved, usually for AI/CADe devices. This is not a performance study as would be conducted for an AI device.
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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 or CADe device, but a general-purpose diagnostic ultrasound system. Hence, no MRMC study or AI-assistance effect size is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm, and is designed for human-in-the-loop operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to compliance with safety and performance standards for an ultrasound system. This includes:
- Engineering specifications and test results: Measuring acoustic output (NEMA UD 2 & 3), electrical safety (IEC 60601 series), and biocompatibility (ISO 10993-1).
- Functional performance: Verifying the device's ability to operate in the stated modes (B, M, Doppler, etc.) and for the specified clinical applications, likely through phantom testing and internal verification.
- Comparison to predicate devices: Demonstration that its performance is "as safe and effective" as established, legally marketed predicate devices, implying similar image quality and diagnostic capabilities.
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The sample size for the training set: Not applicable. This device is a traditional hardware and software diagnostic ultrasound system, not an AI/machine learning product that requires training data in the AI sense.
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How the ground truth for the training set was established: Not applicable, as it's not an AI/machine learning device.
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