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510(k) Data Aggregation
(249 days)
The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.
The Camation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.
Modes of operation include: B-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.
The proposed Carnation series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.
The Carnation series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates.
The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.
The Carnation series Diagnostic Ultrasound System utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system also includes several automated measurement function: wiCalc_Diaph, wiCalc_Vas, wiCalc_Vol.Flow, Automatic trace, wiCalc_VTI, wiCalc_IVC, wiCalc_IMT, those measurement function can assist users to carry out relevant measurement automatically. The output results of those automatic measurement function are for reference only by users, and the final results need to be confirmed and modified by users based on professional knowledge.
The Carnation series Diagnostic Ultrasound System also include the function of wiScan, wiShow, wiGuide and wiNerve. wiScan is an easy-to-use quality assurance and workflow tool that automatically guides the user through an exam to ensure required steps are performed while reducing key strokes. wiShow is a teaching video recording software, which is an independent functional module integrated in the ultrasound diagnostic system. The function enables doctors to record and edit teaching videos, and export the video to a U disk or network storage. wiGuide uses the characteristics of the magnetic field to enhance the visualization effect of the needle by detecting the magnetized needle, and can better detect the position of the needle when it is in the human body. wiNerve is an education purpose tool, which aims to automatic recognition of different anatomical structures and display the recognized anatomical structures in different colors, to help doctors to improve the skills. The results of wiNerve are not used as diagnostic evidence.
Eight models for the main units are included in this submission, that is Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra. There are thirteen different models of probes: C6-1B-H. C6-2-H, C8-3-H, C9-3-H, EV11-3-H, L15-4WB-H, L15-4NB-H, L15-6-H, L22-10-H, L8-3-H, SP5-1-H, P8-3-H and P12-4-H are available for the Carnation series.
The provided text is a 510(k) Summary for the Carnation series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on a specific study designed to meet pre-defined acceptance criteria for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance studies is not present in this document. The document explicitly states that clinical studies were not required to support substantial equivalence.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for device performance (e.g., sensitivity, specificity, accuracy) are reported in this document. The substantial equivalence argument is based on similarities in intended use, technological characteristics, and compliance with recognized standards.
| Feature/Metric | Acceptance Criteria (Not explicitly defined in the document for performance) | Reported Device Performance (as implied by equivalence) |
|---|---|---|
| Intended Use | Covered by predicate device's intended use | Similar to predicate device (K180599), with all proposed indications covered by the predicate. |
| Operation Modes | Similar to predicate, with known differences covered by reference devices. | Similar to predicate (K180599), Holo PW covered by K211886, PANO by K173471. |
| Functions | Similar to predicate, with known differences covered by reference devices. | Similar to predicate, wiGuide and wiNerve similar to K211886. |
| Acoustic Power Levels | Below FDA limits. | Complies with FDA limits; same as predicate (K180599). |
| Biocompatibility | Complies with ISO 10993. | Cytotoxicity, Sensitization, Skin Irritation tests successful (in accordance with ISO 10993). |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. | Complies with IEC 60601-1, IEC 60601-2-37 (safety), and IEC 60601-1-2 (EMC). |
| Software V&V | Complies with FDA guidance for "Moderate" level of concern. | Verification and validation testing conducted; documentation provided as recommended by FDA guidance. |
| Acoustic Testing | Complies with NEMA UD 2-2004 (R2009). | Conducted in accordance with NEMA UD 2-2004 (R2009). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states, "The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set of data from clinical studies for performance evaluation.
- Data Provenance: Not applicable for performance data. Non-clinical testing data (biocompatibility, electrical safety, EMC, software V&V, acoustic testing) was generated 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 as no clinical test set was required or used for performance evaluation for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.
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 device is a "Diagnostic Ultrasound System" and the listed "wiCalc" and "wiNerve" functions are described as "measurement functions for reference only" or "education purpose tool" and "not used as diagnostic evidence." There is no indication of AI assistance for human readers in diagnostic interpretation being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was reported. The device is a diagnostic ultrasound system, not an AI-driven interpretation algorithm meant to function independently for diagnosis. Its automated features are for reference/education.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance evaluation. For non-clinical tests, "ground truth" would be the established standards and specifications (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, NEMA UD 2 for acoustics).
8. The sample size for the training set:
- Not applicable. The document does not describe the development or training of any AI model that would require a 'training set.' The automated functions ("wiCalc", "wiNerve") are not presented as AI models for diagnostic decision-making that would require extensive clinical training data.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model for diagnostic purposes is described.
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(164 days)
The Clivia series Diagnostic Ultrasound System is applicable for adults, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, Abdominal/GYN, Pediatrics, Small Organ(breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Musculoskeletal (Conventional), Musculoskeletal (Superticial), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric), peripheral vessel and Urology exams.
The operator for Clivia series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics.
Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, 3D/4D, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M(AMM) and combined mode.
The proposed Clivia series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.
The Clivia series Diagnostic Ultrasound System can be controlled both by touch screen or the control panel. Its basic function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW-Mode, 3D/4D, Holo PW, Anatomic M(AMM), Tissue Doppler Imaging(TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
Ten different models of probes are available for the Clivia series, that is C6-1B-H, C6-2-H, C9-3-H, L15-4NB-H, L22-10-H, LH15-6-H, SP5-1-H, P8-3-H, EV11-3-H, D7-2-H.
The Clivia series Diagnostic Ultrasound System has the capability for displaying the patient's ECG and trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. ECG is not intended for monitoring or diagnosis.
The Clivia series Diagnostic Ultrasound System has four batteries in total that allows for scanning or other operation without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.
The provided text describes the Clivia series Diagnostic Ultrasound System. However, it does not include details about acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, etc.) or a study that proves the device meets such criteria in terms of diagnostic performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Venue K180599) and adherence to general safety and regulatory standards.
Here's a breakdown of the specific information requested, based on the provided text:
-
A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or image quality metrics) or reported device performance against such criteria. It states that "The non-clinical data support the safety of the device and the performance testing report demonstrate that the Clivia series Diagnostic Ultrasound System should perform as intended in the specified use conditions." but does not elaborate on specific performance metrics. -
Sample size used for the test set and the data provenance:
The document explicitly states: "The subject of this premarket submission, Clivia series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size or data provenance related to diagnostic performance presented. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no clinical studies were performed for diagnostic performance, there were no experts mentioned for establishing ground truth for a test set. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As no clinical studies were performed for diagnostic performance, there is no mention of an adjudication method. -
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 study was done, and the device is a diagnostic ultrasound system, not an AI-assisted device for improving human reader performance. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone performance study for an algorithm was done, as this is a diagnostic ultrasound system, not an AI-driven image analysis algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No ground truth was established for diagnostic performance as no clinical studies are mentioned. -
The sample size for the training set:
Not applicable, as this document does not describe the development or testing of a machine learning algorithm that would require a training set. -
How the ground truth for the training set was established:
Not applicable, as this document does not describe the development or testing of a machine learning algorithm that would require a training set.
Summary of available performance data from the text:
The "Performance Data" section (Section 6) of the document details non-clinical performance data provided in support of substantial equivalence. These include:
- Biocompatibility testing: Conducted using ISO-10993 standards and included cytotoxicity, sensitization, and irritation tests.
- Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1, IEC 60601-2-37 for safety, and IEC 60601-1-2 for EMC.
- Software Verification and Validation Testing: Conducted in accordance with FDA guidance for "Moderate" level of concern software.
- Acoustic testing: Conducted in accordance with NEMA UD 2-2004 (R2009) acoustic output measurement standard, ensuring acoustic power levels are below FDA limits.
The document concludes that "The differences between the Clivia series Diagnostic Ultrasound System and its predicate device do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Clivia series Diagnostic Ultrasound System should perform as intended in the specified use conditions."
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(60 days)
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, convex array, pencil phased and phased array.
This document is a 510(k) summary for the Mindray DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to predicate devices, not to present a de novo clinical study with specific acceptance criteria related to a novel AI-driven diagnostic performance.
Therefore, many of the requested categories for describing acceptance criteria and study details are Not Applicable (NA) in the context of this 510(k) Pre-Market Notification. This document primarily focuses on demonstrating that the new device, with its added transducers, needle-guided brackets, and features, performs equivalently and safely to previously cleared devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (General): The device must be as safe and effective as a legally marketed predicate device, and have the same intended use and technological characteristics, or if there are differences, the differences do not raise new questions of safety and effectiveness and are demonstrated to be safe and effective.
No specific quantitative acceptance criteria or reported device performance metrics in the format of "Accuracy > X%" or "Sensitivity > Y%" are presented in this 510(k) summary because it's for a general diagnostic ultrasound system, not an AI-enabled diagnostic device with specific performance claims for disease detection.
The document demonstrates equivalence through:
- Intended Use: Identical to predicate.
- Technological Characteristics: Employing the same fundamental ultrasonic imaging technology.
- Performance: The new models are stated to have "the same performance and functions with the predicated device DC-80 (K192152)".
- Electrical and Physical Safety: Compliance with recognized standards and acoustic power levels below FDA limits.
- Biocompatibility: Materials for new transducers and needle-guided brackets are either the same as predicate or tested for biocompatibility.
| Acceptance Criteria Category | Details from 510(k) Summary | Reported Device Performance |
|---|---|---|
| Intended Use | Same intended use as predicate device (DC-80 K192152). Applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, small organ, cardiac, vascular, etc.). | The subject device's intended uses are "consistent with traditional clinical practices, FDA guidelines and established methods of patient examination," and are explicitly stated to be the same as the predicate device. |
| Technological Characteristics (Core) | Employs the same technology as predicate devices: "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body." | The document states the subject device "employs the same technology as the predicate devices," and has the "same intended uses and basic operating modes as the predicate devices." |
| Safety - Acoustic Power Levels | Acoustic power levels are to be "below the limits of FDA." | "The acoustic power levels of DC-90/DC-90S/... are below the limits of FDA, which is the same as the predicated device DC-80 (K192152)." |
| Safety - Electrical & Physical | Designed in compliance with FDA recognized electrical and physical safety standards. | "DC-90/DC-90S/... is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80 (K192152)." Compliance with specific standards (ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2-2004, ISO 10993-1, IEC 62366-1, IEC 60601-1-6) is stated. |
| Biocompatibility | Materials of new transducers and needle-guided brackets | |
| are to be "the same as in the predicate device" or tested for biocompatibility. | "The materials of probes and Needle-guided brackets of DC-90/DC-90S/... are the same to the predicate device DC-80 (K192152)." Additionally, "the L13-3WE transducer was testing for biocompatibility." | |
| Cleaning and Disinfection Effectiveness | Disinfection/sterilization methods for new transducers/brackets are to be provided to end-user. | "All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual." |
| Overall Safety and Effectiveness Profile | To be similar to the predicate device. | "Based on the performance data as documented in the study, the DC-90 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." |
| Quality System Compliance | Design, development, and quality process to conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. | "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." |
2. Sample size used for the test set and the data provenance
NA. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML algorithm for diagnostic performance. The non-clinical tests relate to engineering safety and performance standards (e.g., acoustic output, biocompatibility, electrical safety), not diagnostic accuracy derived from a patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
NA. This is not a study assessing the diagnostic performance of an AI algorithm against expert-established ground truth.
4. Adjudication method for the test set
NA. See point 3.
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
NA. This 510(k) is for a general diagnostic ultrasound system, not an AI-assisted diagnostic tool requiring an MRMC study for human reader improvement. While the device does have "Smart" features (e.g., Smart 3D, Smart Pelvic, Smart Planes FH), the submission does not present a comparative effectiveness study demonstrating the incremental benefit of these features for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
NA. This 510(k) is for a general diagnostic ultrasound system, not a standalone AI algorithm. It's an imaging device that produces images for human interpretation, potentially with some "smart" features that assist, but without a claim of standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
NA. In a 510(k) for a general ultrasound system, "ground truth" as it pertains to diagnostic accuracy of an AI algorithm is not typically established or required. The "ground truth" implied in this context would be the known physical and electrical properties of the device components and their adherence to engineering standards.
8. The sample size for the training set
NA. This submission does not describe an AI/ML algorithm with a "training set" for diagnostic performance.
9. How the ground truth for the training set was established
NA. See point 8.
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(234 days)
The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
The Modes of Operation for Acclarix LX9 series include B mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Modes of Operation for Acclarix AX8 include B mode, M mode, Harmonic Imaging, Elastography Imaging and their combination modes.
Acclarix AX8/ Acclarix LX9 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
The provided FDA 510(k) summary for the Acclarix AX8/LX9 Series Diagnostic Ultrasound System does not contain information about studies proving the device meets acceptance criteria related to AI or machine learning algorithms, specific performance metrics for image interpretation (e.g., sensitivity, specificity), or comparative effectiveness studies with human readers.
The document states: "Clinical testing is not required." and emphasizes non-clinical testing for electrical safety, EMC, and compliance with general ultrasound standards. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and general performance (e.g., transducer additions, new imaging modes).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them in the context of AI/ML performance, as such information is not present in the provided text.
Specifically, the following requested information is not available in the provided document:
- A table of acceptance criteria and the reported device performance: No such table is present for AI/ML performance.
- Sample sized used for the test set and the data provenance: Not applicable as no AI/ML performance testing is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not done or reported.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done or reported for AI/ML algorithms.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Performance Data" section solely details non-clinical testing for electrical safety, electromagnetic compatibility (EMC), general ultrasound equipment standards, and biocompatibility. The "Conclusion" explicitly states that "Verification and validation testing has been conducted... This premarket notification submission demonstrates that Acclarix LX9 Series Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices." This substantial equivalence is based on the technical characteristics and intended use, not on specific AI/ML diagnostic performance metrics.
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(126 days)
The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments 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-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and 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, Volume and Pencil probe.
Here's a breakdown of the acceptance criteria and the study information for the DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Evaluated and conducted in accordance with ISO 10993-1. |
| Electrical Safety | IEC 60601-1 | Complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with IEC 60601-1-2. |
| Ultrasound Specific Safety | IEC 60601-2-37 | Complies with IEC 60601-2-37. |
| Acoustic Power Output | FDA Guidance for Industry and FDA Staff "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Below the limits recommended by FDA guidance. |
| Software General Safety | IEC 62304 and FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation testing were conducted and documentation was provided. |
| Usability | IEC 62366 and IEC 60601-1-6 | Designed in compliance with these standards. |
| Risk Management | ISO 14971 | Application of risk management as per ISO 14971. |
| Quality Systems | 21 CFR 820, ISO 9001, ISO 13485 | Conforms with these quality systems. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state specific sample sizes for test sets for the performance data. The sections on performance data refer to compliance with standards and guidelines rather than specific study parameters involving patient data.
Regarding data provenance, the document mentions non-clinical tests (biocompatibility, electrical safety, EMC, acoustic power, software verification/validation) and compliance with international standards. There is no mention of patient data (retrospective or prospective) or countries of origin for test data in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The non-clinical tests described involve compliance with established standards, which don't typically involve human expert ground truth for comparative performance in the same way clinical studies do.
4. Adjudication Method for the Test Set:
This information is not provided in the document. The tests performed are primarily technical and regulatory compliance checks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:
This information is not provided in the document. The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." An MRMC study would be a type of clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "software controlled, ultrasonic diagnostic system" with various "Main Added Features" (e.g., Ultrasound Fusion Imaging, Smart Pelvic Floor, STE/STQ, Strain Elastography, Smart Face, Smart Planes FH, Glazing Flow, Fusion RESP). While these features are algorithm-based, the document does not explicitly detail standalone performance studies for these specific algorithms, nor does it refer to them as "AI" in the context of standalone performance evaluation. The evaluation focuses on overall system compliance with safety and effectiveness standards, and the capabilities of these features as part of the system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests detailed, the "ground truth" is implied by the international and regulatory standards themselves (e.g., IEC, ISO, FDA guidance limits). For instance, acoustic power output is compared against specified limits, and electrical safety against defined safety requirements. There is no mention of clinical ground truth (like pathology or outcomes data) because clinical studies were not conducted.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document describes specific software features but does not delve into the development or training of any potential machine learning components within these features.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as details about training sets and their ground truth establishment are absent.
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(108 days)
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.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). | Device conforms to the standard. |
| IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. | Device conforms to the standard. |
| IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. | Device conforms to the standard. |
| IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes. | Device conforms to the standard. |
| ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices. | Device conforms to the standard. |
| NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3. | Device conforms to the standard (acoustic power levels are below FDA limits). |
| AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. | Device conforms to the standard (biocompatibility). |
| Cleaning and disinfection effectiveness standards (specific standard not explicitly listed, but mentioned for conformance) | Device conforms to applicable standards. |
| Thermal, electrical and mechanical safety standards (specific standards not explicitly listed beyond 60601-1, but mentioned for conformance) | Device conforms to applicable 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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(202 days)
The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.
DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) 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, Volume and Pencil probe.
Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System.
Important Note: This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness as a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to safety, performance aspects comparable to the predicate, and adherence to relevant standards. Clinical effectiveness studies are explicitly stated as "Not applicable."
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the acceptance criteria are not typically expressed as specific performance metrics (like sensitivity/specificity) for a diagnostic task, but rather as compliance with safety standards and equivalence to predicate devices in terms of intended use and technological characteristics.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use Equivalence | The subject device has the same intended uses as the predicate devices (Mindray DC-70 (K163690) and DC-80 (K173471)). |
| Technological Characteristics Equivalence | The subject device has the same technological characteristics as the predicate devices, including B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging, and combined modes. It also uses similar probes. All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements and calculations. |
| Acoustic Output Safety | Acoustic power levels are below the FDA limits, same as the predicate device DC-70 (K163690). |
| Electrical and Physical Safety | Designed in compliance with FDA recognized electrical and physical safety standards, same as the predicate device DC-70 (K163690). |
| Biocompatibility | Evaluated for biocompatibility. |
| Cleaning and Disinfection Effectiveness | Evaluated for cleaning and disinfection effectiveness. |
| Thermal Safety | Evaluated for thermal safety. |
| Mechanical Safety | Evaluated for mechanical safety. |
| Software Life Cycle Processes | Designed in compliance with IEC 62304 (Medical device software Software life cycle processes). |
| Usability Engineering | Designed in compliance with IEC:62366 (Medical devices - application of usability engineering to medical devices) and IEC 60601-1-6 (Usability). |
| Risk Management | ISO14971 (Medical devices - Application of risk management to medical devices) followed. |
| Quality Systems | Design, development, and quality process conform with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "8. Clinical Studies Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, there is no mention of a traditional test set of patient data, sample size, or data provenance (country of origin, retrospective/prospective) for proving device performance in a diagnostic context. The assessment relies on engineering and performance testing against standards and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As clinical studies were "Not applicable," there is no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for diagnostic performance evaluation.
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. The submission explicitly states no clinical studies were required or performed. There is no mention of AI features (other than "Smart3D", "Smart face", "Smart plane CNS", which are likely imaging enhancement features rather than AI for diagnostic interpretation) that would necessitate a comparative effectiveness study with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical studies were conducted for diagnostic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a 510(k) for an ultrasound system, the "ground truth" for demonstrating substantial equivalence primarily relates to:
- Compliance with recognized standards: The physical and electrical safety, acoustic output, and electromagnetic compatibility are tested against established engineering and medical device standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, ISO 10993-1).
- Performance specifications: The ultrasound system's various modes (B-Mode, M-Mode, etc.) and transducer capabilities are assessed against their defined technical specifications and compared to those of predicate devices.
- Physical and material properties: Biocompatibility, cleaning/disinfection effectiveness are evaluated according to relevant standards.
8. The Sample Size for the Training Set
Not applicable. No AI/ML model requiring a training set is described as the primary subject of the 510(k) for demonstrating substantial equivalence as a diagnostic device. The "Smart" features mentioned are likely integrated software functionalities rather than standalone AI for diagnostic interpretation requiring significant training data submitted for review.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model for diagnostic interpretation is discussed.
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