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510(k) Data Aggregation
(198 days)
Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.
This device is a general purpose diamostic ultrasound system intended for use by qualified and trained healtheare 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, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.
The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.
However, I can extract information related to the device's broader regulatory and non-clinical testing.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."
However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Acoustic Output: Below FDA limits (NEMA UD 2-2004 (R2009)) | "The acoustic power levels of [Device Names] are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Electrical and Physical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-6 Ed. 3.1, IEC 60601-2-37 Ed. 2.1 | "Resona R9...is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Biocompatibility: Transducer materials tested under ISO 10993-1. Specific testing for ELC13-4U transducer. | "The patient contact materials of the transducers are tested under ISO 10993-1." (Page 9) "The materials used in the new transducers (except for ELC13-4U) and needle-guided brackets were the same as in the predicate device. And the ELC13-4U transducer was testing for biocompatibility." (Page 5) |
| Cleaning and Disinfection Effectiveness: Provided instructions for 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." (Page 5) |
| Risk Management: Compliance with ISO 14971 | "This device has been tested and evaluated under the following standards: ...ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices." (Page 11) |
| Software Life Cycle Processes: Compliance with AAMI / ANSI / IEC 62304:2015 | "This device has been tested and evaluated under the following standards: ...AAMI / ANSI / IEC 62304:2015, medical device software - software life cycle processes." (Page 11) |
| Usability Engineering: Compliance with IEC 62366-1 Edition 1.0 2015-02 | "This device has been tested and evaluated under the following standards: ...IEC 62366-1 Edition 1.0 2015-02 medical devices - application of usability engineering to medical devices." (Page 11) |
| Overall Safety and Effectiveness Profile: Similar to predicate device. | "Based on the performance data as documented in the study, the Resona R9 series Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." (Page 12) "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." (Page 12) |
| Functional Equivalence: Same intended uses, basic operating modes, technological characteristics, imaging modes, and comparable key safety and effectiveness features as predicate devices (e.g., Resona 7 (K171233), DC-80 (K192152), RS85 (K192903), etc., for specific features like AutoEF, Ultra-Micro Angiography, Smart Fetal HR). Transducers are similar or cleared. New features are comparable to features in other cleared predicate/reference devices. | "Resona R9...has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes." (Page 8) "The subject device also has the same intended uses and basic operating modes as the predicate devices." (Page 8) "The Resona R9...has the same imaging modes as the predicated devices." (Page 10) "The Resona R9...has the same functions as the predicated devices." (Page 10) "The Resona R9...has similar tranducers with the predicated devices." (Page 10) |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or ground truth was established that would require adjudication.
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/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).
8. The sample size for the training set
Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.
9. How the ground truth for the training set was established
Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.
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(125 days)
TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural 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, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging (Contrast agent for LVO),TDI,Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View.
TE7/TE5/TE7 Max/ TE5 Max/TE9 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode , Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO),TDI, Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View. This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array and Volume probe.
This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD. TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System. It largely focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailed performance studies against specific acceptance criteria for novel AI features.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement for ground truth is not explicitly provided in this type of regulatory submission. The submission primarily relies on showing that the new features or modifications are "similar to" or "have been cleared with" existing features in predicate devices. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed performance metrics for the added features like Smart IVC, Smart VTI, Smart B-Line, EPSS, Smart Trace, Auto GA, Smart Bladder, or Smart FHR OB1. Instead, it states that these features are "similar to" or "have been cleared on" predicate devices, implying that their performance is considered equivalent and therefore acceptable.
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| New Applications | Performance of new applications (e.g., ophthalmic, CW to fetal, abdominal, fetal to specific transducers) is comparable to that of predicate devices where these applications were already cleared. | The ophthalmic application has already been cleared with L12-4s in the predicate device TE7/TE5 (K180912). |
| The fetal application with CW has already been cleared with SP5-1s in the predicate device TE7/TE5 (K180912). | ||
| The abdominal application has already been cleared with L13-3s in the predicate device MX7 (K200001). | ||
| The fetal application has already been cleared with L9-3U in the predicate device Resona 7 (K171233). | ||
| Smart 3D | Performance comparable to existing Smart 3D inpredicate devices. | This feature has been cleared with L16-4Hs in the predicate device M9 (K171034). Functionality described: operator moves probe for scanning, system reconstructs and displays a single frame of 3D image. |
| LVO mode | Performance comparable to existing LVO mode in predicate devices. | This feature has been cleared with L10-5 in predicate device ZS3 (K192410). |
| iScape View | Performance comparable to existing iScape View in predicate devices. | The feature has been cleared on the predicate device M9 (K171034). Functionality described: extends field of view by piecing together multiple B images into a single, extended B image. |
| Smart IVC | Automated measurement of IVC inner diameter and calculation of change rate in B mode image is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: automatically measure the IVC inner diameter and calculate the change rate in the B mode image. |
| Smart VTI | Calculation of CO of LVOT to evaluate cardiac function is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to calculate the CO (cardiac output) of the LVOT (left ventricular output tract), so as to quickly evaluate the cardiac function. |
| Smart B-Line | Detection of B-line of the lung in B mode (real-time and freeze) is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to detect the B line of the lung in B mode; supports B-line detecting in both real-time and freeze modes. |
| EPSS | Accurate measurement of the distance between point E and Interventricular Septum when mitral valve is fully open. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: measures the distance between point E and Interventricular Septum when mitral valve is fully open. |
| Smart Trace | Accurate tracing of contours of normal anatomical regions, automatic recognition of margins, and measurement of lengths, area, and circumference. | This feature is similar to the cleared feature Trace on the predicate device Resona 7 (K171233). Functionality described: helps the operator to trace the contour of the normal anatomical regions by automatically recognizing the margin of the target and measures the lengths of major axis, area and circumference of the closed region. |
| Auto GA | Accurate identification of gastric antrum boundary and calculation of its area. | This feature is similar to the feature Area trace on the predicate device TE7/TE5 (K180912). Functionality described: After acquired image(s) of gastric antrum, by freezing image and tapping the Auto GA button, the feature shows boundary of gastric antrum and calculates the area of gastric antrum. |
| Smart Bladder | Accurate measurement of urine volume in the bladder. | The feature has been cleared on the predicate device DC-40 (K183377). Functionality described: used to measure the volume of the urine in the bladder. |
| Smart FHR OB1 | Automatic measurement of fetal heart rate is accurate and reliable. | It is similar to the cleared feature OB FHR (M) on the predicate device Resona 7 (K171233). Functionality described: to measure the fetal heart rate automatically. |
| Acoustic Power | Below FDA limits. | The acoustic power levels of TE7/TE5/TE7 Max/TE5 Max/TE9 are below the limits of FDA, which is the same as the predicated device TE7/TE5 (K180912). |
| Safety (electrical, physical) | Compliance with FDA recognized electrical and physical safety standards. | TE7/TE5/TE7 Max/TE5 Max/TE9 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device TE7/TE5 (K180912). Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971. |
| Biocompatibility | Materials of probes and needle-guided brackets are tested under ISO 10993-1 or are the same as predicate. | The materials of probes and needle-guided brackets of TE7/TE5/TE7 Max/TE5 Max/TE9 are the same to the predicate device or tested under ISO 10993-1. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on "similarity" to predicate devices, implying that testing data from those predicate devices supports the current submission, or that specific testing for these features was performed internally without detailing the datasets.
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)
This information is not provided. The document makes no mention of expert involvement for ground truth establishment related to the new features. Given the approach of "similarity to cleared features," it's likely that established methods of performance evaluation for ultrasound systems were followed, but the specifics are not disclosed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission does not claim to include AI assistance to human readers that would necessitate such a study; rather, it describes automated measurement and image processing features that are presumably integrated into the device's functionality.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the new features (e.g., Smart IVC, Smart VTI, Smart B-Line, Smart Bladder, Smart FHR OB1) imply automated algorithms perform measurements or detections, the document does not explicitly describe a standalone algorithm-only performance study. The context is the overall ultrasound system, and these features are presented as integrated capabilities of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated. Given the nature of ultrasound imaging and a 510(k) submission primarily focused on substantial equivalence for a diagnostic ultrasound system:
- For quantitative measurements (e.g., Smart IVC, Smart VTI, Auto GA, Smart Bladder, Smart FHR OB1), the ground truth would likely be established through manual measurements by trained Sonographers/Physicians using validated techniques, or comparison against other gold standard measurement methods if available.
- For image processing and detection features (e.g., Smart 3D, iScape View, Smart B-Line, Smart Trace), the ground truth would likely involve expert visual assessment and consensus by radiologists/cardiologists/specialists interpreting the images and verifying the function's output.
However, this is inferred, not stated.
8. The sample size for the training set
This information is not provided. The document is a 510(k) summary for an ultrasound system, not a detailed technical report for an AI algorithm. In submissions of this type for devices primarily relying on substantial equivalence, detailed training set information is often not required or included unless the AI component is a truly novel aspect requiring extensive de novo review. The features described are framed as similar to those already cleared.
9. How the ground truth for the training set was established
This information is not provided.
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(135 days)
Hepatus 7/Hepatus 6/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 57/Fibrous 7/ Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric and Peripheral vessel exams.
It is intended to provide 50 Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.
The ViTE and stiffness, and LiSA may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of liver.
The ViTE and stiffness may be used as an aid to clinical management of pediatric patients with liver disease. The clinical applications include:Fetal, Abdominal, Pediatric and Peripheral vessel.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare 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.PW Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging(Contrast agent for Liver), ViTE, LiSA and Combined mode:B+M, PW+M, Color+B. Power+B. PW+Color+B. Power+PW+B.
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 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, PW-mode, Color-mode, Color M-mode, Power/Dirpower mode, THI, Biopsy Guidance, ViTE, Contrast imaging or the combined mode (i.e. B/M-Mode).
This system is a Track 3 device that employs an array of probes that include convex array and phased array.
The provided text only contains regulatory information about clearances for the Hepatus 7/Hepatus 6/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document explicitly states "Clinical Tests: Not Applicable."
Therefore, I cannot provide the requested information based on the given input.
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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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(103 days)
DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging 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 cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
The DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, Power + B, Power + PW +B). This system is a Track 3 device that employs an array of probes that include linear array, convex array.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like sensitivity, specificity, or AUC, which are typical for AI/ML-based diagnostic devices.
Instead, the document is a 510(k) summary for a "DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System," which is a traditional medical imaging device. The "study" referenced in the document is a non-clinical test report demonstrating compliance with various electrical, acoustic, and safety standards, rather than a clinical performance study of the device's diagnostic accuracy.
Here's a breakdown of the available information based on your request, highlighting what is not present:
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A table of acceptance criteria and the reported device performance:
The document does not specify performance acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the ultrasonic diagnostic imaging system. Instead, it refers to compliance with safety and performance standards.The performance relies on its ability to "acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode" and perform "specialized measurements of structures and flow, and calculations," which is an inherent function of an ultrasonic diagnostic system rather than a measured performance metric against a specific clinical outcome.
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Sample size used for the test set and the data provenance:
This information is not applicable as there was no clinical study evaluating diagnostic performance. The document states: "8. Clinical Studies: Not applicable. The subject of this submission, DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence."The non-clinical tests involved evaluating the device against standards, not a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical study with a test set requiring ground truth established by experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there was no clinical study with a test set. -
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:
This information is not applicable. The device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an AI algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as there was no clinical study requiring a ground truth. -
The sample size for the training set:
This information is not applicable as the device is a traditional medical imaging system and not an AI/ML-based device that would require a training set. -
How the ground truth for the training set was established:
This information is not applicable as there was no training set.
In summary, the provided document details a 510(k) submission for a traditional ultrasonic diagnostic imaging system, and therefore, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with non-clinical safety and performance standards, rather than clinical performance criteria or studies typical for AI/ML devices.
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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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(115 days)
TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients 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-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.
TE7/TE5 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI 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 and phased array.
This document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD TE7/TE5 Diagnostic Ultrasound System (K180912) and its substantial equivalence to predicate devices. The information provided heavily references previously cleared devices and standards, indicating that no new clinical study was conducted for this specific submission to establish de novo acceptance criteria or device performance.
Therefore, the requested information elements related to a new study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set sample size, how training ground truth was established) are not applicable as they relate to newly conducted efficacy or performance studies. The submission relies on demonstrating equivalence to existing, cleared devices and compliance with recognized standards.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no new performance study with specific criteria and results is outlined for this submission, the "acceptance criteria" are implied by compliance with safety standards and substantial equivalence to predicate devices. Device performance is considered equivalent to the predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Acoustic output within limits | Compliant with NEMA UD 2-2004 (R2009) |
| Biocompatibility | Compliant with AAMI / ANSI / ISO 10993-1:2009/(R)2013 |
| Cleaning and Disinfection effectiveness | Evaluated and found to conform |
| Thermal, Electrical, and Mechanical safety | Compliant with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 3, IEC 60601-2-37 Edition 2.0 |
| Software Life Cycle Processes | Compliant with AAMI / ANSI / IEC 62304:2006 |
| Risk Management | Compliant with ISO 14971 Second edition 2007-03-01 |
| Intended Use | Same as predicate devices (e.g., K161525 for TE7/TE5) |
| Basic Operating Modes | Same as predicate devices (e.g., B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, etc.) |
| Transducer Materials | Same as predicate devices |
| Needle-Guided Bracket Materials | Same as predicate devices |
Study Proving Device Meets Acceptance Criteria:
The device meets its implied acceptance criteria by demonstrating substantial equivalence to existing legally marketed predicate devices and by compliance with recognized national and international safety and performance standards. The submission explicitly states: "Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Page 31)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new clinical performance or efficacy studies were conducted for this 510(k) submission. The submission relies on non-clinical tests and equivalence to predicate devices.
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. No new clinical performance or efficacy studies were conducted for this 510(k) submission that would require establishing ground truth from experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical performance or efficacy studies requiring adjudication were conducted for this 510(k) submission.
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 submission concerns a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was performed as confirmed by the statement "Clinical Studies: Not applicable. The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 32).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm, and no such performance study was conducted for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No specific ground truth establishment for a new performance study is mentioned in this 510(k) submission. The device's safety and effectiveness are established through compliance with existing standards and comparison to predicate devices, which would have had their performance and safety established previously.
8. The sample size for the training set
Not applicable. No new machine learning or AI algorithm development requiring a training set is described in this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As no new training set is indicated, this question is not relevant to the provided documentation.
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(61 days)
The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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 cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography 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.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than detailing acceptance criteria and performance data for a novel algorithm or AI-driven feature.
Based on the provided information, the device is a general-purpose diagnostic ultrasound system, and the submission does not describe a study involving specific acceptance criteria for a novel AI-driven feature or algorithm. The document explicitly states "Clinical Tests: Not Applicable." and relies on non-clinical tests to demonstrate substantial equivalence to predicate devices.
Therefore, the requested information regarding algorithm-specific acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies with AI assistance is not present in the provided text.
The document indicates that the device meets safety and performance standards through non-clinical testing for compliance with:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 3: 2007-03 (Electromagnetic Compatibility)
- IEC 60601-2-37 Edition 2.0 2007 (Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- AAMI / ANSI / IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes)
- ISO 14971 Second edition 2007-03-01 (Medical Devices - Application of Risk Management)
- NEMA UD 2-2004 (R2009) (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment)
- AAMI / ANSI / ISO 10993-1:2009/(R)2013 (Biological Evaluation of Medical Devices)
The performance of the device is implicitly expected to be "substantially equivalent" to the predicate devices (Mindray DC-8 (K170277), Resona 7 (K171233), DC-70 (K163690), and M9 (K171034)) based on shared technology, intended uses, basic operating modes, materials, acoustic power levels, and compliance with safety standards.
In summary, the provided text does not contain detailed information on acceptance criteria and specific study results for a novel AI or algorithm performance, as it is a 510(k) submission focused on demonstrating substantial equivalence through adherence to general safety and performance standards for an ultrasound system.
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(104 days)
The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is a general purpose, mobile, 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, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ 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. Phased array and convex array.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Resona 6/Resona diagnostic ultrasound system. It indicates that the device has been evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, and no clinical studies were deemed necessary or performed to support this submission.
Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria from the given text, as no such clinical study was conducted. The information provided heavily emphasizes non-clinical testing and comparison to predicate devices, which is typical for 510(k) submissions demonstrating substantial equivalence rather than novel device performance.
However, based on the information implicitly stating that non-clinical tests were sufficient to demonstrate substantial equivalence to predicate devices, we can infer the "acceptance criteria" are compliance with established regulatory standards and the performance of the predicate device.
Here's an analysis of what would be relevant if a clinical study had been performed, and how the available information relates to the request:
Based on the provided document, no clinical study was conducted to prove the device meets specific acceptance criteria in a clinical setting. The submission relies on non-clinical tests and comparison to a legally marketed predicate device (Mindray Resona 7, K171233) to demonstrate substantial equivalence.
Therefore, the following points in your request cannot be directly answered from the provided text:
- Table of acceptance criteria and reported device performance (from a clinical study): Not available. The document states "Non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device." The acceptance criteria are implicitly that the device performs equivalently to the predicate and meets safety standards, as demonstrated by non-clinical means.
- Sample size used for the test set and data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable as there was no clinical test set/ground truth established in a clinical setting.
- Adjudication method for the test set: Not applicable.
- 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 an ultrasound system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the established performance metrics and safety standards.
- The sample size for the training set: Not applicable as no AI/machine learning model is described.
- How the ground truth for the training set was established: Not applicable.
What the document does indicate regarding demonstration of equivalence (which serves as the basis for "acceptance"):
-
Acceptance Criteria (Implicit - based on Substantial Equivalence): The device is accepted if it is "substantially equivalent" to legally marketed predicate devices. This means it must:
- Have the same intended uses.
- Have the same technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate.
- Perform comparably in key safety and effectiveness features.
Reported Device Performance (as demonstrated through non-clinical testing and comparison to predicate):
The document states:
- "Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes."
- "All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations."
- It has the "same intended uses" as the predicate device Resona 7 (K171233).
- "The patient contact materials of the transducers are tested under ISO 10993-1."
- "The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)."
- "designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)."
- "has the same imaging modes as the predicated devices."
- "All of the functions... are the same as the predicated devices."
- "has similar transducers with the predicated devices."
Summary of "Acceptance Criteria" and "Device Performance" as inferred from the 510(k) summary:
Acceptance Criteria (Inferred from Substantial Equivalence) Reported Device Performance (as per 510(k) Summary) 1. Same Intended Use as Predicate: Applicable for adults, pregnant women, pediatric patients, and neonates; for use in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam. The subject device has the "same intended uses and basic operating modes" as the predicate device Resona 7 (K171233). Specific applications listed match the predicate. 2. Same Technological Characteristics (or equivalent safety/effectiveness): Utilizing B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape, TDI, Color M, Strain Elastography, 3D/4D, Contrast imaging (Liver/LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ, and combined modes. The subject device "has the same technological characteristics," "same imaging modes," "all of the functions... are the same," and "similar transducers" as the predicate devices. 3. Safety Standards Compliance: "The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)."
"designed in compliance with the FDA recognized electrical and physical safety standards," specifically:
- NEMA UD 2-2004 (R2009) (Acoustic Output)
- AAMI/ANSI ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance)
- AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 (EMC)
- IEC 60601-1-6 Ed. 3.1 (Usability)
- IEC 60601-2-37 Ed. 2.0 (Specific Ultrasound Safety)
- ISO 14971 (Risk Management)
- AAMI/ANSI/ISO 10993-1:2009/(R)2013 (Biocompatibility)
- AAMI/ANSI/IEC 62304:2006 (Software Life Cycle)
- AAMI/ANSI/IEC 62366:2007/(R)2013 (Usability Engineering) |
| 4. Biocompatibility: Patient contact materials meet safety standards. | "The patient contact materials of the transducers are tested under ISO 10993-1." |
| 5. Cleaning and Disinfection Effectiveness. | "evaluated for... cleaning and disinfection effectiveness" (no specific results provided, but compliance is stated). |
| 6. Thermal, Electrical, and Mechanical Safety. | "evaluated for... thermal, electrical and mechanical safety" (no specific results provided, but compliance is stated). |
In conclusion, the document explicitly states that no clinical studies were conducted for this 510(k) submission. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comprehensive non-clinical testing and adherence to recognized safety and performance standards.
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