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510(k) Data Aggregation
(125 days)
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
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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