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510(k) Data Aggregation
(136 days)
Recho R9W/Recho R9/Recho R9 Pro/Recho R9 Exp/Recho R9S/Recho R9T/Crius R9 CV/Anesus R9 CV/Recho R9 Super/Recho R9 Lumi/Recho R CV/Recho R CVx 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-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), thoracic/pleural, 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, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D, Matrix 4D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver)
The Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T, Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, 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, Matrix 4D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T, Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
This FDA 510(k) clearance letter for the Mindray Diagnostic Ultrasound Systems (K250020) explicitly states that no clinical studies were required or performed to support substantial equivalence.
Therefore, based on the provided document, there is no information available regarding:
- Acceptance criteria based on clinical performance.
- A study proving the device meets clinical performance, as none was conducted.
- Sample size for test sets or their provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and compliance with recognized medical safety standards.
The document highlights the following non-clinical tests and comparisons:
1. Acceptance Criteria & Reported Device Performance (Non-Clinical):
| Acceptance Criteria (Compliance/Safety) | Reported Device Performance (Compliance) |
|---|---|
| Acoustic output limits (FDA) | Below FDA limits (same as predicates) |
| Biocompatibility standards | Compliant (patient contact materials same as predicates or ISO 10993-1 tested) |
| Cleaning and disinfection effectiveness | Evaluated and compliant |
| Thermal, electrical, mechanical safety | Designed to conform with applicable medical safety standards (same as predicates) |
| Electrical safety standards | Compliant with ANSI AAMI ES60601-1 and related IEC standards |
| Electromagnetic compatibility (EMC) | Compliant with IEC 60601-1-2 and IEC TR 60601-4-2 |
| Usability standards | Compliant with IEC 60601-1-6 and IEC 62366-1 |
| Risk Management | Compliant with ISO 14971 |
| Software Life Cycle Processes | Compliant with IEC 62304 |
| Intended Use, Imaging Modes, Features, Functions, and Technological Characteristics | Comparable to and substantially equivalent to predicate devices (K222928, K220242, K182857, K190913, K171314, K240115, K242231) |
2. Sample Size and Data Provenance:
* Not applicable as no clinical studies were performed. The equivalence was based on engineering and performance testing against standards and predicate devices.
3. Number of Experts and Qualifications for Ground Truth:
* Not applicable as the substantial equivalence was not based on clinical performance studies involving expert interpretation.
4. Adjudication Method:
* Not applicable as no clinical studies were performed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
* No MRMC study was done, as explicitly stated, "Clinical Studies: Not applicable."
6. Standalone Performance (Algorithm Only):
* Not applicable as this is a general-purpose diagnostic ultrasound system, and the clearance is for the device as a whole, not a specific AI algorithm with standalone clinical performance metrics. While AI/software features like "Auto Strain LV," "Auto Strain RV," "Auto VQ LA," "X-Vue," and "Quick View" are mentioned, their performance evaluation for 510(k) clearance was not based on a clinical trial but on comparison to cleared predicate devices that already have similar functionalities.
7. Type of Ground Truth Used:
* For the non-clinical tests, the "ground truth" was compliance with established engineering standards, regulatory limits (e.g., FDA acoustic output limits), and comparison to the technical specifications and performance of legally marketed predicate devices.
8. Sample Size for Training Set:
* Not applicable, as no information on specific machine learning model training sets or their sizes is provided for this 510(k) clearance. The focus is on the integrated ultrasound system's safety and effectiveness compared to predicates.
9. How Ground Truth for Training Set was Established:
* Not applicable, as no information on specific machine learning model training or associated ground truth establishment is provided.
In summary, the 510(k) clearance for this Mindray Diagnostic Ultrasound System was granted based on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing, and compliance with recognized standards, rather than through new clinical performance studies.
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(97 days)
Resona I9, Resona I9 Exp. Resona I9T. Resona I9 Easi, Resona I9 Nasa, Resona IV. Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19, Anesus 19, Resona 19W, Recho 19, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).
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.
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19, Resona I9W, Recho 19, Recho 19 Pro, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B. M. PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B. Power+PW+B). Tissue Harmonic Imaging, Smart3D, 4D(Realtime 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 19, Resona 19 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
I'm sorry, but this document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It outlines the device's indications for use, its substantial equivalence to predicate devices based on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and applicable safety standards it conforms to.
However, it explicitly states under "8. Clinical Studies": "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, there is no information in this document regarding:
- Acceptance criteria tables with reported device performance for an AI/algorithm-related study.
- Sample sizes for test sets or data provenance.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- MRMC studies or effect sizes of AI assistance on human readers.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This document is a regulatory clearance for a general purpose diagnostic ultrasound system, not a document detailing the performance and validation of an AI/ML component within such a system.
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(97 days)
Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
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.
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Realtime 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 I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.
Description of Acceptance Criteria and the Study that Proves the Device Meets Them
The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from 510(k) Content) | Reported Device Performance (Summary from 510(k)) |
|---|---|---|
| Intended Use Equivalence | Intended uses are consistent with predicate devices. | The subject device has the same intended uses as the predicate device Resona I9 (K210699), applicable for adults, pregnant women, pediatric patients and neonates for various exams (fetal, abdominal, intra-operative, small organ, cardiac, etc.) and modes of operation (B, M, PWD, CWD, Color, etc.). |
| Technological Characteristics Equivalence | Device operates using the same fundamental scientific technology. | Both subject and predicate systems transmit ultrasonic energy, perform post-processing to generate onscreen display of anatomic structures and fluid flow. They both allow for specialized measurements and calculations. |
| Safety - Material Biocompatibility | Patient contact materials of transducers and needle-guided brackets are the same as predicate devices. | The patient contact materials of the transducers and needle-guided brackets of the subject device are the same as the predicate devices. |
| Safety - Acoustic Output | Acoustic power levels are below FDA limits and are the same as predicate devices. | Acoustic power levels of the subject device are below FDA limits and are the same as the predicate device Resona I9 (K210699). |
| Safety - Electrical, Thermal, Mechanical | Device complies with recognized electrical and physical safety standards. | The subject device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). This is stated to be the same as the predicate device Resona I9 (K210699). |
| Performance - Features and Functions | Equivalent features and functions, or new features cleared in other predicate/reference devices. | The subject device has equivalent features and functions to predicate devices. Specific advanced features (USAT, HRI+, HiFR CEUS, CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro Angiography, DICOM Pediatric SR, DICOM Urology SR, Biopsy Grid) were previously cleared in Resona R9 (K222928). Smart Bladder and ClamAV were cleared in Consona N9 (K221300). IOTA was cleared in Voluson E10 (K181985). |
| Non-clinical Tests | Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety. | Non-clinical tests were performed based on recognized international and national standards (NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). The results support substantial equivalence. |
| Clinical Studies | Not required to support substantial equivalence if non-clinical data is sufficient. | No clinical studies were deemed necessary or performed to support substantial equivalence for this submission. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.
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" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring expert adjudication was conducted.
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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.
8. The sample size for the training set:
- Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.
9. How the ground truth for the training set was established:
- Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.
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(139 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracc/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, 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, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, and TDI.
The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.
TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication.
This system is a Track 3 device that employs phased array probes.
The provided FDA 510(k) summary for the Mindray TE Air Diagnostic Ultrasound System (K231685) does not include any information about acceptance criteria or a study proving the device meets them.
The submission focuses on establishing substantial equivalence without clinical studies. It states: "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Instead of performance criteria based on clinical outcomes, the submission relies on adherence to recognized safety and performance standards for non-clinical aspects, and comparison of technical features to a predicate device.
Therefore, for your request, I must report that the requested information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in the provided document.
The document primarily discusses:
- Device Description: General purpose, software-controlled ultrasound system with B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI modes.
- Intended Use: Abdominal, pediatric, thoracic/pleural, adult and pediatric cardiac, neonatal and adult cephalic, and urology exams for adults, pregnant women, pediatric patients, and neonates.
- Comparison to Predicate: The subject device is compared to a primary predicate device (TE Air in K220051) and a reference device (TEX20 in K220242). The main changes from the primary predicate are the addition of "AutoEF" feature (cleared in TEX20) and support for Android OS and updated iOS.
- Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, conforming to various IEC and ISO standards. The document explicitly states these non-clinical tests support the determination of substantial equivalence.
Without clinical study data, none of the requested performance metrics related to clinical accuracy or effectiveness (e.g., sensitivity, specificity, clinical improvement with AI assistance) can be provided from this document.
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