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510(k) Data Aggregation
(91 days)
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 ultrasound system is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.
Modes of operation include: B (Includes B-Mode and Harmonic (Contrast) imaging (HI)), M, PWD (Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)), CWD, Color Doppler (Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)), Combined Modes (Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)), Color M-Mode (CM), 3D/4D, CEUS (Contrast agent for Liver), ARFI, 2D SWI, Freehand tissue elasticity, CEUS (Contrast agent for LVO).
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.
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(135 days)
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(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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(139 days)
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 TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX201/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11T/Eagus TEX11T/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), 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, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares 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, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares 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.
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. The document describes a general purpose diagnostic ultrasound system and its substantial equivalence to predicate devices, focusing on technical specifications, safety standards, and intended use rather than AI/ML performance metrics.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document explicitly states "Not applicable" for clinical studies to support substantial equivalence.
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(129 days)
Consona N6, Consona N6 Pro, Consona N6 Super, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona No Elite, Consona N6T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), Thoracic/Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast imaging (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.
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T 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. Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, Amplitude 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), Contrast imaging (Contrast agent for Liver).
Subject device 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 document is a 510(k) summary for a diagnostic ultrasound system (Consona N6 series). It appears the device does not rely on AI features requiring specific performance metrics or a human-in-the-loop study for its predicate equivalence. The summary explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, the requested information about acceptance criteria, specific study designs (MRMC, standalone), ground truth establishment for a test set and training set, and expert qualifications for AI/ML performance evaluation cannot be extracted from this document because such studies were not deemed necessary for this device's regulatory review.
The document describes a general diagnostic ultrasound system and focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Similar applications (fetal, abdominal, cardiac, etc.)
- Technological Characteristics: Similar imaging modes (B, M, Doppler), transducers, and features.
- Non-clinical Tests: Compliance with acoustic output, biocompatibility, electrical safety, and software standards.
The only "new option" mentioned that might be interpreted as having an "intelligent" component is "Smart Calc," described as: "Semi-automatically recognizes the contour of the target area and measures the diameter, area and circumference of the target area. The user needs to identify the target area first. When the measures results are not satisfactory, the user can use the trackball to manually edit the contour." However, this is presented as an enhancement based on cleared functions, not a new intended use or a feature requiring a specific AI/ML performance study as typically understood in the context of FDA submissions for AI-enabled devices.
Summary of what cannot be provided given the document:
- Table of acceptance criteria and reported device performance for AI features: Not provided as specific AI performance studies were not cited.
- Sample size and data provenance for a test set: Not applicable; no such test set was described for AI performance.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI performance studies.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Information that can be extracted related to the device as a whole (not AI-specific):
- Non-clinical Tests: The device underwent testing for acoustic output (NEMA UD 2-2004), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), biocompatibility (ISO 10993-1), and software lifecycle processes (IEC 62304). This demonstrates the device meets general safety and performance criteria through adherence to recognized standards.
- Clinical Studies: Explicitly stated as "Not applicable."
- Device Performance: The conclusion states that the device "was found to have a safety and effectiveness profile that is similar to the predicate device" based on "performance data as documented in the study" (referring to the non-clinical tests described).
In conclusion, this document does not contain the information requested about AI acceptance criteria and study designs because the device, as described for this 510(k) submission, does not appear to be an AI-enabled device requiring such specific performance evaluations for its regulatory clearance, or at least, those details are not provided in this public summary.
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(115 days)
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp 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), cardiac (adult, pediatric), 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, PW Doppler, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) and Combined mode: B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B.
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 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 mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) 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.
This document is a 510(k) summary for the Mindray DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System, dated November 2, 2020. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific performance criteria through detailed studies as would be seen in a de novo submission or a PMA.
Therefore, the information regarding acceptance criteria and the study that proves the device meets them mainly revolves around regulatory compliance and comparison to already cleared devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the typical sense for a new AI/software feature. Instead, the acceptance criteria are implicit in the comparison to predicate devices and adherence to recognized standards. The "performance" is stated as being "similar" or "same" as the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary Indication for Use (Fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, and urology exams, and general purpose diagnostic ultrasound for imaging, measurement, display and analysis of human body and fluid) | "DC-30/DC-32/DC-28/DC-26/DC-26/DC-20/DC-30 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), cardiac (adult, pediatric), 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, PW Doppler, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) and Combined mode…" (Page 4) |
| Similarity: "Subject device ... has the similar intended uses with the predicated device DC-30 (K173369)." (Page 6) | |
| Acoustic Power Levels (Below FDA limits) | "The acoustic power levels of DC-30/DC-32/DC-26/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp are below the limits of FDA, which is the same as the predicated device DC-30 (K173369)." (Page 7) |
| Electrical and Physical Safety Standards (Compliance with FDA recognized standards) | "DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-30 (K173369)." (Page 8) |
| (Specific standards listed on Pages 8-9) | |
| Features and Probes (Performance, functions, and safety similar to predicate devices) | "The added probes and Needle-guided brackets… are similar to the predicate device Z60 (K200411) and DC-40 (K183377)." (Page 7) |
| "The added features… has the same performance and functions with the predicated device Z60 (K200411) and DC-40 (K183377)." (Page 7) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "8. Clinical Tests: Not Applicable." (Page 9) This indicates that no clinical "test set" in the context of human data was used to demonstrate the performance of the new features or the overall device for substantial equivalence. The evaluation relies on non-clinical tests and comparisons 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)
Since no clinical tests were performed, there are no details provided on experts or ground truth establishment from clinical data. The "ground truth" for compliance testing is against the established specifications and performance of the predicate device and recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 document specifically states "Clinical Tests: Not Applicable," and this ultrasound system is being cleared based on substantial equivalence to existing devices, not as an AI-assisted diagnostic tool requiring MRMC studies to demonstrate human reader improvement. The "Smart" features mentioned (i.e., Smart Face, Smart NT, Smart OB) are likely automated measurement or optimization tools rather than advanced AI diagnostic algorithms requiring such studies for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical studies are mentioned. The "standalone" performance testing for this type of device would typically involve technical and safety checks against industry standards, not a diagnostic accuracy assessment divorced from clinical use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests and comparisons to predicate devices, the "ground truth" is established by:
- Compliance with recognized industry standards: e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1, IEC 62366-1, IEC 60601-1-6.
- Established performance and specifications of the predicate devices: The functionality, acoustic output, and safety profile of the cleared predicate devices (Mindray DC-30, DC-40, Z60) serve as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. The document does not describe any machine learning/AI models that would require a dedicated "training set" to establish substantial equivalence for this device. The "Smart" features are presented as extensions or improvements consistent with existing device capabilities, not as entirely new, data-trained diagnostic algorithms.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned for AI/machine learning model development.
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