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510(k) Data Aggregation
(127 days)
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, 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, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), 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 MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody 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, Power Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody 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 FDA 510(k) Clearance Letter states that clinical studies were Not Applicable for the Mindray Diagnostic Ultrasound System (K251192) to support substantial equivalence. Therefore, there is no information in this document about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.
The letter explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Instead, the submission relies on:
- Comparison with Predicate Devices: The document extensively details how the subject device is comparable and substantially equivalent to existing cleared predicate devices (e.g., MX7 (K241432), TEX20 (K241201), Resona I8W (K240115), TE Air (K240906), Consona N6 (K221300), QLAB (K190913)) in terms of intended use, imaging modes, features, functions, and technological characteristics.
- Non-clinical Tests: The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, in compliance with various recognized standards (e.g., NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance as they would apply to clinical efficacy/performance for a new AI/software component, because this information is not present in the provided 510(k) summary. The clearance is based on substantial equivalence to existing predicate ultrasound systems and non-clinical safety/performance testing.
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(101 days)
Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel 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, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 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, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 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 document is a 510(k) premarket notification summary for a diagnostic ultrasound system. It outlines the device description, indications for use, comparison to predicate devices, and the non-clinical tests performed. Crucially, the document states "Not applicable" for clinical studies and explicitly says, "The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, based on the provided text, there is no information available regarding acceptance criteria and a study that proves the device meets those criteria in the context of an "AI" or "software" performance evaluation as typically seen for AI/ML-enabled devices. The new features mentioned (e.g., Super Resolution CEUS, Smart Scene) are presented as improvements or enhancements based on cleared functions, or new options that passed related tests without introducing new clinical risks. The focus of this 510(k) is on demonstrating substantial equivalence to predicate ultrasound devices through non-clinical testing and shared technological characteristics.
Here's why the requested information cannot be provided from this document:
- No AI/ML Performance Claim: The document does not describe the device as an AI/ML-enabled diagnostic tool in the sense of providing automated analysis, detection, or diagnosis that would require specific performance metrics like sensitivity, specificity, or AUC based on ground truth. The "Smart Calc" feature mentioned is simply an analysis package.
- Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new ultrasound system is substantially equivalent to existing, legally marketed predicate devices primarily through engineering, safety, and functionality comparisons.
- No Clinical Study Performed/Required: The document explicitly states that clinical studies were "Not applicable" and "not required to support substantial equivalence." This means there was no de novo performance study with a test set, ground truth, or expert readers to evaluate specific diagnostic accuracy or AI assistance.
Table of Acceptance Criteria and Reported Device Performance (as inferable from the document's scope):
| Acceptance Criterion (Inferable) | Reported Device Performance (as stated or implied) |
|---|---|
| Acoustic Output below FDA Limits | Acoustic power levels are below FDA limits, "which are the same as the predicated devices Resona R9 (K222928) and ZS3(K192410)." |
| Compliance with Electrical and Physical Safety Standards | 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, IEC 62304, IEC 62366-1). |
| Biocompatibility | Patient contact materials of transducers and needle-guided brackets are the same as predicate devices or "tested under ISO 10993-1." |
| Cleaning and Disinfection Effectiveness | Evaluated for cleaning and disinfection effectiveness. |
| Intended Uses Comparable to Predicate Devices | Has the same intended uses as the predicate device Resona R9 (K222928), with Ophthalmic and GYN/Pelvic applications cleared in predicate device ZS3 (K192410). Applicable for adults, pregnant women, pediatric patients and neonates for various exams. |
| Imaging Modes and Features Comparable to Predicate Devices | Includes B, M, PWD, CWD, Color Doppler, Power Doppler, Combined modes, Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D, Strain Elastography, STE, STQ, Contrast imaging (for LVO and Liver). These are stated to be comparable with predicate devices. |
| New Features (e.g., Super Resolution CEUS, STVi, Arterial PWV Analysis) | New options are improvements/enhancements based on cleared functions, "no intended uses are added and passed the related tests, no clinical risks introduced." Specific functions are explained (e.g., Super Resolution CEUS for acquiring more contrast image data, STVi for calculating viscosity/frequency dispersion, Arterial PWV for pulse wave velocity). These additions appear to have been accepted as not altering the fundamental substantial equivalence or safety profile, rather than requiring specific performance metrics against an independent ground truth. |
| Quality System Compliance | Manufacturer confirms compliance with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
Regarding the specific questions about an AI/ML performance study, the answers are "N/A" (Not Applicable) because such a study was not performed or required for this 510(k) clearance:
- A table of acceptance criteria and the reported device performance: See table above for inferable, non-AI criteria.
- Sample sized used for the test set and the data provenance: N/A (no clinical test set for AI performance).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study for AI assistance was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was performed.
- The type of ground truth used: N/A.
- The sample size for the training set: N/A (no mention of a training set for an AI model).
- How the ground truth for the training set was established: N/A.
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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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(112 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric , small organ,neonatal and adult cephalic, musculo-skeletal(Conventional and Superficial), thoracic/pleural (For detection of fluid and pleural motion/sliding,), adult and pediatric 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, Color Doppler, Power 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.
This FDA 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence without requiring clinical studies.
Here's a breakdown of the information that is and is not available in the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance acceptance criteria for a novel algorithm or diagnostic capability.
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/Not available. Since no clinical studies were performed to prove the device meets acceptance criteria, there is no test set sample size or data provenance to report. The submission states, "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
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/Not available. As no clinical studies were conducted, no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No test set was used in clinical studies.
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 available. No clinical studies, including MRMC studies, were performed. The device is a general-purpose diagnostic ultrasound system, and the submission does not mention AI assistance for human readers or report any effect sizes. The new software options listed (iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist) are functions cleared in predicate devices, not necessarily AI-driven assistance that would typically be evaluated in an MRMC study for improved reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available. No standalone performance study was conducted. The device is a diagnostic ultrasound system, implying human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. Since no clinical studies were performed, no ground truth was established or used.
8. The sample size for the training set
- Not applicable/Not available. The submission does not describe any training sets or machine learning models that would require one. The modifications primarily involve adding new intended uses and transducers, and incorporating software options already cleared in predicate devices, rather than a new AI algorithm requiring a dedicated training set.
9. How the ground truth for the training set was established
- Not applicable/Not available. As no training set is discussed, no ground truth establishment method for it is provided.
Summary of Device and Substantial Equivalence Justification:
The document is a 510(k) summary for the TE Air Diagnostic Ultrasound System (K240906). The submission aims to demonstrate substantial equivalence to a primary predicate device, the TE Air Diagnostic Ultrasound System (K231685), and several reference devices (Consona N9, MX7, Butterfly iQ).
The proposed device, K240906, introduces several modifications:
- New intended uses: Small organ, musculo-skeletal (Conventional and Superficial), and peripheral vessel exams, which have been cleared in the predicate Butterfly iQ (K202406).
- New transducers: z3P, z3Ps, z3Pt, e3P, e3Ps, e3Pt, a3Px, i5M, z5M, z5Ms, z5Mt, e5M, e5Ms, e5Mt, a5Mx.
- New software options: iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist (Ellipse), B-Hist (Trace), B-Hist (Spline), B-Hist (Rectangle), which have been cleared in the predicate Consona N9 (K221300).
- Operating System update: Android 9 to Android 10.
The substantial equivalence is argued based on:
- Similar technological characteristics to predicate devices.
- Comparable key safety and effectiveness features.
- Same intended uses and basic operating modes (with the added intended uses cleared in another predicate).
- All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements.
- Acoustic power levels of the subject device are below FDA limits, similar to the predicate TE Air (K231685).
- The software app and use of a mobile device screen are similar to the cleared TE Air (K231685).
- OS changes passed related bench tests with no safety risk.
Non-clinical tests were performed for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
No clinical studies were deemed necessary to support substantial equivalence for this device.
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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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