MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW 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) , trans-esoph(Cardiac) 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, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW 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, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW 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 clearance letter for the Diagnostic Ultrasound System (MX6 series, MX5 series, and MX3 series) does not describe acceptance criteria for specific device performance, nor does it detail a study that proves the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical tests related to general safety and design conformance.
Here's an analysis of why the requested information cannot be extracted from this document:
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Table of acceptance criteria and reported device performance: This document explicitly states "Not applicable" for clinical studies and focuses on showing substantial equivalence based on comparison with predicate devices and conformance to general safety and design standards. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or corresponding acceptance criteria presented.
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Sample size, data provenance for test set: Since no clinical or performance study with a test set (in the context of AI/algorithm performance) is described, these details are not present.
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Number of experts, qualifications for ground truth: Not applicable for the same reason as above. No ground truth establishment for a diagnostic performance test is mentioned.
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Adjudication method: Not applicable.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The document states "Clinical Studies: Not applicable." This type of study would typically be performed for devices with AI assistance measuring diagnostic performance.
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Standalone (algorithm only) performance study: Not applicable. The device is a "general purpose diagnostic ultrasound system," implying human operation, and no mention of an "algorithm only" performance is made.
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Type of ground truth used: Not applicable, as no external "ground truth" (like pathology or outcomes data) was used to assess diagnostic performance of the device itself in a clinical study. The equivalence is based on technical features and safety.
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Sample size for training set: Not applicable. The document does not describe the development or training of any AI/ML models that would typically require a training set.
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How ground truth for training set was established: Not applicable, as no training set is mentioned.
Summary of what the document does provide regarding acceptance criteria and "proof":
The "acceptance criteria" for this device's clearance are primarily conformance to established medical device safety standards and substantial equivalence to legally marketed predicate devices (Consona N9 (K221300) as the main predicate, and MX7 (K241432), Resona I9 (K241432), and Resona I9 (K210699) as reference devices).
The "study that proves the device meets the acceptance criteria" is a series of non-clinical tests and a comparison study.
1. Table of Acceptance Criteria (Inferred from the document) and "Reported Device Performance" (Comparison to Predicate):
| Acceptance Criteria (Inferred) | Reported Device "Performance" / Conformance |
|---|---|
| 1. Safety & Essential Performance: Conform to general safety and essential performance standards. | Device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37). Assessed for thermal, electrical, and mechanical safety. |
| 2. Electromagnetic Compatibility (EMC): Conform to EMC standards. | Device conforms to IEC 60601-1-2 (EMC requirements) and IEC TR 60601-4-2 (Guidance on Electromagnetic immunity). |
| 3. Acoustic Output: Acoustic power levels below FDA guidance. | Acoustic power levels are "below the levels specified by FDA guidance 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'". This was verified via testing against NEMA UD 2-2004 (R2009). |
| 4. Biocompatibility: Patient-contact materials are safe. | Patient contact materials (transducers, needle-guided brackets) are either the same as predicate devices or "tested under ISO 10993-1." |
| 5. Cleaning & Disinfection Effectiveness: Effective cleaning and disinfection. | Evaluated for cleaning and disinfection effectiveness (details not provided beyond being "evaluated"). |
| 6. Software Safety: Software development adheres to safety standards. | Conforms to IEC 62304 (medical device software life cycle processes) and IEC 62366-1 (usability engineering). |
| 7. Risk Management: Application of risk management. | Adheres to ISO 14971 (application of risk management to medical devices). |
| 8. Substantial Equivalence: Features, functions, and intended uses are comparable to predicate(s). | "Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination." Device is comparable to Consona N9 (K221300) and MX7 (K241432) regarding intended use, imaging modes, features, functions, and technological characteristics. The systems transmit ultrasonic energy, perform post-processing to display images, and allow measurements and calculations, similar to predicates. The only difference in Indications for Use (Ophthalmic) was covered by a reference predicate. |
Study that Proves the Device Meets the Acceptance Criteria:
The "study" presented is a collection of non-clinical tests conducted to ensure the device meets safety and performance standards, and a comparison against predicate devices to demonstrate substantial equivalence.
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Non-Clinical Tests: These tests confirmed adherence to various international and national standards:
- Acoustic Output: NEMA UD 2-2004 (R2009)
- Electrical Safety & Essential Performance: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
- Electromagnetic Disturbances: IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, IEC TR 60601-4-2 Edition 1.0 2024-03
- Usability: IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
- Basic Safety & Performance of Ultrasonic Equipment: IEC 60601-2-37 Edition 2.1 2015
- Risk Management: ISO 14971 Third Edition 2019-12
- Biocompatibility: ISO 10993-1 Fifth edition 2018-08
- Software Life Cycle Processes: IEC 62304 Edition 1.1 2015-06
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Comparison to Predicate Devices: The submission details a systematic comparison of the subject device (MX6/MX5/MX3 series) with its main predicate (Mindray Consona N9, K221300) and several reference predicates. This comparison covered:
- Intended Use: Minor differences were covered by reference predicates.
- Imaging Modes: Stated to be comparable.
- Features and Functions: Stated to be comparable.
- Technological Characteristics: Stated to be comparable.
- Patient Contact Materials: Verified to be the same or tested under ISO 10993-1.
- Acoustic Power Levels: Shown to be the same as predicate devices and within FDA guidance.
- Electrical and Physical Safety Standards: Device design shown to comply with the same standards as the predicate.
Additional Information (as requested, but N/A for this document):
- Sample sized used for the test set and the data provenance: N/A (no clinical performance test set mentioned)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth for performance study mentioned)
- Adjudication method: 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: N/A (explicitly states "Clinical Studies: Not applicable." This is not an AI-assisted diagnostic device where such a study would be expected.)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a diagnostic ultrasound system, implying human operation, not a standalone algorithm.)
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A
- The sample size for the training set: N/A (no AI/ML model training mentioned)
- How the ground truth for the training set was established: N/A (no training set mentioned)
In conclusion, this document demonstrates that the Diagnostic Ultrasound System adheres to general safety and design standards and is substantially equivalent to existing cleared devices, rather than providing specific diagnostic performance metrics from a clinical study.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.