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510(k) Data Aggregation
(81 days)
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), 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 healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc 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, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.
Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).
Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.
The document explicitly states:
"8. Clinical Studies Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.
Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.
The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:
- Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
- Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
- Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
- Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
- Acoustic Output: The acoustic output is below the FDA limits (Ispta.3
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(119 days)
TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), ThoracicPleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite 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).
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X TEX10 Lite 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 document does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The provided text is a 510(k) summary for a Mindray diagnostic ultrasound system, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria.
The document states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information.
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(53 days)
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 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, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , transesoph(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, Color Doppler, Amplitude 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, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, i iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver) mode.
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
The provided text is a 510(k) summary for a diagnostic ultrasound system (MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System). This document is primarily focused on demonstrating substantial equivalence to a predicate device based on technical characteristics, intended use, and non-clinical testing.
Based on the provided document, the device did not undergo clinical studies to prove its performance against acceptance criteria in the manner requested (i.e., a study comparing device performance against a defined ground truth, potentially involving human readers, and meeting specific statistical thresholds).
The document explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document. The submission relies on non-clinical tests to demonstrate substantial equivalence to established predicate devices.
The acceptance criteria for this type of submission are primarily met through:
- Comparison of Intended Use: Showing that the new device's intended uses are comparable to (or covered by) legally marketed predicate devices.
- Comparison of Technological Characteristics: Demonstrating that the fundamental technology (e.g., imaging modes, physical principles) is substantially equivalent to predicate devices.
- Non-Clinical Performance Testing: Proving the device meets recognized safety and performance standards (e.g., acoustic output, electrical safety, electromagnetic compatibility, biocompatibility, software lifecycle, risk management).
In summary, the document does not contain the information required to populate the requested table or answer the specific questions about clinical study performance, as no such clinical study was required or performed for this 510(k) submission.
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