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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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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):

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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MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/ AnesusME7T/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System is intended 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, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, transesoph( Cardiac) 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, 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/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images.

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, 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 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.

The provided text is a 510(k) summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and shared technological characteristics. Crucially, the document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, a study demonstrating the device meets specific performance acceptance criteria for a diagnostic AI/CAD system with a test set, ground truth, and human reader comparative effectiveness was not performed or required for this submission. The device described is a general-purpose diagnostic ultrasound system, not an AI or CAD system with specific diagnostic performance metrics to meet.

Because no clinical study with acceptance criteria and reported performance was conducted, I cannot fill in the requested table or answer most of the follow-up questions related to such a study.

However, I can extract information regarding non-clinical acceptance criteria and the studies that prove the device meets these.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The following information is not applicable or not provided in the document for the reasons stated above (no clinical study performed):

2. Sample size used for the test set and the data provenance: Not applicable, no clinical test set for diagnostic performance was used. The non-clinical tests relate to device safety and performance according to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a general diagnostic ultrasound system, not an AI/CAD system for interpretation or assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as this refers to a machine learning training set, which is not relevant for this general diagnostic ultrasound system's regulatory submission.
9. How the ground truth for the training set was established: Not applicable.

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