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The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.

The provided FDA 510(k) Clearance Letter for the SV600, SV800 Ventilator describes modifications to an existing device, primarily the addition of neonatal ventilation capabilities and updated monitoring modules. However, the document does not contain the level of detail typically found in a clinical study report for evaluating acceptance criteria and device performance in the way you've requested for studies involving AI algorithms, image analysis, or expert consensus with specific metrics like sensitivity, specificity, or AUC.

This document focuses on providing evidence of substantial equivalence to predicate devices through technical comparisons and various forms of bench testing, software verification, and compliance with consensus standards. It does not present a performance study with acceptance criteria specific to an AI device's output (e.g., accuracy against ground truth, reader performance improvements).

Therefore, I cannot fill out your requested table and answer many of your specific questions as the information is not present in the provided text.

Here's what can be extracted based on the document's content:

Acceptance Criteria and Device Performance (Based on available information)

The document doesn't define "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found for an AI or diagnostic device. Instead, "acceptance criteria" are implied by compliance with various technical specifications and international standards. Device performance is generally reported as "meets specifications" or "is equivalent to the predicate."

Study Details (Based on available information in the 510(k) Summary)

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients, number of readings). The "testing" mentioned refers to engineering, software, and standards compliance evaluations.
   • Data provenance is not provided, as this is not a clinical study report.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The document describes engineering and standards compliance testing, not a clinical study involving expert-established ground truth for performance evaluation of an AI component or diagnostic output.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a clinical study with an adjudication process for ground truth.

4. 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 comparative effectiveness study was done. This document describes a ventilator, not an AI diagnostic or assistance tool in that context. While it includes "Intellicycle" and "Lung Recruitment (SI)" features, these are not presented as AI assistance augmenting human reader performance in a diagnostic capacity.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document implies standalone performance testing for various technical aspects of the ventilator and its integrated modules (CO2, SpO2 sensors) against their respective specifications and standards. For example, SpO2 sensor accuracy is stated as "Measurement accuracy: 70 to 100%: ±2% (adult/pediatric mode)" for the Mindray SpO2 module. However, this is for sensor performance, not a complete "algorithm only" evaluation in the context of AI diagnostic output as typically measured.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the technical and performance testing, the "ground truth" would be established by reference standards, calibrated equipment, and design specifications. For example, a flow sensor's accuracy would be tested against a known, precise flow rate. For biocompatibility, the ground truth is defined by the toxicological profiles dictated by the ISO standards. For software, the ground truth is the functional requirements and design specifications.
   • There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for clinical performance evaluation of an AI component.

7. The sample size for the training set:

   • Not applicable. This document does not describe the development or validation of an AI algorithm with a training set. The "Intellicycle" feature is mentioned, but no details regarding its development, training data, or validation as an AI algorithm are provided.

8. How the ground truth for the training set was established:

   • Not applicable, as no AI training set is described.

Summary Limitations:

The provided text is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It details technical changes, compliance with regulatory standards (e.g., biocompatibility, electrical safety, EMC, software V&V), and functional testing results. It does not outline a clinical performance study with the types of metrics and methodologies commonly associated with evaluating AI-driven diagnostic devices or those requiring expert consensus for ground truth. Therefore, many of your specific questions are not addressed by the provided document.

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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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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

9. How the Ground Truth for the Training Set Was Established

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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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, Power 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. The iOS or Android devices could be mobile platform available from the market, or the Mindray's customized Android platform called AirSight.

This FDA clearance letter for the "TE Air Diagnostic Ultrasound System" (K250024) indicates a medical device rather than an AI-powered diagnostic system requiring specific performance metrics like sensitivity, specificity, or AUC. The clearance is based on substantial equivalence to a predicate device, focusing on similar technological characteristics and intended uses.

Therefore, many of the requested details about acceptance criteria, study design for performance, expert qualifications, and AI-specific metrics are not provided or applicable in this document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the acceptance is based on:

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document describes the clearance of an ultrasound system, not an AI/ML-powered diagnostic algorithm that would typically require a test set of patient data to evaluate algorithmic performance. The clearance is based on equivalence to a predicate device and adherence to safety and performance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. As per point 2, there is no mention of a test set requiring expert-established ground truth for evaluating a diagnostic algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No test set or expert adjudication related to diagnostic performance is detailed in this clearance letter.

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. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant to this clearance document. The TE Air system is a general-purpose diagnostic ultrasound system that interfaces with mobile devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a general diagnostic ultrasound system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. Ground truth in the context of diagnostic performance evaluation for an algorithm is not mentioned, as this is a device clearance based on equivalence and safety standards.

8. The sample size for the training set:

• Not Applicable. There is no mention of an AI/ML algorithm or a training set for such an algorithm in this clearance document.

9. How the ground truth for the training set was established:

• Not Applicable. As per point 8, there is no mention of an AI/ML algorithm or a training set.

In summary:

The provided FDA clearance letter is for a "TE Air Diagnostic Ultrasound System" which is described as a general-purpose diagnostic ultrasound system. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (TE Air K240906) and adherence to a comprehensive set of non-clinical safety and performance standards. The modifications primarily involve the addition of an "AirSight" platform (a customized Android device), which has reportedly passed related bench tests with no safety risk introduced.

The documentation explicitly states in section 7, "Clinical Studies: Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This reinforces that the clearance is not based on a clinical performance study involving diagnostic accuracy metrics or AI algorithm evaluation.

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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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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method: Not applicable.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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):

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.

• 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

• 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.

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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):

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:

1. A table of acceptance criteria and the reported device performance: See table above for inferable, non-AI criteria.
2. Sample sized used for the test set and the data provenance: N/A (no clinical test set for AI performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: No MRMC study for AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was performed.
7. The type of ground truth used: N/A.
8. The sample size for the training set: N/A (no mention of a training set for an AI model).
9. How the ground truth for the training set was established: N/A.

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V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.

V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.

The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.

Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.

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