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The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors:

• VS 9 Vital Signs Monitor
• VS 8 Vital Signs Monitor
• VS 8A Vital Signs Monitor .

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Mindray VS Series Vital Signs Monitors (VS 9/VS 8/VS 8A)
Parameter for Analysis: Temperature (Temp) measurement using the new Mindray Temp Module (TrueTemp) in Predictive mode.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for temperature measurement are based on the requirements of ISO 80601-2-56:2017/Amd.1:2018(E). The summary provides statistical results from a clinical investigation.

Note: The document states that the performance of the TrueTemp module "meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol." While the specific numerical acceptance criteria from the ISO standard are not explicitly listed in the table, the reported performance metrics are the results of testing against those criteria. The predicate device's performance is also included in the table in the full submission, showing similar statistical results.

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

• Sample Size for Test Set:
  • 106 valid cases for oral temperature.
  • 110 valid cases for axillary temperature.
  • 109 valid cases for rectal temperature.
• Data Provenance: The study was a clinical investigation conducted by Mindray. The country of origin is not explicitly stated in the provided abstract, but Mindray is a Chinese company (Shenzhen, Guangdong, P.R. China), suggesting the study likely took place in China. It was a prospective clinical investigation as it aimed to meet specific requirements for validity and accuracy of the new module.
• Subject Demographics: The study included subjects in three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old). The age of subjects ranged from 4 days to 67 years old. The total number of febrile subjects constituted not less than 30% and not greater than 50% of all subjects in each selected age group and body site.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not explicitly provided in the summary. The ground truth (reference temperature) was established by comparing the TrueTemp module's measurements to the "direct mode of WelchAllyn SureTemp PLUS 690." It's likely that a trained clinical professional operated the reference thermometer, but the specific number and qualifications of experts involved in establishing the "ground truth" are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. Given that the ground truth was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690), it implies a direct comparison rather than an expert consensus requiring an adjudication process.

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

This is not applicable. The device is a vital signs monitor that directly measures physiological parameters like temperature. It is not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images/data in a way that would necessitate an MRMC comparative effectiveness study to assess human improvement with AI assistance.

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

Yes, a standalone performance evaluation was done for the temperature measurement function. The clinical investigation directly assessed the accuracy and validity of the "new Mindray Temp Module (TrueTemp)" in its predictive mode compared to a reference standard (WelchAllyn SureTemp PLUS 690). This evaluation focused on the device's intrinsic measurement capabilities without assessing human interaction or interpretation as part of the core performance metrics discussed here.

7. The Type of Ground Truth Used

The ground truth used was comparison to a legally marketed reference device: the "direct mode of WelchAllyn SureTemp PLUS 690," which is itself a clinical thermometer. This is a form of comparative measurement against a recognized standard in the field.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set for the Mindray TrueTemp module's temperature measurement function. Given that this is a hardware module (thermal resistance technique) with associated algorithms for predictive mode, its development and calibration would typically involve internal technical specifications and potentially laboratory testing, but "training set" in the context of machine learning is not directly applicable or reported for this type of device in the provided summary.

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

As no training set information is provided, how its ground truth was established is not discussed in this document.

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ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, thoracc, and vacular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac and Peripheral vessel 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, TDI, Color M.

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.

ViewMate™ Multi 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, TDI, Color M.

ViewMate™ Multi 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 is a 510(k) summary for the ViewMate™ Multi Ultrasound System and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert qualifications, and ground truth are not present in this regulatory document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than presenting specific performance metrics against defined acceptance criteria for a new device's core functionality.

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

This information is not provided in the document. The document states "Non-clinical Tests" were performed, but does not detail a "test set" for performance evaluation in the context of clinical or diagnostic accuracy. It refers to testing against safety and performance standards.

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

This information is not provided in the document. As clinical studies were deemed "Not applicable," there's no mention of experts establishing ground truth for a test set.

4. Adjudication method for the test set

This information is not provided in the document.

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

This information is not provided and is not applicable. The ViewMate™ Multi Ultrasound System is described as a "general purpose diagnostic ultrasound system" and there is no indication it incorporates Artificial Intelligence (AI) or machine learning features that would necessitate an MRMC comparative effectiveness study to assess human reader improvement with AI assistance. Clinical studies are explicitly stated as "Not applicable."

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

This information is not provided and is not applicable. Based on the device description, it's a diagnostic ultrasound system intended for use by healthcare professionals, implying human-in-the-loop operation. There is no mention of a standalone algorithm for independent performance.

7. The type of ground truth used

This information is not provided and is not applicable as clinical studies were not performed. The testing mentioned (acoustic output, biocompatibility, safety standards) does not rely on a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).

8. The sample size for the training set

This information is not provided and is not applicable. Since clinical studies were not required, and there's no mention of AI/machine learning components that typically require training sets, this detail is absent.

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

This information is not provided and is not applicable for the same reasons as point 8.

Summary of what the document does provide regarding device evaluation:

The document indicates that the ViewMate™ Multi Ultrasound System underwent non-clinical tests to demonstrate its safety and effectiveness. These tests included:

• Acoustic output evaluation (against NEMA UD 2-2004 (R2009))
• Biocompatibility evaluation (against ISO 10993-1 Fifth edition 2018-08)
• Cleaning and disinfection effectiveness
• Thermal, electrical, and mechanical safety (against AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text), IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-2-37 Edition 2.1 2015)
• Software life cycle processes (against IEC 62304 Edition 1.1 2015-06)
• Usability engineering (against IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1 Edition 1.0 2015-02)
• Risk management (against ISO 14971 Third Edition 2019-12)

The "study" or evaluation performed was primarily a comparison against recognized industry standards and a predicate device (Resona I9 K210699) to establish substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy or efficacy endpoints. The acceptance criteria for these non-clinical tests would be compliance with the requirements of the listed standards. For example, for acoustic output, the acceptance criterion would be that the acoustic power levels are "below the limits of FDA."

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Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.

This device is a general purpose diamostic 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.

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, Smart 3D, 4D(Real-time 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 R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.

However, I can extract information related to the device's broader regulatory and non-clinical testing.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."

However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.

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

Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.

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

Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or ground truth was established that would require adjudication.

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 provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.

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

Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.

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

Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.

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

Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.

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Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System. It details the device's intended use, classification, comparison to predicate devices, and non-clinical tests conducted. The document explicitly states "Not applicable" for clinical studies, meaning no patient data or expert evaluations were used to establish acceptance criteria or prove device performance through a clinical study as would be typical for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set sizes cannot be extracted from this document. This document pertains to a traditional medical device (ultrasound system) that relies on engineering verification and validation against recognized standards and comparison to predicate devices for substantial equivalence, rather than clinical performance metrics in the way AI/ML devices often do.

Based on the provided text, the device relies on substantial equivalence to predicate devices and adherence to recognized safety standards, not on clinical performance studies with acceptance criteria in the typical sense for AI/ML algorithms.

Here's a breakdown of why the requested information is absent:

• No AI/ML Component: The submission describes an ultrasound system, not an AI/ML-powered device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI performance (e.g., sensitivity, specificity, AUC) is not relevant here.
• Substantial Equivalence: The primary method for gaining clearance is demonstrating "substantial equivalence" to legally marketed predicate devices. This involves showing similar intended use, technology, safety, and effectiveness.
• Non-Clinical Tests: The "Non-clinical Tests" section lists compliance with various electrical, mechanical, acoustic, and biocompatibility standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 14971). These are engineering and safety standards, not performance metrics derived from clinical data in the context of an AI algorithm.
• Clinical Studies Not Applicable: The document explicitly states: "Not applicable. The subject of this submission, DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This directly confirms the absence of the type of study you are asking about.

Therefore, I cannot provide the requested table or bullet points as the information does not exist within the provided text for this specific device clearance. The regulatory pathway for this ultrasound system did not require the demonstration of performance metrics against clinical ground truth in the way your questions imply.

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The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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 cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B mode, M mode, PW mode, CW mode, Color mode, Power/Dirpower mode, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The provided document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. to the FDA regarding their Resona 7 Diagnostic Ultrasound System. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily for proving novel clinical claims or improved clinical effectiveness through extensive clinical trials.

Therefore, the document does not contain information on acceptance criteria for an AI/CADe device's performance, nor does it detail a study proving such performance in the way a clinical study for a novel AI algorithm would. Instead, it focuses on demonstrating that a modified ultrasound system remains substantially equivalent to its predicate.

However, based on the structure of your request and assuming this was a document from which one hoped to extract such information about a theoretical AI/CADe device, I will explain why most of your requested points cannot be answered from this document and what information is relevant to the device's acceptance.

This document is for an ultrasound imaging system, not an AI/CADe device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to traditional ultrasound device performance and safety, not AI algorithm performance.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria for AI performance. The acceptance criteria for this ultrasound system are related to its safety, electrical performance, acoustic output, and imaging capabilities being equivalent to the predicate device. The performance is "proven" by compliance with recognized standards and comparison to the predicate.

• Acceptance Criteria (Implicit for a traditional ultrasound device K-submission):

  • Substantial equivalence to predicate device in terms of intended use, technology, safety, and effectiveness.
  • Compliance with recognized safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
  • Acoustic output levels below FDA limits.
  • Biocompatibility of patient-contacting materials (for new transducers/brackets).
  • Effective cleaning and disinfection.
  • Software lifecycle processes compliance (IEC 62304).
  • Risk management (ISO 14971).
  • Imaging modes and features perform similarly to predicate.

• Reported Device Performance: The document states that the device "has been found to conform with applicable medical safety standards" and "is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." It doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/CADe device, but rather confirms compliance with established engineering and safety benchmarks relevant to ultrasound systems.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document is for a traditional ultrasound imaging system submission (510(k)), not an AI/CADe device. Therefore, it does not describe a "test set" or "data provenance" in the context of an AI algorithm being evaluated on a dataset of patient images.

The "testing" mentioned refers to engineering and safety tests on the physical device and its software, not performance on a clinical image dataset for diagnostic accuracy.

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

Not applicable. This is not an AI/CADe device that requires expert-established ground truth for a test set. The "ground truth" for the device's function is its ability to produce images and measurements according to its specifications and to operate safely, which is verified through engineering tests and comparison to the predicate.

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

Not applicable, for the same reasons as point 3.

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 a 510(k) for an ultrasound system, not an AI-assisted device. The "multi-reader multi-case" study design is typical for evaluating the impact of AI on human reader performance, which is not relevant to this submission.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its operation as an imaging system.

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

Not applicable for an AI/CADe device. The "ground truth" for this ultrasound system relates to its technical performance and safety, which are evaluated against engineering standards and comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device that has a "training set."

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

Not applicable. This is not an AI/CADe device that has a "training set."

Summary from the document's perspective:

The document describes a 510(k) submission for a Diagnostic Ultrasound System (Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB). The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (primarily K162267, Resona 7, and others like DC-8, ZS3).

The "acceptance criteria" and "study" are therefore focused on:

• Safety and Effectiveness: Ensuring the new/modified device is as safe and effective as the predicate.
• Compliance with Standards: A list of recognized consensus standards is provided (e.g., AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 60601-2-37 for ultrasonic equipment, ISO 14971 for risk management, ISO 10993 for biocompatibility, NEMA UD 2 for acoustic output). The "study" is the non-clinical testing performed to show compliance with these standards.
• Functional Equivalence: The device employs the same underlying technology (ultrasonic energy transmission and processing), has the same intended uses (e.g., fetal, abdominal, cardiac exams), and generally the same basic operating modes as its predicate. New transducers and features are added, but they are evaluated in the context of the device remaining substantially equivalent.

The document explicitly states under "8. Clinical Tests: Not Applicable," which further confirms that no clinical studies (like those evaluating AI diagnostic performance or human reader improvement with AI) were conducted or required for this particular 510(k) submission.

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The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.

The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

This document is a 510(k) Summary for the SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Accutorr 7/VS-900 Vital Signs Monitor. It outlines the device's indications for use, description, performance data, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria. Instead, it details various performance specifications for each physiological parameter (Temperature, SpO2, Pulse Rate, NIBP) found in the "Predicate Device (K132038)" column, and states that the "Subject Devices" (Accutorr 7/VS-900) generally have the "Same" performance characteristics. For CO2 monitoring, it references the characteristics of the reference predicate (K152902).

Here's a compilation of the performance specifications, which act as the de facto acceptance criteria based on established predicate device performance:

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The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sy()//Scy(), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

• . The arrhythmia detection. ST Segment analysis of Mortara algorithm. BIS, RM, CCO. SvOz/Scv02, and PAWP monitoring are intended for adult and pediatric patients only:
• ST Segment analysis of Mindray algorithm is intended for adult patients only; ●
• C.O. monitoring is restricted to adult patients only: ●
• ICG monitoring is only for use on adult patients who meet the following ● requirements: height: 122 to 229cm, weight: 30 to 155kg.

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;

ST Segment analysis of Mindray ECG algorithm is intended for adult patients only;

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

The subject Passport Series Patient Monitors includes three monitors:

• . Passport 12M Patient Monitor
• Passport 17M Patient Monitor ●
• T1 Patient Monitor

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12M and 17M Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor. The T1 patient monitor is one of the available modules that can be plugged into the Passport 17M or 12M monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17M and 12M.

Each of the three monitors that are the subject of this 510(k) are modified versions of previously cleared Mindray devices. The Passport 17M and Passport 12M were previously cleared in K132075, on April 18, 2014 and the T1 was previously cleared in K123074 on July 3, 2013.

The provided text is a 510(k) Summary for the Mindray Passport Series Patient Monitors (K143195). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a single study proving that the device meets those criteria.

The core of the submission is that the subject devices are modified versions of previously cleared Mindray devices (K132075 and K123074). The performance data cited refers to functional and system-level testing to evaluate the performance of the modifications and ensure continued adherence to specifications and relevant consensus standards. It does not contain information about a specific single study with acceptance criteria and results.

Given the nature of the K143195 submission as an amendment/modification to existing devices, the information provided focuses on the changes and how these changes do not alter the substantial equivalence to the predicate devices. Therefore, the requested information about acceptance criteria and a detailed study proving the device meets those criteria for the entire device as if it were a novel submission is not explicitly present in the provided text.

However, I can extract information related to the performance characteristics, which serve as implicit acceptance criteria based on the predicate device's performance and general recognized standards for patient monitors.

Here's an attempt to structure the answer based on the available information, noting where specific details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "study summary" format. Instead, it compares the specifications of the subject devices to the predicate device. The "acceptance criteria" are implied to be the specifications of the predicate device and relevant industry standards. The "reported device performance" is generally stated as "Same" or that the new (modified) features "meet specifications" or "are equivalent to the predicate device."

Here's an illustrative table based on the provided "Device Comparison Table," highlighting areas that could be inferred as "acceptance criteria" and "performance":

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

The document does not detail specific sample sizes for test sets for individual parameters or features. It states:

• "Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance."
• "Mindray has conducted testing to ensure the subject devices meet relevant consensus standards."
• "Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003."
• "Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device."

There is no mention of data provenance (e.g., country of origin, retrospective/prospective). The studies appear to be internal V&V testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

There is no information provided regarding the number or qualifications of experts used to establish ground truth for any test sets. The testing referenced appears to be engineering/technical validation against specifications and standards rather than clinical studies requiring expert adjudication of data. For interpretations like 12-lead ECG, it is stated that the feature is equivalent to a previously cleared device (K132026), implying that its validation methods would have been established there.

4. Adjudication Method for the Test Set

No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned. This type of study is typically done for diagnostic imaging devices or algorithms where human interpretation is a key component and the AI is intended to assist, altering reader performance. For a patient monitor, the performance validation is typically against direct physiological measurements and established standards.

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

The entire device (the patient monitor) is a standalone system in the sense that its algorithms process physiological signals and present data and alarms. The performance data described ("functional and system level testing") would inherently be evaluating the algorithms and hardware in isolation from a human interpretation loop. For example, SpO2 accuracy is measured against a reference, not against a human's interpretation of SpO2. The 12-lead ECG interpretation, being an automated algorithm output, would be assessed for its accuracy as a standalone function.

7. The Type of Ground Truth Used

Based on the nature of the device (physiological monitor) and the parameters listed, the ground truth would typically be established by:

• Reference standards/equipment: For parameters like NIBP, IBP, SpO2, Temperature, CO2, etc., the device's measurements are compared against highly accurate reference measurement equipment or simulators.
• Known input signals: For features like arrhythmia detection, standardized ECG waveforms with known arrhythmias are often used.
• Clinical data: For capabilities like 12-lead ECG interpretation, ground truth is usually established by highly experienced cardiologists' interpretations, though the document only refers to equivalence to a previously cleared device for this feature.
• Specifications: The "acceptance criteria" are derived from the performance specifications of the predicate device and relevant international standards.

8. The Sample Size for the Training Set

The document does not describe the development or training of AI/ML algorithms. It is a 510(k) for hardware and software modifications to an existing patient monitor, rather than a novel AI/ML device. Therefore, no information on training set sample size is provided. The functions described (e.g., arrhythmia detection, ST segment analysis) typically rely on established signal processing algorithms, not necessarily machine learning requiring explicit "training sets" in the modern sense.

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

As no training set is mentioned for AI/ML algorithms, this information is not applicable and not provided in the document.

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The CMS network transfers information between Hypervisor Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.

Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.

The CMS network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). CMS is the primary maintainer of communication between other networked devices. It can store, print, review or process information from networked devices. It can also realize remote monitor management function to free doctors from clinical monitoring work and conduct centralized monitoring management.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary.

Important Note: The provided document describes a Central Monitoring System and a Telemetry Monitoring System, which are hardware and software systems for patient monitoring. This 510(k) summary does NOT involve Artificial Intelligence (AI) or machine learning. Therefore, many of the questions related to AI models, such as training sets, ground truth establishment for training, or MRMC studies for AI assistance, are not applicable to this submission.

The "study" described is a series of tests to demonstrate the safety and effectiveness of the traditional medical device, particularly its substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are not framed as specific performance metrics like sensitivity/specificity for a diagnostic algorithm. Instead, they are compliance with recognized standards and successful completion of various engineering and validation tests. The "reported device performance" is the statement that the device passed these tests.

Study Details (Applicable to Traditional Medical Devices, Not AI)

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

   • Sample Size: Not specified in terms of patient data or case numbers typically associated with AI model testing. The "test set" here refers to the actual physical device and its software being subjected to various engineering and validation tests. These tests would involve specific test environments, simulated data inputs, and potentially real patient data in a controlled setting for certain functions (e.g., ECG or SpO2 signal acquisition). The document does not quantify this "sample size."
   • Data Provenance: Not explicitly stated. Given that it's a hardware/software system, testing would likely be performed in a controlled lab environment by the manufacturer (Shenzhen Mindray Bio-medical Electronics Co., LTD, China). There is no mention of external data collection (country of origin, retrospective/prospective) because it's not a diagnostic AI model.

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

   • Not Applicable. For a traditional monitoring system, "ground truth" (e.g., in terms of a gold standard diagnosis) is not established by human experts in the same way it would be for an AI diagnostic algorithm. The system's performance is verified against engineering specifications, known signal properties, and the performance of the predicate device. If human review was involved for specific signals (e.g., ECG waveform review), it's not detailed in this summary.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth for image interpretation or diagnostic tasks involving multiple human readers to resolve discrepancies. This is not relevant for the type of safety and performance testing described for this monitoring system.

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:

   • Not Applicable. This device is not an AI system. Therefore, no MRMC study involving AI assistance would have been performed.

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

   • Partially Applicable / Misaligned Question. The device itself is a "standalone" system in terms of its functions (monitoring, data transfer, storage). Its performance for functions like ECG and SpO2 acquisition is "algorithm only" in the sense that the internal processing is automatic. However, the question typically refers to the standalone performance of an AI diagnostic algorithm. Since this is a monitoring system, its "standalone" performance would be assessed through the various engineering and validation tests (accuracy of readings, reliability of data transfer, alarm functionality, etc.). The document indicates these tests were performed.

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

   • Engineering Specifications and Predicate Device Performance. The "ground truth" for this monitoring system is its adherence to predefined engineering specifications, industry standards (e.g., for physiological measurement accuracy, network communication protocols), and its equivalency to the performance of its legally marketed predicate device (HYPERVISOR VI Central Monitoring System, K080192). For physiological parameters, "truth" would be established by calibrated measurement devices or validated simulators producing known signals.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a "training set."

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

   • Not Applicable. As this is not an AI/ML device, there is no training set or ground truth establishment for it in the context of machine learning.

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The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.

The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array, convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 MHz.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against such criteria. The document is a 510(k) premarket notification summary for the Mindray DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging Systems, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance metrics or clinical study results.

The document primarily covers:

• Device Description: General features and modes of operation (B-Mode, M-Mode, combined).
• Intended Use: Broad clinical applications for various patient populations and anatomical regions.
• Comparison with Predicate Devices: Lists several Mindray systems as predicates, stating "They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device."
• Non-clinical Tests: Mentions evaluations for acoustic output, biocompatibility, cleaning/disinfection, and safety standards conformance (ISO 14971, IEC standards, UL 60601-1, etc.).
• Conclusion: Asserts substantial equivalence based on intended uses, traditional clinical practices, FDA guidelines, manufacturing quality processes, and conformity to safety standards.
• Transducer Information: Detailed tables indicating the clinical applications and modes of operation ("P" for previously cleared or "N" for new indication) for each specific transducer model associated with the DP-5 and DP-7 systems. These tables also note additional features like Tissue Harmonic Imaging and Biopsy Guidance.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text. The 510(k) summary format does not typically include this level of detail about specific performance studies for devices demonstrating substantial equivalence to existing cleared devices.

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