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The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. This device can detect a fetal heart rate value at or after twelve weeks gestation.

The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The FDA 510(k) summary for the Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) does not contain the level of detail typically found in a clinical study report for device acceptance criteria and performance, especially for AI/ML-based devices. This is a traditional medical device (fetal Doppler) and not an AI/ML device, hence some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or training set details) is not applicable or provided in this document.

However, based on the provided text, here's an attempt to extract the relevant information regarding performance and acceptance, and clarify what is not applicable or available:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on its ability to accurately measure fetal heart rate (FHR) within specified ranges and its compliance with relevant electrical safety, EMC, and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-skeletal (both conventional and superficial), The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.

B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.

Please refer to the acoustic output declaration for each transducer as following pages.

B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz.

The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.

The provided text is a 510(k) summary for the "B-Ultrasound Diagnostic System" (K232895). It primarily focuses on demonstrating substantial equivalence to a predicate device (K170856) based on non-clinical testing. Crucially, it explicitly states there was "No clinical study included in this submission," and therefore, it does not contain the detailed information about acceptance criteria and clinical study results that you requested.

Therefore, I cannot extract the information required to populate the table or answer questions 2-9 from the provided text. The document indicates that the device's substantial equivalence and performance were evaluated through non-clinical tests and compliance with various international standards related to electrical safety, EMC, performance, and biocompatibility.

Here's an explanation of why I cannot fulfill your request based on the provided document:

• No Clinical Study Data: The document explicitly states "No clinical study is included in this submission." This means there is no data from human studies or specific performance metrics from such studies.
• Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute performance against specific clinical acceptance criteria in a human study.
• Non-Clinical Testing: The "Non-Clinical Test Conclusion" section lists various standards (IEC, ISO) that the device complies with, but these are general safety and performance standards for medical electrical equipment and ultrasound devices, not acceptance criteria for a specific clinical task or diagnostic accuracy.
• Lack of Performance Metrics for Specific Clinical Use: While the indications for use are listed (e.g., abdomen, gynecology, pediatric), the document doesn't provide performance metrics (like sensitivity, specificity, accuracy, dice score etc.) related to these applications, which would typically be found in a clinical study report.

In summary, the provided document does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria in a clinical context.

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The Color Doppler Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD.

The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.

It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.

The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.
Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.

With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. abundant image processing functions. It is convenient for choice of optimal diagnostic image with perfect image pigeonhole, browse, management functions. Measure, calculation, and report are even complete and convenient with powerful measure software package and perfect measurement.

The device supports linear probe and convex probe. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology etc. .

The provided text is a 510(k) Summary for a Color Doppler Ultrasound Diagnostic System. It aims to demonstrate substantial equivalence to a predicate device and includes information on non-clinical testing and a comparison table. However, it explicitly states:

"No clinical study is included in this submission."

This means there is no information provided in the document regarding acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications and intended use, not clinical efficacy or performance.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

The closest information provided is:

• Non-Clinical Test Conclusion: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• Applied Standards: A list of standards indicating safety and performance compliance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-5, ISO 10993-10, IEC 62133-2, IEC TR 60601-4-2). These standards typically involve technical performance and safety assessments rather than clinical performance acceptance criteria.
• Acoustic Output within FDA guidelines: $Ispta.3 \le 720 mW/cm^2$, MI

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The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

Therefore, many of the requested points cannot be extracted from the provided text.

Based on the information available:

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

The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

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The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.

The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.

ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.

In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.

The provided FDA 510(k) summary (K202757) for the Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 details the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device, being a non-invasive blood pressure measurement system, are primarily based on established international standards for accuracy and safety. The reported device performance is presented as compliance with these standards and specific measurement ranges.

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

• Sample Size: "Total 85 subjects are included in each clinical study." (Page 6)
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer and correspondent are based in China, it is highly probable the clinical study was conducted in China. The study appears to be prospective as it describes a clinical investigation for the purpose of regulatory submission.

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

The document states that the clinical study was conducted "in accordance with ISO 81060-2". ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) outlines specific requirements for the observers and the comparison method to establish ground truth.

While the exact number and qualifications of experts (e.g., clinicians, trained observers) are not explicitly stated in this FDA submission summary, ISO 81060-2 typically requires:

• At least two trained observers to measure blood pressure using a reference sphygmomanometer simultaneously with the device under test.
• These observers must be trained and certified to perform auscultatory blood pressure measurements (e.g., using a mercury column or validated alternative) with high accuracy and reproducibility. The standard often specifies requirements for their training and regular performance validation to ensure inter-observer agreement.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication" method in the context of expert consensus, as this is typically seen in studies where multiple readers interpret images or data and discrepancies need resolving. For blood pressure measurement, ISO 81060-2 mandates a specific comparison method where the device's measurements are compared against simultaneous auscultatory measurements obtained by trained observers. The standard defines how these measurements are to be collected and statistically analyzed (e.g., mean difference and standard deviation between the device and the reference measurements) to determine accuracy, rather than an "adjudication" of differing expert opinions on a specific diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

This device (Electronic Sphygmomanometer/Automatic Blood Pressure Monitor) is a medical measurement device, not an AI-based diagnostic tool that assists human readers in interpreting complex data like medical images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is common for AI tools in radiology or pathology, was not performed or applicable here. The study focused on demonstrating the device's accuracy and safety against established standards and a predicate device through direct measurement comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary evaluation of this device is a standalone performance assessment. The device is designed to automatically measure and display blood pressure and pulse rate without continuous human intervention during the measurement process. The clinical study evaluated the device's direct measurement performance against a gold standard (auscultatory measurements) as per ISO 81060-2.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was expert consensus/reference measurement through a standardized protocol. Specifically, it involved:

• Simultaneous blood pressure measurements taken by trained observers using a reference method (typically auscultation with a mercury sphygmomanometer or validated equivalent) alongside the device under test.
• This is the standard approach defined in ISO 81060-2 for validating automated non-invasive sphygmomanometers.

8. The Sample Size for the Training Set

The document does not mention a training set because this medical device approval is for a physical measurement device, not a machine learning or AI algorithm that requires a separate training set. The "study" described is a clinical validation study to confirm the accuracy and safety of already developed hardware and software, rather than a development and training phase for a learning algorithm.

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

Since there is no "training set" in the context of an AI/ML algorithm for this type of device, this question is not applicable. The device's underlying measurement algorithms are based on established oscillometric principles and do not "learn" from a dataset in the way a deep learning model would.

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The TP500 Infrared Thermometer is intended to measure human body temperature by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.

The Infrared thermometer (model TP500) is a hand-held, battery powered, electronic thermometer that converts a subject's forehead temperature, using the infrared energy emitted in the area around the subject's forehead to an oral equivalent temperature when measured from 1-3cm to the center of the subject's forehead with no contact. The device can be used on people of all ages and is intended to be used in the hospital and other clinical environments.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary for the Contec Medical Systems Co., Ltd. Infrared Thermometer (Model TP500).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of all raw study data. Therefore, some information, especially regarding the specifics of how the ground truth was established for the training set, might not be fully elaborated.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance of an infrared thermometer relates to its accuracy and repeatability. The primary standard for this, as cited, is ASTM E1965-98. The acceptance criteria are implicit in meeting this standard and are explicitly stated in the "Accuracy" row of the comparison table.

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

• Test Set Sample Size: A "controlled human clinical study" was conducted with 108 subjects. These subjects included three age groups:
  • Age 0-1 (35 subjects)
  • Age 1-5 (33 subjects)
  • Age above 5 (40 subjects)
  • The study included both febrile and afebrile persons.
• Data Provenance: Not explicitly stated, but given the manufacturer is China-based, it is highly probable the data was collected in China. The study is described as a "controlled human clinical study," implying a prospective design for gathering the clinical accuracy data.

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

This detail is not provided in the summary. For a thermometer, the "ground truth" would typically be established by a highly accurate reference thermometer (e.g., a rectal thermometer or an oral thermometer operated by a trained healthcare professional, depending on the body site), rather than "experts" in the sense of multiple radiologists reviewing images. The summary states that "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer." This implies a comparison to a gold standard measurement, but the specifics of how many personnel were involved in taking these gold standard measurements or their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments, such as image interpretation, to resolve discrepancies among experts. For objective measurements like temperature, an adjudication method is generally not applicable. Instead, the ground truth is established by a primary, highly accurate measurement method. The summary does not mention any adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically for medical imaging systems where human readers interpret images with and without AI assistance. This device is an infrared thermometer, not an imaging system designed for human interpretation with AI assistance. The study conducted was a clinical accuracy study comparing the device to a gold standard measurement, and implicitly, to the predicate device's performance per the equivalence claim.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone thermometer. Its "performance" is inherently "algorithm only" in the sense that it provides a temperature reading directly. The clinical study evaluated the direct performance of the device's sensor and internal processing (algorithm) against a gold standard. So, yes, a standalone performance evaluation of the device's measurement capabilities was performed.

7. The Type of Ground Truth Used

The type of ground truth used was comparative measurements against a reference standard. The clinical study states that "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer." This means the device's readings were compared against highly accurate, established methods of temperature measurement to determine its accuracy and precision. While not explicitly stated as "rectal temperature" or "oral temperature," for a clinical thermometer, these are the typical gold standards depending on the population and clinical context. The study was conducted in accordance with ASTM E1965-98, which outlines the methodology for such clinical validations including the use of reference thermometers.

8. The Sample Size for the Training Set

Not applicable/Not explicitly stated for an AI training set. This device is a traditional medical device (infrared thermometer), not an AI/ML-based device that learns from a large training dataset in the same way, for example, a diagnostic imaging AI would. Its "algorithm" is based on physics (infrared radiation) and calibrated against known standards, not trained on patient data in an iterative machine learning process. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As explained in point 8, this is not an AI/ML device that requires a training set and associated ground truth in that context. The device's internal calibration and performance are established through engineering design, component selection, and adherence to performance standards like ISO 80601-2-56 and ASTM E1965-98, which involve physical calibrations, not data-driven machine learning training.

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CONTEC™ Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and or trained healtheare professionals.

This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management.

This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc.

The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research.

Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data.

ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system

Button system: to collect the user's key operation input, send the control system to process,

Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper;

Power system: provide power supply for each system module;

The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply.

AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply

LCD display system: display various of settings of waveform information to the user for viewing :

Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system.

after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line.

Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.

The provided document is a 510(k) summary for the CONTEC™ Electrocardiograph (ECG90A). It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria for AI-related functions. The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to AI or MRMC studies, as these are not present in the provided text.

The information primarily focuses on establishing substantial equivalence to a predicate device (CONTEC™ Electrocardiograph, ECG300G) based on non-clinical tests and technical specifications.

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CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.

It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.

The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.

Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.

With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement.

The device supports linear probe and convex probe. The frequency of the device is 2.0 MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. .

The device is consist of three parts: mainframe, transducer(probe), adapter.

The provided text describes the 510(k) submission for the CMS600P2 B-Ultrasound Diagnostic System, asserting its substantial equivalence to a predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device).

Important Note: This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific clinical acceptance criteria through a clinical trial with a human-in-the-loop AI system. Therefore, the information provided will pertain to demonstrating equivalence to an existing medical device's performance, rather than an AI's performance against specific clinical metrics. Many of the requested details, such as "effect size of human readers improving with AI vs. without AI assistance," "standalone (algorithm only) performance," or "adjudication method for the test set," are typically associated with AI/ML-driven devices and are not applicable to this traditional ultrasound system's 510(k) submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the CMS600P2 B-Ultrasound Diagnostic System are primarily based on demonstrating substantial equivalence (SE) to a legally marketed predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device) in terms of:

• Intended Use and Indications for Use
• Technological Characteristics (e.g., imaging modes, frequency range, resolution, safety standards)
• Safety and Effectiveness (demonstrated through non-clinical testing and comparison to predicate)

The performance of the proposed device is assessed against the performance characteristics of the predicate device.

Table of Acceptance Criteria and Reported Device Performance (Comparison to Predicate Device)

Study Proving Acceptance Criteria Met: Non-Clinical Testing and Comparison

The study proving the device meets the acceptance criteria is primarily a non-clinical testing and comparison study against a predicate device, as explicitly stated in the document.

1. Sample Size Used for the Test Set and Data Provenance:

• Test Set: No separate "test set" in the sense of a distinct dataset for an algorithm's performance evaluation is mentioned, as this is a physical diagnostic device, not an AI/ML product. The "test set" would implicitly refer to the device itself undergoing various performance and safety tests.
• Data Provenance: Not applicable in the context of imaging data. The provenances are the device specifications and direct measurements from non-clinical tests conducted on the proposed device and compared to the predicate's known specifications and performance.
• Retrospective/Prospective: Not specified for the "data" as it pertains to device testing against engineering specifications and regulatory standards. The non-clinical tests were conducted on the proposed device.

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

• Not applicable. This submission is for a traditional ultrasound diagnostic system, not an AI/ML-driven device requiring expert consensus for image interpretation or "ground truth" establishment beyond the standard physical and electrical performance measurements. The "ground truth" here is the adherence to engineering specifications and safety standards, as well as the established performance of the predicate device.

3. Adjudication Method for the Test Set:

• Not applicable. No human interpretation or adjudication of diagnostic outputs from the device is described for the purpose of establishing clinical ground truth for a test set. Adjudication methods are typically relevant for studies evaluating human reader performance, especially with AI assistance.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not conducted. The submission explicitly states: "No clinical study is included in this submission." This type of study is common for AI-assisted diagnostic tools to show improvement in human reader performance, which is not the scope of this 510(k) for a basic ultrasound system.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. It is an ultrasound diagnostic system where the user (physician) interprets the images.

6. The Type of Ground Truth Used:

• For the non-clinical tests (e.g., electrical safety, EMC, performance parameters like resolution and depth): The "ground truth" is established by engineering specifications, international consensus standards (IEC, ISO), and the documented performance characteristics of the legally marketed predicate device.
• For biocompatibility: The "ground truth" is established by ISO 10993 series standards for in vitro cytotoxicity, irritation, and delayed-type hypersensitivity.

7. The Sample Size for the Training Set:

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

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. As no training set for an AI/ML algorithm is involved, this question is irrelevant.

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The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool.

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.

The provided document is a 510(k) premarket notification for a Portable ECG Monitor (Model PM10) by Contec Medical Systems Co., Ltd. It declares substantial equivalence to a predicate device (Handheld ECG Monitor Model MD100, K093872).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used in clinical studies for diagnostic accuracy. Instead, it relies on demonstrating compliance with non-clinical performance and safety standards, and technological characteristics similar to a predicate device.

However, we can extract the reported performance for specific parameters:

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

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The assessment of the device's performance for regulatory purposes is primarily based on non-clinical testing and comparison to a predicate device.

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

Since no clinical study was conducted, there is no information on the number of experts or their qualifications for establishing ground truth from a test set.

4. Adjudication Method for the Test Set

As there was no clinical study, there is no adjudication method described for a test set.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. The document states "No clinical study is included in this submission." Consequently, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as the device is an ECG monitor and not an AI-assisted diagnostic tool described in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study of an algorithm's performance without human-in-the-loop was not done, as no clinical study was conducted. The device (Portable ECG Monitor) is described as recording and displaying ECG signals and heart rate, not as employing a complex algorithm that would typically undergo such standalone performance evaluation in a regulatory submission of this nature.

7. Type of Ground Truth Used

As there was no clinical study, no ground truth from expert consensus, pathology, or outcomes data was established or used for the purpose of demonstrating clinical performance. The "ground truth" implicitly referred to here is the accurate measurement of electrical signals and heart rate as per the device's physical and technical specifications, validated through engineering bench testing and compliance with relevant IEC and ISO standards.

8. Sample Size for the Training Set

Since no clinical study was performed and no AI/machine learning algorithm requiring a training set is explicitly described or implied beyond standard signal processing for ECG and heart rate, there is no information regarding a training set sample size.

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

Given that no training set is mentioned or implied for an AI/ML algorithm within the provided document, there is no information on how ground truth for a training set was established.

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The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, measurement etc.

The provided text is a 510(k) Summary for the Contec Medical Systems Co., Ltd Portable ECG Monitor, model PM10. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format as it would for a performance study. Instead, it compares the proposed device's specifications to those of a predicate device to establish substantial equivalence. The "acceptance" in this context is that the device's measured performance aligns with or is sufficiently similar to the predicate's, and meets relevant voluntary consensus standards.

Here's a table based on the "Substantially Equivalent (SE) Comparison" in the document (Table 1):

Explanation of "Acceptance Criteria" for this submission: For a 510(k), the "acceptance criteria" largely involve demonstrating that the device meets recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, ISO 10993-10) and has performance characteristics that are "substantially equivalent" to a legally marketed predicate device. The document explicitly states "The test results demonstrated that the proposed device complies with the following standards" for non-clinical tests.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set, nor any information on data provenance (country, retrospective/prospective). The assessment relies on non-clinical engineering and bench testing, and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study or test set with human data requiring expert ground truth was conducted or submitted (see point 2).

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

Not applicable, as no clinical study or test set was conducted 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. This device is a "Portable ECG Monitor" for recording and displaying heart rate, not an AI-driven diagnostic tool that assists human readers. No MRMC study was conducted.

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

The device's core functions (recording ECG signals and displaying heart rate) are standalone in nature, as it processes the ECG signal and derives heart rate without human intervention in that specific computation. However, this is not an "algorithm-only" performance study in the sense of a complex AI diagnostic algorithm. The non-clinical tests verifying its compliance with standards and its stated heart rate accuracy (±1bpm or 1%) serve as the standalone performance verification.

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

For the non-clinical tests:

• Electrical safety and EMC: Ground truth is defined by the technical requirements and test procedures outlined in the specified IEC standards (IEC 60601-1, IEC 60601-1-2). Compliance with these standards is the "ground truth."
• Biocompatibility: Ground truth is established by the test procedures and acceptance criteria within ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).
• Heart rate accuracy: The accuracy of ±1bpm or 1% would be verified against a known, precise input signal (e.g., using an ECG simulator or a reference standard). The known input signal acts as the "ground truth."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device, not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this device.

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