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CONTEC™ Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.

The Oxygen Concentrator is a small and portable oxygen concentrator. It consisted of air compressor, adsorption tower of molecular sieve, oxygen sensor and flow meter. It adopts pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air.

The machine takes the advantages of small in volume, light in weight, convenient in moving (as it has turning truckle), stable in performance, easy in operating, low in noise, which complies with requirements of medical device.

The OC3D is divided into power module, MCU control module, Pressure detection module, Oxygen concentration detection module, alarm module, Compressor and fan drive module, Solenoid valve drive module, Display driver module, Work indication module, button detection module.

The provided text is a 510(k) summary for the CONTEC™ Oxygen Concentrator Model OC3D. It outlines the device's technical specifications, comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence.

However, the questions you've asked relate specifically to the Acceptance Criteria and Study Design for an AI/ML-based medical device performance evaluation. The provided document is for an oxygen concentrator, which is a physical medical device, not an AI/ML algorithm. Therefore, the information requested in your prompt (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment) is not present in this document because it doesn't apply to the type of device being described.

The document discusses:

• Acceptance Criteria for the Oxygen Concentrator (implied by meeting standards and comparison to predicate): This is shown in the "Table 7-1 Comparison of Technology Characteristics" and the "Non-Clinical Test Conclusion" sections. The device is deemed acceptable if its performance (e.g., oxygen concentration, flow rates, alarms, electrical safety, EMC) meets the requirements of specified international standards (IEC 60601-1, ISO 80601-2-69, etc.) and is comparable to a legally marketed predicate device.
• Study Proving Acceptance: Non-clinical tests were performed to verify compliance with these standards and the substantial equivalence to the predicate device. These tests are not "studies" in the AI/ML sense (i.e., not involving large datasets of images and human interpretation). They are engineering and performance validation tests.

Given the mismatch between your prompt and the provided document, I cannot fulfill your request for AI/ML-specific details.

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CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G. The three models all have three design modules, which are power module, signal acquisition and processing module and control module. The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via single channel/ three channel/ twelve channel. The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode. The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;

The provided document K131900 is a 510(k) summary for the CONTECTM Electrocardiograph. It outlines the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study with acceptance criteria and reported device performance in the way a traditional clinical efficacy study would.

Instead, this document focuses on non-clinical tests to verify that the proposed device meets design specifications and complies with relevant international and national standards. The acceptance criteria are implicit in these standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with corresponding "reported device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is the statement that it complies with the listed standards and its technical specifications match or are similar to the predicate devices.

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy. The tests performed are non-clinical, related to electrical safety, electromagnetic compatibility, and performance according to engineering standards. There is no mention of patient data or its provenance (country of origin, retrospective/prospective).

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

Not applicable. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described.

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 an electrocardiograph, which acquires and displays ECG signals. It does not appear to incorporate AI for interpretation or assistance with human readers. The document does not mention any "Measurement/Analysis Function" for the proposed device, as shown in the comparison table where it explicitly states "No" for this function, contrasting with one of the predicate devices that has "Yes".

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

Not applicable. The device itself is an acquisition device, not an algorithm for interpretation. It explicitly states "No" for "Measurement/Analysis Function."

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

Not applicable. As described, the "ground truth" for this submission are the engineering and medical device standards (e.g., IEC 60601 series, ANSI/AAMI EC11) which define acceptable electrical and physical performance, rather than diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device with an interpretation algorithm.

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

Not applicable. As above, no training set or its ground truth establishment is mentioned.

Summary of the Study:

The "study" described in K131900 is a series of non-clinical bench tests designed to demonstrate that the CONTECTM Electrocardiograph adheres to established electrical safety, electromagnetic compatibility (EMC), and specific performance standards for electrocardiographs. The "acceptance criteria" are the requirements set forth in these international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ANSI/AAMI EC11) and the technical specifications listed in the comparison table, which are either identical or similar to legally marketed predicate devices. The "proof" is the statement that "The test results demonstrated that the proposed device complies with the following standards" and the detailed comparison table that shows its technical specifications meet or are equivalent to the predicate devices. This type of submission is common for medical devices that aim to show substantial equivalence based on technical and performance characteristics, without requiring new clinical efficacy data if the intended use and technology are sufficiently similar to approved predicate devices.

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Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and accessories. The recorder is designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as well as the patient information will be displayed and stored in the memory of the recorder. The information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis software. The analysis results are only used as advisory basis. The accessories contain disposable electrodes, cables, USB connecting line.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria as quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Automatic analysis function verification per AAMI EC 57" was performed, and that "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable." This implies that the device's performance was judged against the requirements of the AAMI EC 57 standard for automated ECG analysis.

Acceptance Criteria (Implied from text):

• Compliance with IEC 60601-1:1988+A1:1991+A2:1995 (Electrical Safety Test)
• Compliance with IEC 60601-1-2:2001+A1:2004 (EMC Test)
• Compliance with IEC 60601-2-47:2001 (Performance Test)
• Compliance with ISO 10993 series standards (Biocompatibility Test)
• Compliance with AAMI EC 57 (Automatic analysis function verification)

Reported Device Performance:
The document states: "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the predicate device."

Table format (best effort given limited data):

It is important to note that the specific quantitative performance metrics (e.g., beat detection accuracy, arrhythmia classification accuracy) required by AAMI EC 57 and the device's actual performance against those metrics are not provided in this summary. The summary only states that the device "complied."

Study Information

The document describes several tests conducted to establish the safety and effectiveness of the device, ultimately concluding substantial equivalence to a predicate device. However, it does not describe a specific clinical study or an algorithm-specific performance study with detailed methodology, sample sizes, and ground truth establishment in the way typically expected for AI/ML device submissions today.

The "Automatic analysis function verification per AAMI EC 57" is the closest mention of a performance evaluation relevant to the analytical components of the ECG system.

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

   • Test Set Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

   • Not specified. The document only mentions that the analysis results are for review by a "trained physician in health facilities." It does not detail who established the ground truth for the verification testing.

3. Adjudication Method for the Test Set:

   • Not specified.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC study is not mentioned. The document describes tests primarily related to electrical safety, EMC, performance against a standard (IEC 60601-2-47), biocompatibility, and automatic analysis verification per AAMI EC 57. There is no information about human reader performance or the effect of AI assistance on human readers.

5. Standalone Performance Study (Algorithm Only):

   • Yes, implicitly. The "Automatic analysis function verification per AAMI EC 57" suggests a standalone evaluation of the algorithm's performance against a recognized standard. However, the details of this evaluation (e.g., specific metrics, dataset) are not provided beyond the statement of compliance.

6. Type of Ground Truth Used:

   • For "Automatic analysis function verification per AAMI EC 57," the ground truth would typically be established by expert review (e.g., cardiologists, electrophysiologists) of the ECG recordings, but this is not explicitly stated or detailed in the document. It is implied by the standard itself.

7. Sample Size for the Training Set:

   • Not specified. The document does not describe the development or training of an AI/ML algorithm, or any associated training data. It refers to an "analysis software" with "automatic analysis function."

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

   • Not applicable/Not specified, as information about a training set or algorithm development is not provided.

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ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

The proposed device, ABPM50 Automatic Blood Pressure Monitor, is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation and BP measurement, which can measure systolic, diastolic and mean 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 can be used on adult, pediatric, and neonatal individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

ABPM50 has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, it has technical alarm function which will be triggered when the battery voltage is lower than 2.3V , and this alarm can not be cancelled unless being closed or the power replaced.

Here's a breakdown of the acceptance criteria and the study details for the ABPM50 Automatic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document states that the clinical tests were conducted following the ANSI/AAMI SP10:2002+A1:2003+A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria are not explicitly detailed in the provided text, this standard generally outlines requirements for accuracy of blood pressure measurements. The document does state that the device "complies with the standard requirements and the accuracy the manufacture declared." Without the explicit declared accuracy from the manufacturer, we can infer that the device meets the general accuracy requirements of the ANSI/AAMI SP10 standard.

General Acceptance Criteria (Inferred from ANSI/AAMI SP10):
The ANSI/AAMI SP10 standard typically requires that:

• The mean difference between the device measurement and reference measurement (mercury sphygmomanometer) should be ± 5 mmHg or less.
• The standard deviation of the differences should be ± 8 mmHg or less.
• A minimum number of subjects (e.g., 85 adult subjects) should be tested.

Study Details

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

   • Sample Size: Not explicitly stated. The document refers to "clinical tests following ANSI/AAMI SP10:2002+A1:2003+A2:2006". This standard specifies a minimum number of subjects (e.g., 85 for adults, with specific requirements for pediatric and neonatal populations, including a minimum of 15 subjects for each age group within those populations). Given it covers "adult, pediatric, and neonatal individuals," it would involve multiple age cohorts.
   • Data Provenance: The study was conducted in Qinhuangdao Maternal and Child Health Hospital. This indicates a prospective study conducted in China.

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

   • Not specified in the provided text. The ANSI/AAMI SP10 standard typically requires simultaneous auscultation by two trained observers for ground truth, often using a Y-tube and a third supervisor, but the exact number and qualifications are not detailed here.

3. Adjudication method for the test set:

   • Not specified. Assuming adherence to ANSI/AAMI SP10, the ground truth would typically be established by trained observers taking manual readings, often with a method to resolve discrepancies between observers, such as averaging or a third adjudicator.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric. This study focused on the standalone accuracy of the blood pressure monitor against a reference method.

   • Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.

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

   • Yes, the study described is effectively a standalone performance study of the ABPM50 device. It tested the device's accuracy in measuring blood pressure and pulse rate (algorithm only) compared to a reference standard (human-measured manual blood pressure, implied by ANSI/AAMI SP10).

6. The type of ground truth used:

   • Expert concensus / Manual auscultatory readings from trained observers. The ANSI/AAMI SP10 standard dictates that the reference blood pressure measurements are taken by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device) simultaneously with the device under test.

7. The sample size for the training set:

   • Not applicable. The provided document describes a clinical validation study for a device, not a machine learning model that requires a distinct training set. The device operates based on oscillometric principles, not a deep learning algorithm trained on a large dataset in the typical sense.

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

   • Not applicable, as a training set for a machine learning model is not explicitly mentioned or implied for this device's function. The "training" for such a device would instead relate to the engineering and calibration processes during development, which aren't typically described with ground truth in the same way as AI models.

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The CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

The proposed device, CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply.

The provided 510(k) summary for the Contec Medical Systems CMS8000 Patient Monitor discusses performance testing but does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. It also does not include information on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as typically expected for advanced AI/ML device submissions.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that performance testing was conducted to "validate and verify that the proposed device, the Patient Monitors met all design specifications." It specifically states clinical tests were performed for SpO2 and NIBP according to ISO 9919 and AAMI SP10 standards. These standards themselves contain acceptance criteria relevant to the performance of pulse oximeters and automated sphygmomanometers. While the document doesn't report the specific acceptance criteria or the numerical results to populate the table directly, it implicitly states that the device met these standards.

Inferred Table Structure (Based on common practice for similar devices and standards):

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

The document states: "Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, the Patient Monitors met all design specifications."

• Sample Size for Test Set: Not specified in the provided text. The standards (ISO 9919, AAMI SP10) would dictate minimum sample sizes for their respective clinical validation components, but these numbers are not present here.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only generically mentions "clinical test" for SpO2 and NIBP functions.

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 given text. While clinical tests were conducted, details about who established the ground truth (e.g., reference measurements by qualified clinicians) are absent.

4. Adjudication method for the test set

This information is not provided in the given text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The device is a patient monitor, not an AI-assisted diagnostic imaging tool where MRMC studies are typically relevant. This submission predates the widespread regulatory focus on AI/ML in medical devices.

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

This concept is not applicable in the context of this traditional patient monitor device. The device inherently provides parameters for human interpretation and action. Its performance is measured directly against reference standards, not as an "algorithm only" component separate from human interaction in the way AI/ML algorithms often are.

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

Based on the mentioned standards for validation:

• For SpO2 (ISO 9919): Ground truth is typically established using a reference oximeter in controlled desaturation studies or by comparing to arterial blood gas measurements (co-oximetry values).
• For NIBP (AAMI SP10): Ground truth is typically established by simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer or another validated reference method.
• For other physiological parameters (ECG, IBP, CO2, RESP, TEMP): Ground truth would be established by comparison to reference measurement devices or validated clinical methods.

The document does not explicitly state these methods but references to the standards imply adherence to their ground truth methodologies.

8. The sample size for the training set

This information is not applicable/provided. The CMS8000 Patient Monitor, as described (submitted in 2011), is a traditional physiological monitor, not an AI/ML device that requires a "training set" in the modern sense. Its algorithms are based on established physiological principles and signal processing, not statistical learning from large datasets.

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

This information is not applicable/provided for the same reason as point 8.

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CONTEC08A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

The proposed device, CONTEC08A Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean 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. The device can be used on adult, pediatric, and neonatal individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

CONTEC08A has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, the device has technical alarm function which will be triggered when the battery voltage is lower than 3.9V, and this alarm can not be cancelled unless being closed or the power replaced.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CONTEC08A Electronic Sphygmomanometer are based on the ANSI/AAMI SP10:2002 & A1:2003 & A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text, the document confirms that "The test results demonstrated that the proposed device comply with the standard requirements and the accuracy the manufacture declared."

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: The clinical test was conducted in Qinhuangdao Maternal and Child Health Hospital, China. This indicates a prospective clinical study conducted in China.

3. Number of Experts and Qualifications

Not explicitly stated in the provided text. The document mentions "clinical test following ANSI/AAMI SP10," but does not detail the involvement or qualifications of experts in establishing ground truth.

4. Adjudication Method

Not explicitly stated in the provided text.

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

Not applicable. The provided text describes a clinical test for an automatic non-invasive blood pressure monitor, not a study evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was conducted. The clinical test evaluated the device's accuracy against the ANSI/AAMI SP10 standard. The device "can automatically complete the inflation, deflation and BP measurement," indicating its standalone capability.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a reference standard for blood pressure measurement, as mandated by the ANSI/AAMI SP10 standard. This standard typically involves comparisons to auscultatory reference measurements performed by trained observers.

8. Sample Size for Training Set

Not applicable. This device is an automatic sphygmomanometer, and the description of its testing focuses on clinical validation rather than a machine learning model that would require a distinct training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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The patient monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.

The proposed device, PM50 Patient Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.

Acceptance Criteria and Device Performance Study for Contec Medical Systems PM50 Patient Monitor

This report details the acceptance criteria and the study conducted to demonstrate that the Contec Medical Systems PM50 Patient Monitor meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PM50 Patient Monitor are based on recognized international standards for SpO2 and NIBP measurement accuracy. The reported device performance is stated to meet these accuracy requirements.

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

The provided 510(k) summary does not explicitly state the specific sample sizes used for the SpO2 and NIBP clinical accuracy evaluation studies.

Data Provenance:

• Country of Origin: The clinical investigation for both SpO2 and NIBP was conducted in Qinhuangdao Maternal and Child Health Hospital, China.
• Retrospective or Prospective: The summary describes "clinical test discussion" and states that the device "was tested," implying a prospective clinical study conducted during the device development and validation phase.

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

The provided 510(k) summary does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not mention any specific adjudication method used for the test set. The clinical studies were conducted to evaluate the device's measurement accuracy against the respective standards.

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

An MRMC comparative effectiveness study was not performed as this device is a patient monitor performing physiological measurements, not an AI/imaging diagnostic device requiring human interpretation alongside an algorithm. Therefore, the effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone performance study was conducted. The clinical accuracy evaluations for both SpO2 and NIBP are standalone studies, assessing the device's ability to accurately measure these physiological parameters independently, without human intervention or interpretation of the device's output.

7. Type of Ground Truth Used

• SpO2: The ground truth for SpO2 was established by evaluating the device "in accordance with Annex EE of ISO 9919." Annex EE specifies a method for evaluating the accuracy of pulse oximeters, typically involving inducing a range of arterial oxygen saturations in healthy volunteers and comparing the oximeter's readings against a co-oximeter (which provides gold-standard arterial blood gas analysis for oxygen saturation). Therefore, the ground truth would be based on co-oximetry readings (reference measurements against a gold standard).
• NIBP: The ground truth for NIBP was established by evaluating the device "in accordance with AAMI Sp10." AAMI SP10 outlines requirements for automated sphygmomanometers, which typically involves comparing the device's measurements against auscultatory readings taken by trained observers using a mercury sphygmomanometer (or a validated equivalent) in a clinical setting. Therefore, the ground truth would be based on trained observer auscultatory measurements (reference measurements against a gold standard).

8. Sample Size for the Training Set

The provided 510(k) summary does not provide information regarding a separate training set or its sample size. For patient monitors like the PM50, the device's core algorithms for SpO2 and NIBP measurement are typically developed and validated against established physiological principles and data, often through extensive internal testing and calibration, rather than a distinct "training set" in the context of machine learning. The clinical studies described are for validation of the finalized device.

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

As noted above, the 510(k) summary does not describe a "training set" in the context of the PM50's development and validation. The ground truth for internal development and calibration would typically be established through controlled experiments using reference devices (e.g., co-oximeters, calibrated pressure transducers) and simulated physiological signals within laboratory settings, based on the principles outlined in the relevant ISO and AAMI standards. The clinical studies documented here are for proving the finalized device's performance against these standards.

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The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.

The product is not a conventional diagnostic tool.

This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.

The provided text is a 510(k) summary for the Contec Medical Systems Co., Ltd. ECG80A Single-Channel Handheld Electrocardiograph. This document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technical specifications. Unfortunately, it does not contain the detailed information necessary to answer the questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." However, it does not provide the details of these design specifications as acceptance criteria or the performance results against them.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert involvement, and ground truth in detail based solely on the provided text.

The information that can be extracted and inferred is limited:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "met all design specifications, including electrical safety, EMC, specifications."
• Reported Device Performance: Not explicitly stated in terms of specific metrics against criteria. The conclusion is that the device "is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534)."

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of experts: Not mentioned.
• Qualifications of experts: Not mentioned.
• Role of Experts: Not mentioned.

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

• Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study is mentioned. This device is an electrocardiograph, not an AI-assisted diagnostic tool as described. It "records and displays ECG waveform." It does not appear to involve AI assistance for interpretation.

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

• Not applicable as this is a device for recording and displaying ECG waveforms, not an algorithm for interpretation. The text states it "provides to the treating physician with relevant data on the cardiac rhythm" but does not indicate automated diagnostic interpretation. Furthermore, it explicitly states "The product is not a conventional diagnostic tool."

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

• Not mentioned.

8. The sample size for the training set

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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

• Not applicable/mentioned, as no algorithm training is indicated for this device.

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The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.

The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, beyond general statements about testing. The document is primarily a 510(k) summary for a Pulse Oximeter (CMS-50E), focusing on its substantial equivalence to a predicate device and its intended use.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided excerpt.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Specific numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, resolution, measurement range, alarm limits, etc., as well as the exact performance metrics achieved by the device against these criteria.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. It's implied that "Laboratory testing was conducted" to validate performance, but details about the origin of data (e.g., country, retrospective/prospective) are absent.

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

• Not applicable/Not specified. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using a reference device (e.g., co-oximeter for SpO2) and not by expert human interpretation of images or signals. The text does not mention any expert involvement in establishing ground truth.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology studies). For a pulse oximeter, the comparison would be against a reference standard.

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 pulse oximeter, which directly measures physiological parameters. It is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

• Yes, implicitly. The "Test Conclusion" states "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications," which implies direct testing of the device's performance (standalone) against its specifications. The device itself operates autonomously to measure SpO2 and pulse rate.

7. The type of ground truth used:

• Not explicitly stated, but for a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using reference medical devices. For SpO2, this often involves a co-oximeter (a device that measures the actual ratio of oxygenated hemoglobin to total hemoglobin in a blood sample). For pulse rate, an ECG or an accurate reference pulse oximeter would commonly be used.

8. The sample size for the training set:

• Not applicable. This is a measurement device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (As above, no training set for this type of device.)

Summary of what is present in the document:

• The device is a non-invasive pulse oximeter for spot-check or continuous monitoring of SpO2 and pulse rate.
• It's intended for adult patients, used through the finger, in home and hospital environments.
• Laboratory testing was conducted to validate and verify that the device met all design specifications, including electrical safety and EMC.
• The FDA determined the device to be substantially equivalent to the predicate device (Pm-60 Pulse Oximeter, K072581).

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Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type.

SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2MHz water proof probe,3MHz normal probe,3MHz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

Contect Pocket Fetal Doppler includes four models, SONOLINE A. SONOLINE B, Baby Sound A and Baby Sound B. They are handheld, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries.

SONOLINE A and SONOLINE B include four interchangeable probes (2MHz normal probe, 2MHz water proof probe, 3MHz normal probe and 3MHz proof resistance probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. Instead, it focuses on the device's substantial equivalence to a predicate device, intended use, and general compliance with standards.

Here's an analysis based on the available information, noting the missing elements:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification," and that "Results of these tests demonstrate compliance to the requirements of all consensus standards." However, it does not specify what those "design specifications" or "consensus standards" are, nor does it provide performance metrics.

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

Not available in the provided text.

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

Not available in the provided text.

4. Adjudication Method for the Test Set

Not available in the provided text.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or mentioned in this document. The device in question is a fetal Doppler and does not involve AI for interpretation or assistance with human readers.

6. If a Standalone Study Was Done

A standalone performance study in the clinical sense (e.g., measuring diagnostic accuracy against a gold standard) is not explicitly detailed with specific metrics. The document mentions "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification." This implies engineering and safety testing were performed standalone for the device, but not a clinical performance study as typically understood in the context of device accuracy.

7. The Type of Ground Truth Used

Based on the nature of the device (a fetal Doppler for detecting heartbeats) and the general regulatory context described, the "ground truth" for the device's primary function would likely be the actual presence or absence of a fetal heartbeat, potentially confirmed by other clinical methods or simultaneous observations. However, the document does not explicitly state how ground truth was established for any performance testing. For electrical safety and EMC, the ground truth would be compliance with established international standards.

8. The Sample Size for the Training Set

Not applicable. The device described is a hardware medical device (fetal Doppler) that detects fetal heartbeats. There is no indication that it utilizes a "training set" in the context of machine learning or AI.

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

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

Summary of what is available:

The provided documents primarily constitute a 510(k) summary for the Contec Pocket Fetal Doppler, aiming to demonstrate its substantial equivalence to an existing legally marketed predicate device (LifeDop Doppler Ultrasound System K-number: K024197). The primary evidence for meeting regulatory requirements lies in:

• Comparison to a predicate device: The device shares similar intended use, technology, and operating principles with the LifeDop Doppler Ultrasound System.
• Compliance with consensus standards: The manufacturer states that laboratory testing was conducted to ensure compliance with electrical safety, EMC, and other specifications, adhering to recognized consensus standards. However, the specific standards and test results are not detailed in this summary.

The document is a regulatory submission focused on proving equivalence and safety based on engineering tests and comparison to a predicate, rather than a detailed clinical performance study with specific acceptance criteria and ground truth derived from expert consensus or pathology.

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