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The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.

The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.

This document is a 510(k) Premarket Notification for the Electronic Pulse Stimulator Model MDTS100, which is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device (Prospera OTC TENSE Electronic Pulse Massager, Model PL029, K122744).

The document details the device's indications for use, its technical characteristics compared to the predicate, and functional and safety testing performed.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical effectiveness. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, which inherently means meeting safety and performance characteristics similar to a device already deemed safe and effective by the FDA. The comparison tables (Table 3-1 and Table 3-2) illustrate the technical characteristics of the proposed device against the predicate.

While no quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device, a table comparing key technical parameters and their reported values for both the proposed and predicate device is provided.

Table: Comparison of Technical Characteristics and Performance

The document concludes that the differences in output parameters (voltage, current, pulse duration, charge) between the proposed device and the predicate device "do not raise any new questions of safety or effectiveness." This statement effectively serves as the "acceptance criteria" for these differing parameters – that they fall within a range considered safe and effective for TENS devices when evaluated against recognized safety standards.

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

The document focuses on non-clinical (bench) testing for substantial equivalence, not clinical studies involving human subjects with a "test set" in the context of clinical performance. Therefore, there is no mention of a human "test set" sample size or data provenance in this submission.

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

Not applicable. This is a non-clinical submission. Ground truth, in a clinical context, is not established for this type of submission.

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

Not applicable. This is a non-clinical submission.

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 Electronic Pulse Stimulator (TENS), not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant to this submission.

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

Not applicable. While the device is "software-driven," the performance evaluation is not an "algorithm-only" standalone test in the context of AI or diagnostic algorithms. The device's performance is tested as a complete system (hardware and software) through bench testing against electrical safety and EMC standards.

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

For the non-clinical testing:

• Electrical Safety & EMC: The "ground truth" is defined by the voluntary standards cited: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, and IEC 60601-2-10:2012. These standards specify thresholds and testing methodologies for electrical characteristics, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators.
• Biocompatibility: The "ground truth" for the electrode pads is established by their prior FDA clearance (K090198) and compliance with ISO 10993 standards, which cover biological evaluation of medical devices.
• Software Validation: The "ground truth" for software functionality is established against the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
• Cleaning: The "ground truth" is simply that the cleaning instructions were tested and found sufficient, as presented in the system test report.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set."

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

Not applicable. This is not an AI/machine learning device.

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The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.

The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.

The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.

The device is for prescription.

The device does not contain drug or biological products.

The device is software-driven and the software validation is provided in software.

The provided text describes the acceptance criteria and a study conducted for a Fingertip Pulse Oximeter (models MD300C208/MD300C198).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly present a "table of acceptance criteria" in the typical format of pass/fail metrics. Instead, the performance specifications are presented as a comparison between the proposed device and the predicate device. The underlying acceptance criteria are implied by the conformance to recognized standards and the demonstration of "similar product specification" and "same performance" as the predicate device.

However, based on the "Performance Specification" section in the comparison tables (Table 3-1 for MD300C208 and Table 3-2 for MD300C198), we can infer the performance metrics and their reported values. The acceptance criteria for the new devices are implicitly that they achieve performance similar to or better than the predicate, and meet the specific accuracies outlined below.

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

The document mentions "clinical accuracy testing" was performed, but does not specify the sample size used for either the clinical or laboratory test sets or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only states that the testing was "in order to ensure that they were appropriate performance and functional features..."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is a Fingertip Pulse Oximeter, which is a direct measurement device and not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This is fundamentally a standalone device. The device itself performs the measurement of SpO2 and pulse rate. The "Performance Test according to ISO 80601-2-61" and "SpO2 and PR Accuracy Test" are examples of standalone performance evaluations. The results of these tests (the accuracy specifications listed above) reflect the device's performance without human intervention in the measurement process itself, beyond placement of the device.

7. The Type of Ground Truth Used

For the accuracy testing of pulse oximeters, the ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry), and for pulse rate, direct physiological measurement. The document mentions "SpO2 and PR Accuracy Test" and adherence to "ISO 80601-2-61," which details requirements for oximeter accuracy including testing against a reference oximeter or co-oximeter. While not explicitly stated as "co-oximetry," this is the standard method for establishing ground truth for SpO2 in such devices.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This device is likely based on traditional signal processing and calibration, rather than machine learning models that require explicit training sets.

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

As no explicit "training set" for a machine learning model is mentioned or implied, this question is not applicable. The device's calibration and performance are established through adherence to standards and direct physical testing, not machine learning training.

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The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.

The proposed device of Fingertip Pulse Oximeter MD300C318T2 is a battery powered fingertip device, with the Durable and Deluxe design. The new kind of fingertip pulse oximeter integrated with Bluetooth wireless technology is designed to monitor SpO2 and pulse rate and connect with telemedicine.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, user interface.

The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The power sources of the proposed device are 2 AAA alkaline batteries. The proposed device has low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds.

The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

The device is software-driven and the software validation is provided in Section of Software.

The document describes the acceptance criteria and the study that proves the device (Fingertip Pulse Oximeter MD300C318T2) meets these criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies that meeting the predicate device's accuracy specifications is the acceptance criterion for the proposed device to demonstrate substantial equivalence. The proposed device shows better accuracy than the predicate in all SpO2 ranges.

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

• Sample Size (Clinical Test Set): 12 healthy adult volunteer subjects
• Data Provenance: Prospective clinical study, conducted in an unspecified country (Yue Bei People's hospital mentioned for the predicate device's clinical test, but the proposed device's clinical test states "conducted ... to evaluate..."). Given the submission is from Beijing Choice Electronic Technology Co., Ltd., it is highly probable the study was conducted in China.

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

The document does not specify the number or qualifications of experts involved in establishing the ground truth for the clinical test. It states "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This indicates that the ground truth was established by laboratory analysis using a reference CO-Oximeter, rather than by human expert consensus or interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement with a reference CO-Oximeter. There was no mention of human adjudication for the clinical accuracy study.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the device's standalone accuracy against a reference method.

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

Yes, a standalone clinical performance study was done. The study measured the accuracy of the MD300C318T2 Fingertip Pulse Oximeter against a reference CO-Oximetry method.

7. The Type of Ground Truth Used

The ground truth used for the SpO2 accuracy assessment was Reference CO-Oximetry applied to arterial blood samples. This is considered an objective, gold-standard method for determining arterial oxygen saturation (SaO2).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" for the device. Pulse oximeters are typically hardware-based devices with embedded algorithms, and while those algorithms are developed and refined, the document does not break down data into training and test sets in the typical AI/ML sense. The performance study refers to the test data for demonstrating accuracy.

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

As no specific training set is outlined in the provided text for an AI/ML context, this question is not directly applicable. The development of the oximeter's algorithm would be based on physiological principles and likely extensive previous data, but the creation of a "ground truth" for a training set in the way a machine learning model would use it is not described.

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The external pulse oximeter (MD50i and MD50p) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult at hospital. This medical device can be reused. Not for continuous monitoring.

The MD50I includes three main parts as SpO2 probe, SpO2 module and 30 pin port. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the 30 pin port is used to connect with iPhone device for digital signal transmission.

The MD50I includes two parts of software, Upper Computer software (Mobile App) and Low Computer Software.

The Upper Computer software is installed in the iPhone device, which is used to receive the measured data (SpO2 and PR) from the MD50I, which has the following functions:

• Measured data (SpO2 and PR) receiving;
• Display the measured data (SpO2 and PR) in real time;
• Graph of the measured data (SpO2 and PR) based on the day/week/month or all of observed data trend.
• Measured data (SpO2 and PR) reviewed, the day/week/month history data could be reviewed;
• Note function, the user can make comments after specified history record;
• History data delete, the user can delete the history records;
• Personal information edit, the user can input their own information and save it;
• Share function, the user can select the specified history record to share with others by email;

The Low computer software is embedded in the MD501, which includes the SpO2 sensor and has the following functions:

• Collect the SpO2 and PR data from patient;
• Transform the electrical signal to digit signal;
• Send the digit signal to the Upper Computer software for display and following process.

The MD50P includes three main parts as SpO2 probe, SpO2 module and USB plug. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the USB is used to connect with PC device for digital signal transmission.

The MD50P includes two parts of software. Upper Computer software (PC App) and Low Computer Software.

The Upper Computer software is install in the PC device, which is used to receive the measured data (SpO2 and PR) from the MD50P, which has the following functions:

• Insert device identified automatically;
• Measured data (SpO2 and PR) receiving;
• Display the measured data (SpO2 and PR) in real time;
• Oxygen saturation, Pulse rate, Pulse bar and waveform are clearly displayed on PC when doing real-time measuring;
• Save the current data into your PC with the format of "txt", "pdf", "xls";
• Data print;
• Personal information edit, the user can input their own information and save it, such as title, patient ID, name, gender, age, height, weight, physician comments;
• Alarm set, set the high/low SpO2 limit and high/low PR limit;
• Saved data reviewed.
• Login interface, the user needs input password and user name to access the account.

The Low computer software is embedded in the MD50P, which includes the SpO2 sensor and has the following functions:

• Collect the SpO2 and PR data from patient;
• Transform the electrical signal to digit signal;
• Send the digit signal to the Upper Computer software for display and following process.

Here's a summary of the acceptance criteria and study information for the External Pulse Oximeter Models MD50I and MD50P, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Clinical Study Test Set Sample Size:
  • For MD50I: 11 subjects (out of 12 initially included, 1 excluded due to unstable pulse rate).
  • For MD50P: 11 subjects (out of 12 initially included, 1 excluded due to unstable pulse rate).
• Data Provenance: The studies were conducted in accordance with international standards (EN ISO 14155-1:2009, EN ISO 14155-2:2009, ISO 9919:2005, EN ISO 9919:2009, BS EN ISO 80601-2-61:2011) and FDA guidance for pulse oximeters. The text does not explicitly state the country of origin for the clinical trial data, but the manufacturer is Beijing Choice Electronic Technology Co., Ltd, China. The studies involved "healthy adult volunteer subjects" and data collection occurred during specified dates in July 2013. This indicates a prospective collection of data for the purpose of the clinical validation.

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

• The clinical studies for SpO2 accuracy used arterial blood CO-Oximetry for ground truth. This is a direct measurement, and therefore, no human experts were used to establish the ground truth for SpO2 accuracy in the clinical trial.

4. Adjudication Method for the Test Set:

• Not applicable, as ground truth for SpO2 accuracy was established via arterial blood CO-Oximetry, not human expert consensus requiring adjudication.

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

• No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The document describes non-clinical performance tests and clinical validation for the device's accuracy in measuring SpO2 and PR, not a study evaluating human reader performance with or without the device.

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

• Yes, the clinical accuracy studies (for both MD50I and MD50P) were standalone performance evaluations of the device's SpO2 accuracy against a reference method (CO-Oximetry), without human intervention in the loop of the measurement and calculation process. The non-clinical simulator tests also represent standalone performance.

7. The Type of Ground Truth Used:

• Clinical Trial Ground Truth: Arterial blood CO-Oximetry was used to provide functional SaO2, serving as the ground truth for SpO2 accuracy comparison.
• Non-Clinical Test Ground Truth: An SpO2 simulator was used to provide known SpO2 and PR values.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a "training set" or its sample size. The studies described are validation or test sets for the device's accuracy. Pulse oximeters generally use established physical principles (Beer-Lambert law) and signal processing, rather than machine learning algorithms that require explicit training datasets in the conventional sense.

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

• Not applicable, as no training set or machine learning algorithm requiring such ground truth establishment is described for this device.

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The Fingertip Pulse Oximeter MD300CL37 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities, and home environments.

The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface.

The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The power sources of the proposed device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically.

The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

The device is software-driven and the software validation is provided in Section of Software.

The document provided describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CL37 and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the document lists "Acceptance Criteria (Predicate Device)" as directly matching the predicate's performance, the primary acceptance criteria for the new device would be to demonstrate performance comparable to the predicate within accepted margins, often specified by standards like ISO 80601-2-61.

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

• Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: The study was conducted in China ("Yue Bei People's hospital" is mentioned as the location of the clinical test, which is a hospital in China). It was a prospective study where subjects were intentionally exposed to induced hypoxia.

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

The document does not specify the number of experts or their qualifications directly involved in establishing the ground truth. It states that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This implies that the ground truth was established by direct physiological measurement using a reference CO-Oximetry device, which is a gold standard for blood oxygen saturation. The expertise would lie in the laboratory personnel operating the CO-Oximetry and the medical staff conducting the induced hypoxia and blood draws, though specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The ground truth was established by direct comparison to a reference CO-Oximetry device. This is a direct measurement comparison, rather than an expert consensus that would typically require adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the device's standalone accuracy against a reference measurement.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the device's accuracy. The clinical test directly compared the device's SpO2 readings to functional SaO2 measured by reference CO-Oximetry.

7. Type of Ground Truth Used

The ground truth used was physiological measurement obtained from Reference CO-Oximetry of arterial blood samples.

8. Sample Size for the Training Set

The document does not specify a sample size for a "training set." This type of premarket notification (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on established principles and clinical validation rather than a deep learning model's training set. The clinical study described is for validation.

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

As no specific training set is discussed for an AI/algorithm in the context of this device's submission, how its ground truth was established is not applicable or detailed in the provided document. The device is a traditional sensor-based medical device, not a machine learning algorithm requiring a separate training phase in the AI sense.

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The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.

The proposed device Fingertip Pulse Oximeter MD300C29-H is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, child and adolescent patient in the hospital.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile and the transducers are reusable and do not need sterilization or re-sterilization.

The device is for prescription.

The device does not contain drug or biological products.

The device is software -driven and the software validation is provided in Software

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 acceptance criteria for the SpO2 accuracy are explicitly stated. The device performance (result of the clinical test) is stated to conform to these specifications.

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

The document does not explicitly state the sample size used for the clinical test set (number of patients or measurements).

The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical test.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the clinical test set.

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

No, an MRMC comparative effectiveness study was not done. This study is a standalone clinical test to verify the device's accuracy against a reference.

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

Yes, a standalone clinical test was performed to assess the accuracy of the device. The "Clinical Test" section states: "The results of the study provide supporting evidence that the Fingertip Pulse Oximeter MD300C29-H is compliance to the accuracy specification claimed by the manufacturer."

7. The Type of Ground Truth Used

The ground truth for the clinical test for SpO2 accuracy is based on the reference standard outlined in ISO 80601-2-61:2011, which dictates the methodology for testing pulse oximeter equipment accuracy (clause 201.12.1). This typically involves comparing the device's readings to measurements from a co-oximeter or other reference method during controlled hypoxemia studies in healthy volunteers.

8. The Sample Size for the Training Set

The document does not mention a training set for an algorithm, as this device appears to be a direct measurement device rather than one employing machine learning that requires a distinct training phase. If there were internal algorithm or calibration factors, the training data for those are not described.

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

Not applicable, as no training set for a machine learning algorithm is mentioned. For the device's internal calibration/development, the ground truth would have been established through a controlled process similar to the clinical test, or using validated calibration artifacts, but this information is not detailed in the provided summary.

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The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient in hospital.

The applicant device of Fingertip Pulse Oximeter MD300CB3 is a battery powered fingertip device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, adolescent, child and infant patient in hospital. The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The devices are software -driven and the software validation is provided in Software.

This document describes the FDA 510(k) submission for the Fingertip Pulse Oximeter MD300CB3. The acceptance criteria and the study used to meet them are detailed below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device's specific SpO2 accuracy is given as a single value (±3% for 70-99%). The applicant device provides a breakdown across different ranges, all of which fall below or within the ±3% range, indicating superior or equivalent accuracy in those segments. The "no definition" for 0-69% SpO2 is a shared characteristic. Other performance metrics for the predicate (PR accuracy, ranges, resolutions) are not explicitly stated with numerical values in the "Comparison with the Predicate Device" table for direct comparison, but the document states "The applicant device has similar device specifications as the predicate device," implying they meet equivalent performance standards.

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

• Sample Size for Test Set: Not explicitly stated as a number of subjects. The document mentions "clinical test for device accuracy is conducted in the Yue Bei people's Hospital." The specific number of patients or recordings used to determine the SpO2 accuracy (Arms) values (1.94, 2.32, 1.95, 1.57) is not provided in this summary.
• Data Provenance: Prospective clinical study conducted in Yue Bei people's Hospital, P.R. China.

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

• This information is not provided in the given text. The ground truth ("Golden Standard" Co-Oximeter) is directly measured by an instrument, not established by human experts.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth is established by a "Golden Standard" Co-Oximeter, not through human expert consensus requiring 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

• A MRMC comparative effectiveness study was not performed. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would involve human readers.

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

• Yes, a standalone performance evaluation was conducted for the device. The clinical study directly assessed the device's accuracy against a "Golden Standard" Co-Oximeter without human interpretation being part of the measurement process. The device's SpO2 and PR measurements are automatically generated.

7. The Type of Ground Truth Used

• Instrumental Ground Truth: The ground truth for the clinical accuracy test was established using a "Golden Standard" Co-Oximeter, as stated: "accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with "Golden Standard" Co-Oximeter."

8. The Sample Size for the Training Set

• This device does not appear to employ machine learning or AI models that would require a separate "training set" in the conventional sense. It is a traditional medical device based on established physical principles. Therefore, this information is not applicable/not provided.

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

• As noted above, there is no mention of a training set for machine learning. The device's operation relies on direct physiological measurement and signal processing algorithms, not a learned model from a training set. Therefore, this information is not applicable/not provided.

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The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).

The proposed devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display SpO2 and pulse rate value.

The proposed devices consist of detector and emitter LED, signal amplify unit, CPU, display unit and power unit.

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.

Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.

The proposed devices of MD300CF3 and MD300CF61 have pulse rate tone modulation function. The function of pulse rate tone modulation is that the device can make a sound of Di-Di-Di to reflect pulse rate in real time.

The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The Fingertip Pulse Oximeters MD300C series share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Fingertip Pulse Oximeters MD300C series are the same.

The devices are software-driven and the software validation is provided in Section of Software

Here's a summary of the acceptance criteria and the study details for the Fingertip Pulse Oximeter MD300C series, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 12 healthy adult volunteer subjects.
• Data Provenance: Prospective clinical test conducted in the lab of the first affiliated hospital, Sun Yat-sen University. The country of origin can be inferred as China, given the manufacturer's location.

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

The document does not explicitly state the number or qualifications of 'experts' in the context of establishing ground truth in the traditional sense of medical image interpretation by radiologists. Instead, the ground truth for SpO2 was established using instrumental analysis:

• Ground Truth Method for SpO2: Arterial blood samples were drawn and immediately analyzed on Reference CO-Oximetry to provide functional SaO2.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the direct instrumental measurement of SaO2 via CO-Oximetry, clinical expert adjudication (like 2+1 reading) is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, an MRMC comparative effectiveness study was not conducted. The study focused on the standalone performance of the device's SpO2 accuracy against a reference standard.

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

Yes, a standalone performance study was conducted. The clinical test evaluated the accuracy of the MD300C63 Fingertip Pulse Oximeter in measuring SpO2 and pulse rate. The accuracy claimed by the manufacturer was supported by the study results.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was reference CO-Oximetry analysis of arterial blood samples (functional SaO2).

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. Pulse oximeters, like the one described, are typically developed based on established optoelectronic principles and verified through clinical studies rather than machine learning models that require distinct training sets (unless specific AI/ML algorithms are integrated, which is not indicated here).

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

As no training set is explicitly mentioned or suggested for an AI/ML context, the method for establishing ground truth for a training set is not applicable based on the provided text. The device's accuracy is validated through the clinical test described, which serves as a verification process against established clinical standards.

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The Fingertip Pulse Oximeter MD300CF315 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is not for continuous monitoring.

The applicant device of Fingertip Pulse Oximeter MD300CF315 is a battery powered fingertip device, which can detect, display and speak out the measured %SpO2 and pulse rate value. The device is normally applied to adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The devices are software -driven and the software validation is provided in Section 11 Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fingertip Pulse Oximeter MD300CF315:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the proposed device:

• Shares the same Blood Oxygen Module with the predicate device MD300C.
• Meets design specifications and is Substantially Equivalent (SE) to the predicate device based on bench tests.

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

• Sample Size: Not explicitly stated for specific clinical data. The document states "Bench tests were conducted to verify that the proposed device met all design specifications." However, for the clinical aspect related to SpO2 and PR accuracy, the crucial sentence is: "The Fingertip Pulse Oximeter MD300CF315 share the same Blood Oxygen Module with the predicate device MD300C, so we believe the clinical test of MD300CF315 can be exempted." This implies that no new clinical test data was gathered for this specific submission to demonstrate clinical performance if the predicate device already had sufficient clinical data.
• Data Provenance: Not applicable as a new clinical test was exempted for the proposed device due to shared components. For the predicate device's data, the provenance is not mentioned in this document.

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

• Not applicable, as a new clinical test for the proposed device was exempted. For the predicate device's original clinical validation, this information is not provided in the given text.

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

• Not applicable, as a new clinical test for the proposed device was exempted.

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. Pulse oximeters are devices that provide direct measurements (SpO2, PR) and do not involve human "readers" interpreting results in the way an imaging AI might. This type of study is not relevant for this device.

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

• The description of the device's operation ("photo detector ... collects and converts the light into electronic signal...translated into an oxygen saturation measurement") strongly suggests it's a standalone algorithm. The device measures and displays SpO2 and PR. There is no mention of a human-in-the-loop for interpreting the device's primary outputs. The device itself performs the measurement and calculation, fitting the definition of "standalone" algorithm for its core function.

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

• For the technical specifications (SpO2, PR accuracy), the ground truth for pulse oximeters is typically established through direct arterial blood gas analysis with an oximeter (Co-oximeter) as the reference method in controlled desaturation studies. While not explicitly stated for this device's exemption, this is the industry standard for validating pulse oximeter accuracy. For other parameters like dimensions, weight, and environmental requirements, the ground truth would be physical measurements and standard environmental testing.

8. The sample size for the training set:

• Not applicable. This device utilizes a direct measurement principle and associated algorithms, not a machine learning model that requires a distinct "training set" in the conventional sense. The algorithms are based on established physiological principles and signal processing, which are "trained" or designed during product development using engineering principles and established calibration methods, rather than by feeding large datasets to an AI model.

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

• Not applicable, as per the explanation in point 8. The "ground truth" for calibrating and validating the device's SpO2 and PR measurement algorithms would involve precise measurements from a reference method (e.g., arterial blood gas analysis) during the initial development and verification of the blood oxygen module, which is shared with the predicate device.

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The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc).

The proposed device MD300W4 consists of MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit.
It can measure, store, review and display the SpO2% and pulse rate value, time, ID number, pulse bar and battery power status, the connection of probe, and transmit data by GPRS or USB cable.
The power supply is 4.2V Li-battery with capacity 1250mAh. The device can not be used to measure when it charges for the Li- battery.
The Pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in probe collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device has one model detachable sensor as the accessory of which the skin-contacting material is silicon. It is listed below:
M-50G (510(k) number: K082487)
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or probe is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in Section 14 Software on page 14-1.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Device Performance Study for Wrist Pulse Oximeter MD300W4 (K122046)

Based on the provided 510(k) summary, the device is a modified Wrist Pulse Oximeter, MD300W4, and its performance is evaluated against the predicate device, MD300W (K081125), and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MD300W4 are largely aligned with its predicate device and industry standards for pulse oximeters. The reported device performance is presented as compliance with these specifications.

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