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The Pulse Oximeter is a handheld 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 homecare. The device can be used by the people whose finger thickness is between 8mm and 22mm(0.3 inches to 0.9 inches).

The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. The MD300C228 is adopted LCD screen to display to display SpO2, Pulse Rate value (PR), Perfusion Index (PI), pulse bar, brightness level, battery indicator, signal indicator and waveform, it has 7 display modes, the brightness level can be adjusted 1-5 level. The measured data can be transmitted to APP through Bluetooth. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LCD display screen, user interface and button control circuit.

Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660mm, 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 enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel.

The subject 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 provided text describes the acceptance criteria and a clinical study conducted for the Pulse Oximeter MD300C228. This device is a pulse oximeter, not an AI/ML device, so certain requested details such as number of experts for ground truth, adjudication methods, MRMC studies, and training set information are not applicable in this context. However, I will extract and present the relevant information provided for this medical device.

Acceptance Criteria and Device Performance:

The primary performance metric mentioned is SpO2 accuracy.

Study Details:

1. Sample Size and Data Provenance:

   • Sample Size: 11 healthy adult volunteer subjects (ages 20-42yr, with light to dark pigmentation, including male and female).
   • Data Provenance: The document does not explicitly state the country of origin for the clinical study, but the manufacturer is based in Beijing, China. The study appears to be prospective, as it involved inducing hypoxia in volunteers to collect data.

2. Number of Experts and Qualifications for Ground Truth:

   • This criterion is not applicable as the "ground truth" for SpO2 accuracy was established through direct measurement using a reference co-oximeter, not through expert consensus or interpretation of images.

3. Adjudication Method:

   • Not applicable, as the ground truth was based on direct co-oximeter measurements, not subjective evaluations requiring adjudication.

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

   • Not applicable. This is a study to validate the accuracy of a standalone pulse oximeter device, not an AI-assisted diagnostic tool for human readers.

5. Standalone Performance:

   • Yes, a standalone performance study was conducted. The clinical study aimed to evaluate the SpO2 accuracy performance of the pulse oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood co-oximeter. The reported Arms of 1.8% is a measure of the device's standalone accuracy.

6. Type of Ground Truth Used:

   • Physiological Measurement/Reference Device: The ground truth for SpO2 accuracy was established by analyzing arterial blood samples with a reference co-oximeter, providing functional SaO2.

7. Sample Size for Training Set:

   • Not applicable. This is a hardware pulse oximeter device, not an AI/ML algorithm that requires a training set. The device's performance is based on its optical and signal processing design.

8. How Ground Truth for Training Set was Established:

   • Not applicable as there is no training set for this type of device.

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The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.

The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.

The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.

Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.

Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. 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.

This FDA 510(k) summary provides information on the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter, including its acceptance criteria and the studies conducted to demonstrate its performance.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document relies on compliance with recognized standards for its acceptance criteria, particularly ISO 80601-2-61 for pulse oximeter equipment accuracy.

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

• Sample Size for Clinical Test (SpO2 Accuracy): 11 healthy adult volunteer subjects.
• Data Provenance: The clinical study was conducted at Yue Bei People's Hospital. The origin is inferred to be China, as Beijing Choice Electronic Technology Co., Ltd. is based in Beijing, China. The study appears to be prospective as it involved recruiting subjects and performing specific tests.

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

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. It mentions that the clinical study evaluated SpO2 accuracy "as compared to arterial blood CO-Oximetry." CO-Oximetry is the gold standard for measuring arterial oxygen saturation, and its results are considered highly accurate, typically not requiring expert interpretation for ground truth establishment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given that the ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is an objective measurement, an adjudication method for disagreements on ground truth would generally not be necessary for this specific performance metric.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or of any effect size related to human readers improving with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve multiple human readers.

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

The SpO2 accuracy performance study described is essentially a standalone performance study. The device's measurement of SpO2 is directly compared to an objective gold standard (arterial blood CO-Oximetry), without human intervention in the interpretation of the device's output. The device itself (algorithm) provides the SpO2 reading.

7. Type of Ground Truth Used

The ground truth used for the SpO2 accuracy testing was arterial blood CO-Oximetry.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. Pulse oximeters typically rely on established optical principles and signal processing algorithms rather than machine learning models that require large training datasets in the same way AI algorithms for image analysis might. The "algorithm" here refers to the signal processing rather than a deep learning model.

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

As there is no mention of a training set in the context of typical machine learning, there is no information on how ground truth for a training set was established.

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The Pulse Oximeter is a handheld 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 hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit. Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. 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 enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel. The subject 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.

Here's a breakdown of the acceptance criteria and the study details for the Pulse Oximeter, 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

• Sample Size: 11 healthy adult volunteer subjects.
• Data Provenance: The study was conducted in a controlled clinical setting. The specific country of origin is not explicitly stated, but the manufacturer is based in China. The study was prospective in nature, as it involved actively recruiting subjects and conducting measurements to evaluate the device's performance.

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 used or their qualifications for establishing the ground truth. It states that the ground truth was obtained via "arterial blood CO-Oximetry," which is a laboratory method, not an expert assessment.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for the test set. The ground truth was established through a direct objective measurement (arterial blood CO-Oximetry).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the Pulse Oximeter against an objective ground truth, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily assessed the standalone performance of the Pulse Oximeter (algorithm only, as it's a direct measurement device). The reported ARMS value of 1.5% is a measure of the device's accuracy in determining SpO2 levels without human interpretation beyond reading the display.

7. Type of Ground Truth Used

The ground truth used was arterial blood CO-Oximetry. This is considered a gold standard for measuring oxygen saturation in arterial blood.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. Pulse oximeters, particularly those based on established principles like spectrophotometry, often rely on physics-based algorithms and extensive calibration rather than machine learning models requiring large training datasets in the same way AI algorithms do.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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The Pulse Oximeter is a handheld 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 hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).

The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted 1-10 level.

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 enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel.

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.

The device is for prescription.

The device does not contain drug or biological products.

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

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document indicates that the device's performance was compared to its predicate device and to standards. For SpO2 and PR accuracy, the acceptance criteria are generally established by standards like ISO 80601-2-61.

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

• Sample Size: 11 healthy adult volunteer subjects.
• Data Provenance: The study was a prospective clinical study conducted to validate SpO2 accuracy. The country of origin is not explicitly stated, but the manufacturer is based in Beijing, China, suggesting the study likely occurred in China or an affiliated location. The subjects had "light to dark pigmentation, include male and female."

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

The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, the ground truth was established by "arterial blood co-oximeter," which is a laboratory instrument. This implies expert handling and interpretation of the co-oximeter results, but no specific human expert qualifications are provided for the ground truth establishment itself. Clinical personnel would have been involved in drawing blood samples and operating the co-oximeter.

4. Adjudication Method for the Test Set

Not applicable. This was a quantitative measurement comparison study against a reference standard (co-oximeter), not a qualitative assessment requiring adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the pulse oximeter against a clinical reference standard. It did not involve human readers interpreting results with or without AI assistance.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The clinical study described in Section 7 (Clinical Test) was conducted to evaluate the SpO2 accuracy performance of the proposed pulse oximeter itself, without human-in-the-loop interaction for interpretation, other than operating the device.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / reference standard measurement from an "arterial blood co-oximeter." This is considered a gold standard for measuring arterial oxygen saturation (SaO2).

8. The Sample Size for the Training Set

The document does not provide information regarding a training set or its size. As this is a traditional medical device (pulse oximeter) and not explicitly a machine learning/AI device in the context of image analysis or complex pattern recognition requiring a training set, such information would typically not be present in its 510(k) submission. Pulse oximeters operate based on established physiological principles and algorithms, rather than training on large datasets in the way modern AI models do.

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

Not applicable, as no training set information is provided or implied for this type of device.

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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 (leg) due to strain from exercise or normal household and work activities.

The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness. Its accessories include connecting wires, electrode pads, 2 AAA batteries. The device is for over the counter use. The device does not contain drug or biological products. The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.

This document is a 510(k) premarket notification for an Electronic Pulse Stimulator (Model MDTS100), seeking clearance for market. The core purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study with defined acceptance criteria for a novel AI/device performance.

Therefore, the requested information regarding acceptance criteria, performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

Explanation:

• Device Type: The device is an Electronic Pulse Stimulator, a transcutaneous electrical nerve stimulator (TENS) for pain relief. TENS devices are well-established medical devices.
• Regulatory Pathway (510(k)): The 510(k) pathway "demonstrates that the device is at least as safe and effective as a legally marketed predicate device that is not subject to premarket approval (PMA)." It primarily relies on demonstrating substantial equivalence in technological characteristics, intended use, and safety/performance without requiring new clinical efficacy trials for established device types unless there are significant differences that raise new questions of safety or effectiveness.
• Stated Testing: The document mentions various engineering and safety tests, such as biocompatibility, electrical safety, EMC, performance bench tests (e.g., output amplitudes, pulse durations), and software verification/validation. These tests ensure the device meets established engineering and safety standards, and its performance parameters are within acceptable ranges for a TENS device.
• Absence of Clinical Testing: The document explicitly states: "The clinical testing was not needed in this submission." This confirms that efficacy was not assessed through a clinical trial with human subjects.
• Focus on Equivalence: The "Comparison list of the technological characteristics" table (pages 5-7) directly compares the proposed device to the predicate device, emphasizing identical or very similar specifications across all key parameters (e.g., waveform, output voltage/current, pulse duration, frequency, number of output modes). The conclusion (page 8) explicitly states, "The proposed device and the predicate device have same performance specification."

Summary of inapplicable information based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is established through comparison to a predicate device and engineering benchmarks, not a separate clinical study with predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set involving patient data for clinical performance evaluation is described. System performance (e.g., electrical parameters) is tested on the device itself.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No "ground truth" for clinical outcomes or diagnoses is established as there is no clinical study.
• 4. Adjudication method: Not applicable. No clinical data requiring adjudication.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not feature an AI algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable. No AI model or training set is mentioned for the device's function.
• 9. How the ground truth for the training set was established: Not applicable.

The "study that proves the device meets the acceptance criteria" in this 510(k) context is primarily the bench testing, electrical safety testing, software verification, and the demonstration of substantial equivalence to the predicate device through side-by-side comparison of technical specifications, as detailed in the document. The acceptance criteria for these tests are typically engineering standards and limits rather than clinical performance metrics.

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The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients.

Respiratory rate (RR) is intended for adults only.

The Pulse Oximeter is intended for use in hospitals, hospital-type facilities and homecare environment.

The Pulse Oximeter is not intended for patients with:

• cardiopulmonary disease
• cardiac dysrhythmias, unstable patients, or patients in the ICU
• respiratory insufficiency or recovering from surgery or trauma
• morbid obesity
• severe arrhythmia

The Pulse Oximeter is not intended for patients who are:

• injured, disabled or physically deformed
• pregnant or lactating
• taking drugs that stain the blood.

The Pulse Oximeter is not designed to detect apneas.

The proposed device Fingertip Pulse Oximeter MD300CI218R is a battery powered device. It can detect and display the measured %SpO2 ,pulse rate,respiratory rate and perfusion index and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR , respiratory rate, perfusion index, and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power mav be low.

The proposed device is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients, respiratory rate (RR) for adult in hospital-type facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.

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 fingertip 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.

Here's an analysis of the acceptance criteria and study information for the Pulse Oximeter (K211400), based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document describes the device performance in terms of accuracy for SpO2 and Pulse Rate (PR), and Mean Error and Root Mean Square (RMS) error for Respiratory Rate (RR).

Note: The reported device performance for SpO2 and PR is stated as "same as" or "similar to" the predicate devices in the comparison table, which indicates it meets the predicate's performance. For RR, a specific clinical study was performed.

Study Information

Here's an breakdown of the study information based on your requested criteria:

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

   • SpO2 Measurement: The summary states that clinical testing for SpO2 measurement was conducted as part of K181503 (secondary predicate device) and was not repeated for this submission, as there was no change in the SpO2 measurement function. The sample size and data provenance for the original SpO2 clinical test are not provided in this document.
   • Respiratory Rate (RR) Measurement: A specific clinical test was performed for RR.
     • Sample Size: 11 healthy adult volunteer subjects and 22 patients. (Total of 33 subjects)
     • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it was a clinical test performed by "Choice" (Beijing Choice Electronic Technology Co., Ltd.), implying it was likely prospective for the purpose of this submission. No specific region or country is disclosed for the subjects.

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

   • For SpO2: Not applicable in this submission as the clinical test data was carried over from the predicate. Information on ground truth experts for the original predicate study is not available in this document.
   • For RR: The document does not specify the number of experts used or their qualifications for establishing the ground truth for the respiratory rate during the clinical test. It only states that a "clinical test" was performed and a "clinical study report was presented in Performance Testing-Clinical Study Report."

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

   • The document does not provide information about any adjudication method used for either the SpO2 (from predicate) or the RR clinical test.

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

   • No MRMC comparative effectiveness study was mentioned. This device (Pulse Oximeter) is a standalone measurement device and not described as incorporating AI for human reader assistance.

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

   • Yes, the device itself is a standalone measurement device (algorithm only, without human-in-the-loop assistance in the sense of AI-aided diagnosis). The clinical test for Respiratory Rate directly assessed the device's performance against a reference standard in patients.

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

   • SpO2: The type of ground truth for SpO2 from the predicate study is not specified in this document, but typically, pulse oximeter accuracy studies use fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples as the gold standard.
   • RR: The document does not explicitly state the specific method used to establish the ground truth for respiratory rate in the clinical study. Common ground truth methods for RR measurement include manual counting by trained personnel or capnography.

7. The sample size for the training set:

   • The document does not provide any information about a "training set" or "training data" for this device. This implies that the device's algorithms were likely developed and validated internally against engineering standards and potentially historical data, rather than through a separate, explicitly described machine learning training pipeline in this regulatory submission. For traditional medical devices like this, the 'training' phase might be part of the R&D and engineering design process rather than a distinct 'training set' as understood in AI/ML contexts.

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

   • Not applicable, as no training set information is provided.

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Infrared Thermometer is a reusable thermometer intended for the intermittent determination of human body temperature in a non-contact mode using the center of the forehead as the measurement site on people of all ages. It can be used by consumers in the household environment and by healthcare provider.

The infrared thermometer uses infrared temperature sensor to detect infrared energy radiated from the forehead. The intensity of the emitted energy depends on the temperature of the object. The infrared probe can recognize the emitted energy and transfer it to an electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to a temperature reading, which is displayed on the screen. This is a continuous non-invasive method of measuring body temperature. After measuring the forehead temperature with an infrared temperature sensor, the calculated temperature value is obtained. 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 Infrared Thermometer, Model CFT-308, consists of the following parts:
a) Infrared sensor
b) Integrated circuit
c) Microprocessor (with Bluetooth function) (Bluetooth transmission is optional)
d) OLED display
e) Buzzer
f) 2 Buttons ("Start" button, "Measuring" button)
g) Alkaline batteries; size AAA, 2 x 1.5 V
h) Lens

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Thermometer (K211752):

Note: The provided document is a 510(k) summary, which often provides a high-level overview rather than granular detail for all study aspects. Some specific information (like the exact number and qualifications of experts for ground truth establishment within the clinical study, or specific effect sizes for MRMC studies if applicable) are not explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

The clinical study for the Infrared Thermometer Model CFT-308 aimed to demonstrate accuracy compared to a reference thermometer. The accuracy criteria are derived from the referenced standards, specifically ISO 80601-2-56:2017 and ASTM E1965-98:2016.

Important Note on "Reported Device Performance": The table above directly extracts the claimed accuracy from the comparison table (Table II-1) within the 510(k) summary, which represents the device's declared accuracy. The clinical study was performed to validate this declared accuracy. The document states, "Through clinical trials, the measured temperature of subject device and armpit thermometers are compared to demonstrate the measurement accuracy of subject device meets its declared accuracy range."

Study Details

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

   • Sample Size: 150 subjects completed the clinical trial.
     • 15 subjects aged 0 to 3 months.
     • 35 subjects aged 3 months to 1-year-old.
     • 50 subjects aged from 1 to 5 years old.
     • 50 subjects aged 5 years and above.
   • Data Provenance: Prospective clinical study conducted in China ("second hospital of Tianjin medical university").

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

   • The document implies that the ground truth was established by a "reference thermometer (Model Number: CRW-23)" which measured "armpit test temperature." It does not explicitly state that human experts were used to establish this ground truth beyond operating the reference thermometer. For an infrared thermometer, the reference standard is typically another calibrated thermometer (often an invasive one like an oral or rectal thermometer in some studies, or an axillary/armpit thermometer as used here) rather than expert consensus on a subjective measure. Therefore, "experts" in the traditional sense for ground truth labeling (e.g., radiologists interpreting images) are not directly applicable or specified for this type of device. The accuracy of the reference thermometer itself would be implicitly relied upon.

3. Adjudication method for the test set:

   • This is not applicable or specified for this type of device where the ground truth is established by a reference thermometer, not by subjective human interpretation requiring consensus.

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

   • No, an MRMC study was not done. This device is an infrared thermometer, not an AI-assisted diagnostic tool interpreted by human readers.

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

   • Yes, for clinical accuracy, the study evaluates the performance of the device (CFT-308) itself in measuring temperature compared to a reference standard (CRW-23). While a human operates the device, the performance being assessed is the device's ability to accurately measure temperature relative to the ground truth, effectively a standalone performance assessment of the measurement component.

6. The type of ground truth used:

   • The ground truth was established using a reference thermometer (Model Number: CRW-23) measuring armpit temperature. This represents a form of empirical measurement/reference standard, aiming to provide an accurate physiological temperature reading against which the non-contact forehead thermometer's readings are compared.

7. The sample size for the training set:

   • The document does not specify a separate "training set" sample size. The clinical study described is for validation/testing. Infrared thermometers are typically calibrated during manufacturing, and their algorithms are based on physics and laboratory calibration rather than a machine learning "training set" in the common sense for AI algorithms.

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

   • As no explicit "training set" for an AI algorithm is mentioned, this question is not directly applicable. The device's underlying physics and pre-determined calibration (which leverages established temperature standards) would form its operational basis.

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Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.

The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm.

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Monitor MD2000C based on the provided text:

Acceptance Criteria and Device Performance

The direct acceptance criteria for the Vital Signs Monitor MD2000C are not explicitly stated as a separate table within the document in terms of specific performance targets for NIBP, SpO2, and PR beyond accuracy ranges. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MD2000B and MD300M for SpO2, and Multi-parameters health Examination System for NIBP).

The performance data available relates to the MD300M (for SpO2) and Multi-parameters health Examination System (for NIBP), which the new device MD2000C claims to be identical to in those modules.

Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: The "Implied Acceptance Criteria" are based on the performance of the predicate devices which the new device is seeking equivalence to. The direct acceptance criteria for the specific device are not explicitly listed in a regulatory numerical format but are demonstrated through equivalence to these predicate performances.

Study Information:

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

• SpO2 Accuracy Study (MD300M):
  • Sample Size: 12 healthy adult volunteer subjects (6 females, 6 males)
  • Demographics: Ages 21-43 years, 47-82 kg, 155-185 cm, with a representative range of pigmentation.
  • Data Provenance: Conducted in Yue Bei People's Hospital. Prospective study. Country of origin not explicitly stated but implied to be China (as the manufacturer is Beijing Choice Electronic Technology Co., Ltd.)
• NIBP Accuracy Study (Multi-parameters health Examination System):
  • Sample Size: 85 subjects (35 child subjects aged 3-12 years, 50 adult subjects)
  • Data Provenance: Conducted in PLA Rocket Force Characteristic Medical Center. Prospective study. Country of origin not explicitly stated but implied to be China.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for either the SpO2 or NIBP studies.
  • For SpO2, ground truth is typically established using a co-oximeter in controlled desaturation studies (e.g., fractional oxyhemoglobin measurement compared to pulse oximeter readings).
  • For NIBP, ground truth is typically established simultaneously with a reference auscultatory or invasive blood pressure measurement taken by qualified personnel.

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

• The document does not provide details on any adjudication methods used for the test sets. The studies appear to be direct performance comparisons against a reference standard rather than assessments requiring multiple human interpretations.

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 was performed. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides physiological parameters directly.

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

• Yes, standalone performance was evaluated. The studies described for SpO2 and NIBP accuracy directly measure the device's performance against a reference standard, without human interpretation of the device's output influencing the accuracy metrics. The device itself is designed to provide direct physiological measurements.

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

• SpO2: The ground truth for SpO2 accuracy studies is typically established by fractional oxyhemoglobin measurement using a co-oximeter during controlled hypoxia conditions. This is considered the reference standard for pulse oximetry.
• NIBP: The ground truth for NIBP accuracy studies is established by simultaneous measurements using a reference auscultatory method (e.g., mercury sphygmomanometer with stethoscope by trained observer) or an invasive arterial line, compared to the device's oscillometric readings.

8. The sample size for the training set:

• The document does not specify sample sizes for training sets. It describes the device's performance through validation studies (test sets) for specific modules that were adopted from previously cleared devices. It's implied that the algorithms within these modules were developed and potentially trained using proprietary datasets not detailed in this 510(k) summary.

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

• The document does not specify how ground truth was established for any potential training sets. This information would typically be part of the internal development process for the SpO2 and NIBP algorithms, which predates this 510(k) application (as the modules are reused from previously cleared devices).

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The Fingertip Pulse Oximeter MD300CI218 is a handheld 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 hospital-type facilities and homecare environment.

The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low. The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information. 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 fingertip 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 510(k) premarket notification for the Fingertip Pulse Oximeter MD300CI218. It includes details about the device, its intended use, comparison to a predicate device, and various tests conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SpO2 (oxygen saturation) and PR (Pulse Rate) accuracy are implicitly stated as the device's accuracy specifications, which are identical to the predicate device. The performance is reported in the clinical test results.

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

• Sample Size for Test Set: 12 healthy adult subjects.
• Data Provenance: The clinical study was conducted from March 9-11, 2018, in the Yue Bei People's Hospital, cardiovascular medicine, in China. It was a prospective study where subjects were intentionally involved for the purpose of testing the device.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test (e.g., co-oximeter readings for SpO2 accuracy). It only mentions that the study followed ISO 80601-2-61:2011, which outlines specific methodologies for pulse oximeter testing, implying that the ground truth would have been established using reference methods as per the standard.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. For pulse oximetry accuracy testing as per ISO 80601-2-61, ground truth is typically established by arterial blood gas analysis using a co-oximeter, where direct measurements serve as the reference, rather than expert adjudication.

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 technical performance test of a medical device (pulse oximeter) against a reference standard, not an AI-assisted diagnostic study involving human readers.

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

Yes, this was a standalone performance study. The MD300CI218 Finger Pulse Oximeter is a device that directly measures and displays SpO2 and pulse rate. The clinical test evaluated the accuracy of the device's measurements compared to a reference standard (likely arterial blood sampling and co-oximetry, as per the ISO standard). There is no "human-in-the-loop" interaction for interpreting the device's output, beyond a clinician reading the displayed values.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical study was based on the methodology described in ISO 80601-2-61:2011. This standard typically mandates the use of reference co-oximeter measurements from arterial blood samples (induced hypoxia studies) as the ground truth for SpO2 accuracy. The document states, "The SpO2 accuracy performance results showed the MD300CI218 Fingertip Pulse Oximeter to have an Arms of 1.66 during steady state conditions over the range of 70-100%," which is a standard metric derived from comparing device readings to co-oximeter readings.

8. The Sample Size for the Training Set

This document describes a clinical validation study for a medical device that does not appear to involve a machine learning or AI algorithm that requires a "training set." The device is based on established optical principles (Lambert-Beer Law) for pulse oximetry. Therefore, the concept of a "training set" as it applies to AI models is not relevant here.

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

As noted in point 8, there is no mention or indication of a "training set" for an AI model. The device operates on optical principles rather than an AI/ML algorithm that is 'trained' on data.

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MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

The proposed devices Wrist Pulse Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission. The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

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