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The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.

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

This document describes a 510(k) premarket notification for a medical device, which means the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy from scratch. Therefore, the "acceptance criteria" discussed here are primarily focused on meeting regulatory standards and demonstrating comparable performance to the predicate device, rather than establishing de novo clinical effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance claims for this pulse oximeter relate to SpO2 accuracy and Pulse Rate accuracy. The acceptance criteria are implicitly defined by the standard ISO 80601-2-61 and the device's stated accuracy, which is compared directly to the predicate device.

Note on SpO2 Range Difference: The document explicitly states and justifies the difference in SpO2 range. While the predicate measures 0-100%, the subject device measures 35-100%. The justification is that this difference is acceptable as it aligns with the verification per ISO 80601-2-61.

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

• Sample Size (Clinical Test Set): 12 adult healthy volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It describes the study as "Clinical testing conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2017... and the FDA Guidance Document for Pulse Oximeters." This suggests it was a prospective study designed to meet these specific guidelines. The volunteers had varying skin tones (Fitzpatrick I-VI), indicating an effort for demographic representation.

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

This type of device (pulse oximeter) does not typically involve expert readers for ground truth establishment. The ground truth for SpO2 accuracy is based on arterial blood CO-Oximetry, which is considered the gold standard for measuring blood oxygen saturation. This is a direct physiological measurement and does not require subjective expert interpretation in the same way imaging studies might.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by direct physiological measurement (CO-Oximetry), which does not involve subjective interpretation or a need for adjudication among experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI algorithms where human readers interpret medical images, and the AI is used to assist or replace human interpretation. A pulse oximeter directly measures physiological parameters and does not involve human interpretation of complex medical cases.

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

Yes, the core performance testing of the device for SpO2 and Pulse Rate accuracy is a standalone assessment of the algorithm's ability to measure these parameters against the gold standard (CO-Oximetry). The device operates independently to provide these measurements.

7. The Type of Ground Truth Used

The type of ground truth used was outcomes data / physiological measurement, specifically: arterial blood CO-Oximetry. This is the standard reference method for determining actual arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not provide information on the training set size. For a medical device like a pulse oximeter, "training" might refer to the development and calibration of the internal algorithms and hardware during the design phase, rather than a distinct "training set" of data in the common machine learning sense used for AI algorithms. The clinical study described served as the validation test set.

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

The document does not describe how a "training set" ground truth was established. The focus of this 510(k) submission is on validating the final device's performance against established standards (ISO 80601-2-61) and comparing it to a predicate device, using clinical data collection and CO-Oximetry as ground truth for that validation. If there were internal iterative development and calibration, the specifics of those processes are not detailed in this public regulatory summary.

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This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). 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 660 nm, which is red light; the other is 905 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

Here's a breakdown of the acceptance criteria and study information for the Fingertip Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

• Sample Size for Test Set: The exact number of human adult volunteers is not specified in the provided text.
• Data Provenance: The study involved human adult volunteers, suggesting a prospective study. The country of origin is not explicitly mentioned.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions "co-oximetry" as the method for determining arterial oxygen saturation (SaO2) which is the ground truth. This is an objective measurement from a laboratory instrument.
• No information is provided about the number of experts or their qualifications as establishing ground truth was done through a laboratory instrument (co-oximetry), not subjective expert assessment.

4. Adjudication Method for the Test Set

• Since ground truth was established through objective co-oximetry measurements, an adjudication method like 2+1 or 3+1 by human experts is not applicable and therefore not mentioned.

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

• No MRMC study was done. This device is a standalone measurement device (Fingertip Pulse Oximeter) and does not involve human readers interpreting output with or without AI assistance. The performance evaluation focuses on the device's accuracy against a gold standard (co-oximetry) in measuring SpO2 and pulse rate.

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

• Yes, a standalone performance study was done. The entire clinical study described is focused on the device's inherent accuracy in measuring SpO2 and pulse rate without human intervention beyond application of the device and co-oximetry measurement.

7. Type of Ground Truth Used

• The ground truth used was outcomes data (specifically, arterial oxygen saturation (SaO2) as determined by co-oximetry). Co-oximetry is considered a highly accurate and objective method for measuring arterial oxygen saturation.

8. Sample Size for the Training Set

• Not applicable / Not explicitly mentioned. The provided document describes a premarket notification (510(k)) for a medical device that measures physiological parameters. It does not indicate the use of machine learning or AI models that would typically require a training set. The device appears to operate based on established physiological principles and signal processing algorithms, not a deep learning model.

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

• Not applicable. As mentioned above, there is no indication of a training set for machine learning in this context.

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The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). 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 660 nm, which is red light; the other is 905 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by 2 AAA alkaline batteries. The device mainly composed of PCB board, On/Off button, OLED or LED or LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:

The document is a 510(k) Premarket Notification for a Fingertip Pulse Oximeter (Model LT-F20 and LT-F21). It seeks to demonstrate substantial equivalence to a legally marketed predicate device. The core of the performance data revolves around meeting established standards for pulse oximeters.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeter equipment, which the subject device claims compliance with. The reported performance is directly stated.

Note on PR Accuracy: The document explicitly highlights a difference in PR accuracy between the subject and predicate devices. While the predicate states "±2", the subject device states "±1% or ±3bpm, whichever is greater." The manufacturer justifies this difference by stating, "The PR measurement has been verified according to declared range and accuracy. Thus, this difference does not raise different questions of safety and effectiveness."

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

• Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, it does not specify the exact number of subjects or the sample size used for the clinical test set.
• Data Provenance: The data is described as collected from "human adult volunteers." The document doesn't explicitly state the country of origin, but given the manufacturer's location (Zhuhai Linte Medical Instrument Co., Ltd. in China), it's highly probable the study was conducted there. The clinical study is described as having been performed under an "approved protocol with subject informed consent," implying a prospective data collection.

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 for the test set. It mentions "co-oximetry," which is an objective measurement, not expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The primary ground truth for oxygen saturation (SpO2) is stated as "arterial oxygen saturation (SaO2) as determined by co-oximetry," which is an objective, quantitative measurement technique and does not typically require human adjudication in the same way as, for example, image interpretation.

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

No. This document describes the validation of a medical device (pulse oximeter) against physiological measurements and established standards, not a comparative effectiveness study involving human readers and AI assistance for interpretation. Therefore, there is no discussion of MRMC studies or effect sizes of human reader improvement with AI.

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

Yes, implicitly. The core of the product is an automated measurement device. The clinical study evaluated the device's accuracy (its "algorithm" or measurement capability) in determining SpO2 and PR against a "human reference standard" (arterial co-oximetry). The device itself functions without human interpretation of its raw sensor data to produce the SpO2 and PR readings.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy was "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is an objective, gold-standard laboratory measurement for hemoglobin derivatives.

8. The Sample Size for the Training Set

This document describes a premarket notification for a hardware device (pulse oximeter) with embedded software/firmware for calculating SpO2 and PR. While such devices have internal algorithms, the document does not discuss a "training set" in the context of machine learning/AI models that might have distinct training and test phases. The performance validation is described as a clinical study evaluating the device's output against a reference standard. If an internal algorithm was developed using a dataset, that information is not provided here.

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

As no specific "training set" for an AI/ML model is mentioned, there is no information on how its ground truth was established. The clinical study described is for performance validation, not algorithm training.

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The Fingertip 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 and child patients in hospital-type facilities, and homecare.

Fingertip pulse oximeter, LOX100A, LOX100B, LOX100C, LOX100D, mainly include of signal acquisition module, signal processing module, prompt module, detector, and emitter LED, display and user interface module, power supply module, the device is used to measure the patient's blood oxygen saturation (SpO2) and pulse rate (PR). The device is mainly composed of main board PCB, lamp panel PCB, sensor, OLED screen, button, silicone gel pad and enclosure.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Fingertip pulse oximeter:

Device: Fingertip pulse oximeter (Model LOX100A, LOX100B, LOX100C, LOX100D) by Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the comparison of the subject device against a predicate device (K161560) and adherence to relevant standards. The "Acceptance Criteria" are implied by the requirements of these standards and the equivalence to the predicate, with "Reported Device Performance" reflecting the subject device's demonstrated capabilities.

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

• Test Set Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: Retrospective (implied, as the study results are presented as completed data for review), conducted on healthy adult volunteers. The document does not explicitly state the country of origin, but given the company's location (Shenzhen, China) and common regulatory practices, it's likely the study was conducted there or in a region with compatible regulatory/ethical standards.

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

The document states that arterial blood samples were analyzed on a "reference co-oximeter" to provide the functional SaO2 for comparison. This implies an objective, instrumental ground truth, not one established by human experts. Therefore, the "number of experts" for ground truth establishment is not applicable in this context. The co-oximeter itself serves as the gold standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established objectively by a co-oximeter, not through human expert consensus requiring adjudication.

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

No. An MRMC study was not described. The study focused on the device's standalone accuracy against a measured physiological ground truth (co-oximetry), not on evaluating human reader performance with or without AI assistance. This device (a pulse oximeter) is a direct measurement device, not an AI diagnostic aid that assists human interpretation.

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

Yes. The clinical study described is a standalone performance test of the device, where the Fingertip pulse oximeter's SpO2 readings were directly compared to arterial blood co-oximeter readings. There's no human "in the loop" for interpreting the device's output influencing the accuracy validation.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was outcomes data in the form of arterial blood co-oximetry readings (functional SaO2). This is considered a highly objective, gold-standard method for determining true arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For a pulse oximeter, the core measurement principle is based on pre-established physiological principles (Lambert-Beer law, absorption characteristics of oxygenated/deoxygenated hemoglobin), not on machine learning models that require distinct training and test sets in the same way. The device's calibration and algorithm development would have utilized extensive physiological data, but this is distinct from a "training set" for a new AI algorithm.

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

Given that this is a pulse oximeter and not an AI-driven diagnostic image analysis tool, the concept of a "training set" with ground truth in the typical machine learning sense is not applicable here. The device's underlying algorithm relies on the physical properties of light absorption by blood components, which were established through fundamental scientific research over many decades. The device is calibrated and validated against established standards (like ISO 80601-2-61) and objective physiological measurements (like CO-oximetry) rather than "training" an AI model.

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The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. The differences between different models only includes the color of the non-patient contacting shell part and the size. And the color display screen of BSX221/BSX223/BSX261/BSX263/BSX281/BSX283 is OLED, while that of BSX231/BSX233/BSX251/BSX253 is TFT.

The provided document describes the K202324 submission for "Fingertip Pulse Oximeter, Models BSX221, BSX223, BSX261, BSX263, BSX281, BSX283, BSX231, BSX233, BSX251, BSX253." The acceptance criteria and the study proving the device meets these criteria are detailed in the "510(k) Summary" section, particularly under "7. Predicate Device Comparison" and "8. Performance Testing."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory document outlines the performance specifications, which serve as the acceptance criteria, and the reported performance of the proposed device.

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 states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."

However, the specific sample size (number of subjects/patients) used for this clinical test set, or the data provenance (country of origin, retrospective/prospective nature), is not explicitly mentioned in the provided 510(k) summary. ISO 80601-2-61:2011 Annex EE typically outlines requirements for such studies, including participant numbers, but the summary does not detail the results of the specific study performed.

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

For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a co-oximeter and arterial blood samples in a controlled desaturation study. This process usually does not involve "experts" establishing a subjective ground truth in the same way as, for example, image interpretation. Instead, it relies on objective laboratory measurements.

The document does not explicitly state the number or qualifications of "experts" involved in establishing the ground truth for the clinical accuracy testing, as the ground truth itself is derived from reference measurements (co-oximetry).

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

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective interpretation is involved, such as reading medical images, and disagreements between multiple human readers need to be resolved to establish ground truth.

For a pulse oximeter's clinical accuracy study (desaturation study), the ground truth for SpO2 values is established by a reference co-oximeter and arterial blood gas analysis, which is an objective measurement without subjective interpretation or the need for adjudication among multiple human experts. Therefore, adjudication methods are not applicable in this context and are not mentioned.

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

This device is a Fingertip Pulse Oximeter, a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not relevant to this type of device and was not performed. The submission does not mention AI assistance or human reader improvement.

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

Yes, the primary performance evaluation for a pulse oximeter is based on its standalone (algorithm only) performance. The device directly measures and displays SpO2 and pulse rate. The "Clinical data" section explicitly states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011," which refers to a desaturation study where the device's readings are compared against a co-oximeter, without human intervention in the device's measurement process.

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

For the clinical accuracy testing mentioned, the ground truth for oxygen saturation (SpO2) and pulse rate would be established using reference medical devices and laboratory analyses. Specifically, for SpO2 accuracy, this involves:

• Co-oximetry: Measuring arterial oxygen saturation (SaO2) from arterial blood samples using a laboratory co-oximeter.
• Arterial blood gas analysis: Providing other relevant blood gas parameters.
  This is considered the gold standard for determining SpO2 accuracy in human subjects.

8. The sample size for the training set

The document does not mention the use of machine learning or AI models that would require a "training set" in the context of device development. The pulse oximeter operates based on established physical principles of light absorption by hemoglobin. Therefore, there is no mention of a training set in this 510(k) summary.

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

As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.

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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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The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

Not Found

This FDA 510(k) clearance letter for the Fingertip Pulse Oximeter (Model JPD-500F) does not contain detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria.

FDA 510(k) clearance letters primarily state that the device is "substantially equivalent" to a legally marketed predicate device. They typically do not include the raw data, study designs, or detailed performance metrics that would be found in a full submission. The letter confirms the device type, its classification, and intended use.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, one would need to access the full 510(k) submission document or a summary thereof, which often includes details of the performance testing and acceptance criteria.

However, I can infer some general information about what would typically be required for a pulse oximeter's acceptance criteria and how a study would prove it, even if the specifics are not in this document:

Inferred Information (Based on typical regulatory requirements for pulse oximeters, not directly from this document):

1. Table of Acceptance Criteria and Reported Device Performance: This would typically involve accuracy and precision metrics for SpO2 and pulse rate.

   • Acceptance Criteria (Example):
     • SpO2 Accuracy: Aroot mean square (ARMS) difference between the device reading and reference measurement ≤ 3.0% saturation for SpO2 values between 70% and 100%. Clinical bias (mean difference) might also be specified.
     • Pulse Rate Accuracy: Mean absolute difference (MAD) or ARMS difference between device reading and reference measurement ≤ 5 bpm for pulse rates between X and Y bpm.
   • Reported Device Performance: This would be the actual ARMS, bias, or MAD values achieved in the clinical study.

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

   • Sample Size: For SpO2 accuracy, typically involves at least 10-15 healthy adult volunteers for induced hypoxia studies (SpO2 levels typically varied down to ~70%). The number of measurements taken for each subject at various saturation levels would be substantial. Pediatric studies would involve a separate cohort.
   • Data Provenance: Prospective, controlled clinical study; likely performed in a clinical setting (e.g., hospital, specialized lab) where reference SpO2 can be accurately measured (e.g., using arterial blood gas analysis with a co-oximeter). Country of origin is often the manufacturing country or a location with appropriate facilities for such studies.

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

   • Not applicable for SpO2 and Pulse Rate accuracy. The "ground truth" for pulse oximetry is typically established through direct physiological measurements, not expert consensus.
   • For SpO2, the gold standard (ground truth) is typically arterial blood gas analysis using a co-oximeter. This is a direct laboratory measurement, not an expert visual assessment.
   • For Pulse Rate, the ground truth can be simultaneously recorded ECG or a direct arterial line measurement.

4. Adjudication method for the test set:

   • Not applicable for SpO2 and Pulse Rate accuracy. Adjudication is used when human interpretation is part of the ground truth establishment (e.g., reading medical images). Here, direct instrumental measurements provide the ground truth.

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

   • Not applicable. This device is a standalone measurement device, not an AI-assisted diagnostic tool that interprets complex data for human readers. Therefore, an MRMC study is irrelevant.

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

   • Yes, this is a standalone performance study. Pulse oximeters are designed to provide direct measurements, so their performance is inherently evaluated in a standalone manner. The device outputs SpO2 and pulse rate, and these outputs are compared against a reference standard.

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

   • For SpO2: Co-oximetry of arterial blood samples.
   • For Pulse Rate: Electrocardiogram (ECG) or arterial line measurement.

8. The sample size for the training set:

   • This information would not be relevant for a traditional pulse oximeter like this (JPD-500F). Pulse oximeters rely on optical principles and signal processing algorithms that are typically developed based on physiological models and empirical calibration, not machine learning algorithms that require large "training sets" in the sense understood in AI/ML contexts. The "calibration" would be performed during device design and manufacturing using established standards.

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

   • As above, not applicable in the AI/ML sense. Calibration procedures involve ensuring the device's optical sensors and algorithms accurately convert light absorption measurements into SpO2 and pulse rate, typically checked against known physical standards and reference instruments during development and manufacturing.

To summarize, while the provided document confirms the FDA clearance for the device, it lacks the detailed performance study information. The questions regarding expert consensus, adjudication, MRMC studies, and AI-like "training sets" are generally not applicable to the analytical performance evaluation of a pulse oximeter, which relies on comparing device output against direct physiological reference measurements.

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The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,

The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

The provided document is a 510(k) premarket notification for a medical device, specifically a Fingertip Pulse Oximeter (Model YK-81C). While it describes the device, its intended use, and a clinical study for SpO2 accuracy, it does not present a formal table of "acceptance criteria" for the device's performance in the typical sense of a pre-defined set of metrics that must be met. Instead, it describes compliance with recognized standards and presents the results of a specific performance test.

Here's an attempt to extract and synthesize the information based on your request, with an understanding that the document isn't structured around explicit "acceptance criteria" in a table format but rather demonstrates compliance and performance results.

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the relevant ISO standard for pulse oximeters regarding SpO2 accuracy.

Note on Acceptance Criteria: The document does not explicitly state an "acceptance criteria" value for the SpO2 accuracy (Arms) that the device must be less than or equal to. However, the study was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 "Procedure for invasive laboratory testing on healthy volunteers." This standard outlines the methodology for evaluating pulse oximeter accuracy, and the resulting Arms value is used to demonstrate performance. Typically, a lower Arms value indicates better accuracy, and regulatory bodies often have an expectation around this value based on the standard. For many pulse oximeters, an Arms value of 3.0% or less in the 70-100% range is often considered acceptable for regulatory clearance. The reported 2.53% falls within typical acceptable ranges.

II. Study Details

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

   • Sample Size: 12 healthy adult volunteer subjects.
   • Data Provenance: The study was conducted in a laboratory setting (likely in China, given the manufacturer's location, though not explicitly stated for the study site). It was a prospective study involving induced hypoxia.

2. 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 of experts used to establish ground truth or their qualifications.
   • The ground truth was established by arterial blood CO-Oximetry, a laboratory analytical method, not by human expert assessment.

3. Adjudication Method for the Test Set:

   • Not applicable / None directly stated. The ground truth (SaO2) was determined by an objective lab measurement (CO-Oximetry) of arterial blood samples, not by expert consensus or adjudication. The device's SpO2 readings were compared to these objective measurements.

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

   • No, an MRMC study was NOT done. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. For a pulse oximeter, the primary evaluation is device accuracy against a physiological reference.

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

   • Yes, in essence. The clinical trial evaluated the device's SpO2 accuracy performance by comparing its readings directly to arterial blood CO-Oximetry. While a human applies the device, the performance metric (Arms) is a direct measure of the device's algorithmic output against the physiological reference.

6. The Type of Ground Truth Used:

   • Outcomes Data / Physiological Standard (Arterial Blood CO-Oximetry): The ground truth for SpO2 accuracy was established by analyzing arterial blood samples using a reference CO-Oximeter, which provides functional SaO2. This is considered the gold standard for SpO2 accuracy assessment in pulse oximetry.

7. The Sample Size for the Training Set:

   • Not applicable / Not stated in the context of this document. This document describes a 510(k) submission for a finished medical device. The clinical study described is a validation study (test set) for the device's accuracy, not a study for training an AI model. Pulse oximeters typically rely on well-established physiological principles and calibrations, not 'training data' in the machine learning sense, although their internal algorithms are developed and refined using extensive data. The document focuses on proving the device's performance against a standard after its design and internal algorithms are finalized.

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

   • Not applicable. As mentioned in point 7, there's no "training set" described in the context of this 510(k) document. The device's internal algorithms would have been developed and calibrated by the manufacturer, likely using proprietary methods and data, but this information is not part of the regulatory submission's clinical performance evaluation.

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Fingertip Pulse Oximeter A310 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

Fingertip Pulse Oximeter A310 is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Finger 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 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. This equipment mainly composed of PCB board, On/Off button, mode button, OLED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device does not support the measurement in the condition of low perfusion. The device is not intended for life-supporting or life-sustaining. The device is reusable and does not need sterilization.

Here's a breakdown of the acceptance criteria and study details for the Fingertip Pulse Oximeter A310, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the SpO2 accuracy is ±3% for the range 70-100%, and the reported RMS values are all less than 3%, thus meeting this criterion. For Pulse Rate (PR) accuracy, the document states "complies with the declaration of specification at the normal condition," implying that the device met the stated accuracies of ±2 bpm (30-99 bpm) and 2% (100-235 bpm).

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

• Sample Size for Test Set: 12 healthy adult volunteers (8 men, 4 women).
• Data Provenance: The study was a clinical evaluation conducted on human subjects, implying a prospective study design. The country of origin is not explicitly stated, but the company is based in Milpitas, California, USA, suggesting the study likely took place in the USA or under US regulatory standards.

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

The ground truth for SpO2 was established using a laboratory CO-Oximeter on blood samples. While this is a highly accurate method, the document does not specify if human experts (e.g., lab technicians, doctors) were involved in interpreting or validating the CO-Oximeter results, or their specific qualifications if they were. The CO-Oximeter itself serves as the 'expert' in this context.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 was derived directly from blood samples analyzed by a CO-Oximeter, which provides objective measurements. There was no mention of multiple human readers or a consensus process for the SpO2 ground truth.

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

No, an MRMC comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the device against a CO-Oximeter, not on how human readers' performance might improve with or without AI assistance.

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

Yes, a standalone performance study was conducted. The clinical evaluation directly compared the SpO2 readings from the Fingertip Pulse Oximeter A310 (algorithm only, as it's a non-invasive device for automated measurement) against the ground truth established by a laboratory CO-Oximeter.

7. The Type of Ground Truth Used

The type of ground truth used for SpO2 accuracy was direct physiological measurement via a laboratory CO-Oximeter on arterial blood samples (SaO2). This is a highly accurate and objective form of physiological reference.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about a training process for the device's algorithm. For pulse oximeters, the core technology relies on established physical principles of light absorption by oxygenated and deoxygenated hemoglobin, rather than machine learning models that require explicit training sets. The "accuracy" is typically about calibration and hardware/software performance within these physical limits.

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

Not applicable, as no training set was mentioned.

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The Fingertip Pulse Oximeter MD300CG11/MD300CG51 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 with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.

The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working 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 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 devices are normally applied to adult, adolescent, child and infant in hospital and home environments.

The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.

The provided document describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CG11/MD300CG51 and its substantial equivalence to a predicate device (MD300CB3).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a detailed comparison table between the proposed devices (MD300CG11/MD300CG51) and the predicate device (MD300CB3). This table essentially serves as the acceptance criteria for the proposed device, demonstrating that its performance characteristics are substantially equivalent to the legally marketed predicate.

Key takeaway on acceptance criteria and performance: The acceptance criteria are implicitly defined by the specifications of the predicate device (MD300CB3). The reported performance shows that the proposed devices (MD300CG11/MD300CG51) meet or are substantially equivalent to these criteria. Minor differences in display type, direction, and SpO2 display/measurement range (99% vs 100%) are noted, but these are considered not to affect the substantial equivalence for regulatory purposes.

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 explicitly states: "Clinical Test: The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2."

Therefore, no clinical test set was used for the demonstration of substantial equivalence given the product's classification and similarity to the predicate. The device's performance was evaluated through non-clinical testing. The provenance of any underlying test data from these non-clinical tests is not specified, but the applicant company is based in China.

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

Since no clinical test set was used, there were no experts required to establish ground truth from clinical data. The accuracy claims for SpO2 and PR are based on engineering performance tests against established standards.

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

No adjudication method was used for clinical data as no clinical test set was deemed necessary.

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

This is not applicable. The device is a standalone medical device (Fingertip Pulse Oximeter) and does not involve AI assistance for human readers or interpretation of medical images.

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

Yes, the device's performance was evaluated as a standalone product. The non-clinical tests described (SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test, Performance Test after Disinfection, Shelf-life Test) evaluate the device's intrinsic performance against established standards like ISO 80601-2-61.

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

For the non-clinical performance tests, the "ground truth" is defined by the calibrated reference measurements and standards outlined in ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment. This standard specifies a method for evaluating pulse oximeter accuracy against a co-oximeter or other reference method under controlled hypoxia conditions. The document mentions that performance tests were conducted "in accordance with ISO 80601-2-61."

8. The sample size for the training set

This is not applicable. The Fingertip Pulse Oximeter is a hardware device that directly measures and displays physiological parameters. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense.

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

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

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