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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

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The Fingertip Pulse Oximeter (Wireless) are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during nomotion condition.

The main function of the Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings. The Fingertip Pulse Oximeter (Wireless) is also built in with a Bluetooth low energy (BLE) function to perform data transmission.

The provided documentation is for a 510(k) premarket notification for the Leadtek Fingertip Pulse Oximeter (Wireless). It establishes substantial equivalence to a predicate device (K193350) and does not present detailed new clinical study data for the subject device beyond referencing the predicate. Therefore, some of the requested information cannot be fully provided from the given document as it refers to the predicate device's clinical testing.

Here's a breakdown of the requested information based on the provided text, focusing on the subject device's demonstrated performance and criteria where available, and referencing the predicate device's clinical study for SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)

For the SpO2 accuracy, the document explicitly states that no new clinical testing was performed for the subject device because its pulse oximetry algorithm and measuring technology are the same as the predicate device (K193350). Therefore, the clinical data refers to the predicate device's clearance.

The document does not provide the specific sample size, country of origin, or whether the study was retrospective or prospective for the predicate device's clinical test. It only states that "A clinical study was conducted on the predicate device for K193350 clearance to demonstrate the safety and performance."

For non-clinical performance and wireless coexistence, these were laboratory-based tests and not human clinical studies.

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)

This information is not provided in the document. As the clinical study was for the predicate device and the details are not elaborated here, the specifics of ground truth establishment and expert qualifications are absent. Typically, for pulse oximeter accuracy studies, arterial blood gas measurements (co-oximetry) performed by trained medical personnel serve as the reference standard (ground truth).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document.

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 Fingertip Pulse Oximeter, which directly measures physiological parameters (SpO2 and pulse rate). It does not involve "human readers" interpreting images or data that would be enhanced by AI assistance in the way an MRMC study would assess. The "Wireless" aspect refers to data transmission, not AI-driven interpretation.

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

Yes, the core SpO2 and pulse rate measurement algorithm performs in a standalone manner. The device outputs direct measurements based on light absorption. The "Wireless" functionality is for data transmission, not for an AI algorithm interpreting the results for a human. The non-clinical performance testing validated the algorithm's accuracy (Arms value

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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.

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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.

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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 Leadtek Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition.

The main function of the Leadtek Fingertip Pulse Oximeter is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking. The Fingertip Pulse Oximeter determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Leadtek Fingertip Pulse Oximeter (K193350).

Key Takeaways from the Document:

• This device is a Fingertip Pulse Oximeter intended for non-invasive spot checking of SpO2 and pulse rate in adults and adolescents.
• It's seeking Substantial Equivalence (SE) to a predicate device (Onyx Vantage 9590, K112843).
• The primary performance evaluation is for SpO2 accuracy and Heart Rate (HR) accuracy.
• The device's performance is gauged against recognized a standard: ISO 80601-2-61:2011 (Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: A total of 10 subjects were enrolled for the clinical evaluation.
• Data Provenance:
  • Country of Origin: Not explicitly stated in the provided text.
  • Retrospective or Prospective: The clinical evaluation was "conducted," implying a prospective study where data was collected for this submission. The text doesn't mention the use of pre-existing data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document describes a clinical evaluation where SpO2 accuracy was measured against a reference method (likely arterial blood gas analysis, though not explicitly stated, this is standard for pulse oximeter accuracy studies).
• It does not mention the use of "experts" in the sense of human readers interpreting data, as would be common for an AI/imaging device. The ground truth for pulse oximetry is derived from instrumental measurements, not human interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the ground truth for SpO2 accuracy is typically established by invasively measured arterial oxygen saturation (SaO2) via co-oximetry, not by human adjudication of readings from the device itself.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. For a pulse oximeter, the core performance is algorithmic (device output) and doesn't involve human interpretation to the same degree. The study here focuses on the device's accuracy against a clinical reference standard.

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

• Yes, a standalone performance evaluation was indeed done. The clinical evaluation specifically assessed the "Leadtek Fingertip Pulse Oximeter" and its "SpO2 accuracy" and "performance results" against a reference standard. This is the direct, unassisted performance of the device's algorithm.

7. The Type of Ground Truth Used

• The ground truth for SpO2 accuracy was established through clinical evaluation conducted in accordance with ISO 80601-2-61. This standard typically requires comparing the device's SpO2 readings with values obtained from a reference co-oximeter measuring arterial oxygen saturation (SaO2) in desaturation studies. The document states "The functional oxygen saturation (SpO2) measurements were validated in accordance with ISO 80601-2-61." and that the accuracy was "calculated using the root-mean-square (Arms)." This strongly implies direct physiological measurements from subjects desaturated to various SpO2 levels.

8. The Sample Size for the Training Set

• The document does not mention a "training set" or "training data." This device is a traditional medical device (hardware with embedded software for signal processing and calculation), not an AI/Machine Learning model in the modern sense that typically requires a large training dataset distinct from a test set. The performance validation relies on the device itself as a complete system, built according to specified engineering principles, and then tested for accuracy and safety.

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

• Not applicable, as no separate "training set" is described or implied for this type of device and its validation.

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The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospital-type facilities, home environments, and transport.

The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients.

The subject device, MightySat Rx, was previously cleared under K150314 as a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (PR), calculation of Perfusion Index (Pi) and optional Pleth Variability Index (PVi) in adults and pediatrics. The current submission concerns the MightySat Rx's measurement of respiration rate through photoplethysmogram analysis (designated as RRp).

Like the secondary predicate (K150314), the device is a spot check pulse oximeter and does not include alarms. The device has the combined function of a pulse oximeter monitor and a reusable sensor. It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries.

The MightySat Rx also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices, such as a smartphone.

1. Acceptance Criteria and Reported Device Performance (RRp Measurement):

2. Sample Size and Data Provenance for Test Set:

• Prospective Study: 28 healthy volunteers. Data provenance is not explicitly stated but implies a controlled clinical setting, likely within the US given the FDA submission.
• Retrospective Study: 59 hospitalized subjects. Data provenance is not explicitly stated but implies a clinical setting, likely within the US.

3. Number and Qualifications of Experts for Ground Truth:

The document states that the RRp measurements were compared against "manual, clinician-scored capnograms." The number of clinicians and their specific qualifications (e.g., years of experience, specialty) are not provided in this document.

4. Adjudication Method for Test Set:

The adjudication method for establishing ground truth is not explicitly stated beyond "manual, clinician-scored capnograms." It does not mention whether multiple clinicians were used or if a specific adjudication process (e.g., 2+1, 3+1) was employed.

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

No MRMC comparative effectiveness study is mentioned for the RRp measurement. The studies described are focused on the standalone performance of the device.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the RRp measurement. Two clinical tests were performed to validate the accuracy:

• A prospective analysis on 28 healthy volunteers.
• A retrospective analysis on 59 hospitalized subjects with different clinical conditions.

7. Type of Ground Truth Used:

The ground truth used for the RRp measurement was "manual, clinician-scored capnograms" obtained from a Capnostream20 device (K060065). This indicates a form of expert consensus based on instrument readings.

8. Sample Size for Training Set:

The document does not explicitly state the sample size used for the training set for the RRp algorithm. It mentions that the technology change for RRp is a "software change which utilizes the same hardware as the secondary predicate," and that "the primary predicate and subject device both rely on the technological principle of respiration-induced variations in the photoplethysmogram." This suggests that the algorithm likely learned from data that exhibits these physiological variations, but the specific training dataset size is not provided.

9. How Ground Truth for Training Set was Established:

The document does not explicitly describe how the ground truth for the training set was established. It notes that "both devices rely on the technological principle of respiration-induced variations in the photoplethysmogram," and references a scientific paper on multiparameter respiratory rate estimation. This implies that the algorithm's development (and thus its training, if applicable) was based on established physiological principles and potentially data where these variations were known or measured by other validated methods. However, the exact method for establishing ground truth for any potential training set is not detailed.

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The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospital-type facilities, and home environments.

The AS-301/AS-302/AS-301-L/AS-302-L/AS-303/AS-304/AS-304-L/AS-311 Fingertip Pulse Oximeter manufactured by ACURIO provides noninvasive blood oxygen measurement by the dual-wavelength spectrophotometric technique, and shows the results by the OLED. The oximeter is easy to operate, small in volume, light in weight, convenient in carrying, low consumption in design and with strong resistance to ambient light interference. 2pcs of AAA batteries can be continuously used for 20 hours, and the battery voltage can be indicated. The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults in hospitals, hospital-type facilities, and home environments.

The components of the oximeter include the body part and a hanging rope.

Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger), to a receiver on the other side. Two beams of different wavelength of lights (660nm red and 895nm near infrared light) can be focused onto a human nail tip through c clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.

The provided text describes the 510(k) summary for the AS-3XX Series Fingertip Pulse Oximeter. Here's a breakdown of the requested information:

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

The acceptance criteria for the SpO2 accuracy are implicitly defined by the ISO 80601-2-61 standard, stating that the error should be "far less than the scope specified in the STANDARD." The reported performance is summarized by the "root-mean-squared (Arms value) for all subjects." The standard typically requires an Arms value of ≤ 3% for SpO2 in the range of 70-100%. While the exact Arms value is not explicitly stated, the text indicates compliance.

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

• Sample size for test set: 10 healthy, nonsmoking, light-to-dark-skinned subjects.
• Data provenance: The study was a prospective clinical hypoxia accuracy testing (controlled desaturation study) conducted in an "independent research laboratory." The country of origin is not explicitly stated, but the submission is from a Chinese company (Xiamen Acurio Instruments Co., Ltd).

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)

No experts were used to establish the ground truth in the traditional sense of medical image interpretation. The ground truth for oxygen saturation (SaO2) was established objectively through blood samples analyzed by a CO-oximeter.

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

There was no adjudication method involving multiple human readers, as the ground truth was based on objective measurements from a CO-oximeter.

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 such MRMC comparative effectiveness study was done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a standalone performance study was conducted. The device's measured SpO2 values were compared directly against the SaO2 values obtained from blood samples via a CO-oximeter. The study evaluates the algorithm's (device's) accuracy independently.

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

The type of ground truth used was objective laboratory measurement: arterial hemoglobin oxygen (SaO2) values determined from blood samples with a CO-oximeter.

8. The sample size for the training set

The document does not explicitly mention a "training set" or "training data" in the context of an algorithm or AI development. Pulse oximeters operate on established physical principles (dual-wavelength spectrophotometry). Any internal calibration or parameter optimization would typically be part of the device's design and engineering, rather than a distinct "training set" as understood in machine learning.

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

As there is no explicit mention of a training set in the AI/machine learning sense, this information is not provided. The device's operation is based on physical principles of light absorption by hemoglobin, not on a machine learning model that requires a labeled training dataset in the same way.

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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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