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Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

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

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

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

   • Not applicable. This device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

8. 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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Avidhrt Sense is a handheld spot-checking measurement device, indicated to do the following:
• Non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician).

Avidhrt Sense SpO2 is intended for use in adult patients in the home environment. The Avidhrt Sense SpO2 is not for continuous monitoring, use during motion or for patients with low perfusion. The Avidhrt Sense SpO2 is not intended for pediatric use.

Avidhrt Sense SpO2 is a handheld spot-checking measurement device designed for non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is used in conjunction Avidhrt Sense SpO2 smart phone app that displays the SpO2.

Here’s a breakdown of the acceptance criteria and study proving device performance for the Avidhrt Sense SpO2, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Note: The document states "satisfied the prespecified performance criteria" for the Arms values, indicating these reported values are within the acceptable limits.

Study Details Proving Device Meets Acceptance Criteria

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

• Sample Size: 12 healthy volunteer subjects.
• Data Provenance: The study was a "controlled hypoxia or desaturation study," which is typically a prospective, controlled clinical study conducted in a specialized lab environment. The country of origin is not explicitly stated in the provided text.

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

• This information is not explicitly stated in the provided text. For a controlled hypoxia study, the "ground truth" (arterial oxygen saturation, SaO2) is established by directly measuring blood gas samples using a co-oximeter, which is considered the gold standard. The experts involved would typically be medical professionals (e.g., physicians, nurses, lab technicians) trained in arterial blood draws and blood gas analysis.

3. Adjudication Method for the Test Set:

• Not applicable in the traditional sense for this type of study. Ground truth (SaO2) is directly measured from arterial blood samples. The document mentions "Two arterial blood samples were then obtained, approximately 30 seconds apart," which indicates a method to confirm stability, but not an adjudication of human-interpreted results.

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

• No, an MRMC study was not done. This type of study (comparative effectiveness of human readers with/without AI assistance) is relevant for AI-powered diagnostic imaging devices. The Avidhrt Sense SpO2 is a direct measurement device, and the clinical study focuses on its accuracy against a gold standard (arterial blood gas analysis) rather than improving human interpretation of complex data.

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

• Yes, the clinical study performed (controlled hypoxia study) is a standalone performance assessment of the device's SpO2 measurement accuracy without human interpretation as part of the primary outcome. The device's output (SpO2 readings) was directly compared against the ground truth.

6. The Type of Ground Truth Used:

• Expert Consensus/Pathology/Outcomes Data: Not used in this context.
• Direct Measurement from Arterial Blood Samples: The ground truth for SpO2 accuracy was established by obtaining arterial blood samples and analyzing them for oxyhemoglobin saturation (SaO2) at controlled, stable levels of induced hypoxia. This is considered the reference standard for oximeter accuracy studies (often referred to as co-oximetry).

7. The Sample Size for the Training Set:

• The document does not mention a separate "training set" or its sample size. For traditional medical devices like oximeters, the manufacturing and design process relies on known physiological principles and validated components rather than machine learning models that require distinct training data. If any internal optimization or calibration used patient data, it is not specified as a "training set" in the context of machine learning.

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

• Not applicable, as no dedicated "training set" (in the machine learning sense) is described or needed for this type of device according to the provided text. The accuracy validation is performed on a discrete test set against a clearly defined gold standard.

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The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.

The provided text is a 510(k) summary for a Pulse Oximeter (Models PO2, PO2A, PO2B) and does not contain information about an AI/ML-driven device. Therefore, it is not possible to describe acceptance criteria or a study related to an AI/ML device based on this document.

The document primarily focuses on demonstrating the substantial equivalence of the subject pulse oximeter to a predicate pulse oximeter (K191088 Checkme O2 Pulse Oximeter) by meeting established performance standards for pulse oximeters, such as ISO 80601-2-61.

Here's an analysis based on the information available in the document, demonstrating why it doesn't fit the AI/ML framework you've described:

General Device Performance (Pulse Oximeter):

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal "acceptance criteria table" in the context of an AI/ML model. Instead, it provides a comparison table of the subject device's specifications and performance metrics against a predicate device.

   Characteristic	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Subject Device)
   SpO2 Accuracy (70-100%)	±2%	1.77% ARMS
   Pulse Rate Accuracy	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)
   SpO2 Measurement Accuracy (ARMS)	≤ 2% (from ISO 80601-2-61)	1.77%
   Work Mode	Spot-check and continuous data collection (not continuous monitoring)	Spot-check and continuous data collection (not continuous monitoring)
   Intended Application Site	Finger	Finger

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

   • Test Set Description: The "clinical validation testing of the SpO2 performance" was conducted on "healthy adult volunteers."
   • Sample Size: The exact number of healthy adult volunteers is not specified in the document.
   • Data Provenance: The document states "Measured values are from a controlled lab study in healthy volunteers." It does not specify the country of origin. The study appears to be prospective, as it involved actively testing subjects with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable to this device. For a pulse oximeter, "ground truth" for SpO2 and pulse rate is established using a co-oximeter and ECG (or similar reference standard) on induced hypoxia studies, as per ISO 80601-2-61. There are no "experts" in the AI/ML sense establishing ground truth labels for images or other complex data. The "ground truth" clinical values are collected by qualified personnel trained in conducting such studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. For a pulse oximeter, the reference measurements from the co-oximeter are the ground truth, and human adjudication is not part of the process.

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 question is not applicable. The device is not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This question is not applicable in the context of an AI/ML algorithm. The performance of the pulse oximeter itself (which contains an algorithm to calculate SpO2 and PR from optical signals) was evaluated in a standalone manner against reference standards in the clinical study. The device's performance is inherently "standalone" in its measurement function, as it provides direct numerical outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For SpO2 accuracy, the ground truth was arterial oxygen saturation measured by a co-oximeter (from blood samples) during induced hypoxia, as per ISO 80601-2-61. For pulse rate, the ground truth would typically be derived from an electrocardiogram (ECG) monitor. This is a physiological reference standard, not expert consensus or pathology.

8. The sample size for the training set:
   This question is not applicable. The document describes a traditional medical device (pulse oximeter) that uses a pre-defined algorithm based on physical principles (absorption of red and infrared light). It does not mention any "training set" for an AI/ML model. The "algorithm" for SpO2 calculation is based on principles of spectroscopy and physiological models, not machine learning from a dataset in the way a deep learning model would be trained.

9. How the ground truth for the training set was established:
   This question is not applicable for the same reasons as #8. There is no training set for an AI/ML model described.

In summary, the provided document details the regulatory clearance for a traditional medical device (pulse oximeter) based on established performance standards, and therefore, the questions tailored for AI/ML device evaluations are generally not relevant.

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The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver.

The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.

The provided text is a 510(k) Summary for the Aulisa Oximeter Module (2nd Gen.). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the full study design and results of performance evaluations in the granular detail requested.

However, based on the information provided, here's an attempt to extract the relevant details for the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "The SpO2 accuracy data were calculated using the Accuracy root-mean-square (ARMS) and the results which indicated that the subject device had an ARMs less than 3 digits during steady-state conditions over the range of 70-100% were in compliance with the specified performance claimed by the manufacturer." This is the primary performance claim related to SpO2 accuracy.

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

• Sample Size: The document only states "The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects." It does not specify the number of subjects (sample size).
• Data Provenance: The document does not explicitly state the country of origin. It describes the test as a "clinical evaluation," implying a prospective study.

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

This information is not provided in the document. For an oximeter, "ground truth" for SpO2 is typically established by arterial blood gas analysis, which does not involve experts in the same way as, for example, image interpretation.

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

This information is not applicable/provided as the "ground truth" for SpO2 accuracy in oximetry is typically established by a direct comparison to a reference standard (e.g., co-oximetry of arterial blood samples), not by expert adjudication.

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

This is not applicable. The Aulisa Oximeter Module is a device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic tool that requires human readers for interpretation. Its performance is evaluated against reference standards, not human readers.

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

Yes, the SpO2 accuracy evaluation (against ISO 80601-2-61 and FDA Guidance) would be considered a standalone performance test of the device's ability to measure SpO2. The device directly measures and outputs these values, so its performance is inherently "standalone."

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

The ground truth for SpO2 accuracy in oximetry studies is typically established using arterial blood gas analysis (specifically, co-oximetry) as the reference standard, allowing for precise measurement of arterial oxygen saturation. This is implied by the reference to ISO 80601-2-61, which outlines these methodologies.

8. The sample size for the training set

This information is not applicable/provided. This device is a hardware oximeter module that directly measures physiological signals and processes them to derive SpO2 and pulse rate. It does not appear to involve a machine learning model that would require a separate "training set" in the common sense of AI/ML development. Its "training" would be more akin to calibration and algorithm refinement based on engineering principles and physiological models.

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

As per point 8, this is not applicable.

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Models: U403-91, U410-91 Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile. The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.

The Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) are subject to the following acceptance criteria and the performance study described was conducted to prove the device meets these criteria. It's important to note that the provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a full clinical trial report for novel device approval.

1. Table of Acceptance Criteria and Reported Device Performance

Note¹: The document states that according to ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent, despite the difference in stated accuracy metrics for pulse rate.

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

• Sample Size:
  • Clinical Study Test Set: 12 human adult volunteers.
  • Data Points: The clinical study contains "more than the minimum 200 data points."
• Data Provenance:
  • The document implies the clinical study was conducted by or on behalf of Unimed Medical Supplies Inc., which is based in China. The data provenance regarding the country of origin of the study conduct is therefore likely China or an authorized testing facility.
  • The study involved clinical hypoxia tests, which are prospective in nature, as they involve actively inducing hypoxia in volunteers to collect data on sensor performance.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. However, for pulse oximetry accuracy studies involving induced hypoxia, the ground truth (arterial oxygen saturation, SaO2) is typically established by co-oximetry readings from arterial blood samples, which are analyzed by laboratory equipment. This process relies on the accuracy of the co-oximeter and the proper drawing and handling of blood samples by trained medical personnel. It doesn't involve subjective expert consensus in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable. For pulse oximetry accuracy studies using induced hypoxia and co-oximetry, the ground truth is an objective physiological measurement from a laboratory instrument (co-oximeter) from arterial blood samples. There is no human adjudication process involved in establishing this ground truth, unlike with subjective visual assessments in imaging.

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

No. The provided document details a clinical study to validate the device's standalone accuracy against established physiological measurements (co-oximetry) in human volunteers. It is not an MRMC study comparing human reader performance with and without AI assistance, as the device is a sensor for measuring physiological parameters, not an AI-powered diagnostic imaging tool.

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

Yes. The clinical hypoxia test described is a standalone performance test for the Unimed Reusable Finger Clip SpO2 Sensors. The study directly assesses the device's ability to accurately measure SpO2 against the ground truth (SaO2 from co-oximetry) without human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / physiological measurement, specifically:

• Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood for pulse oximeter accuracy studies.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For medical device premarket notifications like this, the focus is on a verification/validation study (the "clinical study" mentioned here) rather than an AI/machine learning model where distinct training and test sets are common. The device is a sensor, not a machine learning algorithm that undergoes a training phase.

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

As this is a sensor device and not an AI/ML model, there isn't a "training set" in the typical sense for which ground truth would be established for model training. The "ground truth" (SaO2 via co-oximetry) was established for the 12-subject clinical validation study as described above.

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The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in 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 device is prescription only.

The subject device AVITA Pulse Oximeter with Bluetooth is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

The provided text is a 510(k) Summary for the AViTA Pulse Oximeter (SP62B). It addresses medical device regulation, but it does not describe acceptance criteria and a study that proves the device meets specific acceptance criteria in the manner requested (e.g., in the context of an AI/ML algorithm's performance).

Instead, the document details the equivalence of the new device to a predicate device based on various non-clinical performance and safety tests, and a clinical validation of SpO2 performance.

Therefore, I cannot fully answer your request based on the provided text because the information specifically about "acceptance criteria and a study that proves the device meets the acceptance criteria" for an AI/ML device's performance, including details like sample size for test sets, data provenance, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, is not present.

The document mentions "acceptance criteria" generally for biocompatibility tests, electrical safety, and EMC testing, but not for an AI/ML performance study as implied by your detailed questions.

Here's what can be extracted and inferred from the text regarding the device's overall performance validation, with limitations noted:

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

The document states performance specifications rather than explicit acceptance criteria in a table format for each test, but the overall statement is that the device "met the acceptance criteria" for various tests. For SpO2 accuracy, the performance is explicitly stated.

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

• Test set sample size: For the clinical performance testing, it mentions "healthy, adult volunteers." The exact number (sample size) is not specified in the provided text.
• Data provenance: "healthy, adult volunteers." The country of origin is not specified. The study was prospective as it involved clinical validation testing.

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

• This information is not applicable in the context of a pulse oximeter's SpO2 accuracy against a reference measurement. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements (co-oximetry) in a controlled desaturation study, where the ABG is the direct, objective ground truth. Expert readers are not usually involved in establishing ground truth for SpO2 values.
• The document implies the adherence to ISO 80601-2-61 for clinical performance, which outlines the methodology for such studies.

4. Adjudication method for the test set:

• Not applicable/Not specified. For SpO2 accuracy, the "ground truth" is typically the co-oximeter measurement from arterial blood, not a subjective interpretation requiring adjudication.

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

• No. This is not an AI/ML device for diagnostic image interpretation. It is a pulse oximeter measuring physiological parameters.

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

• Not applicable in the AI/ML sense. The device itself is "standalone" in that it directly measures SpO2 and PR; it's not an AI algorithm assisting a human interpreter.

7. The type of ground truth used:

• For SpO2 accuracy, the ground truth is implied to be co-oximetry measurement from arterial blood gas (ABG), as is standard for pulse oximeter validation according to ISO 80601-2-61. The document states "Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

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

• Not applicable. (See point 8)

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Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile. The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensors have identical material composition and performance characteristics to the predicate device.

Here's a breakdown of the acceptance criteria and study information for the Unimed Reusable Finger Clip SpO2 Sensors, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that the clinical study was conducted with "human adult volunteers," including "sufficient darkly pigmented subjects." However, the exact number of subjects (the sample size) is not specified.
• Data Provenance: The data is prospective as it was collected in a "clinical study... under an approved protocol with subject informed consent." The country of origin is not explicitly stated, but the submission is from "Unimed Medical Supplies Inc." located in "Shenzhen, China." It's reasonable to infer the study was conducted there or arranged by their organization.

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

The document mentions that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used to establish the ground truth. This is a direct physiological measurement and does not involve human expert interpretation for ground truth establishment. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was established by co-oximetry, which is an objective measurement, not a subjective interpretation requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an oximeter sensor, which directly measures physiological parameters (SpO2 and pulse rate). Its performance is evaluated against a gold standard method (co-oximetry), not by comparing human reader performance with and without AI assistance.

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

Yes, the clinical study performed appears to be a standalone (algorithm only) performance evaluation. The device, an SpO2 sensor, directly provides measurements. The study evaluated the accuracy of these measurements against a reference method (co-oximetry) without integrating a human in the loop for interpreting the device's output.

7. Type of Ground Truth Used

The ground truth used was outcomes data (physiological measurements), specifically "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is considered a clinical gold standard for measuring blood oxygen levels.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device (SpO2 sensor), not an AI/machine learning algorithm that requires a training set. The device operates based on physical principles (two-wavelength relative optical absorption) and is validated through clinical performance against a reference standard.

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

Not applicable. As the device is not an AI/machine learning algorithm, there is no training set and therefore no ground truth established for a training set.

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The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1001 Series Digital Vital Sign Monitoring System (K182822) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device flashes LED light as a visual alarm signal, to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play. The subject device contains an Oximeter Box and an Oximeter Sensor resulting in device configuration and model names as listed below.

The provided text describes the acceptance criteria and performance study for the Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018).

Here's the breakdown of the information requested:

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

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

• Sample Size: The document does not explicitly state the exact number of subjects used in the clinical evaluation. It mentions "healthy male and female, light to dark skinned subjects."
• Data Provenance: The study was a clinical evaluation conducted on human subjects. The details on the specific country of origin are not provided, but it pertains to the validation of a device manufactured by "Taiwan Aulisa Medical Devices Technologies, Inc." The study is prospective in nature, as it is a "clinical evaluation for SpO2 accuracy was conducted on healthy male and female..."

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

The document does not provide information about experts establishing ground truth for the test set or their qualifications. The clinical evaluation describes measuring SpO2 and pulse rate on subjects, which implies comparison against a reference oximeter or arterial blood gas measurements, but doesn't detail the expert review process for ground truth.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

The primary clinical testing described is a standalone performance evaluation of the device's SpO2 accuracy against a reference method (likely arterial blood gas measurements, standard for pulse oximeter accuracy testing per ISO 80601-2-61), without a human-in-the-loop aspect being assessed. The device itself automatically measures and transmits data.

7. The type of ground truth used

The ground truth for SpO2 accuracy in the clinical evaluation was established by comparing the device's measurements against a reference method, typically arterial blood gas measurements (which are the gold standard for SpO2 calibration and accuracy testing in pulse oximetry, as implied by compliance with ISO 80601-2-61). The reported metric is Accuracy root-mean-square (ARMS).

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. For pulse oximeters, the development and verification typically involve laboratory calibration and then human clinical studies for validation. If any internal model training occurred, those details are not provided in this 510(k) summary.

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

As no specific training set is mentioned for data-driven model training, the method for establishing its ground truth is not applicable or provided in this document. The device's performance is validated through clinical evaluation in accordance with established standards for pulse oximeters.

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The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.

The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.

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

The document provided is a 510(k) Premarket Notification from the FDA for a Pulse Oximeter. It describes the device, its intended use, and a comparison to a predicate device, including non-clinical and clinical data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria Table and Reported Device Performance

• IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-11 Edition 2.0 2015-01
• ISO 80601-2-61: 2017
  (Statement of compliance, not a numerical performance metric, beyond the clinical accuracy which is detailed elsewhere). Electrical safety explicitly stated: "Conformed to IEC60601-1, IEC 60601-1-11". |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • FS20P: 10 healthy female adult volunteer subjects.
  • FS20C: 13 healthy adult volunteer subjects.
• Data Provenance: The studies involved volunteer subjects, implying prospective data collection. The document does not specify the country of origin of the study data, but the submitting company is based in China, so it is highly likely the studies were conducted there. The subject skin tones (Fitzpatrick 1-6) suggest a diverse population, but this is a characteristic, not a location.

3. Number of Experts and Qualifications for Ground Truth

• The document describes a clinical study for SpO2 accuracy compared to arterial blood CO-Oximetry. This is a direct physiological measurement, implying that no human expert adjudication was used to establish the ground truth for SpO2. The CO-Oximeter itself is the "expert" or gold standard.
• Therefore, the concept of "number of experts" for ground truth establishment, as typically applied to image-based diagnostic AI, is not directly applicable here.

4. Adjudication Method for the Test Set

• None, as the ground truth was established by direct physiological measurement using a CO-Oximeter, which is considered a gold standard for SpO2. No human adjudication process (like 2+1 or 3+1) was necessary or mentioned for the SpO2 values.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance.
• For a pulse oximeter, the device directly measures physiological parameters (SpO2 and PR). The clinical study focused on validating the device's accuracy against a gold standard (arterial blood CO-Oximetry), not on improving human reader performance.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The clinical studies directly measured the device's (i.e., the pulse oximeter's algorithm/measurement system) SpO2 accuracy (ARMS) against a gold standard (arterial blood CO-Oximetry). The reported ARMS values (1.70% for FS20P and 1.71% for FS20C) are metrics of the device's standalone performance.

7. Type of Ground Truth Used

• The ground truth used was outcomes data / physiological measurement, specifically arterial blood CO-Oximetry. This method provides a direct, highly accurate measurement of arterial oxygen saturation, serving as the gold standard for SpO2.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. For a traditional medical device like a pulse oximeter, particularly one based on well-established principles of optical measurement, there isn't typically an "AI training set" in the sense of machine learning. The device's calibration and design would be based on engineering principles and potentially internal validation data, but not typically a labeled "training set" like an AI performs. The studies described are for validation/testing the accuracy of the final device.

9. How Ground Truth for the Training Set Was Established

• This question is not applicable as there is no mention of an "AI training set" or a separate training set in the context of this device's submission. The described clinical studies are for performance validation (test set), not for training an algorithm.

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EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.

The EvieWED Ring is a rechargeable noninyasive wearable is an open arrow design that allows for a snug fit and comfort during fluctuations in fluid retention and/or weight changes. There is an optical sensor that collects physiological signals and an app that processes the signals and provides spot SpO2 and pulse rate (PR) measurements during a spot check on a user's connected iOS phone. The ring is designed to be worn continuously and is waterproof, allowing the user to wear the device during handwashing, showering, and bathing without damaging the ring.

The EvieMED Ring is designed for accurate pulse oximeter readings inside of a clinical setting. The device is for a single user but can be used for many users, with the rechargeable battery in the ring and the charger expected to last 2 years or more. The device is not life-sustaining or life-supporting and does not include alarms. It is not indicated for use in motion or in conditions of low perfusion.

The device is supplied in a labeled box that includes a wearable, a charger, a USB-C cable, and a quick start guide. The ring is provided in common ring sizes (e.g., US 5 through US 12). Operation of the device depends on connection to the user's device running iOS 16.0 and above where the EvieWED Ring Mobile Application has been installed and registered, and a user-supplied AC adaptor is required for recharging the charger.

The provided text describes the acceptance criteria and the study conducted for the EvieMED Ring, a pulse oximeter. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Eleven (11) healthy young adults (3 male, 7 female). The text also mentions "4 rings/subject" and approximately "25 samples/subject" for a total of 816 pooled samples.
• Data Provenance: The study was conducted at an "independent lab" with subjects placed into "controlled hypoxia." This suggests a prospective, controlled clinical study. The country of origin is not explicitly stated but is implicitly within the US context given the FDA submission.

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

The text describes an "IRB-approved SpO2 accuracy study" where "SaO2 and test samples were taken" and "SaO2 data was compared to the test (SpO2) data." This strongly implies that arterial blood gas (SaO2) measurements were used as the gold standard/ground truth. There is no mention of human experts establishing ground truth for this type of accuracy study; it relies on the direct physiological measurement from arterial blood.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct physiological measurement (arterial blood gas) and statistical comparison, not expert consensus or adjudication.

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

No, an MRMC study was not performed. This device is a standalone pulse oximeter, and the study focused on its accuracy compared to a physiological gold standard, not on human reader performance with or without AI assistance.

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

Yes, this was a standalone performance study. The device's SpO2 and pulse rate readings were directly compared to a reference measurement (SaO2 from arterial blood) without a human interpretation loop.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / direct physiological measurement specifically, arterial blood gas (SaO2) measurements. Subjects were desaturated under controlled conditions, and their SaO2 was measured directly and compared to the device's SpO2 readings.

8. The Sample Size for the Training Set

The document does not specify a training set size. The described study is a clinical validation study on a test set, performed to demonstrate the accuracy of the device. For a device like a pulse oximeter, the core algorithm for SpO2 calculation is typically based on established biophysics and signal processing, often refined and designed during internal development rather than being "trained" on a large dataset in the machine learning sense, at least not in a way that would be detailed in a 510(k) summary focused on validation. If machine learning was used, the training data would be internal to the company and not usually disclosed in this summary.

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

Not applicable, as a specific "training set" and its ground truth establishment are not described in this regulatory submission summary. The accuracy study described is a clinical validation (test set) study.

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