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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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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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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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Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospit, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.

The Nellcor™ OxySoft™ Neonatal/Adult SpO2 Sensor, OxySoftNHC monitors the amount of oxygen in the patient's blood (oxygen saturation) or SpO2 and pulse rate after applying the sensor on the finger, foot, or hand. The sensor utilizes a pair of light emitting diodes (LEDs) employing light at two wavelengths, and the time varying absorbance of the tissue due to the pulsatile blood signal is obtained, amplified from a photodiode to determine functional arterial oxygen saturation. A clinician will prescribe the sensor for use as spot check or continuous use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. The OxySoftNHC sensor can be used with all Nellcor™ compatible systems. The sensor consists of a sensor assembly and cable assembly and is provided sterile (EtO) and is meant for single use.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Device Name: Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN/OxySoftNHC

Study Details

The provided text describes several clinical and non-clinical studies to demonstrate the device's performance.

1. "MDT20002VALNIC: Performance evaluation of the OxySoftN neonatal sensor in the NICU compared to SaO2"

• Sample size: 27 patients (neonates)
• Data Provenance: Clinical study, prospective (data collected to evaluate sensor in NICU). No country of origin is explicitly stated, but clinical studies for FDA clearance are typically conducted in the US or in countries adhering to similar ethical and regulatory standards.
• Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis of simultaneously drawn arterial blood samples, which is an objective measurement.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
• Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard.
• Type of ground truth: Objective measurement (SaO2 values obtained from CO-oximeter analysis of arterial blood).
• Training set sample size: Not specified as this is a clinical validation study, not an algorithm training study.
• Training set ground truth: Not applicable.

2. "MDT20037CYBOXY: Validation of the OxySoftN to Determine the Gentleness on Fragile Skin"

• Sample size: Not explicitly stated but implied through "healthy elderly subjects."
• Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
• Experts for ground truth: Not applicable – ground truth involved objective measurements like evaporative water loss (TEWL) and skin protein disruption.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This study compared the subject device to the predicate device regarding skin gentleness.
• Standalone performance: Yes, it directly measured the device's effect on skin.
• Type of ground truth: Objective measurements (TEWL, amount of skin protein disruption).
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

3. "MDT20047OXSNOF: Sensor-Off Validation of the OxySoftN sensor in Healthy Adults"

• Sample size: Not explicitly stated but implied through "a sequence of steps for different sensor off configurations was performed per subject."
• Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
• Experts for ground truth: Not applicable – ground truth was the observation of whether a "Sensor Off" message appeared.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This was a standalone functional validation.
• Standalone performance: Yes, it evaluated a specific safety feature of the device.
• Type of ground truth: Objective observation (presence/absence of "Sensor Off" message within 1 minute).
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

4. "MDT20038CYBADH: Multiple Reposition Peel Adhesion on Human Skin Validation, OxySoftN"

• Sample size: Not explicitly stated but implied through "volar forearm of healthy adults."
• Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
• Experts for ground truth: Not applicable – ground truth was the objective measurement of peel adhesion.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This was a standalone functional validation.
• Standalone performance: Yes, it directly measured the adhesion performance.
• Type of ground truth: Objective measurement (peel adhesion after repositioning).
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

5. "MDT20028OXYLOV: SpO2 Accuracy Validation of the OxySoftN sensor via Reference CO-Oximetry in Healthy, Well-Perfused Subject"

• Sample size: "healthy adult subjects" - specific number not provided.
• Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
• Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis of simultaneously drawn arterial blood samples, and for pulse rate, via 3-lead ECG.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
• Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard.
• Type of ground truth: Objective measurement (SaO2 values from CO-oximeter; 3-lead ECG for pulse rate).
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

6. "MDT20006OXYVMT: SpO2 Accuracy Validation of the OxySoft sensor via Reference CO-Oximetry Motion Study"

• Sample size: "diverse subject population" - specific number not provided.
• Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
• Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
• Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard under motion and non-motion conditions.
• Type of ground truth: Objective measurement (SaO2 values from CO-oximeter).
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

General Notes on Training Sets:
For medical devices like oximeters, "training set" and "ground truth for training set" are typically relevant to machine learning algorithms. Pulse oximeters, as described, use a fundamental technology based on spectrophotometry and plethysmography, which are physics-based principles, not typically machine learning algorithms requiring explicit training data in the same way an AI diagnostic tool would. The performance data presented here are for validation and verification of the physical sensor and its underlying technology against established physiological standards and safety requirements.

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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 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.

As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.

The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin.

Four types of sensor housings are described in this submission:

• Reusable soft tip sensor comprised of an integrated silicone rubber tip.
• Reusable finger clip sensor with rigid halves and silicone pads
• Disposable non- adhesive sensor with sponge and velcro backing.
• Disposable adhesive sensors constructed of a medical tape laminate.

Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.

This document is a 510(k) summary for a pulse oximetry sensor (SpO2 Sensor), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and study design for an AI/ML device, such as sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.

The document states: "The subject and predicate devices are exactly the same. The sensors are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device." This indicates that the regulatory clearance is based on the device being identical to previously cleared devices, rather than on independent performance testing of a novel AI/ML algorithm.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or any of the other AI/ML specific information requested.

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The Reusable and Disposable 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 40kg. The sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

The proposed device, Reusable and Disposable SpO2 sensors are the accessory of the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), and it is used to attach the patient's finger and measure oxygenation of blood from detecting the infrared-light and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation values and heart rate conditions.

The Reusable and Disposable SpO2 sensors consist of compatible connectors, cable, and patient sensor terminal. And the optical components of sensor are designed to a light emitting diode and a light detector. Red and Infrared lights are shone through the terminal tissues. Then parts of the emitting lights are absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. The light detector detects the light volume transmitted through the tissues on the basis of blood pulse, then the microprocessor calculates a value for the oxygen saturation by measuring the absorbance of the wave peak and the wave trough. The saturation values are determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes a 510(k) premarket notification for reusable and disposable SpO2 sensors. It details performance data, including biocompatibility, electrical safety, EMC, and clinical studies. However, the document does NOT contain information about AI/ML models or their performance, nor does it specify acceptance criteria for such models, or the details of ground truth establishment by experts for AI/ML development.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML, as the provided text pertains to a standard medical device (SpO2 sensor) without any indication of AI components.

To answer your question accurately, I would need a document that describes the performance of an AI-powered medical device.

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The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile

The provided document describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR. This is not an AI/ML device, but a reprocessed physical sensor. Therefore, many of the typical acceptance criteria and study components for an AI/ML device (like an algorithm's performance, human reader improvement, expert consensus for ground truth on images, training sets, etc.) are not applicable here.

Instead, the study focuses on demonstrating substantial equivalence to an existing predicate device by showing that the reprocessed sensor meets performance specifications and safety standards similar to a new device. The "ground truth" here is the actual arterial oxygen saturation measured by a co-oximeter, and the "device performance" refers to the accuracy of the SpO2 sensor against this gold standard.

Here's an attempt to extract and reframe the information based on the prompt's requirements, noting where AI/ML specific criteria do not apply:

Device: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
Device Type: Reprocessed pulse oximeter sensor (physical hardware, not an AI/ML algorithm)

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, as a pulse oximeter, is its accuracy in measuring SpO2. This is evaluated against an established standard (ISO 80601-2-61:2011).

Note: "Arms" refers to the "Accuracy Root Mean Square" deviation, which is a statistical measure of accuracy for pulse oximeters.

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 10 healthy adult volunteer subjects.
   • Data Provenance: The study was conducted in a laboratory setting on healthy volunteers. The exact country of origin is not specified, but the context implies it's within the US, given the FDA submission. It was a prospective clinical trial.
   • Subject Demographics: Ages 25 to 36 years; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable in the typical AI/ML sense where human experts label images.
   • The ground truth for SpO2 was established invasively using a co-oximeter (arterial blood gas analysis), which is the gold standard for measuring arterial oxygen saturation. This does not involve human expert interpretation of images. The study followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections."

3. Adjudication Method for the Test Set:

   • Not applicable. This study is a direct comparison of the device reading against an objective, invasive gold standard (co-oximetry), not an interpretation that requires adjudication by multiple experts.

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

   • No. An MRMC study is relevant for AI/ML systems that assist human interpretation of medical images. This device is a sensor that directly measures a physiological parameter. The study focuses on the sensor's accuracy, not its impact on human reader performance.

5. Standalone (Algorithm Only) Performance:

   • Yes, but framed differently. This is a hardware device, not an algorithm. The "standalone performance" is the accuracy of the reprocessed sensor itself (Model MAXNAR) in measuring SpO2 and pulse rate against the co-oximeter standard, without further human interpretation other than reading the display. The reported performance of 2% SpO2 accuracy is this standalone performance.

6. Type of Ground Truth Used:

   • Outcomes Data/Physiological Measurement (Invasive Gold Standard): Arterial oxygen saturation (SpO2) measurements obtained via co-oximetry on arterial blood samples from healthy volunteers. This is considered the true physiological value.

7. Sample Size for the Training Set:

   • Not applicable. This isn't an AI/ML algorithm that requires a training set. The "training" for a reprocessed device involves the manufacturing and reprocessing procedures themselves, ensuring they meet the original equipment manufacturer's specifications and performance.

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

   • Not applicable. As above, no training set in the AI/ML context. The closest analogy would be the validation of the reprocessing methods to ensure the sensor performs "as new." This involves non-clinical tests (biocompatibility, disinfection, shelf life, electrical, tissue heating, pulse rate accuracy, active element assessment, adhesive peel, environmental testing, visual inspection, cleaning efficacy) to establish that the reprocessed device meets specifications. The clinical study mentioned verifies the final performance.

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The Disposable SpO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults in hospital environment.

The proposed device, Disposable SpO2 Sensor is an accessory to the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 cleared in K113623. The sensor shall be connected to its corresponding monitor through adapter cable model CK-03-452. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light are emitted through fingertips and received by a photodiode can be induced to change with pulse light intensity; the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The provided text is a 510(k) Summary for a Disposable SpO2 Sensor (K200069). It details the device's technical specifications, intended use, and comparison to a predicate device (K191279). The document also outlines the performance data submitted to support the substantial equivalence determination, including biocompatibility, non-clinical, and clinical studies.

Based on the provided text, here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a clinical hypoxia test conducted on human adult volunteers to validate the accuracy of the Disposable SpO2 Sensor against arterial oxygen saturation (SaO2) determined by co-oximetry. This clinical study was performed according to ISO 80601-2-61:2017 and FDA guidance for Pulse Oximeters - Premarket Notification Submissions.

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

• Sample Size: The document states "human adult volunteers" but does not specify the exact number of subjects used in the clinical hypoxia test.
• Data Provenance: The data is prospective clinical data obtained from human adult volunteers. The country of origin is not explicitly stated, but the applicant and correspondent are based in Shenzhen, China.

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

The document does not provide information about the number or qualifications of experts used to establish the ground truth. It states that arterial oxygen saturation (SaO2) was "determined by co-oximetry," which is a laboratory method, not typically an expert consensus per se.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The ground truth was established by co-oximetry.

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

No, an MRMC comparative effectiveness study was not conducted. This is a medical device, specifically a sensor, that provides a direct measurement, rather than an interpretation requiring multiple readers.

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

Yes, the clinical hypoxia test evaluated the standalone performance of the device's ability to measure SpO2. The device functions as a sensor with an algorithm to calculate SpO2 and PR, and the clinical study validated this algorithm's accuracy without a human explicitly "in the loop" for interpretation.

7. The Type of Ground Truth Used

The type of ground truth used was outcomes data / reference standard measurement, specifically arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is a highly accurate laboratory method for measuring various hemoglobin species, including SaO2.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a sensor and likely uses empirically derived algorithms and calibration, rather than a machine learning model that requires a distinct training set. The clinical study mentioned is for validation/testing.

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

As no training set is explicitly mentioned or implied for a machine learning model, the method for establishing its ground truth is not applicable in this context. The core algorithm for pulse oximetry is based on known physical principles of light absorption by blood components.

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The Disposable SPO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.

The proposed device, Disposable SpO2 Sensor is accessory to the oximeter, which is intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeter. It is only intended for adult. The sensor shall be connected with the corresponding monitor (Nellcor N-600). Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The provided text describes a 510(k) premarket notification for a Disposable SpO2 Sensor and includes information about its performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. While it states that clinical studies were conducted to verify accuracy and that the device complies with ISO 80601-2-61:2017, the specifics of those studies (sample size, ground truth methodology, expert qualifications, etc.) are lacking.

Therefore, I will extract what is available and indicate where information is not provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

• Sample Size (Test Set): Not specified.
• Data Provenance: Human adult volunteers, prospective study (clinical hypoxia test). Country of origin is not specified, but the submission sponsor and correspondent are based in Shenzhen, China.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The ground truth was established by "co-oximetry," which is an objective measurement rather than expert consensus on images.

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 an accessory device (SpO2 sensor) for an oximeter, not an AI-powered diagnostic system involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, the performance evaluation of the Disposable SpO2 Sensor for SpO2 accuracy and PR accuracy is a standalone assessment of the device's measurement capabilities. The clinical hypoxia test specifically aims to validate the accuracy of the device against a reference standard (co-oximetry). There is no "human-in-the-loop" component in the performance of the sensor itself, as it is a measurement device.

7. The type of ground truth used

• Type of Ground Truth: Arterial oxygen saturation (SaO2) as determined by co-oximetry, which is considered an objective, established medical measurement for blood oxygen levels.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning. The device's performance is verified through clinical testing against a reference standard rather than through algorithm training on a dataset.

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

Not applicable as no training set for a machine learning algorithm is discussed. The device is a direct measurement sensor.

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