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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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The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 kg.

The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. 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 contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

The provided document describes a 510(k) summary for the Flexi-Stat SpO2 Sensor, indicating its substantial equivalence to a predicate device for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. However, the document does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets those criteria in a format that allows for the extraction of all the requested information.

Here's an analysis of what can and cannot be extracted from the provided text, based on your questions:

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

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points.
• Data Provenance:
  • Country of Origin: Not specified. It mentions studies conducted "in an independent research lab," but the location of this lab is not given.
  • Retrospective or Prospective: Not specified, but "clinical hypoxia studies" typically imply a prospective design where the device is tested on subjects under controlled conditions.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "ground truth" was established by "arterial blood samples analyzed on a laboratory co-oximeter," which implies laboratory personnel or medical professionals were involved in sample collection and analysis, but their qualifications are not detailed.

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

• Adjudication Method: Not applicable/not specified. For an SpO2 sensor, the "ground truth" is typically a direct physiological measurement (co-oximetry) rather than an interpretation requiring adjudication among human experts.

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

• MRMC Comparative Effectiveness Study: No. This type of study is not relevant for an SpO2 sensor, which provides direct physiological measurements rather than aiding human readers in interpreting images or complex data. The device itself is a measurement tool, not an AI-assisted diagnostic aid for interpretation.

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

• Standalone Performance: Yes, in terms of the device's measurement accuracy. The clinical hypoxia studies directly compared the Flexi-Stat's measurements to the co-oximeter’s results, indicating its performance as a standalone measurement device. There is no "human-in-the-loop" aspect to analyze beyond a clinician using the device.

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

• Type of Ground Truth: Arterial blood samples analyzed on a laboratory co-oximeter. This is a direct physiological measurement and considered the gold standard for arterial oxygen saturation.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. The device is a traditional electro-optical sensor, not an AI/ML algorithm that requires a "training set" in the machine learning sense. Its design and calibration would be based on engineering principles and physiological models, not data-driven training.

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

• How Ground Truth for Training Set was Established: Not applicable. As mentioned, this is not an AI/ML device that uses a "training set" with established ground truth in the typical sense.

Summary of what the document implies about the study:

The document indicates that Elekon Industries, USA, Inc. conducted "clinical hypoxia studies in an independent research lab" where the Flexi-Stat SpO2 Sensor was "compared to arterial blood samples analyzed on a laboratory co-oximeter." The conclusion was that the device was "found to be equivalent to predicate device accuracy claims." This suggests a prospective, controlled clinical study designed to assess the accuracy of the SpO2 sensor against a gold standard (co-oximetry) under varying oxygen saturation levels induced by hypoxia. However, specific details such as the number of subjects, the range of SpO2 values tested, the statistical methods used, or the actual accuracy data (e.g., bias, precision, A-rms values) are not provided in this summary. The assessment focuses on demonstrating substantial equivalence to a predicate device, rather than detailing the full performance characteristics of the new device.

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The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. 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 contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

The provided document describes the Mediaid SpO2 Sensor and its clearance. However, it does not include detailed acceptance criteria or a comprehensive study report with all the requested information. The document focuses on demonstrating substantial equivalence to predicate devices based on a clinical hypoxia study and other tests.

Here's the information that can be extracted and a summary of what is not present:

Missing Information:

• Specific numerical acceptance criteria for SpO2 accuracy (e.g., A_rms value, range of acceptable deviation).
• Specific numerical acceptance criteria for pulse rate accuracy.
• The exact "reported device performance" against those criteria.
• Sample size used for the test set beyond "2 or subjects" which is likely a typo for "20 subjects".
• Data provenance details like country of origin for the clinical hypoxia study.
• Number of experts, their qualifications, or adjudication methods for ground truth, especially for the clinical hypoxia study.
• Whether an MRMC comparative effectiveness study was done, or its effect size.
• Sample size for the training set or how its ground truth was established, as this is a standalone device without an explicit AI/ML component described for training.

Available Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format with numerical criteria and corresponding reported performance. The document generally states that the device was "found to be equivalent to predicate sensors" and "2 or [likely "20"] subjects" were tested.

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

   • Sample Size (Test Set): "2 or subjects" (likely a typo, intended to be "20 subjects")
   • Data Provenance: Clinical hypoxia studies conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The study was retrospective or prospective is not stated, but clinical hypoxia studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not specified. The ground truth was established by an "arterial blood co-oximeter." Experts might have been involved in the operation or interpretation, but their role in establishing "ground truth" (beyond operating the co-oximeter) is not detailed.

4. Adjudication method for the test set: This information is not specified.

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: An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this context, as the device is an SpO2 sensor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance was evaluated in a standalone manner as an SpO2 sensor. The "clinical hypoxia studies" compared the sensor's readings to arterial blood co-oximetry. It's an algorithm-only performance in the sense that the sensor produces a reading directly.

7. The type of ground truth used:

   • For oxygen saturation (SpO2): Arterial blood co-oximeter
   • For pulse rate: Samples were analyzed on a "facorater J ou vi [likely a typo for a type of device or method] performed to verify pulse rate accuracy." Further details on this are not provided.

8. The sample size for the training set: This is a physical sensor, not an AI/ML model that typically requires a "training set" in the computational sense. Therefore, this concept does not apply directly to the information provided. The development process would involve calibration and internal testing, but not a "training set" as understood in a machine learning context.

9. How the ground truth for the training set was established: See point 8. Not applicable in the context of this device and information provided.

Summary of Device Performance Study (as described):

The Mediaid SpO2 Sensors were evaluated through "clinical hypoxia studies" conducted in an "independent research lab."

• Methodology: The SpO2 sensors were compared directly to an "arterial blood co-oximeter," which served as the ground truth.
• Outcome: The sensors were "found to be equivalent to predicate sensors" based on this comparison.
• Pulse Rate: "Samples analyzed on a facorater J ou vi performed to verify pulse rate accuracy."
• Other Tests: Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.

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The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The Flexi-Stat SpO2 Sensor is indicated for use in patients weighing >30 kg.

The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. 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 contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

Here's a breakdown of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated. The text mentions "clinical hypoxia studies" without specifying the number of subjects.
• Data Provenance: Clinical hypoxia studies conducted in an independent research lab. The country of origin is not specified, but the submission is from Elekon Industries, USA, Inc.

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. However, the ground truth was "arterial blood samples analyzed on a laboratory co-oximeter," implying that experts in laboratory co-oximetry would have been involved in analyzing these samples.

4. Adjudication method for the test set:

• Not applicable. The ground truth was established through direct comparison with arterial blood samples analyzed on a co-oximeter, not through expert consensus 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:

• Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic tool for which MRMC studies are typically performed. The study focused on the sensor's accuracy compared to a reference standard.

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

• Yes, in essence. The performance testing described is standalone for the device. The Flexi-Stat SpO2 sensor's readings were compared directly to the ground truth from arterial blood samples without human interpretation being part of the device's measurement process, though human operators would connect and read the oximeter display. The focus was on the sensor's accuracy.

7. The type of ground truth used:

• Reference Standard: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.

8. The sample size for the training set:

• Not applicable / Not specified. This device is a physiological sensor, not a machine learning algorithm that typically requires a distinct training set. The performance testing validates its function.

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

• Not applicable. As a non-AI physiological sensor, there isn't a "training set" in the machine learning sense. The ground truth for performance evaluation was established by comparing sensor readings to concurrently drawn and analyzed arterial blood samples using a laboratory co-oximeter.

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