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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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The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).

The sensor shall be connected with its corresponding monitor. 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 pulse rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

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

This device is a Reusable SpO2 Sensor, an accessory to patient monitors used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document specifically details performance criteria and claims for SpO2 and PR accuracy compared to a legally marketed predicate device.

Note: The document emphasizes substantial equivalence to the predicate device, meaning the new device's performance is demonstrated to be equivalent to a device already cleared by the FDA. The performance data presented are in direct comparison to the predicate's stated specifications.

Study Details Proving Device Meets Acceptance Criteria:

The information provided is typical for a 510(k) submission, focusing on demonstrating substantial equivalence rather than a detailed standalone clinical study report.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, the specific number of adult volunteers (sample size) used for the clinical accuracy testing is not provided in this summary.
• Data Provenance: The data appears to be prospective clinical data gathered specifically for this submission, as indicated by "Clinical testing has been performed under an approved protocol with subject informed consent." The country of origin for the data is not explicitly stated, but the submitting company and correspondent are based in Shenzhen, China.

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

• This information is not provided in the document. For pulse oximetry clinical studies, ground truth is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment or interpretation.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of medical images or data where subjective decisions are made. For a pulse oximetry study where ground truth is established by a quantitative measurement (co-oximetry), traditional adjudication methods as described are not applicable.

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

• No, an MRMC study was not done. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in diagnostic imaging. This device is a sensor, and its accuracy is assessed quantitatively against a gold standard (co-oximetry), not through human reader interpretation. Therefore, questions about an effect size of human readers improving with AI assistance are not applicable to this type of device and study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes, in essence. The clinical accuracy study ("Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry") assesses the performance of the device (including its internal algorithm for calculating SpO2 and PR) against a gold standard. While the device outputs data for human use, the accuracy assessment itself is effectively a standalone performance evaluation of the sensor and its processing capabilities.

7. The Type of Ground Truth Used:

• The ground truth used for the clinical accuracy testing was arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set:

• This information is not provided in the 510(k) summary. For medical devices, particularly sensors, "training set" is often interpreted as the data used during the development and calibration of the device's algorithms. The summary focuses on the validation data (clinical studies) rather than internal R&D or algorithm training data.

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

• As the sample size and specific details of a "training set" (in an AI/ML context) are not explicitly mentioned for this device's development, the method for establishing ground truth for any such internal data is not provided. However, it is inferred that similar, highly accurate methods (like co-oximetry) would have been used during the sensor's design and calibration phases to ensure its foundational accuracy.

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The Disposable and 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 40 kg at hospital facilities.

The proposed device, Disposable and Reusable SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeters or patient monitors. The SSD-001-W09AN sensors is disposable while the SS-010-AF10 and SS-018-AF10 sensors are reusable. They are only intended for adult.

The sensor shall be connected with its corresponding monitor. 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).

Here's an analysis of the provided information regarding the acceptance criteria and study for the Disposable SpO2 Sensors and Reusable SpO2 Sensors:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the acceptance criteria for SpO2 and Pulse Rate (PR) accuracy, and it reports that the device meets these requirements.

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

• Sample Size: 12 human adult volunteers were used for each clinical study (there were two studies). This means a total of 24 human adult volunteers were used for the two studies combined.
• Data Provenance: The studies were described as "Clinical hypoxia test results obtained in human adult volunteers." The document doesn't specify the country of origin, but it implies a prospective clinical study using induced hypoxia.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. It only states that the ground truth for arterial oxygen saturation (SaO2) was "determined by co-oximetry."

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication method used for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sensor, and the clinical study focuses on its accuracy against a gold standard (co-oximetry) rather than a comparison of human reader performance with and without AI assistance.

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

Yes, the accuracy tests described are effectively a standalone performance evaluation of the device. The device itself (sensor and its internal algorithms for calculating SpO2 and PR) is directly compared against the ground truth (co-oximetry) measurements. There's no human 'reading' or interpretation of the sensor's output being evaluated in this context, other than potentially reading the numerical display that the device provides.

7. The Type of Ground Truth Used

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is a recognized gold standard for measuring oxygen saturation in blood.

8. The Sample Size for the Training Set

The document does not mention the sample size for any training set. Given that this is a sensor (hardware with embedded algorithms) rather than a software-as-a-medical-device (SaMD) based on AI/Machine Learning that typically requires extensive re-training, it's possible that a distinct "training set" as understood in deep learning contexts was not highly relevant or explicitly documented. The development process likely involved calibration and verification, which might use internal datasets not explicitly labeled as "training."

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

Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models.

The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).

This document describes the validation of SpO2 Sensors. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." While the specific number of volunteers is not explicitly stated in this summary, it is implied that a sufficient number participated to "validate the accuracy."
• Data Provenance: The data was obtained from clinical hypoxia tests conducted in human adult volunteers. The document does not specify the country of origin, but the submitting company is based in China. The study appears to be prospective as it involves active testing on human subjects.

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

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth. It states that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used as the ground truth. This suggests that the ground truth was established through a gold standard measurement technique rather than human expert interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by co-oximetry, which is a direct measurement, not an interpretation requiring adjudication.

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

No. This study is for an SpO2 sensor, not an AI or imaging device where human readers would interpret results. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance

Yes, in a sense. The primary performance evaluation (SpO2 and Pulse Accuracy) is an assessment of the device's ability to measure these parameters against a known ground truth (arterial oxygen saturation by co-oximetry). While the sensor is an accessory to an oximeter, its accuracy is evaluated inherently as a standalone measurement component interacting with the human body to produce data.

7. Type of Ground Truth Used

The ground truth used was outcomes data/physiological measurement. Specifically, "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a laboratory method considered a gold standard for measuring oxygen saturation in arterial blood.

8. Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (SpO2 sensor), not an AI algorithm that requires a separate training set. The device's underlying principles are based on established physics (red and infrared light absorption of hemoglobin), not machine learning from a large dataset.

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

Not applicable, as there is no training set mentioned or implied for this type of medical device.

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

The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor.

The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

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 sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda).

The Unimed Disposable and Reusable SpO2 Sensors were evaluated through clinical testing, specifically a clinical hypoxia study, to establish their accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the clinical test results but does not provide a table with specific numerical acceptance criteria or detailed performance metrics like accuracy range (e.g., A_rms value) against arterial oxygen saturation (SaO2). It broadly states that "Clinical test results support device accuracy claims for the specified saturation range."

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers."

• Sample Size: Not explicitly stated, though it refers to "human adult volunteers" (plural), indicating more than one.
• Data Provenance: The study was "prospective" as it involved "clinical hypoxia test results obtained in human adult volunteers" under an "approved protocol with subject informed consent." The country of origin of the data is not specified.

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

This information is not provided in the document. The ground truth (SaO2) was determined by co-oximetry, which is a laboratory measurement. While experts would be involved in performing and interpreting co-oximetry, the document doesn't detail their number or qualifications as it pertains to establishing the ground truth for the test set.

4. Adjudication Method for the Test Set:

This is not applicable as the ground truth was established by co-oximetry, which is a quantitative measurement, not a subjective interpretation requiring adjudication among experts.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device itself against a clinical standard (co-oximetry), not on how human readers improve with or without AI assistance.

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

Yes, the clinical hypoxia test evaluated the standalone performance of the Unimed Disposable and Reusable SpO2 Sensors. The study assessed the device's accuracy in continuously monitoring SpO2 and pulse rate against arterial oxygen saturation (SaO2) determined by co-oximetry. There is no mention of a human-in-the-loop component in this specific clinical test.

7. The Type of Ground Truth Used:

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective laboratory measurement from arterial blood samples.

8. The Sample Size for the Training Set:

This information is not provided. The document describes a clinical "validation" study (test set), not a study focused on training a model.

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

This information is not provided. As mentioned above, the document describes a validation study for the device, not a training study for an algorithm.

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Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients in hospitals, hospital-type facilities, mobile, and home environments.

The Envisen Disposable and Reusable SpO2 Sens ors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors.

Envisen Reusable Oximeter Sensors ar e finger clip type sensors with specifications validated to meet the requirements for compatibility with each specified manufacturer ser ies. Ea ch finger clip is comprised of a plastic shell with silic one pads which position the optical components to measure throught he finger, and a cable with manufacturer specific connector.

Envisen Disposable Oximeter Sensors consist of adhesive medical tape assemblies which are provide d in three different configurations for application on a dult, pediatric, and infant patients. Each sensor uses a cable with manufacturer specific connector.

sensors are labeled for c ompatibility for a specific All manufacturer/monitor series and includes the following elements:

• 트 Optical and electronic specifications specific to the monitor type
• Connector configuration specific for the monitor type 트

Sensor labeling clearly specifies the manufacturer/monitor type with two compatibility statements:

• . Compatibility label attached to the sensor cable
• Compatibility information provided on the instructions for use. .

Both reusable and dispos able sensors utilize configurations (finger clip, adhesive tapes) which have wide industry and clinical acceptance.

The provided text describes a 510(k) summary for the Envisen Disposable and Reusable Oximeter Sensors. While it states that clinical testing was performed to validate accuracy, it does not provide specific acceptance criteria or detailed results of that study.

Therefore, I cannot fulfill all parts of your request with the given information. I can, however, extract what is available regarding the study and what is missing.

Missing Information:
The document does not explicitly state the acceptance criteria for the device's performance. It only states that clinical hypoxia test results were obtained "to validate the accuracy" and that clinical test results "support device accuracy claims for the specified saturation range."

Here's what can be extracted and what is missing in relation to your request:

1. Table of acceptance criteria and reported device performance

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

• Sample Size for Test Set: "human adult volunteers" - Specific number not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the clinical study, but the submitting company is Envisen Inc. in Shenzhen, China.
  • Retrospective or Prospective: "Clinical testing has been performed under an approved protocol with subject informed consent." This phrasing strongly suggests a prospective study.

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

• Number of Experts: Not applicable as the ground truth was "arterial oxygen saturation (SaO2) as determined by co-oximetry," not an expert reading.
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication method: Not applicable. The ground truth was objective measurement via co-oximetry, not 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

• MRMC Study: No. This device is an oximeter sensor, not an AI-assisted diagnostic imaging device requiring human reader interpretation. The clinical study focused on the device's standalone accuracy against a physiological gold standard.

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

• Standalone Performance: Yes, implicitly. The clinical hypoxia test evaluated the "accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's performance against a gold standard, without human interpretation as part of the primary measurement.

7. The type of ground truth used

• Type of Ground Truth: Physiological measurement - "arterial oxygen saturation (SaO2) as determined by co-oximetry."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. Oximeters are typically calibrated during manufacturing and their performance is based on established biophysical principles, not on a "training set" in the machine learning sense. The clinical study described is a validation, not a training activity.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set for this type of device.

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EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.

The EnviteC Reusable SpO2 Sensors type Nihon Kohden are pulse oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturer.

EnviteC's Reusable SpO2 Sensors type Nihon Kohden are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Two types of sensor housings are offered in this submission:

• A soft rubber finger sensor with unitary sealed tube type construction (two sizes: large and medium)
• An ear clip with rigid halves positioned by mild spring force and an ear hanger for the cable

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer.

Each sensor type includes the following features:

• Connector pin-outs specific for the manufacturer type
• Component specifications specific for the manufacture type

Each sensor clearly specifies the manufacturer type with two compatibility statements:

• One printed on or attached to the sensor
• One on the instructions for use.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states that "All sensors met the acceptance criteria" for non-clinical tests and that "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2." However, it does not provide the specific numerical acceptance criteria for SpO2 accuracy or other performance metrics. Without these, a detailed table cannot be created.

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

The text states that "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO2 Sensors type Nihon Kohden under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry."

• Sample Size for Test Set: Not explicitly stated. The text mentions "subjects," but no number is provided.
• Data Provenance: Not explicitly stated, but the testing was performed "under an institutionally approved protocol with subject informed consent," suggesting a prospective clinical study. The country of origin is not specified, though the submitter is from Germany.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. However, the ground truth was "determined by cooximetry," which is a laboratory method, not typically established by clinical experts in the same way, for example, diagnosing an image. The cooximetry results themselves would serve as the objective ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by cooximetry, an objective measurement, not by expert consensus requiring an adjudication method.

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

• Was it done?: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described focuses on the direct accuracy of the device against an objective measurement (cooximetry), not on human reader performance with or without AI assistance.
• Effect size of human readers improvement: Not applicable, as no MRMC study was performed.

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

Yes, a standalone study was performed. The clinical testing described directly assesses the sensor's performance ("performance and accuracy of the EnviteC Reusable SpO2 Sensors") against an objective ground truth (arterial oxygen saturation determined by cooximetry). This is a direct test of the device's accuracy without a human in the loop for interpretation or intervention.

7. Type of Ground Truth Used

The ground truth used was cooximetry, which provides an objective measurement of arterial oxygen saturation (SaO2).

8. Sample Size for the Training Set

Not applicable. The device is a medical sensor (SpO2 sensor), not an AI algorithm that requires a training set. The "training" in this context would refer to calibration or manufacturing parameters, not a data-driven machine learning step.

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

Not applicable, as there is no training set in the AI/machine learning sense for this type of device.

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The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.

Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).

Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients

Philips Disposable SpO2 Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.

Not Found

The provided text discusses regulatory approval for Philips SpO2 sensors but does not contain information about acceptance criteria or a study proving device performance against specific criteria. The document describes a 510(k) submission for a labeling change to add compatibility with non-Philips monitors. The testing mentioned in the document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry sensors functionality meets all reliability requirements and performance claims." However, it does not provide details on specific acceptance criteria values, reported device performance metrics, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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