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

The Flexi-Site 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 silicone casing. The sensor cable is terminated in a Hypertronics style connector.

Here is an analysis of the provided text regarding the acceptance criteria and the study that proves the Flexi-Site SpO2 Ear Sensor meets those criteria:

Device Acceptance Criteria and Performance

While the document explicitly states the "Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2", it does not provide a pre-defined acceptance criterion for this metric. The listed value of 3.84% is simply the result obtained from the performance testing. In a typical regulatory submission, there would be a target accuracy value (e.g., "Accuracy Ams shall be less than 4%"). However, based on the provided text, the 3.84% value implicitly met the FDA's unstated or assumed requirements for substantial equivalence to the predicate devices.

Study Details

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

   • Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies," but does not provide the number of subjects or data points included in these studies.
   • Data Provenance: The studies were "clinical hypoxia studies conducted in an independent research lab." While the country of origin is not specified, clinical hypoxia studies typically involve human subjects whose oxygen levels are carefully controlled. The phrasing "clinical hypoxia studies" implies a prospective study design where data was collected specifically for this purpose.

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

   • Number of Experts: Not applicable. The ground truth was established by laboratory co-oximetry, not by expert consensus.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The ground truth was established by direct comparison to arterial blood samples analyzed on a laboratory co-oximeter, a gold standard measurement, which does not typically involve expert adjudication in the same way imaging or subjective diagnostic tasks might.

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:

   • MRMC Study: No. This device is an SpO2 sensor, which provides automated measurements, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Yes, implicitly. The performance data presented (Accuracy Ams of 3.84%) refers to the device's measurement accuracy compared to a reference standard, without any explicit mention of human interpretation or intervention in the measurement process itself. The SpO2 sensor is an automated measurement device.

6. The type of ground truth used:

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

7. The sample size for the training set:

   • Sample Size: Not applicable. As an electro-optical sensor, the device's operation is based on established physical principles for light absorption by hemoglobin. It's not a machine learning or AI device that requires a training set in the conventional sense. Its "training" is in its design and calibration, not in learning from a large dataset.

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

   • Ground Truth Establishment: Not applicable, as no training set was used in the machine learning sense. The device's fundamental operating principles and calibration would be based on well-understood physiological and optical science.

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These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.

Here's a summary of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.

The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit.

The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.

The provided text describes a 510(k) summary for the Stat-Shell Disposable SpO2 Sensor. Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the Stat-Shell Disposable SpO2 Sensor in terms of specific performance metrics (e.g., accuracy ranges for SpO2 or pulse rate). Instead, it focuses on demonstrating substantial equivalence to a predicate device and meeting certain standards.

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

• Sample Size: The document does not specify a quantitative sample size for the "simulated use bench testing" or the other bench testing. It refers to "bench testing" in general terms.
• Data Provenance: The document does not provide details about the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be laboratory/bench testing rather than clinical study data.

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

This information is not provided in the document. The testing described is bench testing, not a clinical study involving expert assessment or ground truth derived from human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described is bench testing, not a clinical study involving human judgment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench testing to ensure substantial equivalence and adherence to standards, not a study evaluating human reader performance with or without AI assistance.

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

The device is an SpO2 sensor accessory to a pulse oximeter, which is inherently a sensor that generates a measurement. The "algorithm" or measurement capability resides within the pulse oximeter it connects to. The testing described is for the sensor itself to ensure it functions correctly as an input to the oximeter. Therefore, a standalone algorithm performance study in the sense of AI evaluation is not applicable or described. The performance of the sensor (mechanical, electrical, optical) was assessed.

7. The Type of Ground Truth Used

The ground truth for the bench testing would have been established by engineering specifications, calibration standards, and validated test equipment. For example, for "oximeter compatibility," the ground truth would be successful communication and accurate readings provided by the oximeter when connected to the Stat-Shell sensor, verified against known references or the predicate device's expected performance. For biocompatibility, EMC, and safety, the "ground truth" is adherence to established industry and regulatory standards.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.

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

This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.

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The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg.

The SpO2 Wrap Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 LED's and photodiode are contained in a flexible, L-shaped housing that is positioned over the desired patient digit and secured in place with a fabric wrap. The sensor cable is 3-12 feet in length and is terminated in DB-9 and Hypertronics style connectors.

This document is a 510(k) summary for a medical device (SpO2 Wrap Sensor), which typically outlines the device, its intended use, comparison to predicate devices, and a summary of performance data to demonstrate substantial equivalence. However, it does not contain a detailed study proving acceptance criteria with specific performance metrics as commonly found for AI/ML-based devices.

The document states: "Changes to the predicate device do not affect those aspects of the device related to accuracy. Changes to the photodiode's mechanical size affects the device's ability to be recognized by the compatible oximeter. Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode. Other bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility, EMC, safety, and pulse oximeter standards."

Based on the provided text, a detailed study with specific acceptance criteria and performance data for the SpO2 Wrap Sensor's core function (SpO2 and pulse rate accuracy) is not provided. The performance data discussed focuses on verifying that the modifications to the predicate device (housing/attachment and smaller photodiode) do not negatively impact accuracy and that the device meets existing standards.

Therefore, many of the requested details about acceptance criteria and study particulars for a new device's performance cannot be extracted directly from this 510(k) summary because the focus is on demonstrating substantial equivalence of a modified device, not proving the de novo performance of a novel device.

Here's an attempt to answer the questions based only on the provided text, with many fields indicating "Not N/A" or "Not Applicable" due to the nature of this particular 510(k) summary:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified. The document mentions "simulated use bench testing" and "other bench testing" but does not give a sample size for these tests.
• Data Provenance: Not specified. Testing appears to be bench testing.

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

• Not applicable. This type of device (SpO2 sensor) is typically validated against reference instrumentation or clinical measurements, not through expert ground truth establishment in the way AI/ML devices are validated.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are relevant for expert consensus on image interpretation or complex diagnostic tasks, which is not the nature of SpO2 sensor validation.

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 is not an AI/ML device, and no human reader study is mentioned or relevant for this type of medical device.

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

• Not applicable. This is not an AI/ML algorithm; it's an electro-optical sensor.

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

• Not explicitly stated, but for SpO2 sensors, ground truth is typically established by co-oximetry (arterial blood gas analysis) for oxygen saturation and ECG or invasive arterial pressure monitoring for pulse rate in clinical studies. For bench testing, it would involve calibrated reference instruments. The document only mentions "simulated use bench testing" and "other bench testing" without detailing the ground truth methodology.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors.

The Epic Medical Equipment Services. Inc. E403-09 SpO2Finger Sensor is a reusable clip-on finger sensor with the optical components, protected in a hard plastic case. It functions without skin penetration, electrical contact, or heat transfer. This electrooptical sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The E403-09 Finger 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 E403-09 is three feet in length and is terminated in a DB9 style connector as is the predicate sensor. The E403-09 is used with E710-09 10 foot cable which both extends the length of the E403-09 as well as adapts the DB9 connector to a Nicolay style connector which connects to the oximeter.

The E412-09 is equivalent to the E403-09 (3 foot) plus E710-09 (10 foot). The E412-09 is 12 feet long and terminates with a Nicolay style connector.

This document describes the 510(k) submission for the Epic Medical Equipment Services E403-09 SpO2 Finger Sensor. The information provided outlines the device's technical characteristics, non-clinical tests, and limited details on clinical tests.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the E403-09 SpO2 Finger Sensor. However, it indicates that the device's accuracy was established through comparison with blood samples analyzed on a multiwavelength hemoximeter. The conclusion states that "Clinical validation studies demonstrates the successful use of the sensor and its ability to provide accurate information."

Therefore, based on the provided text, the acceptance criterion implicitly relates to demonstrating accurate SpO2 measurements. No specific numerical performance metrics (e.g., accuracy range, bias, precision) are given in the summary.

Study Information

The document provides very limited details about the clinical study.

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but the study was described as "Controlled hypoxia studies."

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

• Not specified. The ground truth method was "blood samples analyzed on a multiwavelength hemoximeter," implying laboratory analysis rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by instrumental analysis ("multiwavelength hemoximeter") of blood samples, not by human expert review 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 finger sensor, not an AI-assisted diagnostic imaging device. No MRMC study was conducted or is relevant.

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

• Yes, this was a standalone performance study. The device's SpO2 measurements were compared directly against blood gas analysis, without human interpretation as part of the primary measurement pathway.

7. The Type of Ground Truth Used

• Clinical Ground Truth: Blood samples analyzed on a multiwavelength hemoximeter. This is a common and accepted method for establishing the ground truth for arterial oxygen saturation.

8. The Sample Size for the Training Set

• Not applicable. This device is a sensor and does not utilize machine learning or AI algorithms requiring a training set in the conventional sense. Its "training" or calibration would be inherent to its physical design and factory calibration processes rather than a data-driven training set.

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

• Not applicable, as there is no training set mentioned for this device.

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Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda, Novametrix 500, Novametrix Superbright, Spacelabs oximeter module, Criticare, BCI, Datascope.

Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring.

This document is a 510(k) clearance letter from the FDA for a medical device (Epic Series E100 SpO2 Finger Sensor). It does not contain the detailed acceptance criteria and study information typically found in a device's design validation report or clinical study summary.

Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not elaborate on the specific performance metrics or the studies conducted to demonstrate those metrics.

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