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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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