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TS-F-D
The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds)

TS-E-D
The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)

TS-W-D
The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds)

TS-SE-3
The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are singlepatient use. Patient weight range All patients

TS-AF-10 and TS-AF-25
The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients

Trusignal SpO2 Interconnect cables
The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.

Pulse oximeter sensors and interconnect cables connecting to patient monitors

Here's a breakdown of the acceptance criteria and the study details for the TruSignal® SpO2 Sensors and Interconnect Cables, based on the provided 510(k) summary:

1. Acceptance Criteria and Device Performance

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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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