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The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and - if under clinical supervision-home environments. The SenTec Digital Monitoring System is for prescription use only.

The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only.

The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

SenTec's Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes are too small to ensure adequate sensor application.

SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatic, and neonatal patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon doxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-MI, are for single use.

SenTec's Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use.

V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/ or trend reporting and statistical analysis of data measured by the SDM is required. V-STATS is not intended to provide diagnosis; it is intended to supplement and not to replace any part of the SDM monitoring procedures.

Device Description

The SenTec Digital Monitoring System (SDMS) as listed under K101690 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], the digital sensors V-Sign™ Sensor (model VS-A/P) and its successor V-Sign™ Sensor 2 (model VS-A/P/N), connecting cables, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR) using the ear lobe, forehead or cheek as monitoring site in adult and pediatric patients. It is furthermore designed for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites. V-STATS™ is an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS.

The additions and expanded indications of the SenTec Digital Monitoring System (SDMS) introduced by this new 510(k) submission are summarized below:

This new 510(k) submission expands the intended use of the SDMS by introducing non- invasive, transcutaneous oxygen (tcPO2) by measuring the oxygen partial pressure (PO2) as new monitoring parameter to the SDMS. Introducing the tcPO2 parameter includes updated firmware versions of the existing SenTec Digital Monitor (SDM) and the introduction of a new digital sensor (OxiVenT™ Sensor, see below).
This new 510(k) submission introduces SenTec's OxiVenT™ Sensor, model OV-A/P/N. The - OxiVenT™ Sensor is a combined sensor for the continuous measurement of transcutaneous oxygen (tcPO2), as well as the previously cleared measurement of transcutaneous carbon dioxide (tcPCO2), oxygen saturation (SpO2) and pulse rate (PR).
V-Sign™ Sensor 2 (model VS-A/P/N) has been cleared under K101690. This new 510(k) submission expands the intended use by introducing new SpO2/PR measurement sites in adult and pediatric patients: Next to the already existing measurement sites on the forehead and cheek, new the upper arm and area on the back above the shoulder blade are added.
This new 510(k) submission expands the intended use of the Multi-Site Attachment Rings, models MAR-MI and MAR-SF, approved under K101690 and K071672. to attach the new OxiVenT™ Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninyasive carbon dioxide and/or oxygen tension monitoring is required for adult. pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the V-Sign™ Sensor 2 or the new OxiVenT™ Sensor to the forehead, cheek, as well as the new pulse oximetry (SpO2/PR) measurement sites upper arm as well as on the shoulder blade.
This new 510(k) submission introduces the Staysite™ Adhesive pad (REF SA-MAR), an additional adhesive pad that can be used optionally if more secure attachment is required – the pad is attached on top off the Multi-Site Attachment Rings (MAR-SF/MI).
The V-STATS™ PC software for trend data reporting and remote monitoring (cleared in K101690) has been updated to version 4.00 in order to incorporate download and display of the new PO2 parameter.

In total, the modifications, additions, and enhancements described above represent the step-wise evolution of the SenTec Digital Monitoring System (SDMS) to provide improved monitoring as well as expanded measurement and reporting capabilities. A traditional 510(k) has been selected instead of a special 510(k) because some of the changes affect the indications for use.

AI/ML Overview

The provided text describes the SenTec Digital Monitoring System (SDMS) and its modifications/expansions, focusing on proving its substantial equivalence to predicate devices. However, it does not explicitly
detail a randomized controlled trial (RCT) or a specific study that includes all the requested elements for acceptance criteria and device performance in a summary table format. Instead, it references various tests and studies conducted to ensure compliance with standards and demonstrates performance.

Here's an attempt to extract and synthesize the information based on your request, as much as possible from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of what you'd typically expect for a clinical study with primary and secondary endpoints. Instead, it lists technical specifications and accuracy claims, often comparing them to predicate devices. The "reported device performance" is given as meeting these specified accuracy requirements or being equivalent to predicate devices.

Metric / Parameter	Acceptance Criteria (Implicit from Predicate/Claims)	Reported Device Performance (SDMS with V-Sign™ Sensor 2 and/or OxiVenT™ Sensor)
SpO2 Accuracy	V-Sign™ Sensor 2: 70 - 100%: ± 2% (Arms) for all approved sites.OxiVenT™ Sensor: 70 - 100%: ± 2.25% (Arms) for all approved sites.< 70%: unspecified. (These are the claims, acting as acceptance criteria for the new device as they align with/are compared to the predicate's claims)	V-Sign™ Sensor 2: 70 - 100%: ± 2% (Arms).OxiVenT™ Sensor: 70 - 100%: ± 2.25% (Arms).Results from clinical studies show that "reported saturation values from the SDMS meet specified accuracy requirements." (Implies meeting the claimed ranges).
PR Accuracy	± 3 bpm (Claimed)	± 3 bpm."Bench performance testing verified that the SenTec Digital Monitoring System (SDMS) measures pulse rate values within specified accuracy claims for all supported sensor types."
PCO2 Drift	typically < 0.5%/h (Claimed, aligned with predicate)	typically < 0.5%/h
PCO2 Linearity	typically < 1.0 mmHg (0.13 kPa) (Claimed, aligned with predicate)	typically < 1.0 mmHg (0.13 kPa)
PO2 Drift	< 0.1%/h (Claimed)	< 0.1%/h
PO2 Linearity	< 1 mmHg (0.1 kPa) (Claimed)	< 1 mmHg (0.1 kPa)

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

Test Set Sample Size: The document states that "Clinical studies were performed using the SenTec Digital Monitoring System (SDMS) with healthy adult volunteer subjects". However, it does not specify the exact number of subjects or cases (sample size) used in these clinical studies.
Data Provenance: The studies were conducted with "healthy adult volunteer subjects." The country of origin is not explicitly stated. The studies are described as "Clinical studies," implying prospective data collection for the purpose of this submission.
- Retrospective/Prospective: Based on the description ("Clinical studies were performed..."), the data appears to be prospectively collected for the purpose of demonstrating device performance for this regulatory submission.

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

The document primarily discusses technical performance and accuracy against a reference standard rather than expert-established ground truth for a diagnostic interpretation.

For SpO2 monitoring, the ground truth was "arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference." This is a high-precision instrument-based reference, not an expert panel.
For PCO2 and PO2, comparison is made against the performance of predicate devices or established technical specifications. There's no mention of experts establishing a diagnostic ground truth.

Therefore, this section is not applicable in the traditional sense of diagnostic AI studies requiring expert interpretation.

4. Adjudication Method for the Test Set

As the ground truth for the clinical studies was established using a CO-Oximeter (a reference instrument) for SpO2 and technical specifications/predicate device performance for other parameters, there was no need for an adjudication method by expert reviewers. This section is not applicable.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies described are focused on the device's accuracy against a physical reference standard, not its impact on human reader performance or diagnostic accuracy.
Effect Size: Not applicable, as no such study was performed or described.

6. Standalone Performance

Yes, a standalone performance study was done. The described "Clinical studies" and "Bench Performance testing" assess the device's accuracy and performance in measuring physiological parameters (PCO2, PO2, SpO2, PR) independently. The results (e.g., SpO2 accuracy of ± 2% for V-Sign™ Sensor 2 and ± 2.25% for OxiVenT™ Sensor for 70-100% range against CO-Oximeter, PR accuracy of ± 3 bpm, PCO2/PO2 drift and linearity) are indicative of the device's standalone performance.

7. Type of Ground Truth Used

SpO2: Arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference. This is an objective, instrument-based reference standard.
PCO2, PO2, PR: Performance claims are evaluated against technical specifications and comparison to predicate devices. While not explicitly stated as "ground truth" for each specific study, the acceptance of these metrics implies internal validation against established physical or chemical reference methods for sensor calibration and accuracy.

8. Sample Size for the Training Set

The document describes the device as a "SenTec Digital Monitoring System (SDMS)," which is a hardware-based medical device with integrated software/firmware for physiological monitoring. This is not an AI/ML device in the context of typical training sets for models. Therefore, the concept of a "training set" in the machine learning sense is not applicable to this device as described.

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

Since there is no "training set" for an AI/ML model in the context of this traditional medical device submission, this question is not applicable.

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