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The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.

The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+

The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.

The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:

• "No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
• "The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."

Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.

For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.

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

Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.

4. Adjudication Method for the Test Set

Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.

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

The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.

7. The Type of Ground Truth Used

For the non-clinical aspects:

• Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
• Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
• Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
• Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
• Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.

For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.

8. The Sample Size for the Training Set

The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.

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

As no new training set for algorithms was used in this submission, this question is not applicable.

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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.

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.

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.

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PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.

The provided document describes the PeriFlux 6000, a transcutaneous oxygen/carbon dioxide monitor, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with safety and performance standards. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the way typically expected for an AI/ML device.

The information provided is largely about regulatory compliance, intended use, device description, and comparison to predicate devices, rather than a detailed performance study with quantitative acceptance metrics.

Therefore, I cannot directly extract the full requested information about acceptance criteria and a study proving device performance as it's not present in the provided text. I will address the points that can be inferred or are explicitly stated, and note where information is missing.

Summary of Acceptance Criteria and Device Performance for PeriFlux 6000

The provided document describes the regulatory submission for the PeriFlux 6000, focusing on its substantial equivalence to predicate devices and compliance with relevant safety and performance standards. It does not present specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the "acceptance criteria" are implied to be adherence to recognized international consensus standards for medical electrical equipment and transcutaneous partial pressure monitoring.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the new device "meets the performance requirements" and "is equipped with the required safety mechanisms," and "fully complies" with the listed international standards. However, it does not provide detailed measurement accuracy, precision, bias, sensitivity, specificity, or similar quantitative performance metrics that would typically be expected from a device study. The provided text is a summary for regulatory clearance, focusing on equivalence and standard compliance rather than a detailed performance report.

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

• This information is not provided in the document. The filing focuses on compliance with standards rather than clinical testing with a specific test set.

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

• This information is not provided in the document. Ground truth establishment with experts is generally associated with clinical or image-based diagnostic studies, which is not the type of study described here for a transcutaneous monitor.

4. Adjudication method for the test set:

• This information is not provided in the document. Adjudication methods are typically used in studies involving expert review where consensus on ground truth is required.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported) as this device is a standalone physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• The PeriFlux 6000 is a standalone device for continuous non-invasive transcutaneous monitoring. The document states it is "a modern transcutaneous oxygen/carbon dioxide monitor that meets the performance requirements." While it doesn't detail a specific "standalone study" with quantitative results beyond compliance with standards, its function is as a standalone measurement device. The performance claims are inherently for the algorithm/device itself.

7. The type of ground truth used:

• For the technical and performance standards, the "ground truth" would be the defined specifications and test methods within the cited international consensus standards (e.g., IEC 60601-1, IEC 60601-2-23). The device's performance is measured against these established engineering and safety benchmarks.
• For the physiological measurements (tcpO2/tcpCO2), traditional ground truth in such devices often involves comparison to arterial blood gas measurements, but the document does not specify if such a comparison was part of the "performance requirements" that were met.

8. The sample size for the training set:

• This information is not applicable as the PeriFlux 6000 is a hardware monitor based on established physiological measurement principles (Clark sensor, Stow-Severinghaus-type sensor), not an AI/ML device that requires a "training set" in the conventional sense.

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

• This information is not applicable for the same reason as point 8.

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IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

IntelliVue TcG10 Measurement Module:

Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module.

The modified Philips IntelliBridge EC10 and EC5 ID modules build an external medical device solution to collect data from external devices at the bedside providing the data to patient monitors, and patient monitoring networks. The modified EC10 and EC5 ID modules support the interface of the IntelliVue patient monitors with the new IntellVue TcG10 Measurement Module.

The new IntellVue TcG10 Measurement Module is a device for the continuous and noninvasive measurement of the transcutaneous partial pressures of blood gas carbon dioxide (pCO2) and oxygen (p02) of patients from all pediatric subgroups and of adult patients not under gas anesthesia in hospital environment. The transcutaneous measurement of pCO2 and pO2 makes use of the fact that carbon dioxide and oxygen gases are able to diffuse through body tissue and skin and can be detected by a sensor placed at the skin surface. By warming up this sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The transcutaneous blood gas values (tcpCO2 and tcpO2) have to be interpreted primarily as the blood gas partial pressures prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the corresponding arterial blood gas partial pressure.

The provided 510(k) summary (K110474) describes the Philips IntelliVue TcG10 Measurement Module and related system components. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing. It explicitly states that clinical data are not required for this type of device according to specific guidance documents.

Therefore, the information requested regarding a study proving acceptance criteria for AI performance is largely not applicable to this submission, as it concerns a medical device that measures transcutaneous blood gas pressures, not an AI-powered diagnostic or assistive tool.

However, I can extract the information that is present about performance and testing from the document.

Acceptance Criteria and Device Performance (Based on "within specifications" and "substantially equivalent"):

Study Details:

1. Sample size used for the test set and the data provenance: Not specified for a "test set" in the context of an AI study, as this refers to a medical device's performance testing. The document states "bench performance testing."

   • Data provenance: Not applicable.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant to this device's non-clinical performance testing.

3. Adjudication method for the test set: Not applicable.

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 measurement module, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm. This device is a standalone measurement module. Its performance was tested as a system comprising the measurement module and modified patient monitors/interface modules.

6. The type of ground truth used:

   • For the non-clinical performance tests: The ground truth was based on the specifications cleared for the predicate devices. This implies that measurements from the new device were compared to established engineering and performance standards expected for such devices, likely using calibrated instruments or reference methods in a laboratory setting.
   • "Pass/Fail criteria were based on the specifications cleared for the predicate devices."

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

Additional Notes from the Document:

• Clinical Performance Tests: "Clinical data are not required in accordance to the special controls guidance document... A clinical evaluation was conducted including literature review and clinical acceptance studies with experienced nursing and physician staff." This "clinical evaluation" appears to be an assessment of user experience and acceptance rather than a clinical trial to establish diagnostic accuracy against a ground truth.
• Basis of Equivalence: The primary basis for substantial equivalence is the use of "identical functional measurement and calibration module as the predicate device" and "identical Radiometer tc Sensor 84 and the identical medical accessories." The changes are primarily software modifications for interfacing and an internal power supply.

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The SenTec Digital Monitoring System - consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.

V-Sign™ Sensor, model VS-A/P, and V-Sign™ Sensor 2, model VS-A/P/N, are indicated for use with the SenTec Digital Monitor when continuous non-invasive 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 and of V-Sign™ Sensor 2 is indicated for carbon dioxide tension monitoring only.

SenTec's Ear Clip, model EC-MI, is intended for use with V-Sign™ Sensor or V-Sign™ Sensor 2 when continuous, non-invasive carbon, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach V-Sign™ Sensor or V-Sign™ Sensor 2 to the ear lobe 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 or V-Sign™ Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, non-invasive carbon dioxide tension monitoring is required for adult, pediatric, and neonatal patients. They are intended to attach the V-Sign™ Sensor 2 to the forehead or the cheek when continuous, non-invasive carbon dioxide tension, oxygen saturation, and pulse rate monitoring is required for adult and pediatric patients. The Multi-Site Attachment Rings, model MAR-MI, are for single use.

SenTec's multi-compatible and reusable SpO2 Soft Sensors, models RSS-L, RSS-M and RSS-S, are indicated for use with the monitoring devices indicated in the respective sensor directions for use when continuous non-invasive monitoring of oxygen saturation, and pulse rate are required for patients weighing more than 20 kg.

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 the 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.

Caution: Federal law restricts this device to sale by or on the order of a physician.

The SenTec Digital Monitoring System (SDMS) as listed under K071672 is a device consisting of a standalone monitor [SenTec Digital Monitor (SDM)], a digital sensor [V-Sign™ Sensor (model VS-A/P)], 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 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.

This new 510(k) introduces the following additional features/functions to the SDMS:

• V-Sign™ Sensor 2 (model VS-A/P/N) [successor of V-Sign™ Sensor (model VS-A/P) with improved embedded hardware/software] for PCO2, SpO2, PR monitoring using the ear lobe, the forehead or the check as monitoring site in adult and pediatric patients as well as for PCO2-only monitoring in adult, pediatric and neonatal patients using conventional PCO2 measurement sites
• SpO2 Soft Sensor (models RSS-L, RSS-M, RSS-S) with the SpO2 Adapter Cable (model SC-XX; where XX=150, 250, or 750) for continuous and non-invasive SpO2/PR monitoring in patients weighing more than 20 kg. These conventional oximetry sensors, which are applied to a patient's digit, must be connected to the SDM by using the new SpO2 Adapter Cable.
• V-STATS™, an optional PC software application for remote monitoring and/or trend reporting and statistical analysis of the data measured with the SDMS.

This new 510(k) furthermore introduces the following modifications/enhancements:

• Modified intended use for the Multi-Site Attachment Rings: In K071672 the Multi-Site Attachment Rings (model MAR-MI, formerly designated MAR-A/P; and model MAR-SF, formerly designated MAR-A/P/N) were listed for continuous and non-invasive PCO2-only monitoring. This new 510(k) submission expands the intended use for both models to additionally include continuous and noninvasive SpO2 and PR monitoring if V-Sign™ Sensor 2 (model VS-A/P/N) is applied to the forehead or cheek of adult or pediatric patients. In K071672 the Multi-Site Attachment Ring (model MAR-MI) was listed for use in adult and pediatric patients. This new 510(k) submission expands the intended use for the Multi-Site Attachment Ring (model MAR-MI) to additionally include the neonatal population. Proposed labeling states that model MAR-MI can be used for patients with mature and intact skin, whereas for patients with sensitive/fragile skin model MAR-SF must be used.
• Modified firmware for the SenTec Digital Monitor: the modified firmware of the SDM introduces an expanded sensor temperature / site time management two new monitoring parameters (Pulsation expanded benser comports the new sensors being introduced with introduced with this new 510(k).

The provided text describes the SenTec Digital Monitoring System (SDMS) and its modifications. However, it does not contain specific acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy thresholds) for the device's performance, nor does it detail a study designed to explicitly "prove" the device meets such criteria with reported performance metrics against those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons, and it states that the device "meets specified requirements" and is "safe, effective and performs as well as the predicate devices."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance with specific numerical values for metrics like sensitivity, specificity, or accuracy, as these are not explicitly stated. Similarly, details regarding sample sizes for test sets, data provenance, ground truth establishment methods, number/qualifications of experts, adjudication methods, or MRMC studies are not present in the provided document.

Here's an analysis of the information that is available, and what is missing based on your request:

Missing Information (based on your request):

• Specific numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
• Reported device performance against specific numerical acceptance criteria.
• Sample sizes for test sets used for clinical performance studies.
• Data provenance (country of origin, retrospective/prospective) for clinical studies.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for test sets.
• MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
• Details of a standalone (algorithm only) performance study.
• Specific types of ground truth used (e.g., pathology, outcomes data) for clinical studies.
• Sample size for any training set.
• How ground truth for any training set was established.

Available Information (related to your request):

The document broadly mentions performance, but not in the detailed, quantitative format requested for acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document states "Clinical studies were performed using the SenTec Digital Monitoring System with healthy adult volunteer subjects..." but does not give a number of subjects.
• Data Provenance: The subjects were "healthy adult volunteer subjects," implying prospective data collection during the clinical study. Country of origin is not specified, but SenTec AG is based in Switzerland.

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

• Not specified. The ground truth method involved "arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference," which is an objective measurement rather than expert consensus on images or interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as the ground truth was an objective measurement (CO-Oximeter reference to arterial blood samples) rather than expert interpretation.

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:

• No MRMC or human-AI comparative effectiveness study is mentioned. The device is a monitoring system and not primarily an AI-driven image interpretation or diagnostic aid for human readers.

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

• The clinical performance data described refers to the "SenTec Digital Monitoring System" as a whole. While the device does have software, the clinical study appears to assess the output of the device (saturation values) against a reference standard, which is essentially a standalone performance assessment of the device's measurement capability. However, it's not "algorithm only" in the sense of an AI diagnostic tool; it's the performance of the integrated monitoring system.

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

• For the clinical studies, the ground truth for oxygen saturation was "arterial hemoglobin oxygen saturation determined from arterial blood samples with a CO-Oximeter as reference."

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a medical device undergoing 510(k) clearance, which typically involves demonstrating substantial equivalence and performance to established standards/predicates, rather than training a machine learning model. The software mentioned is primarily for data management, display, and remote monitoring.

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

• Not applicable/Not specified, as there is no mention of a training set for an AI model.

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The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia.

The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.

The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitoring System (K043003) which consist of a basic unit that has touch screen and two modules. One module for the combined tcpO2/tcpCO2 monitoring and one for SpO2. Both new modules have an integrated callbration unit. Both Sensors can be used with either earclip- or a conventional fixation ring application system. In addition the CombiM also comes with a double adhesive ring. The software of the TCM 4/40 basic unit has been updated (to version 3.01) and two new modules have been developed to enable the use of the sensor technology from the TOSCA500 Monitoring System (K063434) and from the MicroGas 7650 rapid (K003943). Thereby the SpO2 and tcpCO2 can be measured using the new TCM TOSCA module and the combined SpO2/tcpCO2 sensor of the TOSCA500 system. The tcpO2 and tcpCO2 can be monitored using the new TCM CombiM module and the combined tcpOz/tcpCO2 sensor of the MicroGas 7650 rapid system. A new single tcpCO2 sensor can also be used with this module.

This document is a 510(k) Premarket Notification Submission for the TCM TOSCA/CombiM Monitoring System. It describes the device's intended use and claims substantial equivalence to predicate devices, but does not contain any information about clinical studies or acceptance criteria with reported device performance.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of submission often focuses on demonstrating equivalence through comparison of technical characteristics and intended use, rather than presenting new clinical study data to establish performance against acceptance criteria for a novel device.

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The Linde TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO₂, functional oxygen saturation SpO2 and Pulse Rate in adults and pediatrics.

The Linde TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.

The system consists of a Tosca Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCO2 part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; a Tosca Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.

Here's an analysis of the provided text regarding the Linde TOSCA 500 Monitoring System, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the PCO2, SpO2, or Pulse Rate measurements. Instead, it makes general statements about the device's performance. The "Substantially Equivalent Device" (K032291) is referenced, implying that the acceptance criteria are likely aligned with the performance demonstrated by that predicate device. However, without access to the predicate device's documentation, specific numerical criteria cannot be extracted from this submission.

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

• PCO2 Clinical Studies:
  • Sample Size: Not explicitly stated. The text mentions "adults and infants."
  • Data Provenance: Clinical comparative studies. The country of origin is not specified but is implicitly European given the submitter's address (Basel, Switzerland). It is a prospective study as it refers to "clinical comparative studies...were performed."
• SpO2 Clinical Studies:
  • Sample Size: Not explicitly stated. The text mentions "healthy adults volunteers."
  • Data Provenance: Clinical studies. The country of origin is not specified but implicitly European. It is a prospective study as it refers to "clinical studies...were performed."
• SpO2 Algorithm (Masimo SET):
  • Sample Size: Not explicitly stated for specific a number, but generally mentioned as "healthy adult volunteers."
  • Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The origin of this foundational data for Masimo SET is not specified by geographical location, but it underlies the SpO2 performance. This would be prospective data collection.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. For the PCO2 and SpO2 clinical studies, the ground truth was established by:

• PCO2: Arterial blood gas values. These would typically be analyzed by trained laboratory personnel.
• SpO2: Arterial blood samplings with a co-oximeter. These would also be analyzed by trained laboratory personnel.

The "experts" in this context would be the medical professionals (e.g., physicians, nurses, lab technicians) responsible for collecting and analyzing the arterial blood gas and co-oximetry data, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the PCO2 or SpO2 clinical studies. The ground truth (arterial blood gas and co-oximeter readings) are typically objective measurements from laboratory equipment, not subjective assessments requiring adjudication like image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was performed as this device is a monitoring system directly measuring physiological parameters, not an AI or CAD (Computer-Aided Detection/Diagnosis) system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device's performance is effectively standalone. The clinical studies (comparing transcutaneous PCO2 to arterial blood gas, and TOSCA SpO2 to co-oximeter SpO2) are designed to assess the accuracy of the device's measurements directly against a gold standard, without human intervention in the device's measurement process itself. The "algorithm" for SpO2 (Masimo SET Signal Extraction Technology) is an integral part of the device's standalone operation.

7. The Type of Ground Truth Used

• Transcutaneous PCO2: Arterial blood gas values. This is a recognized gold standard for measuring blood PCO2.
• Functional Oxygen Saturation (SpO2): Arterial blood samplings with a co-oximeter. Co-oximetry is considered a gold standard for measuring arterial oxygen saturation.
• Pulse Rate: Not explicitly detailed, but generally derived from the same optical sensor as SpO2, and the ground truth would typically be from an ECG or another validated pulse measurement method. The submission does not detail the pulse rate ground truth specifically but implies it performed as intended.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the TOSCA 500 itself in the machine learning sense. The Masimo SET technology, which is incorporated into the TOSCA 500, did use human blood studies to develop its look-up table and algorithms. For Masimo SET:

• Sample Size: Not explicitly stated as a number, but generally mentioned as "healthy adult volunteers."
• Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states."

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

For the foundational Masimo SET technology (which informs the SpO2 measurements of the TOSCA 500):

• Ground Truth Establishment: "laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The co-oximeter measurements served as the ground truth against which the optical signals were correlated to develop the SpO2 look-up tables and algorithms.

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The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

The TCM4/40 Monitoring Systems essentially consist in a monitor unit, a combined oxygen/carbon dioxide interface module along with the combined electrodes assembly and (for the TCM40 only) an oxygen saturation/pulse module with a selection of three sensors.

The provided 510(k) Premarket Notification for the Radiometer Copenhagen TCM4/40 Monitoring Systems does not contain a typical study with acceptance criteria and reported device performance in the way a clinical trial or algorithm performance study would.

Instead, the submission relies on compliance with established consensus standards for medical devices and existing predicate devices to demonstrate safety and effectiveness. Therefore, many of the requested data points (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training) are not applicable or explicitly stated in this type of submission.

Here's an attempt to answer your questions based only on the provided text, indicating when information is not present:

Acceptance Criteria and Study Details for Radiometer TCM4/40 Monitoring Systems

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are framed in terms of compliance with regulatory standards for medical devices. The "reported device performance" is implicitly that it meets the requirements of these standards.

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

Not applicable. No specific "test set" in the context of a clinical performance study with patient data is mentioned. The evaluation relies on compliance with standards. The document explicitly states: "Based upon the extensive use of consensus standards covering all aspects of safety and performance, no clinical evaluation was deemed necessary to assess the product performance levels."

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

Not applicable. No ground truth establishment for a test set is described, as no clinical performance study was deemed necessary.

4. Adjudication method for the test set

Not applicable. No test set requiring expert adjudication is described.

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 a monitoring system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

This refers to the performance of the device's monitoring capabilities. The "standalone" performance is established through its compliance with the listed consensus standards for transcutaneous oxygen/carbon dioxide monitoring and pulse oximetry. The exact performance metrics (e.g., accuracy, precision) as measured against these standards are not detailed in this summary, but the conclusion is that the device "performs up to the requirements of the relevant international consensus standards."

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's safety and effectiveness is the requirements specified within the cited international consensus standards. The device's design and testing were assessed against these established engineering and performance criteria.

8. The sample size for the training set

Not applicable. The device's technological characteristics are adaptations of existing, previously cleared devices (TCM400, TCM3, OxiMAX N-550). There's no mention of a "training set" in the context of machine learning or AI.

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

Not applicable. No training set is described. The device's development appears to be based on established engineering principles and components from predicate devices, validated against consensus standards.

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The SenTec Digital Monitor System (comprising the SenTec Digital Monitor, V-Sign™ Sensor and Accessories) is indicated for continuous noninvasive monitoring. The SenTec Digital Monitor System is indicated for use in hospital type realities, includes intra-hospital transport environments, and clinical supervision, home environments. The SenTec Digital Monitor System is for prescription use only.

The V-Sign™ Sensor, model VS-A/P, is indicated for use with the Sentec Digital Monitor when continuous noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients.

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated for patients weighing 30 kg or more, using exclusively the ear lobe as the monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application).

Caution: Federal law restricts this device to sale by or on the order of a physician.

The Sentec Digital Monitor System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous noninvasive measurement of cutaneous carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor).

The V-Sign™ Sensor combines within one digital sensor the technology to measure cutaneous PCO2 with the optical elements (LED, photodetector) needed for pulse oximetry. The PCO2 measurement of the V-Sign™ Sensor is based on a Stow-Severinghaus type PCO2 sensor. The V-Sign™ Sensor slightly raises the temperature at the monitoring site to achieve the cutaneous PCO2 measurement. Safe temperature is achieved using two independent measurement and control systems. The sensor is applied to the patient's ear lobe using SenTec's single patient use Ear Clip and a thin layer of Sensor Gel.

The Sentec Digital Monitor (SDM) is equipped with an integrated calibration unit, the Docking Station, allowing an automatic PCO2 sensor calibration that begins when the V-Sign™ Sensor is stored in the Docking Station. This ensures that the V-Sign™ Sensor is continuously ready to use.

The V-Sign Disposable Set provides a straight-forward preparation of the V-Sign™ Sensor - with the ease of 4 "Push-and-Turn" procedures, all necessary steps to exchange the sensor's membrane are performed.

The Sentec Digital Monitor System (SDMS) is intended for continuous non-invasive monitoring of cutaneous partial pressure of carbon dioxide (PCO2), functional oxygen saturation (SpO2), and pulse rate (PR).

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the device met specified requirements based on various tests. For the purpose of this response, I infer the performance from the statements made about the device's functionality and comparison to predicate devices, and the successful completion of testing.

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

• Test Set Sample Size: The document only states "healthy adult volunteer subjects" were used for the clinical studies. No specific number is provided.
• Data Provenance: The data is prospective, generated from clinical studies with healthy adult volunteers. The country of origin is not explicitly stated, but the manufacturer is Sentec Inc. located in Switzerland.

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

Not applicable. The ground truth for SpO2 and PCO2 measurements was established using objective measurement devices (CO-Oximeter and direct PCO samples), not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from reference devices/methods, not through expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a monitor, not an AI for interpretation, so improvements in human reader performance with AI assistance are not relevant here.

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

Yes, the studies described are essentially standalone performance evaluations of the device (monitor and sensor) against reference standards. The results demonstrate the device's accuracy and performance independent of human interpretation or interaction other than operation.

7. The Type of Ground Truth Used

• For SpO2 and PCO2: Objective physiological measurements using a CO-Oximeter and direct PCO samples.
• For Pulse Rate: Laboratory pulse rate simulator.
• For Safety: Compliance with national and international standards.

8. The Sample Size for the Training Set

Not applicable. The Sentec Digital Monitor System is a sensing device, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying technology is based on established biophysical principles (2-wavelength SpO2 measurement, PCO2 electrode technology) and not on learned patterns from a large dataset. Calibration is mentioned, but this is a technical adjustment using known references, not a "training set" for an algorithm.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The device uses an integrated calibration unit (Docking Station) for daily PCO2 sensor calibration, which relies on known gas values for accurate measurements.

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When installed in the Periflux System 5000, the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide.

The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and facility offices. It is intended to monitor transcutaneous pCO₂ in adults and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.

The Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit.

The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.

The provided document is a 510(k) Summary of Safety and Effectiveness Data for the Perimed Transcutaneous PO₂ and PCO₂ Monitor (PF5040). It details the device's general information, a brief description, its intended use, and a comparison to a predicate device. Importantly, it mentions testing was performed to demonstrate the safety and performance characteristics and that the device met test requirements and performed in accordance with applicable standards. However, it does not explicitly detail the acceptance criteria or the specifics of the study that proves the device meets those criteria.

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• Not specified in the provided text. The document refers to "testing" but does not describe the methodology for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set:

• Not specified in the provided text.

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

• Not mentioned or implied in the provided text. The document focuses on demonstrating the device's performance against "test requirements" and "applicable standards," not comparative effectiveness with human readers or AI assistance.

6. If a Standalone Performance Study was done:

• The text states, "Testing was performed to demonstrate the safety and performance characteristics of the Transcutaneous PO₂ and PCO₂ Monitor (PF5040)." This implies a standalone performance evaluation of the device itself. However, it does not explicitly use the term "standalone study" in the context of an algorithm's performance only without human in the loop. Given the nature of a medical monitoring device, the "device" performance is inherently standalone in its measurement function.

7. Type of Ground Truth Used:

• Not specified in the provided text. The nature of transcutaneous monitoring suggests comparison with a reference standard for blood gas measurements, but this is not explicitly stated.

8. Sample Size for the Training Set:

• Not applicable/mentioned. This device is a monitor, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable/mentioned, as it is not an AI/machine learning algorithm.

Summary of what is present:

The document states that the device was tested to demonstrate its safety and performance and that it met test requirements and applicable standards. It establishes substantial equivalence to a predicate device, the Novametrix TCO₂M Transcutaneous O₂/CO₂ Monitor, based on similar indications for use, measurement principles, and output ranges. However, specific quantitative acceptance criteria or detailed study results are not included in this summary. The FDA's letter indicates clearance for marketing based on this summary.

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