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The LuMon™ System is a noninvasive, non-radiation device that provides information on regional impedance variation within a cross-section of a patient's thorax. Graphical and numerical information is presented to the user as an adjunctive tool to other clinical information to support the user to assess a patient's respiratory condition.

The LuMon™ System is indicated for neonatal and infant patients with chest circumferences between 16.5 - 50 cm and adolescent through adult patients with chest circumferences between 76 - 128 cm who are breathing spontaneously or require mechanical ventilation in professional healthcare facilities.

Impedance-based respiratory rate monitoring is indicated for adults 22 years and older whose chest circumference is above 76 cm only.

The LuMon™ System also displays selected physiological and respiratory parameters from supported bedside devices.

The LuMon™ System does not measure regional ventilation of the lungs.

The LuMon™ System is a compact and lightweight Electrical Impedance Tomography (EIT) system that provides noninvasive monitoring of variations of regional air content/volume within a cross-section of the patient's thorax and patient respiration. It displays the results as real-time EIT images, waveforms, and derived parameters.

The system consists of a controller display unit, signal acquisition connector cable, and patient-applied conductive textile electrode belts. The system can connect to external bedside devices such as ventilators and monitoring devices to display contextual information for interpretation of EIT measurements.

The provided FDA 510(k) clearance letter and summary for the LuMon™ System contains information regarding its acceptance criteria and the studies conducted to demonstrate its performance. However, some specific details commonly found in a comprehensive study report (e.g., exact sample size for each clinical study, number of experts for ground truth, adjudication methods beyond "clinician-scored") are not explicitly stated in this high-level summary.

Based on the provided text, here's a structured response addressing your request:

Acceptance Criteria and Device Performance for LuMon™ System

The LuMon™ System underwent extensive non-clinical (bench and pre-clinical) and clinical testing to demonstrate its safety and effectiveness. The acceptance criteria are implicitly defined by the performance characteristics presented in the comparison tables and the successful attainment of stated accuracies and correlations.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established as equivalent to or better than the predicate/reference devices, or as meeting pre-defined tolerances for specific parameters.

• Data Provenance: Not explicitly stated regarding country of origin for clinical data. The studies are described as "pre-clinical" and "clinical," with no indication of being retrospective. "Clinical testing was performed to support safety and effectiveness" generally implies prospective data collection for regulatory purposes.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: For the Respiration Rate study, the reference standard was "Clinician-scored EtCO2 capnogram." This implies medical professionals were involved in establishing the ground truth, but their specific qualifications (e.g., types of physicians, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• For Respiration Rate Ground Truth: "Clinician-scored EtCO2 capnogram" implies expert review. However, the exact adjudication method (e.g., 2+1, 3+1, majority vote, independent reads with reconciliation) is not specified.

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

• It is not explicitly stated that a specific MRMC study was conducted to compare human readers with and without AI assistance.
• The device is presented as an "adjunctive tool to other clinical information to support the user," meaning it assists clinicians rather than replacing them. Its effectiveness is shown through its ability to provide accurate EIT data and respiratory rate, which clinicians would then integrate into their assessment. The summary focuses on the device's accuracy relative to reference standards or predicate devices, not on direct human-AI performance comparison studies.

6. Standalone (Algorithm Only) Performance

• Yes, the performance characteristics listed in the tables (e.g., R-squared correlations for EIT-CT, accuracy for RRi against reference standards, SNR, voltage accuracy) represent the standalone performance of the algorithm and the device. The clinical studies compare the device's output itself to established medical standards or other modalities, distinct from how a human user might interpret or use that output.

7. Type of Ground Truth Used

• Pre-clinical (Regional Impedance Distribution): Differential CT changes in aeration (healthy and injured lungs, one- and two-sided intubation) and "established physiological changes" were used as ground truth.
• Clinical (Global Volume Changes): Body plethysmograph traces and Ventilator flow-sensed volumes were used as ground truth.
• Clinical (Regional Impedance Distribution): The Timpel Enlight 2100 predicate comparison was used for ground truth.
• Clinical (Respiration Rate): Clinician-scored EtCO2 capnogram was used as ground truth.

8. Sample Size for the Training Set

• The information provided is a 510(k) summary, which typically focuses on validation. The sample size for the training set is not provided in this document. Training data details are usually proprietary and not disclosed in 510(k) summaries unless directly relevant to the regulatory pathway or substantial equivalence claim.

9. How Ground Truth for the Training Set Was Established

• The document does not specify how ground truth was established for the training set. Similar to the training set size, details about the training data and its ground truth establishment are generally considered proprietary and are not typically included in a public 510(k) summary. The summary focuses on the independent test data performance.

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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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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.

Ask a specific question about this device

The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor 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.

The V-Sign™ Sensor, model VS-A/P, is 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 the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.

SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, 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 to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.

SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensorto conventional measurement sites for carbon dioxide tension monitoring,

SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.

The SenTec Digital Monitoring 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 and non-invasive monitoring of carbon dloxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor) applied to the ear lobe with the SenTec Ear Clip.

This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:

• MAR-A/P/N for adult, pediatric and neonatal patients .
• MAR-A/P for adult and pediatric patients

The monitoring features of the SDMS are unchanged

The Multi-Site Attachment Rings consists of a round adhesive pad integrated with a snap ring. The adhesive pad attaches to the patient's skin at the measurement site and the snap ring captures the V-Sign™ Sensor while permitting rotation and removal/reinsertion of the ring is prepared for application by removing an adhesive liner film.

The provided document describes the SenTec Digital Monitoring System (SDMS) and its 510(k) submission for new multi-site attachment rings. However, the document does not contain specific acceptance criteria or details of a clinical study that proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states:

• "In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
• "The results of all laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements." (However, these "specified requirements" are not detailed or quantified in the provided text).
• "As described above, the SenTec Digital Monitoring System with Multi-Site Attachment Rings performs in a manner equivalent to the predicate devices. Device safety is substantiated by risk analyses and biocompatibility of patient contact materials."

Therefore, based on the provided text, I cannot complete many of the requested sections as the information is not present. The device's "performance" is primarily described as being "equivalent" to predicate devices, and the document explicitly states that no additional clinical studies were performed.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be created. The document does not provide a table of acceptance criteria or quantified performance metrics for the SenTec Digital Monitoring System with the new multi-site attachment rings. It only states that "laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements" and performs "in a manner equivalent to the predicate devices."

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

• Not applicable for clinical studies. The document explicitly states: "In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
• For non-clinical tests: "Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2." The sample size, data provenance, and specific results of these application tests are not provided.

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

• Not applicable. No clinical test set or ground truth established by experts is described, as no clinical studies were performed for this specific submission.

4. Adjudication method for the test set

• Not applicable. No clinical test set 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

• No. This is a medical device for monitoring physiological parameters (PCO2, SpO2, PR), not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is not relevant or mentioned.

6. 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 monitoring system and its performance is assessed based on its ability to accurately measure physiological parameters, not an algorithm's classification performance. The "clinical performance data" section states no additional clinical studies were required or performed.

7. The type of ground truth used

• Not explicitly stated for the "specified requirements" or equivalence claim. For the initial predicate device (K041548), one would infer that the ground truth for PCO2 and SpO2 measurements would have been established using reference methods (e.g., arterial blood gas analysis for PCO2/SpO2, and ECG for pulse rate). However, for this specific submission, no new ground truth is described as no new clinical studies were performed. The "equivalence" relies on the ground truth established for the predicate devices.

8. The sample size for the training set

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

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

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

Summary of available information regarding performance:

• Non-Clinical Performance:
  • Biocompatibility testing: "All materials met Biocompatibility requirements" per ISO 10993-1:2003.
  • Risk/Hazard Analysis: "All hazards were mitigated to ALARP levels... and residual risks were determined to be acceptable."
  • Application tests: "confirmed that the sensor was properly positioned for measurement of PCO2." (No further details on sample size or specific results provided).
• Clinical Performance:
  • "no additional Clinical studies were required and none were performed."
  • The device is deemed to perform "in a manner equivalent to the predicate devices."

In essence, the 510(k) submission for the new multi-site attachment rings for the SenTec Digital Monitoring System relies on showing substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.

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