(170 days)
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:
| Acceptance Criteria (Explicit) | Acceptance Criteria (Implied/General) | Reported Device Performance (General) |
|---|---|---|
| None explicitly stated with numerical targets in the provided text. | Meets specified requirements (general) | "The results of all laboratory tests demonstrate that the SenTec Digital Monitoring System meets specified requirements." |
| None explicitly stated with numerical targets in the provided text. | Safe and effective (general) | "The clinical and non-clinical testing performed demonstrates that the SenTec Digital Monitoring System is safe, effective and performs as well as the predicate devices, and therefore, it is substantial equivalent to the predicate devices." |
| None explicitly stated with numerical targets in the provided text. | Performs as well as predicate devices (general) | "The clinical and non-clinical testing performed demonstrates that the SenTec Digital Monitoring System is safe, effective and performs as well as the predicate devices, and therefore, it is substantial equivalent to the predicate devices." |
| None explicitly stated with numerical targets in the provided text. | Measures pulse rate values within specified accuracy claims (for bench tests) | "Bench performance testing verified that the SenTec Digital Monitoring System measures pulse rate values within specified accuracy claims for all supported sensor types." |
| None explicitly stated with numerical targets in the provided text. | Reported saturation values meet specified accuracy requirements (for clinical studies) | "The results from the clinical studies show for all supported sensors and claimed monitoring sites that the reported saturation values from the SDMS meet specified accuracy requirements." |
| None explicitly stated with numerical targets in the provided text. | Biocompatibility requirements met | "All materials met Biocompatibility requirements." |
| None explicitly stated with numerical targets in the provided text. | Software developed according to FDA guidelines for MODERATE level of concern devices; verified to requirements, validated to intended use | "The SenTec Digital Monitoring System software was developed in accordance with FDA quidelines for MODERATE level of concern devices. The software was verified to requirements and validated to meet the specified intended use(s)." |
| None explicitly stated with numerical targets in the provided text. | Hazards mitigated to ALARP levels, residual risks acceptable | "All hazards were mitigated to ALARP levels (as low as reasonably possible) and residual risks were determined to be acceptable." |
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.
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.