(25 days)
The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit. surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU),
The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters.
The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram. invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous p02 and respiratory mechanics, The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardlography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or anglog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK™
The Patient Data Module can be used with the Solar 8000i in a bedside configuration or with the Transport Pro in a transport configuration.
The Patient Data Module (PDM) acquisition device acquires, measures processes, and stores patient physiological parameters. Patient physiological parameter data acquired by the PDM includes 12-Lead ECG, up to four invasive blood pressures (as options), non-invasive blood pressure, Masimo pulse oximetry or Nellcor pulse oximetry, two temperatures, impedance respiration and cardiac output.
The Transport Pro is a host patient monitor that provides continuous patient monitoring capability when coupled with a compatible acquisition device. The Transport Pro is a lightweight, rugged patient monitor that can be used in a transport environment. The Transport Pro provides a means to view patient parameter information and to alert the clinician of parameter limit violations via visual and audible alarms. The Transport Pro must be coupled with the PDM acquisition device with a PDM dock or the TRAM Module acquisition device (K053121) with a TRAM chute.
The Solar 8000i is a host patient monitor that provides continuous patient monitoring capability when coupled with compatible acquisition devices or when connected to the GEMS-IT UNITY network. The Solar 8000i is used in a bedside patient care environment. Like the Transport Pro host patient monitor, the Solar 8000i can be coupled with either the PDM acquisition device or the TRAM Module acquisition device (K053121). Patient physiologic data may also be received from the GEMS-IT Tram-net network and/or multi-parameter modules, or discrete modules located in a TRAM-rac (remote acquisition) housing.
The provided text is a 510(k) Summary for a physiological patient monitor (Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module). It details the device's intended use, description, and comparison to predicate devices. However, it does NOT provide specific acceptance criteria or the results of a detailed study to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc.
Instead, the "Test Summary" section indicates that the submission is for a design modification and that the device "complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission." It then lists general quality assurance measures applied during development, such as "Performance testing" and "Safety testing." The conclusion states that "The results of these measurements demonstrated that the Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is as safe, as effective, and performs as well as the predicate devices."
Therefore, based on the provided document, I cannot fulfill all parts of your request.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., minimum accuracy percentages, sensitivity, specificity, etc.) for physiological parameter measurements, nor does it report specific performance metrics from a study. It only generically states compliance with voluntary standards and that performance is "as well as the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not mention any sample sizes for test sets, data provenance, or whether data was retrospective or prospective. The "Test Summary" refers to internal quality assurance measures rather than a specific clinical or performance study with defined cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. The document does not describe any specific process for establishing ground truth using experts, nor does it mention a "test set" in the context of expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. As no expert review or test set is described, no adjudication method is mentioned.
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:
- Cannot be provided. This device is a physiological patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study. The document focuses on the measurement and display of physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but no specific study details. The device itself is designed for standalone performance in continuously acquiring and processing physiological data. However, the document does not describe a standalone study with reported performance metrics. It implies that "performance testing" was done as part of quality assurance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided explicitly. Given that the device measures physiological parameters (ECG, blood pressure, pulse oximetry, temperature, etc.), the "ground truth" for its performance would typically involve comparison to a gold standard measurement device or method for each parameter. However, the document does not state what specific ground truth methods were used during their performance testing.
8. The sample size for the training set:
- Cannot be provided. This device is not described as involving a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable, as there's no mention of a "training set."
Summary of available information:
The document describes a regulatory submission (510(k)) for a physiological patient monitor. The focus is on demonstrating substantial equivalence to predicate devices. The "Test Summary" outlines general quality assurance processes rather than a detailed clinical performance study with specific metrics. The conclusion relies on demonstrating that the new design modification is as safe, effective, and performs as well as the previously cleared predicate devices. Specific quantitative performance data, sample sizes, and ground truth methodologies usually found in performance studies are not detailed in this type of summary.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.