(8 days)
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing trends for retrospective review.
The provided document (K042569) is a 510(k) summary for the Criticare Systems, Inc. Model 8600 Vital Signs Monitor. It outlines the device description, intended use, comparison to a predicate device, and compliance with standards. However, it does not contain specific study results or detailed acceptance criteria with performance numbers for the device itself. Instead, it relies on demonstrating substantial equivalence to a predicate device and compliance with general performance standards.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert involvement, and ground truth establishment cannot be extracted directly from this document.
Here's an attempt to answer based on the available information and recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Performance | Equivalence to predicate device (CSI Model 8100 / 8500 Vital Signs Monitor K012059) | The 8600 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. |
| NIBP Performance | Compliance with EN 60601-2-30 (Safety), EN 1060-1, EN 1060-3 (incl. EN 475 Alarm Performance), AAMI SP-10 | Compliance with listed standards verified. |
| ECG Performance | Compliance with EN 60601-2-27 (Safety), AAMI EC-13 (Basic ECG Performance) | Compliance with listed standards verified. |
| Oximetry (SpO2) Performance | Compliance with EN 865 (Equivalent to ASTM F 1415) | Compliance with listed standards verified. |
| Capnometry (CO2) Performance | Compliance with EN 864 (Equivalent to ASTM F 1456) | Compliance with listed standards verified. |
| Invasive Blood Pressure (IBP) Safety | Compliance with EN 60601-2-34 | Compliance with listed standards verified. |
| Oxygen Analyzer Performance | Compliance with EN 13698, EN 12598 (Equivalent to ASTM Fo ASTM) | Compliance with listed standards verified. |
| Electrical Safety | Compliance with EN 60601-1 Medical Electrical Safety | Compliance with listed standards verified. |
| EMC Compliance | Compliance with IEC 601-1-2 EMC Compliance | Compliance with listed standards verified. |
| Biocompatibility | Compliance with ISO 10993-5, 10-11 Biocompatibility | Compliance with listed standards verified. |
| MR Compatibility | Per its labeling claims. | The 8600 monitor is MR Compatible per its labeling claims. |
Important Note: The document states that performance has been "confirmed to be equivalent" and "compliance has been completed." It does not provide the specific quantitative results from these compliance tests or detail what "equivalent" means in terms of a specific delta or accuracy range. The "acceptance criteria" are generally implied by the requirement to meet these recognized standards.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. The document states "field experience" with the predicate device and "equivalence testing" and "applicable objective standards compliance." It does not describe specific clinical studies or test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
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 510(k) summary. The submission relies on compliance with established performance standards, which implicitly require certain testing methodologies, but the details of expert involvement are not disclosed.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given the nature of a vital signs monitor and the reliance on performance standards, a formal adjudication process using multiple experts for a test set is unlikely to be described at this level of detail.
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
This information is not applicable and not provided. The 8600 Vital Signs Monitor is a device that provides physiological data; it is not an AI-powered diagnostic tool that assists human "readers" or interpreters in the way an imaging algorithm would. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor. Its performance is assessed against recognized standards for accuracy and reliability of physiological measurements. The document states its performance "has been confirmed to be equivalent to the predicate device" and that it "complies with applicable safety and performance standards." This implies standalone performance testing against those standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of a vital signs monitor, as implied by compliance with standards like EN 1060-1 for NIBP or EN 865 for Oximetry, would typically involve:
- Reference Devices: Highly accurate, calibrated reference measurement devices (e.g., invasive arterial lines for IBP, calibrated gas analyzers for CO2/O2, etc.).
- Simulators/Phantoms: Calibrated simulators or phantoms for specific parameters (e.g., ECG simulators, NIBP cuffs with controlled pressure waveforms).
- Clinical Studies: For parameters like NIBP or SpO2, clinical studies comparing the device's readings to reference measurements in human subjects are often required by the standards.
However, the specific methods for establishing ground truth are not detailed in this 510(k) summary, beyond the mention of compliance with the listed standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Vital signs monitors, especially from 2004, typically rely on established signal processing algorithms and hardware engineering rather than machine learning models that require "training sets" in the modern AI sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons as point 8. The device's underlying technology likely involves well-understood physiological sensing and signal processing, not a "training set" with associated ground truth as understood in contemporary AI/ML development.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).