(319 days)
The monitor is intended for spot-check monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The Accutorr 3 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. It consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
The Accutorr 3 Vital Signs Monitor is designed to monitor a fixed set of physiological parameters including Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP) and Temperature (TEMP). This monitor provides 3 different SPO2 modules manufactured by Mindray, Masimo or Nellcor.
The provided text describes the regulatory submission for the "Accutorr 3 Vital Signs Monitor." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies with specific metrics.
The document primarily focuses on:
- Device Description: A compact, easy-to-use vital signs monitor for SpO2, PR, NIBP, and TEMP on adult, pediatric, and neonatal patients.
- Intended Use: Spot-check monitoring of physiological parameters in healthcare facilities.
- Predicated Device: VS-800 Vital Signs Monitor (K072235).
- Non-clinical Tests: Compliance with various international and national safety, biocompatibility, electromagnetic compatibility, and performance standards.
- Clinical Studies: States that NIBP and TEMP modules were "evaluated for clinical accuracy" and "tested and evaluated under applicable clinical standards" (ISO 80601-2-56 for thermometers and ISO 81060-2 for non-invasive sphygmomanometers). However, it does not provide the results of these clinical studies, specific acceptance criteria, or details of the study design.
- Conclusion: Claims the device is "as safe, as effective, and perform as well as the predicate device" based on testing.
Therefore, most of the requested information cannot be extracted from this document because the detailed results of clinical studies and acceptance criteria are not published here.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document only mentions that the NIBP and TEMP modules were evaluated for clinical accuracy against specific standards (ISO 80601-2-56 and ISO 81060-2). It does not list the specific acceptance criteria (e.g., mean difference, standard deviation, accuracy zones) or the reported performance values from those evaluations.
2. Sample size 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 states clinical accuracy evaluations were performed for NIBP and TEMP but gives no details about the sample size, data origin, or study design (retrospective/prospective).
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)
- Not applicable / Cannot be provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging). For vital signs monitors, ground truth is usually established via reference methods (e.g., invasive blood pressure, rectal temperature, CO-oximetry for SpO2) rather than expert consensus on interpretive tasks. The document does not specify how ground truth was established, beyond referencing the clinical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. Adjudication methods are typically used in studies where multiple human readers assess data and discrepancies need resolving (e.g., image interpretation). This is not relevant for the type of clinical accuracy evaluation performed for a vital signs monitoring device.
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 not an AI-assisted diagnostic device, but a vital signs monitor. MRMC studies or AI assistance are not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially applicable. The NIBP and TEMP modules underwent "clinical accuracy" evaluations. For a vital signs monitor, these evaluations inherently test the device's "standalone" performance against a reference standard. However, no performance metrics are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred, but not explicitly stated with details. For NIBP, the standard (ISO 81060-2) typically requires comparing the device's readings against simultaneous readings from a reference method (e.g., intra-arterial blood pressure). For temperature, the standard (ISO 80601-2-56) usually involves comparison against a highly accurate reference thermometer measurement (e.g., rectal or tympanic probe depending on the device's site). The document does not explicitly state these methods were used, only that the device was evaluated under these standards.
8. The sample size for the training set
- Not applicable / Cannot be provided. This device is not described as using machine learning or AI that would involve a "training set." Its core functionality relies on established physiological measurement principles.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. See point 8.
§ 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).