(240 days)
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles. The Model 95000-A Bedside/Transport Monitor supports product configurations with almost any combination of clinical parameters that provide the following: A means for continuous monitoring of: Electrocardiographic signals in order to detect: Normal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation. (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs and tachycardia, and ST segment deviations. Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea. Invasive blood pressure in order to detect abnormal events such as high and low blood pressure. Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions. Temperature in order to detect abnormal events such as high and low temperatures. Carbon dioxide. Oxygen. A means for episodic monitoring of: Non-invasive blood pressure signals to detect abnormal events such as high and low blood pressure. (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) values.
The Model 95000-A Bedside/Transport Monitor is a multi-parameter patient monitor that is capable of acquiring, analyzing, monitoring and displaying a variety of physiological parameters including: electrocardiograph (ECG), respiratory effort, non-invasive blood pressure (NIBP), temperature, invasive blood pressure, pulse oxygen saturation (SpO2), cardiac output, carbon dioxide (CO2) and oxygen (O2).
The provided text is a 510(k) summary for the Model 95000-A Bedside/Transport Monitor. It describes the device, its indications for use, and a statement of substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study data that rigorously proves the device meets those criteria.
Instead, the document states:
- "Non-clinical Performance: Spacelabs Medical performed non-clinical testing on the Model 95000-A Bedside/Transport Monitor to confirm the safe and effective performance of the device. The test results indicate that the device functions as expected."
This is a general statement and does not provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's what can be inferred and explicitly stated:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safe and effective performance | "The test results indicate that the device functions as expected." |
| Substantial equivalence to predicate devices (K013046 and K941165) | "The Model 95000-A Bedside/Transport Monitor is substantially equivalent to Spacelabs Medical's currently cleared and marketed devices." |
| Capability to acquire, analyze, monitor, and display specific physiological parameters (ECG, respiration, NIBP, temperature, invasive BP, SpO2, CO, CO2, O2) | "The Model 95000-A Bedside/Transport Monitor is a multi-parameter patient monitor that is capable of acquiring, analyzing, monitoring and displaying a variety of physiological parameters..." |
| Detection of normal and abnormal cardiac rhythms (adults only for some) | Device provides "A means for continuous monitoring of: Electrocardiographic signals in order to detect: Normal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation. (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs and tachycardia, and ST segment deviations." |
| Detection of abnormal respiration events | Device provides "A means for continuous monitoring of: Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea." |
| Detection of abnormal invasive blood pressure events | Device provides "A means for continuous monitoring of: Invasive blood pressure in order to detect abnormal events such as high and low blood pressure." |
| Detection of desaturation due to abnormal pulmonary or circulatory functions | Device provides "A means for continuous monitoring of: Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions." |
| Detection of abnormal temperatures | Device provides "A means for continuous monitoring of: Temperature in order to detect abnormal events such as high and low temperatures." |
| Continuous monitoring of Carbon Dioxide | Device provides "A means for continuous monitoring of: Carbon dioxide." |
| Continuous monitoring of Oxygen | Device provides "A means for continuous monitoring of: Oxygen." |
| Detection of abnormal non-invasive blood pressure events (adults only for some) | Device provides "A means for episodic monitoring of: Non-invasive blood pressure signals to detect abnormal events such as high and low blood pressure. (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) values." |
Questions with Answers/Inferences from the Text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document only mentions "non-clinical testing" was performed, but no details on sample size, type of data (simulated, real patient data), or data provenance.
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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 specified. There is no mention of expert involvement in establishing ground truth for testing. This type of detail is generally not included in a 510(k) summary for a patient monitor unless specifically required for a novel alarm algorithm or diagnostic feature.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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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 device is a physiological patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but not detailed. The "non-clinical testing" likely assessed the device's algorithms and sensors directly. However, the details of such standalone performance are not provided. The device's function is inherently "standalone" in its data acquisition, analysis, and display, designed for use by a healthcare professional.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. For a patient monitor, ground truth would typically be established through highly calibrated reference equipment or simulated physiological signals to verify accuracy against known values. The document doesn't provide these specifics.
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The sample size for the training set:
- Not applicable/Not specified. This device is a traditional patient monitor, not explicitly described as having an AI/machine learning component that would require a "training set" in the common sense. Its algorithms are likely deterministic and based on established physiological principles and signal processing.
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How the ground truth for the training set was established:
- Not applicable/Not specified. (See point 7.)
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and generally states that "non-clinical testing" confirmed safe and effective performance. It lacks the granular detail about specific performance studies, acceptance criteria, and methodology that would be expected for a detailed study report.
§ 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.