(261 days)
Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease
Monitoring of patients in out-of-hospital convalescence settings
Monitoring of patients by physicians, clinics, or skilled care facilities
Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting
The device is not intended to sound real time alarms
This device does not replace physician's care
The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.
The Instromedix LifeSigns™ Cardiac Monitoring System is a device designed for diagnostic monitoring of stabilized patients in out-of-hospital environments. The FDA has cleared this device through the 510(k) pathway (K964408), signifying its substantial equivalence to predicate devices. The provided document focuses more on the regulatory submission and equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and corresponding results in a table format.
However, based on the information provided, we can infer the approach taken for demonstrating performance and regulatory acceptance.
Inferred Acceptance Criteria and Reported Device Performance
While explicit numerical acceptance criteria for accuracy, sensitivity, or specificity are not provided in the document, the core assertion for 510(k) clearance is substantial equivalence to legally marketed predicate devices. This implies that the LifeSigns System's performance for vital signs measurements (ECG, SpO2, heart rate, blood pressure) meets a level comparable to these established devices.
| Acceptance Criterion (Inferred from Substantial Equivalence and Performance Testing) | Reported Device Performance |
|---|---|
| Accuracy of Vital Signs Measurement | "The rests demonstrate that the LifeSigns System provides performance equivalent to the predicate devices and components." |
| - ECG Acquisition and Display | |
| - SpO2 Measurement | |
| - Heart Rate Measurement | |
| - Blood Pressure Measurement (Oscillometric) | |
| Compliance with Applicable Standards | "meets applicable standards for performance and EMC compliance." |
| Electromagnetic Compatibility (EMC) | "electromagnetic environmental susceptibility and emissions" tested and found compliant. |
| Safety and Efficacy | "Performance, safety, and efficacy of the LifeSigns System are substantially equivalent as compared to the predicate devices and components." |
Study Details from the Provided Document:
Due to the nature of a 510(k) summary, specific details regarding sample size, data provenance, expert qualifications, and detailed study methodologies are not extensively provided as they would be in a clinical trial report. However, based on the text:
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "performance testing of vital signs measurements." It can be inferred that a test set of data was used to demonstrate equivalence, but the size and specifics (e.g., retrospective/prospective, country of origin) are absent. This would typically be detailed in a separate test report referenced in the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For vital signs monitoring devices, ground truth is typically established by comparing the device's readings against a recognized standard (e.g., another FDA-cleared device, a calibrated reference instrument, or manual measurements by trained professionals). The document does not specify the number or qualifications of experts involved in this ground truth establishment, if any were required beyond technical calibration.
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Adjudication method for the test set: Not applicable based on the information provided. Adjudication methods like "2+1" are typically used in studies involving subjective interpretations (e.g., image reading), where multiple experts provide opinions that need to be reconciled for ground truth. For objective vital signs measurements, direct comparison to a reference standard is more common.
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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: Not applicable. The LifeSigns System is a vital signs monitoring device, not an AI-powered diagnostic tool requiring human interpretation improvement studies. It collects and displays objective physiological data.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the system as collecting and displaying vital signs data. The "algorithm" here would pertain to the signal processing for ECG, SpO2, heart rate, and blood pressure calculation. The performance testing would inherently be standalone in terms of the device's ability to accurately measure these parameters before human interpretation of the trends or values.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The specific type of ground truth is not detailed. For vital signs, ground truth would typically come from:
- Calibrated reference equipment: For blood pressure and SpO2, direct comparison to highly accurate and calibrated reference devices or invasive measurements.
- Simultaneous recordings/manual verification: For ECG and heart rate, comparison to simultaneously acquired gold standard ECGs or manual heart rate calculation from rhythms.
The document mentions performance testing, implying direct measurement and comparison, rather than subjective expert consensus, pathology, or outcomes data, which are more common for diagnostic imaging or disease progression studies.
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The sample size for the training set: Not applicable and not provided. The LifeSigns System predates the common approach of using large training sets for deep learning or AI algorithms. Its functions for acquiring ECG, SpO2, heart rate, and blood pressure are based on well-established signal processing and measurement principles, not machine learning trained on large datasets.
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How the ground truth for the training set was established: Not applicable, as no training set in the modern AI sense is described or implied for this device.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).