(119 days)
The IDM100 is for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous monitoring.
Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3-lead thythm for evaluation and diagnosis of patient cardiac function. ECG calculation of diagnostic measurements is provided for adult patients only.
• Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
• Patient temperature provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal, and axillary temperatures.
• SpO2 Oximeter for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2), wulse rate, and optional Respiratory Rate.
• Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
• Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.
• Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.
• Manual interface for height, weight, respiratory rate, and other manually captured patient information.
The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.
Here's the information regarding the IDM100 device's acceptance criteria and the study that proves it meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Spirometry | According to American Thoracic Society (ATS) Standards, particularly ATS/ERS Task Force Standardisation of Lung Function Testing: Standardisation of spirometry (2005) | Results obtained were within the range of accuracy required by ATS. |
| Audiometry | ANSI/ASA S3.6-2010: Specification for Audiometers | Results were satisfactory. |
| ECG Measurements | CSE Database Verification and Clinical Verification | Results were satisfactory (implicit, as "validated"). |
| NIBP Device Evaluation | EN1060-3, Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | Results were satisfactory. |
| Tympanic Thermometer | Accuracy testing | Results were satisfactory. |
| Low Perfusion SpO2/Pulse Rate Accuracy | Simulated Low Perfusion Saturation and Pulse Rate Accuracy Study | Results were satisfactory. |
| Software Validation | FDA guidelines for the Moderate Level of Concern | Successfully performed and documented. |
| Transportation Simulation | ISTA Procedure 2A (2011), ASTM D4169-14 | Results were satisfactory. |
| Biocompatibility | Cytotoxicity, irritation, and sensitization for the patient contact sensor | Test reports obtained and reviewed were satisfactory. |
| Usability | Human factors usability testing | Successfully conducted. |
| General Safety & Performance | IEC 60601-1 (2005+CORR. 1+CORR. 2), IEC 60601-1-2 ed3.0, IEC 60601-2-25 ed 2.0, IEC 60601-2-49 ed 2.0, IEC 60601-1-11 | Results were satisfactory for all listed standards. |
Study Details:
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Sample sizes used for the test set and data provenance:
- Spirometry: Not explicitly stated, but the testing was "performed according with American Thoracic Society (ATS) Standards."
- Audiometry: Not explicitly stated.
- ECG Measurements: Not explicitly stated, but involved "three methods: CSE Database Verification, Data Collection, and a Clinical Verification."
- NIBP Device Evaluation: Not explicitly stated, involved "visual inspections and testing."
- Tympanic Thermometer: Not explicitly stated, involved "accuracy testing."
- Low Perfusion SpO2/Pulse Rate Accuracy: Not explicitly stated, involved a "Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator."
- Data Provenance: Not specified, but given the nature of the device and testing, it's likely a mix of lab-based/simulated data and potentially clinical data (for ECG clinical verification). The document does not specify country of origin or whether it was retrospective or prospective.
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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. Ground truth for most tests appears to be based on established industry standards and reference instruments (e.g., ATS standards for spirometry, ANSI/ASA for audiometers, CSE Database for ECG, EN standards for NIBP, and reference devices for temperature/SpO2). For "Clinical Verification" of ECG, it implies expert review, but the number and qualifications are not detailed.
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Adjudication method for the test set:
- Not explicitly stated. The document simply reports that "results were satisfactory" or "validated" against specified standards or reference data.
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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 MRMC comparative effectiveness study is mentioned. This device is a vital signs monitor and diagnostic tool, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies involving human readers and AI. The device's functionality is about data acquisition and display, with some automated measurements (like ECG diagnostics for adults, MAP calculation), not interpretation by human readers that would be augmented by AI in the context of a typical MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance testing against standards for each of its functions (ECG measurements, Spirometry, Audiometry, NIBP, etc.). The device itself performs these measurements or calculations without explicit human intervention in the measurement acquisition and initial processing phase, though a healthcare professional is responsible for operating it and interpreting the results.
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The type of ground truth used:
- Reference Standards/Devices: For spirometry, ATS standards. For audiometry, ANSI/ASA S3.6-2010. For ECG, CSE Database and clinical verification. For NIBP, EN1060-3. For temperature and SpO2/pulse rate, accuracy testing against reference (simulators or calibrated devices).
- Clinical Verification: Mentioned for ECG, implying comparison to established clinical methods or expert opinion.
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The sample size for the training set:
- Not applicable/Not mentioned. The document describes a medical device for vital sign measurement and diagnostic tests, not a machine learning or AI algorithm that would typically require a training set in the conventional sense for its core functionality. The "Software Validation" refers to general software engineering principles and risk assessment, not AI model training.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model is described.
§ 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).