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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

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set for an AI model is described.

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The IDM100 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), adolescent (>12 years &

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 provided document is a 510(k) Summary for the IDM100 device. While it describes various tests performed for safety and effectiveness, it does not clearly present specific acceptance criteria in a table format for performance metrics or a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Tempus IC2, K152124) by comparing indications for use, technological characteristics, and by performing various verification and validation tests against recognized standards.

Here's an attempt to extract and synthesize the requested information based on the provided text, highlighting where information is not explicitly available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by conformity to specific standards and satisfactory results from various tests, rather than explicit numerical thresholds given in a table. The document focuses on demonstrating that the IDM100's components meet established standards for similar devices or that its overall performance is comparable to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• ECG Clinical Testing:
  • Sample Size: "18 normal and abnormal ECG patients" were compared for the 12-lead ECG function.
  • Data Provenance: Not specified (e.g., country of origin). It's described as a "clinical evaluation," suggesting prospective data collection for this specific comparison, but this is not explicitly stated.
• Other Tests (e.g., Low Perfusion, Tympanic Thermometer, NIBP): Sample sizes are not mentioned. These appear to be bench or lab-based tests rather than patient studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• ECG Clinical Testing: The document states that the IDM100 and the Welch Allyn CP150 (predicate) "provide comparable testing result, with no impact to the interpretation of the patients ECG." This implies that the interpretation was assessed, likely by experts, but the number and specific qualifications of these experts are not provided.
• Other Tests: Ground truth for these tests would typically be established by calibrated instruments or reference standards, not human experts in the conventional sense.

4. Adjudication Method for the Test Set

• ECG Clinical Testing: An explicit adjudication method (e.g., 2+1, 3+1) is not described. The statement "no impact to the interpretation of the patients ECG" suggests an expert review or comparison, but the process is not detailed.
• Other Tests: Adjudication methods are not applicable for these types of technical compliance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus human readers without AI assistance, was not mentioned or described in this document. The device itself is a vital signs monitor and data collection system, not an AI interpretation device that assists human readers in diagnostic tasks.

6. Standalone (Algorithm Only) Performance Study

• This device is not an algorithm that provides standalone diagnostic interpretations; it's a medical tablet integrating various diagnostic tools. Therefore, a standalone algorithm performance study, as typically understood for AI/ML devices, was not performed or described. The components (e.g., ECG, NIBP, SpO2) within the IDM100 undergo their own performance evaluations against standards, which implicitly represent their "standalone" capability. The statement "Passing IEC 60601-02-25 confirms the safety and accuracy for IDM100 12-lead and 3-lead IDM ECG testing" relates to the standalone performance of the ECG module.

7. Type of Ground Truth Used

• ECG Clinical Testing: The ground truth for the "normal and abnormal ECG patients" is implicitly their clinical presentation/diagnosis as determined by standard clinical practice and the predicate device's output, which the IDM100 was compared against. It's a comparison to a predicate device's output and clinical interpretation, rather than de novo gold standard like pathology or long-term outcomes.
• Other Tests (e.g., Tympanic Thermometer, NIBP): The ground truth for these tests comes from calibrated reference standards as defined by the respective international standards (e.g., EN1060-3 for NIBP).

8. Sample Size for the Training Set

• This document describes a medical device integrating existing, FDA-cleared diagnostic components and a tablet interface for data collection and transmission. It does not mention the use of a machine learning or AI algorithm that would require a distinct "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

• As the document does not describe the use of a machine learning or AI algorithm requiring a training set, this question is not applicable.

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