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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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