FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature.

The Cardiac Monitor, Model 1500, is intended to be used in a professional medical environment such as hospitals, clinics and research institutions. The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance by the operator.

The user of the Cardiac Monitor, Model 1500, shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

AI/ML Overview

The provided text is related to a 510(k) submission for the Zynex Medical Cardiac Monitor, Model 1500. However, it does not contain specific acceptance criteria, reported device performance data, details of clinical studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods that would be required to fully answer the request.

The document primarily focuses on regulatory compliance, outlining the device's indications for use, its comparison to predicate devices, and adherence to general medical device safety standards. It emphasizes that the device provides numerical values and that a physician is responsible for making judgments based on these numbers, explicitly stating: "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers." This indicates that the device itself is not making diagnostic claims that would typically require validation against a clinical ground truth for diagnostic accuracy.

Therefore, many of the requested items cannot be extracted from this document because the information is not present. The device is not an AI/ML device that would typically undergo the kind of detailed performance studies described in the prompt (e.g., MRMC studies, standalone algorithm performance against a clinical ground truth). Instead, it's a monitoring device whose performance is assessed against established safety and electrical standards.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a clinical study. The document focuses on compliance with general medical device standards.
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the Cardiac Monitor, Model 1500. The document states that the device "met all applicable requirements" of the listed standards and is "substantially equivalent" to its predicates.

Parameter Monitored	Acceptance Criteria (Not explicitly stated as numerical performance targets in this document)	Reported Device Performance (No specific numerical data provided)
Bioelectrical Impedance	Compliance with relevant medical device safety standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1) and substantial equivalence to predicate devices (BioZ.com System).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
Heart Rate	Compliance with relevant medical device safety standards and substantial equivalence to predicate devices (BioZ.com System, Wrist Ox2 3150).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
ECG Amplitude	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (BioZ.com System).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
PPG Amplitude	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (Wrist Ox2 3150).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
Skin Temperature (Continuous)	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (TemporalScanner Thermometer).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: The document does not describe a clinical performance study with a "test set" in the context of an AI/ML device validating diagnostic accuracy. The evaluation appears to be based on adherence to safety standards and comparison to predicate devices' design and methodology.

3. 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 Applicable / Not Provided: There is no mention of experts establishing ground truth for a test set, as the device is for monitoring and not making diagnostic claims itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No adjudication method is mentioned because no clinical test set for diagnostic claims is described.

5. 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: No MRMC study was done, as this is a physiological monitoring device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This is a hardware monitoring device, not an algorithm. Its "performance" is based on the accuracy and reliability of its physiological measurements, which are then interpreted by a qualified operator/physician. The document notes that "Operation is to be performed as uninterrupted patient surveillance by the operator" and "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The device's "ground truth" would be the actual physiological parameters measured, validated through calibration and comparison to established measurement techniques, but specific details are not in this document.

8. The sample size for the training set

Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable / Not Provided: Not an AI/ML device requiring a training set.

Summary

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.