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The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.

The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor.

The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.

The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device collects and uploads a dedicated patient's ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system.

The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythm data to a iOS® mobile device using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Clinical Client Application software (Spaulding ECG) to collect a 12-lead ECG.

The Spaulding ECG application then communicates to the Spaulding webECG server to upload ECG data through an Internet connection.

The document provided outlines the K150564 submission for the Spaulding Electrocardiograph 2100iQ. The study performed is a non-inferiority comparison study against a predicate device (Spaulding IQ Electrocardiograph 1000). The focus of the comparison appears to be on specific technical changes and overall performance rather than clinical diagnostic accuracy per se.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table for measures like sensitivity, specificity, or accuracy for diagnosing specific conditions. Instead, it focuses on demonstrating equivalence to the predicate device across various features and safety standards. The reported device performance is summarized as "comparable results" to the predicate.

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

The document does not specify a sample size (e.g., number of patients, number of ECGs) for the test set used in the comparison study.
The data provenance is from a comparison test against a predicate device using a calibrated simulator with arrhythmia capabilities. This implies the data is generated in a controlled environment using simulated cardiac signals, not from human subjects. The country of origin for this simulation data is not specified, but the applicant is based in West Bend, Wisconsin, USA. The study is a prospective comparison of the new device against the predicate under various simulated conditions.

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

No human experts were used to establish the ground truth for this simulator-based comparison test. The "ground truth" for the test set was the known outputs of the calibrated simulator.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was based on a calibrated simulator, no human adjudication was described or needed for this specific comparison test. The comparison involved checking if the device's output matched the simulator's pre-programmed signals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided text. The study described is a technical comparison of the device's signal acquisition and transfer capabilities against a predicate, using a simulator, not a study of human reader performance or diagnostic accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a form of standalone performance was demonstrated through the comparison test. The device (Spaulding Electrocardiograph 2100iQ) was tested directly against a calibrated simulator to acquire and transfer data, without human interpretation as part of the data acquisition/transfer performance comparison. The device provides "un-interpreted 12-lead ECG data".

7. The Type of Ground Truth Used

The ground truth used for the comparison test was the known, pre-programmed signals and conditions from a calibrated ECG simulator.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set. This type of 510(k) submission (for an ECG device) often focuses on technical equivalence and safety rather than a machine learning algorithm's performance requiring a separate training set. The device provides "un-interpreted 12-lead ECG data," implying it's not performing automated diagnoses that would typically involve a vast training dataset for pattern recognition.

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

Not applicable, as no training set or machine learning algorithm requiring such a set is described in the provided text.

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The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use:

• The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) of infants (29 days up to 2 years).
• The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The person proust he experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
• The device is not intended to be used as a vital signs physiological monitor.
• It is not designed for out of hospital transport.
• lt is not designed for use in highly invasive environments, such as an operating theatre.
• The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The proposed Spaulding IQ is an electrocardiograph that combines proprietary hardware, current industry technologies and an off-the-shelf personal computer to achieve a highly reliable electrocardiograph. The IQ is a standard 12-lead non-interpretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical setting. The IQ combines proprietary hardware and an off-the-shelf personal computer. The concept behind the IQ is to provide the user with an ECG acquisition module that can also transfer the acquired ECG record to a participating PC. The PC side of the system will employ installed proprietary software applications to record and process it for display, printing and storage, or further processing. The device may be used in medical clinics and offices of any size, to include Clinical Research Organizations.

The system will be based on two major components:

• An ECG acquisition module that can (1), acquire the patient demographics by means of an incorporated voice signal input component that uses current industry voice recognition technology and (2) acquire a patient 12-lead ECG. The patient ECG and voice signal data will, be stored on the module in local memory and subsequently transferred to a PC Station via a standard USB connection.
• Proprietary Software Application(s) (Mason Protocol) installed on a participating networked PC, that will receive the ECG data from the Acquisition Module and will communicate bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and authentication, submits the resulting ECG and demographic and visit information to the Clinical Server and allows the user to select the appropriate visit protocol and enter patient's demographic and visit data.

This document is a 510(k) premarket notification for the Spaulding Clinical IQ Electrocardiograph. It establishes substantial equivalence to predicate devices, but does not contain a study demonstrating the device meets specific acceptance criteria.

The document describes the device, its intended use, and indications for use, and confirms its clearance by the FDA. However, it does not provide the kind of performance data, study design, or ground truth establishment that would typically be detailed in a clinical validation study.

Therefore, I cannot provide the requested information, particularly:

1. A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report device performance data.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or provided. The device is a non-interpretive ECG system, meaning it acquires and displays ECGs but does not provide automated interpretations that would be compared to human readers. The document explicitly states: "The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data."
6. Standalone performance: While the device is "non-interpretive," meaning it doesn't provide automated diagnostic outputs in the way an AI algorithm might, its core function is to acquire and display ECGs accurately. This document does not describe technical performance metrics (e.g., signal-to-noise ratio, frequency response, common mode rejection ratio, bandwidth) that would typically be assessed for an ECG device to demonstrate its standalone accuracy in acquiring the ECG signal itself. Thus, a standalone accuracy study for the core signal acquisition is not detailed here.
7. Type of ground truth used: Not applicable as no ground truth is described.
8. Sample size for the training set: Not applicable as this document pertains to a traditional medical device, not an AI/ML algorithm that would typically have a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for device clearance and does not detail a study comparing the device's performance against specific acceptance criteria.

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