(159 days)
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.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Spaulding Electrocardiograph 2100iQ) |
|---|---|---|
| ECG Data Acquisition | Ability to acquire 12-lead ECG data accurately. | Acquires 12-lead ECG data. |
| ECG Data Transfer | Reliable transfer of ECG data without discrepancy. | Data transferred wirelessly (Bluetooth®) was compared to predicate's USB transfer; "no discrepancy" found in acquired and transferred data. |
| Arrhythmia Detection (for signal integrity) | Accurate representation of various cardiac rhythms, including arrhythmias. | Tested with varying beats per minute, ventricular tachycardia, and ventricular fibrillation conditions, showing "comparable results" to the predicate. |
| Safety - Electrical | Compliance with electrical safety standards (e.g., ISO 60601-1 ed 3.1, IEC 60601-2-25:2011). | "Tested in a wider range of electrical tests than the predicate... Complies with the current 60601-1 ed 3.0." |
| Safety - Environmental | Compliance with environmental operational conditions. | "Tested in a wider range of environmental conditions than the predicate... Can be used in transit settings as a portable device." Significantly wider range of temperature conditions covered. |
| Safety - Water Ingress/Particulate Matter | Compliance with IP rating (e.g., IEC 60529). | "Tested and complies with a higher water ingress and particulate matter rating (IP22) than the predicate (IPX21)." |
| Safety - Mechanical | Compliance with mechanical safety standards (e.g., ISO 60601-1 ed 3.1). | "Tested in a wider range of impact and vibration tests than the predicate... Extends use environments to home settings and transit settings as a portable device." |
| Safety - EMC | Compliance with electromagnetic compatibility standards (e.g., IEC 60601-1-2:2007 ED. 3.0 Class B). | "Tested for electromagnetic disturbances the same as the predicate... Can be used in transit settings as a portable device." |
| Pacemaker Interaction | Ability to acquire ECG data in the presence of pacemaker pulses. | "Has ability to acquire ECG data in the presence of pacemaker pulses" and "additional ability to give a visual notification...when a pacemaker pulse is detected." |
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.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).