(64 days)
The Bard LabSystem III* EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping, and storage of cardiac electrophysiologic data.
The Bard STAMP Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the Bard LabSystem [III]* EP Laboratory) that can record and display the information.
The LabSystem III is a microprocessor based data acquisition system. that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure, and digital data from other devices like fluoro systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. Although Bard Electrophysiology manufactures and distributes ECG leadwires and catheters, these devices are not included with the LabSystem III.
The amplifier filters and transmits the data to the computer where it is stored on optical disks and displayed on video monitors. The Bard LabSystem III EP Laboratory is available with a dual screen to provide the user with a review screen to analyze data and generate reports at the same time real-time data is being acquired. The real-time screen displays and records real-time data. This system allows the user to perform signal measurements and to print out waveforms.
The system is a software driven tool that acquires and displays data, stores and reports data. The system can also acquire and display data from other sources such as an RF generator. It does not transmit alarms or arrhythmias, nor does it have arrhythmia detection capabilities.
The provided text describes the Bard LabSystem III EP Laboratory, a data acquisition system for electrophysiology procedures. However, it does not contain a dedicated study proving device performance against specific acceptance criteria.
Instead, the document details the device's technical characteristics, its intended use, a comparison to a predicate device, and compliance with various national and international safety and software standards. The FDA's 510(k) clearance is based on a determination of substantial equivalence to existing legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria.
Here's an analysis of the information that is available, addressing your questions to the best extent possible given the document limitations:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document states: "Software qualification is performed in-house on the system with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem III." However, the specific acceptance criteria and the numerical results are not reported. The focus is on compliance with standards and substantial equivalence, not a direct performance study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document discusses "software qualification" and compliance with standards, but no details on specific test sets (sample size, country of origin, retrospective/prospective nature) are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As no specific test set or clinical study is detailed, the method for establishing ground truth and the experts involved are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study is not mentioned. The document focuses on the device's technical capabilities and its substantial equivalence to predicate devices, and that it facilitates physician analysis, but not how it improves human reader performance. In fact, it explicitly states: "The system does not... analyze data acquired during an EP procedure."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, standalone testing of hardware and software was performed, though not in the context of an algorithm's diagnostic performance. The document states: "Software qualification is performed in-house on the system with results that meet acceptance criteria" and "All equipment pertaining to the LabSystem is tested and certified to meet the following national and international safety standards." These tests would be assessing the device's functionality and safety independently.
7. The Type of Ground Truth Used
The concept of a "ground truth" in the clinical diagnostic sense (e.g., pathology, outcomes data) is not applicable or mentioned in this submission. The "ground truth" here would relate to the correct functioning of the hardware and software according to design specifications and regulatory standards. For example, testing current leakage (EN60601-1:1990) would have a known "ground truth" value for acceptable leakage.
8. The Sample Size for the Training Set
This information is not provided. The device is a data acquisition and display system, not a machine learning model that would typically have a "training set" in the modern AI sense.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The "study" described is primarily focused on compliance with established standards and internal "software qualification" processes, rather than a clinical performance study with defined acceptance criteria and a test set.
- Non-Clinical Tests: The document lists several IEEE and EN standards related to electrical medical devices, software quality assurance, test documentation, verification & validation, and requirements specifications. It also mentions EN standards for EMC and patient leakage current.
- Methodology: "Software qualification is performed in-house on the system with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem III." This suggests internal testing against design specifications and regulatory requirements.
- Basis for Approval: The FDA's 510(k) clearance is based on a determination of substantial equivalence to predicate devices. This means that the FDA found the LabSystem III to be as safe and effective as other similar devices already on the market, despite specific modifications made to the hardware and software. The argumentation is that "These modifications do not raise new issues of safety and effectiveness."
In conclusion, this 510(k) summary provides evidence of compliance with safety and software standards and a comparison to a predicate device to establish substantial equivalence for a data acquisition system. It does not detail a clinical performance study with specific acceptance criteria, test set sizes, expert ground truth, or adjudication methods in the way a diagnostic AI device submission might.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).