(150 days)
The Bard LabSystem™ 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.
When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.
The LabSystem EP Recording System 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 fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.
The provided document is a 510(k) Summary for the Bard LabSystem™ PRO EP Recording System, specifically for its V3.1 software. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving device performance against specific acceptance criteria. This type of regulatory submission typically relies on a comparison to existing, legally marketed devices rather than presenting novel performance studies with acceptance criteria, especially for software updates to established systems.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not present in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available in the document. The document does not describe specific acceptance criteria or report quantified device performance metrics (e.g., sensitivity, specificity, accuracy) for the V3.1 software. The submission aims to show "substantial equivalence" to predicate devices, implying that its performance is comparable, but it doesn't present a study with specific targets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the document. There is no mention of a test set, its sample size, or the provenance of the data.
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 available in the document. Given no test set is described, there's no information on experts establishing ground truth for it.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the document. No information on an adjudication method for a test set is provided.
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
- Not applicable/Not available in the document. This device is an EP recording system for acquiring, analyzing, and displaying cardiac electrophysiologic data and 3D electroanatomical maps during electrophysiology procedures. It does not appear to be an AI-driven diagnostic system that assists human readers in the way an MRMC study typically assesses for AI. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available in the document. The device is a "computer and software driven data acquisition and analysis tool" that "facilitate[s] the gathering, display, analysis by a physician." It is inherently designed for use by a physician, not as a standalone, fully autonomous diagnostic algorithm. No standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in the document. Since no specific performance study or test set is described, there's no information on the type of ground truth used.
8. The sample size for the training set
- Not available in the document. This document does not discuss a training set. The device appears to be a software update for an existing system, and the submission emphasizes regulatory compliance and substantial equivalence rather than a machine learning model's training and validation process.
9. How the ground truth for the training set was established
- Not available in the document. Since no training set is mentioned, there's no information on how its ground truth was established.
Summary of Non-Clinical Testing Section (Relevant to the overall submission but not specific performance metrics):
The document states: "The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards." While this indicates quality control and development processes, it doesn't provide specific device performance acceptance criteria or study results against those criteria. The "Summary of Non-Clinical Testing" is a high-level statement about adherence to quality systems and standards, rather than a detailed report of a performance study.
§ 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).