(322 days)
The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed.
The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.
A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes.
These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.
The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.
The provided text does not contain detailed information about specific acceptance criteria and a structured study proving the device meets these criteria in the format requested.
The document is a 510(k) premarket notification summary for the Ablamap® Software, which primarily focuses on demonstrating substantial equivalence to a predicate device (Abbott Electrophysiology RhythmView™ Workstation). While it mentions "Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed," and "Testing demonstrated that the software met design requirements and functioned as intended," it does not provide:
- A table of specific numerical acceptance criteria and reported performance values.
- Details on the sample size used for the test set or its provenance.
- The number or qualifications of experts used for ground truth establishment.
- Adjudication methods.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Standalone algorithm performance data.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size or ground truth establishment methods for a training set.
The document refers to software design verification and validation testing, which indicates that internal testing was performed to ensure the software met its design specifications and complied with relevant standards (IEC 62304, ANSI/AAMI/IEC 62366-1, ISO 14971). However, these are general statements about internal quality assurance and regulatory compliance, not a detailed clinical performance study with defined acceptance criteria and results as typically released for AI/ML medical devices where clinical efficacy is a primary concern.
Therefore, based on the provided text, it's not possible to answer the requested questions about acceptance criteria and the study that proves the device meets them with specific details. The filing demonstrates equivalence based on intended use, indications for use, and technological characteristics, rather than a quantifiable clinical performance study against specific metrics.
§ 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).