(30 days)
The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.
Not Found
The provided document is a 510(k) premarket notification clearance letter for the EP-WorkMate® with RPM™ Mapping System, dated August 2, 2003. This type of document indicates substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or extensive study results in the format requested. The letter focuses on regulatory clearance, not detailed performance metrics.
However, based only on the information provided in this document, here's what can be extracted, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the clearance letter. Regulatory clearance letters confirm substantial equivalence to a predicate device, but they do not typically detail the specific acceptance criteria or the specific device performance values as determined by studies submitted to the FDA.
2. Sample size used for the test set and the data provenance:
This information is not provided in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the clearance letter.
4. Adjudication method for the test set:
This information is not provided in the clearance letter.
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:
This information is not provided in the clearance letter. The device is described as an "EP-WorkMate® with RPM™ Mapping System," which is a "Programmable diagnostic computer" for "diagnostic electrical stimulation of the heart." This suggests the device is used for electrophysiology (EP) studies and mapping, not necessarily an AI-powered image analysis tool that would typically involve a multi-reader study of human interpretation improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not provided in the clearance letter. Given the nature of a "diagnostic computer" for EP procedures, it's highly likely that it's intended to be used with human operators (electrophysiologists).
7. The type of ground truth used:
This information is not provided in the clearance letter.
8. The sample size for the training set:
This information is not provided in the clearance letter.
9. How the ground truth for the training set was established:
This information is not provided in the clearance letter.
Summary based on the provided document:
The document is an FDA 510(k) clearance letter confirming that the EP-WorkMate® with RPM™ Mapping System is "substantially equivalent" to legally marketed predicate devices. It states the "Indication for Use" is "for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping."
The letter does not include details about specific performance metrics, acceptance criteria, study designs (like sample sizes, expert qualifications, adjudication methods), or ground truth establishment for either training or test sets. Such granular information is typically found in the 510(k) submission itself or related study publications, not in the clearance letter.
§ 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).