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510(k) Data Aggregation
(147 days)
ZOLL RESCUENET 12-LEAD
The RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
The proposed RescueNet 12-Lead is a software-only product. RescueNet 12-Lead is a web-based management system that uses a web browser to provide quick, easy access to 12-Lead records sent from ZOLL defibrillators, and physiological and patient data from other patient care systems. With RescueNet 12-Lead, users can view, distribute, close, add notes, and print 12-Lead records, and can search for Inbox and/or closed 12-Lead records, and run reports.
The provided text describes a 510(k) premarket notification for the "RescueNet 12-Lead" device, which is a software-only product designed for the transmission and reception of medical data. The application indicates that the device's substantial equivalence is based on its similarity to a predicate device, the Physio-Control LIFENET System (K102757).
Crucially, the provided document does not detail specific acceptance criteria or an explicit study that proves the device meets such criteria in terms of clinical performance. Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device through performance testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements and Performance Specifications (Implicitly, to be equivalent to the predicate device) | "Extensive performance testing ensures that RescueNet 12-Lead performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." |
| Safety and Effectiveness (Implicitly, to be equivalent to the predicate device) | "Performance testing of RescueNet 12-Lead demonstrates that its features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness." |
Explanation: The document states that "Extensive performance testing ensures that RescueNet 12-Lead performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." This phrasing implies that the acceptance criteria are linked to achieving equivalence with the predicate device's established performance and functional requirements. However, the specific quantitative or qualitative acceptance criteria themselves are not enumerated in this document.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a test set sample size or its data provenance (e.g., country of origin, retrospective or prospective). The "performance testing" mentioned appears to refer to validation of the software's functionality and equivalence rather than a clinical study with a patient data test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a clinical study involving a test set that required expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not describe an MRMC comparative effectiveness study or any effect size related to AI assistance for human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The device is described as a "data transmission and reception system" for 12-Lead ECG reports and other data, intended for "diagnosis, disposition, and therapy decisions by qualified medical personnel." This indicates it's a tool for human review, not a standalone diagnostic algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not directly applicable in the context of a diagnostic algorithm here. The performance testing focuses on the software's ability to transmit and receive data accurately and reliably, rather than its ability to interpret medical data independently.
7. Type of Ground Truth Used:
Not applicable. The "performance testing" described in the document pertains to the software's ability to transmit and receive data, not to its diagnostic accuracy against a medical ground truth (like pathology or outcomes data).
8. Sample Size for the Training Set:
Not applicable. The device is a data transmission and reception system, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation or diagnostic prediction.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through "extensive performance testing" of the software's functionality and its ability to act as a data transmission and reception system, similar to its predicate device. It does not contain information about clinical studies with specific acceptance criteria, test sets, ground truth establishment methods, or AI performance metrics as typically expected for diagnostic AI/ML devices.
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