(174 days)
ZOLL ePCR iOS is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). ZOLL ePCR iOS is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. ZOLL ePCR iOS is indicated for use by health care providers whenever there is a need for generation of a patient record.
The proposed ZOLL ePCR iOS is a software-only product. ZOLL ePCR iOS is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). ZOLL ePCR iOS is non-alarming software that runs on various iOS devices (iOS is the Apple operating system for use on iPads and iPhones).
This document does not contain the detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document is a 510(k) premarket notification letter from the FDA to ZOLL Medical Corporation for their ZOLL ePCR iOS device.
Here's what can be extracted and what is missing:
Information Present in the Document:
- Device Name: ZOLL ePCR iOS
- Intended Use: "ZOLL ePCR iOS is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). ZOLL ePCR iOS is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. ZOLL ePCR iOS is indicated for use by health care providers whenever there is a need for generation of a patient record." (Page 3 & 5)
- Predicate Device: ZOLL RescueNet ePCR (K103473), cleared on 05/13/2011. (Page 5)
- Technological Characteristics Comparison: The ZOLL ePCR iOS is similar to the predicate device, but uses a different operating system (iOS vs. Microsoft Windows). Both are software-only products for data collection, storage, and printing, and synchronize to a data server. (Page 5)
- Performance Testing Mention: The document states, "Extensive performance testing ensures that ZOLL ePCR iOS performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." (Page 5)
Information NOT Present in the Document (and therefore cannot be provided in the requested table/format):
- Specific Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria for the device's performance. It only generally states that testing ensures it performs "as well as the indicated predicate device and meets all of its functional requirements and performance specifications."
- Reported Device Performance: No specific performance metrics (e.g., accuracy, reliability rates, speed) are provided.
- Sample Size for Test Set: Not mentioned.
- Data Provenance (country, retrospective/prospective): Not mentioned.
- Number of Experts for Ground Truth & Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study Details: Not mentioned. The document primarily focuses on substantial equivalence to a predicate, not necessarily a comparative effectiveness study against human readers.
- Standalone Performance: While it mentions "software-only product," it doesn't detail standalone performance metrics. The intended use clearly involves a human user (caregiver).
- Type of Ground Truth Used: Not mentioned.
- Sample Size for Training Set: Not mentioned (as this device focuses on data collection/storage, not typically an AI model that requires a training set in the conventional sense).
- How Ground Truth for Training Set was Established: Not applicable given the nature of the device as described.
This 510(k) summary is a regulatory document confirming substantial equivalence to a predicate device, which allows the new device to be marketed. It generally does not include the granular details of performance studies as would be found in a clinical trial report or a more extensive engineering report. It relies on the assertion that "Extensive performance testing" was conducted.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).