(108 days)
Score Software is an accessory to two NPB pulse oximeters. It is intended to provide clinicians with the ability to collect, edit, and analyze trend data recorded by a Nellcor Symphony™ N-3000 pulse oximeter or a Nellcor Puritan Bennett™ N-200 pulse oximeter. It provides general functions that are not intended to diagnose any specific disease.
Score Software retrieves data from certain pulse oximeters such as the Nellcor Puritan Bennett Models N-200 and N-3000, displays recorded data, analyzes the data, and generates a report for the user to review. The report includes both raw wave forms and summary statistics such as number desaturations. The event definitions are defined by the user.
The provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The document is a 510(k) summary for "Score Software (Models 4520 and 4530)," which is described as pulse oximeter display software. It outlines the intended use, device description, and comparison to a predicate device (Nellcor P200S Thermal Printer).
The "Summary of Performance Testing" section only states very generally:
- "Testing was performed to confirm that Score Software is capable of meeting its intended functional requirements. Score Software passed all tests."
- "All software was tested in compliance with the Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review published by the Office of Device Evaluation within the CDRH. Score passed all tests."
This general statement does not provide any specific acceptance criteria, performance metrics, study details, sample sizes, ground truth establishment, or any of the other specific information requested in your prompt.
Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).