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Sathlaster is intended for use an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter's face. SatMaster produces graphs and statistics describing a patient's Pulse Oximerry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter's display.

SatMaster is the name of EMG Scientific's Computerized Pulse Oximetry Software product. This product consists of a Program Diskette, a Software License, a User Manual, and a Test Cable. Thus, SatMaster is a software-only "device," intended for use with an MS-DOS, PC-type computer provided by the end-user. Briefly, the SatMaster software provides a PC computer user the capability of transferring Pulse Oximetry data from a Pulse Oximeter, storing the data on the computer, displaying the data in various forms, annotating the data, calculating statistics, and printing the results.

The provided document is a 510(k) Summary for a software device called "SatMaster," a Computerized Pulse Oximetry Software. This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through a clinical study with acceptance criteria.

Therefore, the document does NOT contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for such a test set.
• Number of experts or their qualifications for establishing ground truth for a test set.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to AI improvement.
• Details of a standalone (algorithm only) performance study.
• Type of ground truth used (e.g., pathology, outcomes data) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

Analysis of the Provided Information:

The document focuses on demonstrating that SatMaster is substantially equivalent to a predicate device (Nellcor N-250 Pulse Oximeter, which is a combination of Nellcor N-200 Pulse Oximeter and Nellcor N-50 Powerbase).

Instead of clinical studies with acceptance criteria, the document provides:

1. Device Description and Intended Use: SatMaster is a software-only device that transfers, stores, displays, annotates, calculates statistics, and prints pulse oximetry data from approved pulse oximeters. It is intended as an accessory to enhance a caregiver's use of Pulse Oximeters, providing trends over long periods.
2. Comparison to Predicate Device:
   • Equivalence: SatMaster performs similar functions to the Nellcor N-50 Powerbase portion of the N-250, such as extracting data, displaying trend information, producing tabular lists, and generating histograms of SaO2 levels.
   • Differences: SatMaster is not a patient monitor, does not provide alarms or ECG/Pleth waveform output, does not power the oximeter, and provides additional reports and data-management functions not present in the predicate device.
3. Safety and Effectiveness Argument:
   • The document argues that SatMaster's use should have no impact on the safety of the Pulse Oximetry monitoring process because the Pulse Oximeter itself (an approved device) performs the primary monitoring, and SatMaster only processes the data after collection.
   • It states that SatMaster software has been "designed and extensively tested to insure the correctness and accuracy of SatMaster's data retrieval, data management, data storage, statistical calculations, and reports." However, no details about these tests (e.g., methodology, sample sizes, specific metrics, or acceptance criteria) are provided.
   • It claims enhancements in safety and effectiveness compared to the predicate device, such as requiring patient ID entry (reducing mix-up risk) and generating more extensive reports.
   • It cites published articles describing research performed using SatMaster by various researchers, implying its clinical value. This is anecdotal evidence of device utility rather than a formal study proving specific performance metrics against defined acceptance criteria.

In summary, to directly answer the request, the provided 510(k) summary does not contain the information typically found in a study demonstrating a device meets acceptance criteria. It relies on a demonstration of substantial equivalence to an existing device and general statements about testing and clinical utility, rather than specific performance metrics against established thresholds.

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