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The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, epidural or irrigation of fluid space. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The Spectrum IQ Infusion System with Dose IO Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors and increase accuracy of infusion documentation.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

The proposed device, Spectrum IQ Infusion System with Dose IQ Safety Software is a large volume infusion system that provides safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the infusion of pharmaceutical drugs, blood and blood products through intravenous administration sets at user selectable rates and volumes, and a software application that allows the generation, configuration and management of a downloadable drug library into the pump.

This document is a 510(k) premarket notification from the FDA, indicating that the Spectrum IQ Infusion System with Dose IQ Safety Software is substantially equivalent to a previously cleared device (K220417). The document focuses on regulatory approval rather than providing detailed study information for acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this text.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states that "Performance testing for the software was completed" but does not detail the acceptance criteria or the results of this testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document does not discuss the specifics of any test set used or its data provenance.

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 document. No details about expert involvement in establishing ground truth are mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication methods are described.

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 document. The document's purpose is regulatory clearance based on substantial equivalence, not a detailed clinical comparative effectiveness study involving human readers and AI assistance. The device is an infusion pump with safety software, not an AI diagnostic tool that would typically involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not explicitly stated or detailed in the document. The device includes "Dose IQ Safety Software" intended to "reduce operator interaction through guided programming" and "automate the programming of infusion parameters and documentation," which implies an algorithmic component. However, the document does not describe standalone performance testing of this algorithm without a human in the loop, nor does it specify "algorithm only" performance. It refers to "Performance testing for the software."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. The document does not specify how ground truth was established for any performance testing.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" or its size.

9. How the ground truth for the training set was established

This information is not provided in the document. As no training set is mentioned, naturally, how its ground truth was established is also not present.

Summary of what can be gleaned from the document:

This FDA 510(k) clearance letter (K222048) for the Spectrum IQ Infusion System with Dose IQ Safety Software indicates that the device is substantially equivalent to a predicate device (K220417, cleared on 04/29/2022). The scope of the current notification is to update the software and associated labeling of the pump. It states that "Performance testing for the software was completed." However, the details of this testing, including acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not included in this regulatory document. The document focuses on the administrative aspects of substantial equivalence for regulatory approval.

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