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The Spectrum IQ Infusion System with Dose IQ Safety Software 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, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software 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 IQ 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.

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

Spectrum IQ is a large volume pump within the Spectrum IQ infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides 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 controlled administration of fluids including pharmaceutical drugs, blood and blood products through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

Dose IQ is a standalone software application installed on a hospital-provided computing platform and used to create a drug library file. Dose IQ facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file includes customers' dosing limits and additional pump configuration settings. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023.

The provided FDA 510(k) clearance letter for the Spectrum IQ Infusion System with Dose IQ Safety Software (K251636) does NOT describe a study involving an AI/Machine Learning algorithm for diagnostic or prognostic purposes, which would typically involve the criteria you've outlined.

Instead, this device is an infusion pump with safety software, intended to reduce operator interaction through guided programming to minimize "pump programming errors." The summary explicitly states: "This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023." This suggests that the changes are primarily bug fixes, usability improvements, and potentially enhanced safety features rather than the introduction of a novel AI-driven diagnostic tool.

Therefore, many of the requested details about acceptance criteria and study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. These criteria are typically relevant for AI/ML-enabled devices that perform interpretation of medical images, signals, or patient data for diagnostic or prognostic purposes where "ground truth" and human reader performance are central to validation.

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (K230041) through a comparison of technological characteristics and non-clinical performance and safety testing.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Device Performance (Based on the provided document)

The document doesn't present specific quantitative acceptance criteria in a table format for a "study" as you might expect for an AI/ML diagnostic device. Instead, "acceptance criteria" for an infusion pump typically refer to meeting defined performance specifications (e.g., volumetric accuracy, alarm thresholds, power consumption, environmental limits) and safety standards (e.g., IEC 60601 series).

The document states that "Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use." However, it does not provide the specific quantitative criteria or the numerical reported device performance for each. It assumes these were adequately documented in the full submission to FDA.

The "performance" described relates to the functional aspects of the pump and software:

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The Spectrum IQ Infusion System with Dose IQ Safety Software 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, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software 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 IQ 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 IO Infusion System with Dose IO 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) summary for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230041). It references a previous 510(k) notification (K222048) for the Spectrum IQ Infusion System with Dose IQ Safety Software as the predicate device.

The provided text focuses on the K230041 submission, which specifically addresses an update to the algorithm and labeling related to the upstream occlusion alarm of the pump. It states that performance testing for the software was completed for this update.

However, the document does not provide detailed information about acceptance criteria or specific study results for this particular update. It primarily asserts substantial equivalence to the predicate device and mentions that the scope of the notification is limited to the occlusion alarm update.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for the occlusion alarm algorithm validation are not present in the provided text. The information below is limited to what can be inferred or directly stated from the provided document, acknowledging the significant gaps.

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance for the updated upstream occlusion alarm algorithm. It only mentions that "Performance testing for the software was completed" for this update. Without the actual test plan or report, these details cannot be provided.

Study Information (Specific to the upstream occlusion alarm algorithm update)

1. Sample size used for the test set and the data provenance:

   • Not specified. The document states "Performance testing for the software was completed" but does not give details on the size or nature of the test set used for the occlusion alarm algorithm.
   • Data provenance: Not specified. It's likely internal testing data, but the origin (e.g., country, retrospective/prospective) is not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. Given it's a software/algorithm update for an occlusion alarm, ground truth would likely be established through controlled experimental setups (e.g., intentionally inducing occlusions) rather than expert review of clinical cases.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like "2+1" are typically for subjective assessments (e.g., image interpretation). For a technical alarm system like an occlusion detector, the "ground truth" is objectively verifiable (e.g., physical presence of an occlusion).

4. 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:

   • No. An MRMC study is not relevant here. This device is an infusion pump with a safety algorithm, not an AI diagnostic tool requiring human interpretation. The "AI" (algorithm) in this context is automating a safety function, not assisting human "readers" with diagnostic tasks.

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

   • Likely yes by implication, but not explicitly stated. The "performance testing for the software" would typically involve evaluating the algorithm's ability to detect occlusions in a controlled environment as a standalone component of the pump's safety system. The entire pump system, which includes the algorithm, operates primarily in a standalone manner to detect occlusions and trigger alarms, though a human operator would then respond to the alarm.

6. The type of ground truth used:

   • Not specified, but likely objective, empirical truth. For an occlusion alarm, ground truth would be established by physically creating true occlusion events (and non-occlusion conditions) in a laboratory or simulated environment and measuring the algorithm's response. This is an objective "engineering" ground truth, not pathology, expert consensus, or outcomes data in the traditional sense.

7. The sample size for the training set:

   • Not specified. There's no mention of a training set or machine learning model in the context of this specific occlusion alarm algorithm update. It might be a rule-based or signal-processing algorithm rather than a machine learning algorithm requiring a distinct training set. If it is a machine learning algorithm, the training set size is not provided.

8. How the ground truth for the training set was established:

   • Not specified. Due to the lack of information on a training set or its nature.

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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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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, arterial, subcutaneous, 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 IO Infusion System with Dose IQ 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 healtheare 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.

The provided text is a 510(k) summary for the Baxter Healthcare Corporation's Spectrum IQ Infusion System with Dose IQ Safety Software. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria related to its performance in reducing programming errors or increasing documentation accuracy, which are stated as its intended use.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K173084), whose clearance date was May 11, 2018. The current 510(k) (K220417) is specifically for updating the cleaning instructions for the device.

Therefore, based only on the provided text, I cannot extract the information required to populate the table and answer the study-related questions.

The "Indications for Use" section mentions:
"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."

However, the document states in the "DISCUSSION OF NONCLINICAL TESTS" section: "The scope of this notification is to update the cleaning instructions. Performance testing for the cleaning agents was completed. Biocompatibility is not affected by this notification. The intended use and function of the proposed device is the same as the predicate device."

And in the "CONCLUSION" section: "The scope of this notification is to update the cleaning instructions per the performance testing. The intended use and function of the proposed device is equivalent to the predicate 510(k), currently commercialized device."

This explicitly indicates that the current submission (K220417) is not about new performance studies for reducing programming errors or increasing documentation accuracy. It's about cleaning instructions.

To answer your request, a different document that details the original performance study for K173084 (the predicate device) or a subsequent study focusing on the "reduce pump programming errors and increase accuracy of infusion documentation" claim would be needed.

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