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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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Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids.

Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps.

Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump.

Dose IQ Safety Software is intended to be used by licensed pharmacists.

Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Dose IQ is a standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform. It provides the hospital's pharmacists the ability to create and configure a facility-specific drug library file for the either the Novum IQ Large Volume Pump or the Novum IQ Syringe Pump. Dose IQ stores the created drug library for future transfer to an infusion pump that is compatible with the drug library file through the IQ Enterprise Gateway, or via a USB. It is intended to be used by multiple users simultaneously. Authorized users access the software though a Google Chrome web browser (build 76.0.3809.100 and above).

Creating a facility-specific drug library in Dose IO is one method to implement a Dose Error Reduction System (DERS) – a safety system intended to reduce medication errors. A hospital-defined drug library defines medications with individual concentrations, concentration limits, dosing units, dosing limits, alarm configuration settings, and administration requirements that are specific to each patient care area. Pump programming values are checked against these hospital-defined limits. The pump alerts clinicians if programmed values exceed these limits. Also included in the drug library are hospital-defined individual care area settings and general pump settings. DERS is not active when programming an infusion using Basic Mode, which requires the pump user to manually specify the parameters for the infusion on the pump, therefore only individual Care Area settings, general pump settings, and pump default settings apply.

Dose IQ does not directly interface with or control the compatible infusion pump. It solely provides the ability to create a drug library file that can then be loaded to the compatible infusion pump. Dose IO does not deploy the file to the pump; this is done by USB media or the IQ Enterprise Gateway software. A copy of the drug library file is stored in each pump, so that the pump can operate, without real-time interaction, with other components of the Novum IQ Platform.

Baxter provides a list of syringe containers that are permissible with the Novum IQ Syringe pump based on specific syringe brands and sizes. The Approved Syringe List is available on Baxter's Technical Service Portal and must be uploaded into Dose IQ. The Approved Syringe List cannot be modified in Dose IQ. The pharmacist selects the required syringe brands and sizes from this Approved Syringe List to create the Facility Syringe List for use within the hospital. Dose IQ incorporates the Approved Syringe List and the Facility Syringe List as part of the drug library file for the Novum Syringe pump.

The provided text describes the 510(k) premarket notification for the Baxter Dose IQ Safety Software. However, it explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, there is no information in the provided document about "acceptance criteria" based on clinical performance, a "study that proves the device meets the acceptance criteria" in a clinical context, or details like sample size, expert ground truth establishment, MRMC studies, or standalone performance.

The document primarily focuses on non-clinical testing, verification, and validation to demonstrate substantial equivalence to a predicate device. It details software testing and a human factors evaluation.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, primarily from a non-clinical testing and verification/validation perspective:

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

Since the document does not present clinical acceptance criteria, the "acceptance criteria" implied here are related to software verification and validation, and meeting design inputs and user needs. The reported performance is a general statement of successful completion of these tests.

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

• Test Set Sample Size: Not applicable in the context of clinical data, as no clinical testing was performed. For non-clinical software testing, the "sample size" would refer to the number of test cases, which is not specified but implied to be comprehensive enough for "functional testing, regression testing, smoke & sanity testing, code review, static analysis, and unit testing."
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the test data (e.g., specific testing labs or environments), but it implies internal company testing or external contracted testing. The testing is non-clinical verification and validation, not retrospective or prospective clinical data.

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

• Not applicable as no clinical ground truth was established from expert readings or similar methods for a clinical test set. The "truth" for software testing is defined by the functional and non-functional requirements and design specifications.
• For the human factors study, it was conducted "with the intended user population." The number and specific qualifications of these users (e.g., licensed pharmacists, as per the indications for use) are not detailed.

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

• Not applicable as no clinical test set requiring adjudication of expert opinions was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states, "No clinical testing was performed."

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

• Again, no clinical performance studies were conducted. The device itself is "standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform." Its primary function is to create drug libraries for infusion pumps, not to directly perform real-time patient-facing actions or diagnoses that typically warrant standalone algorithm performance metrics. It's a tool for pharmacists to configure other medical devices.

7. The type of ground truth used:

• For non-clinical software testing: The ground truth is effectively the design requirements, specifications, and established functional behavior of the software as defined by the developers and verified against those specifications.
• For the Human Factors evaluation: The "ground truth" would be the successful completion of tasks by intended users in a simulated environment, demonstrating the usability and safety in typical use scenarios.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that learns from a "training set" of data in the typical sense (e.g., image datasets). It's a configuration and management software.

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

• Not applicable, as there is no "training set" for an AI/ML model described.

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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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Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump to support the controlled administration of fluids.

Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the Novum IQ Syringe Pump.

Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump.

Dose IQ Safety Software is intended to be used by licensed pharmacists.

Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Dose IQ is a standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform. It provides the hospital's pharmacists the ability to create and configure a facility-specific drug library file for the Novum IQ Syringe Pump. Dose IQ stores the created drug library for future transfer to an infusion pump that is compatible with the drug library file through the IQ Enterprise Gateway, or via a USB. It is intended to be used by multiple users simultaneously. Authorized users access the software though a Google Chrome web browser (build 76.0.3809.100 and above).

Creating a facility-specific drug library in Dose IO is one method to implement a Dose Error Reduction System (DERS) – a safety system intended to reduce medication errors. A hospital-defined drug library defines medications with individual concentrations, concentration limits, dosing units, dosing limits, alarm configuration settings, and administration requirements that are specific to each patient care area. Pump programming values are checked against these hospital-defined limits. The pump alerts clinicians if programmed values exceed these limits. Also included in the drug library are hospital-defined individual care area settings and general pump settings. DERS is not active when programming an infusion using Basic Mode, which requires the pump user to manually specify the parameters for the infusion on the pump, therefore only individual Care Area settings, general pump settings, and pump default settings apply.

Dose IQ does not directly interface with or control the compatible infusion pump. It solely provides the ability to create a drug library file that can then be loaded to the compatible infusion pump. Dose IO does not deploy the file to the pump; this is done by USB media or the IQ Enterprise Gateway software. A copy of the drug library file is stored in each pump, so that the pump can operate without real-time interaction with other components of the Novum IQ Platform.

Baxter provides a list of syringe containers that are permissible with the Novum IQ Syringe pump based on specific syringe brands and sizes. The Approved Syringe List is available on Baxter's Technical Service Portal and must be uploaded into Dose IQ. The Approved Syringe List cannot be modified in Dose IQ. The pharmacist selects the required syringe brands and sizes from this Approved Syringe List to create the Facility Syringe List for use within the hospital. Dose IQ incorporates the Approved Syringe List and the Facility Syringe List as part of the drug library file for the Novum Syringe pump.

The provided text is a 510(k) summary for a medical device called "Dose IQ Safety Software." This document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing, but it does not describe a clinical study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study typically would.

Instead, the document emphasizes non-clinical testing, verification, and validation against design input requirements, user needs, and intended use, as well as demonstrating substantial equivalence to a predicate device. It explicitly states: "No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide a response that directly answers the request for "a table of acceptance criteria and the reported device performance" from a clinical study, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance" in the context of real-world clinical performance evaluation against health outcomes or diagnostic accuracy via expert read. The provided text deals with software verification and validation, and human factors.

However, I can extract the information related to the non-clinical acceptance criteria and validation efforts described in the document:

1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance

The document describes non-clinical testing against requirements for performance and safety. The acceptance criteria are broadly defined as meeting "design inputs and user needs" and "design and cyber security requirements."

• Potential risks mitigated, residual risk acceptable.
• Design verification and validation acceptable.
• Device meets clinically valid essential performance. |
  | Performance and Safety Requirements | "Performance testing of the Dose IQ Safety Software was verified against requirements for performance and safety, and to provide objective evidence that the device intended use is met."
• "Validation demonstrated that design inputs and user needs were met."
• "System verification demonstrated that design outputs meet design and cyber security requirements. All the testing met acceptance criteria." |
  | Software Verification and Validation (FDA Guidance) | Per FDA guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (2005) (considered a major level of concern):
• "Software testing included Functional testing. Regression Testing. Smoke & Sanity testing, code review, static analysis, and unit testing."
• Outcome: All testing met acceptance criteria. |
  | Human Factors Evaluation (Usability) | Per IEC 62366-1ed. 1.0 b:2015 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (2016):
• Conducted in a simulated environment with intended user population, use environment, and scenarios.
• Outcome: "Results of the human factors study show the device is suitable for its intended use." |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "sample size" for a test set in the traditional sense of a clinical study (e.g., number of patients/cases). The testing described is software verification and validation, and human factors testing.

• Software Testing: These tests typically involve testing code against requirements, not patient data in the sense of a clinical study. The document mentions "Functional testing. Regression Testing. Smoke & Sanity testing, code review, static analysis, and unit testing." The "test set" would be the collection of test cases designed to cover software functionalities and requirements.
• Human Factors Evaluation: Conducted in a "simulated environment." The "sample size" for this would be the number of "intended user" participants. This number is not specified in the document.
• Data Provenance: Not applicable for clinical data. The tests are focused on software functionality, safety, and usability in simulated environments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable in the context of this submission. The "ground truth" for software functionality is defined by the design requirements and specifications themselves. For the human factors study, the "intended user population" was involved, but specific expert qualifications or adjudication for establishing a "ground truth" in terms of diagnostic reads or outcomes are not relevant to this type of testing.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a human-in-the-loop diagnostic study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "No clinical testing was performed in support of this premarket notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "Dose IQ Safety Software" is a standalone software application ("not embedded in pumps") that allows pharmacists to "create and maintain drug libraries." Its function is to configure pump settings. The "performance" assessment focuses on whether the software correctly generates these drug libraries according to specifications, and whether it is usable by pharmacists. Therefore, the non-clinical testing described effectively is a "standalone" performance assessment of the software's ability to meet its functional requirements and safety objectives. The document doesn't provide specific quantitative metrics of its "performance" (e.g., accuracy, precision) in the way one would for a diagnostic AI, but rather confirms its successful verification and validation.

7. The Type of Ground Truth Used:

• For software functionality: The "ground truth" is based on the defined "design input requirements" and "user needs."
• For human factors: The "ground truth" is based on the objectives of usability and safety in simulated clinical conditions, assessed by the "intended user population."

8. The Sample Size for the Training Set:

Not applicable. This is a software application for creating drug libraries, not a machine learning or AI model that is "trained" on a traditional dataset (e.g., medical images for diagnosis). The software's logic and rules are presumably programmed based on medical and engineering specifications relevant to infusion pump operation and drug administration safety.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's design and functionality is established through established medical device development processes, regulatory standards, clinical guidelines for drug administration, and engineering specifications for infusion pumps.

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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.

Ask a specific question about this device

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

The proposed device, which is the subject of this Traditional 510(k) premarket notification, is the Spectrum IQ Infusion System with Dose IQ Safety Software. The Spectrum IQ Infusion System with Dose IQ Safety Software is a large volume infusion pump system that provides delivery of fluids into a patient in a controlled manner. The system includes a software controlled, electromechanical pump used for the infusion of fluids such as 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 feedback-controlled, motorized pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The pump utilizes a primary and secondary processor to maintain operation while providing infusion pump capabilities for a wide range of applications.

The pump is specifically manufactured and calibrated for use with Baxter's standard administration sets, as indicated in the device labeling. For use, the administration set is loaded into the infusion pump. After acceptance of program parameters, the pump is started and fluid is propelled by the peristaltic action of the pumping mechanism. The pump is designed to create smooth fluid dynamics, precise volumetric accuracy, and a uniform flow rate. None of the pump materials contact the fluid path of the administration set.

The Dose IQ Safety Software is a software application that allows for the generation, configuration, and management of a downloadable drug library into a selected Spectrum pump. The drug library can be loaded directly into the pump through a wireless network host or through an Infrared Data Association (IrDA) device. The Dose IQ Safety Software operates on a standard software, Microsoft Windows®, platform.

Using the Dose IQ Safety Software application, a facility can develop preprogrammed delivery profiles, advisories, and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus aiding in the reduction of medication errors. The Dose IO Safety Software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The Dose IQ Safety Software application also provides a feature to restrict/limit the access of data to only appropriate personnel, providing additional security and rights to specific users.

The Spectrum IQ Infusion System with Dose IQ Safety Software is also capable of automatically populating infusion parameters based on an infusion order that is wirelessly received from a facility's electronic medical record (EMR) system. Although the pump can accept remote orders and populate the infusion parameters, it requires a clinician to verify the information before the start of an infusion.

This FDA 510(k) summary for the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software details the device's characteristics and its comparison to a predicate device, focusing on non-clinical testing.

Here's an analysis of the provided text in the context of your request:

1. Table of acceptance criteria and the reported device performance:

The document states that "Non-Clinical testing of the Spectrum IQ Infusion system with Dose IQ Safety Software met all acceptance criteria". However, it does not explicitly list the quantitative acceptance criteria for each test and its specific performance result in the format of a table you requested. Instead, it broadly states "Per Baxter Test Methods" for several categories of testing. We can infer some performance characteristics from the "Technological Characteristics and Substantial Equivalence" section, which compares the proposed device to the predicate.

Here's an attempt to construct a table based on the provided information, understanding that concrete acceptance criteria and specific numerical performance against those criteria are not explicitly detailed for most points, but rather implied by meeting "Baxter Test Methods" and showing "substantial equivalence":

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., number of devices tested, number of simulated scenarios).
The data provenance is from non-clinical testing performed by Baxter Healthcare Corporation, including bench testing and human factors evaluation in a simulated environment. There is no mention of country of origin of data beyond Baxter's internal testing as the manufacturer. The tests are prospective in nature, assessing the device's performance against defined requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions a "Human Factors evaluation in a simulated environment" and states it's intended to ensure use errors are not greater than minimal risk. It also mentions "trained healthcare professionals" for intended users.
However, the document does not specify the number of experts, nor their specific qualifications, who established a "ground truth" or evaluated the human factors test set. It implies user testing with qualified personnel but no detail is provided.

4. Adjudication method for the test set:
The document does not describe any adjudication method for establishing ground truth or resolving discrepancies in any of the testing. The testing is primarily "verification against requirements," implying a pass/fail outcome against predefined specifications rather than a consensus-driven ground truth process.

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:
No MRMC study was mentioned or performed. This device is an infusion pump with safety software, not an AI-assisted diagnostic imaging or decision-support tool where "human readers improve with AI" would be a relevant metric. The "Dose IQ Safety Software" automates programming and provides advisories, which is a form of decision support/error reduction, but not in the context of interpreting medical cases like radiologists.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The core device is an infusion pump, which operates independently in its functional delivery of fluids. The "Dose IQ Safety Software" provides automation but "requires a clinician to verify the information before the start of an infusion," indicating a human-in-the-loop system for critical operations. Standalone performance for the pump itself (e.g., flow rate accuracy) was implicitly tested through the "Pumping Subsystem Testing" and "System Level Testing" (which met acceptance criteria), but this is not an "algorithm-only" standalone performance in the typical sense of AI/ML.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is predominantly based on pre-defined engineering and performance requirements and compliance with consensus standards. For the human factors evaluation, the ground truth would be the identification of critical tasks and the assessment of use errors against pre-established risk thresholds, likely based on expert judgment and safety analyses. It's not "pathology" or "outcomes data" in a diagnostic sense.

8. The sample size for the training set:
No training set is mentioned. The document describes a "Dose IQ Safety Software" which allows for the creation and management of a drug library and automated programming. This is a rule-based or reference data-based system, not an AI/ML system that would require a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
As no training set (in the AI/ML sense) is mentioned, this question is not applicable. The "ground truth" for the drug library data would be established by the facility's clinical policies, pharmaceutical guidelines, and expert medical input during the configuration of the drug library itself.

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