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The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.

The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.

The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged.

The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.

The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

The provided text is a 510(k) summary for the DEKA Infusion System and DEKA Administration Set. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification, specifically an increased maximum programmable flow rate and an update to tilt angle detection.

However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria, the study proving the device meets the criteria, sample sizes, expert involvement, ground truth, or MRMC studies for an AI/ML-based device.

This document is for a mechanical/electrical infusion system that uses a camera for drop formation detection and flow rate measurement, not an AI/ML diagnostic or prognostic device that would involve a training set, test set, expert adjudication, or MRMC studies in the way your questions imply. The "Vision System Performance" mentioned is likely related to the camera's ability to accurately detect drops, not a complex AI model requiring extensive human-in-the-loop validation or ground truth established by multiple medical experts interpreting images.

Therefore, I cannot extract the requested information from this document. The questions you've asked are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving image interpretation or complex diagnostic algorithms. This 510(k) summary does not describe such a device or its corresponding validation studies.

The closest aspects discussed are:

• Acceptance Criteria for Flow Rate Accuracy: Mentioned as "± 10% nominally" and "± 25% under environmental limits of normal use." The document states "All tests met acceptance criteria."
• Study Proving Device Meets Criteria: "Formal performance testing was conducted on all areas of the subject device that are impacted by its changes with respect to the predicate device."
• Performance Data: "Flow Rate Accuracy," "Vision System Performance," "Stopping Flow," and "Device Handling Alarms" were tested.

But none of these provide the level of detail (sample size, expert ground truth, adjudication, MRMC) specific to AI/ML device validation that your questions are designed to elicit.

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The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.

The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.

The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.

The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

This document describes the regulatory submission for the DEKA Infusion System and DEKA Administration Set, emphasizing their substantial equivalence to previously cleared devices. It outlines performance data related to device testing but does not contain information on studies proving the device meets acceptance criteria related to AI/human reader performance or ground truth established by experts for such studies.

Therefore, I will extract relevant information that is present and note the absence of information specifically requested for AI/human reader performance studies.

Here's the analysis based on the provided text:

Acceptance Criteria and Device Performance (as far as described for the hardware components):

Study Details (based on provided text):

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

• See table above. The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate devices and relevant industry standards. Performance is reported as "identical," "similar," or "equivalent." Specific quantitative performance values are provided for flow rate accuracy, range, VTBI, and time to detect occlusion.

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

• The document states "Performance testing was conducted in order to verify and validate each subject device for its respective intended use." However, it does not provide specific sample sizes (e.g., number of devices, number of test runs) for these tests, nor does it explicitly mention data provenance (e.g., country of origin, retrospective/prospective for any study in the typical sense of a human-in-the-loop or AI performance study). The tests are described as nonclinical in nature, implying laboratory testing of the devices themselves.

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

• This information is not applicable as the document describes performance testing of a physical medical device (infusion system and administration set), not an AI-enabled diagnostic device requiring expert interpretation for ground truth. There is no mention of "experts" beyond the general statement "under the supervision of a qualified clinician" for device use.

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

• This is not applicable for the type of device and testing described. Adjudication methods are typically used in clinical studies involving human readers and interpretations of medical images or data.

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 is not applicable as the DEKA Infusion System and Administration Set are hardware devices, not AI-enabled diagnostic software that assists human readers.

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

• This is not applicable as the device is not an algorithm for diagnostic interpretation. Its "control mechanism" uses a "Video camera and vision processing system with a flow control valve" to measure and control flow rates, which is an integrated system function, not a standalone AI algorithm for interpretation.

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

• For the hardware performance tests mentioned (e.g., flow rate accuracy, alarm conditions, electrical safety), the "ground truth" would be established by physical measurements, adherence to engineering specifications, and compliance with recognized industry standards (e.g., AAMI TIR101, IEC 60601 series, ISO 8536-4). It's not a medical "ground truth" like disease presence or absence.

8. The sample size for the training set:
* This is not applicable. There is no mention of an AI model or a "training set" in the context of this device's regulatory submission. The device uses "vision processing" for its function, but the approval is for the physical device, not an AI model that undergoes a typical training and validation regimen as seen in AI/ML submissions.

9. How the ground truth for the training set was established:
* This is not applicable. As there is no explicitly mentioned "training set" for an AI model for clinical interpretation, there is no ground truth establishment method described.

Summary of what is present and what is not:

• Present: Detailed comparison of the subject devices (DEKA Infusion System and DEKA Administration Set) to their respective predicate devices across various characteristics, including technical specifications, performance parameters (like flow rate, alarms), and adherence to relevant medical device standards. The document confirms that extensive nonclinical performance testing was conducted to support substantial equivalence.
• Not Present: Any information related to AI-specific study designs, human reader performance, expert consensus for ground truth in diagnostic interpretation, or sample sizes for clinical trials/test sets/training sets for AI models. This is consistent with the device being a hardware infusion system, not an AI-enabled diagnostic tool in the typical sense.

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The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.

The Volumetric Infusion Controller (VIC) is a gravity-based electronic infusion controller relying on head height to provide the delivery pressure necessary to meet the target infusion delivery rates. The drip chamber of an administration set is monitored by a vision system for drop growth. This information is used to provide feedback to the flow control valve to establish and maintain the target flow-rate without user intervention.

Here's an analysis of the acceptance criteria and study information for the Volumetric Infusion Controller, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Flow Rate Accuracy & Maintenance of Set Flow Rate despite changes in Head Height: The text does not explicitly state the number of devices or test runs/infusions used for each specific condition within these tests. However, the data provided shows a range of percentages for the "Test Results," implying multiple measurements were taken. The study was a bench test, conducted in accordance with IEC 60601-2-24:2012. The provenance is not specified, but it can be inferred to be from the manufacturer's testing (DEKA Research & Development). This would be prospective data collection.
• Reliability Analysis (MTBF): The test involved multiple devices ("devices are setup...continuously infusing solutions"). The actual number of infusion hours before discontinuing testing, with zero failures, was 7951 hours. The number of individual devices is not specified, nor is the cumulative number of "uses" for the 7951 hours. This is also prospective bench testing data.
• Other Testing (Electrical, EMC, Safety Control Mechanisms, Software, Human Factors): No specific sample sizes for these tests are provided in the summary. These are generally conducted as part of product development and validation, likely under controlled laboratory conditions, making them prospective bench testing.

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

• The studies described are bench tests and human factors evaluations, not clinical studies involving expert medical interpretation of data for ground truth establishment in a diagnostic context.
• For the performance testing (flow rate, reliability), the "ground truth" is defined by the objective physical measurements and adherence to specified standards (e.g., IEC 60601-2-24). No human experts are used to establish ground truth in this context; rather, calibrated measurement equipment and predefined standards serve this purpose.
• For Human Factors testing, usability evaluation and human factors testing were conducted, which would typically involve end-users (e.g., medical professionals), but the number and qualifications of these individuals, or how "ground truth" (e.g., successful task completion) was established, are not detailed in this summary.

4. Adjudication method for the test set:

• Not applicable. The reported studies are bench tests and engineering validations, not studies requiring adjudication of human-interpreted data. The results are based on objective measurements against pre-defined engineering and performance criteria.

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, an MRMC comparative effectiveness study was not done. This device is a Volumetric Infusion Controller, not an AI-powered diagnostic tool that assists human readers/interpreters. The FDA letter explicitly states, "A clinical investigation was not conducted, as the bench testing and human factors testing is sufficient to show the product is substantially equivalent in performance for its intended use."

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

• Yes, the performance tests described (Flow rate accuracy, Maintenance of set flow rate, Reliability analysis, Electrical/hardware/mechanical safety, EMC, Alarms, Software V&V) were all standalone (algorithm/device only) performance evaluations. The device's ability to accurately control fluid delivery and operate reliably was tested independent of human interaction for the core performance metrics. Human factors testing assessed the interaction of users with the device, but the device's technical performance itself was standalone.
• The "vision system" that monitors drop growth and controls the flow valve functions as an algorithm/device-only system once initialized, without continuous human intervention.

7. The type of ground truth used:

• Objective physical measurements against predefined engineering standards and specifications (e.g., mL/hr, percentage accuracy, hours of operation). For example, flow rate accuracy is measured against the programmed flow rate. The reliability is measured against a statistical model for MTBF.

8. The sample size for the training set:

• This device does not appear to involve a "training set" in the context of machine learning, which is typically associated with AI/ML algorithms that learn from data. While the device uses a "vision system" and "similar algorithms" for drop detection, the text does not describe a machine learning model that was "trained" on a dataset. It refers to the vision system as using "similar algorithms" to make distinctions, implying a rules-based or traditional image processing approach rather than a modern deep-learning "training" paradigm. Therefore, a training set as typically understood for AI/ML is not applicable here based on the provided information.

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

• As a training set for an AI/ML model is not indicated from the text, the method for establishing its "ground truth" is not applicable. The device's "vision system" relies on specific detection algorithms that are likely designed and validated by engineers based on physical principles of drop formation and optical detection, rather than being "trained" on labeled data.

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The Pacer Model 100 Infusion Controller is indicated for use in:

• 1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36" of water) is not required.
• 2. The delivery of intravenous drugs where positive pressure (above 36" of water) is not required.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacer Model 100 Infusion Controller." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

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Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number KR84307 K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.

Not Found

This document is a 510(k) substantial equivalence letter for a replacement battery for an infusion pump. It does not contain any information regarding acceptance criteria or a study proving device performance related to a diagnostic or AI-driven medical device.

Therefore, I cannot provide the requested information in the structured format because the input document does not pertain to the type of device or study described in the prompt's requirements.

The document is a regulatory communication from the FDA to a manufacturer regarding a "Rechargeable Battery Part Number M12/500-3P" for an "Infusion Pump." It confirms the device's substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market it. This type of regulatory approval does not typically include detailed performance studies with acceptance criteria as would be required for a diagnostic or AI-powered medical device.

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Replacement battery for IVAC Corp. 123233 230, 600 Infusion Controller, 510(k) Number K884307.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Not Found

I apologize, but the provided text is a 510(k) Pre-Market Notification letter from the FDA regarding a medical device, specifically a replacement battery for an infusion pump. This document does not contain information about acceptance criteria for a study, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA determined the device is substantially equivalent to a product already on the market, which is a different process than evaluating a study that proves a device meets specific acceptance criteria. The letter and its enclosure (Indications for Use) focus on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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