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The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.

AlV's Smart Label for Propofol is a replacement for the Smart Label manufactured by the Original Equipment Manufacturers (OEM) for the InfusO.R. pump. AIV does not manufacture the pump. The Smart Label for Propofol is an accessory for the pump and is also available as a replacement part.

The AIV Smart Label for Propofol uses the same type of construction and has the same technological characteristics as the predicate device - the accessory supplied with the InfusO.R. pump. This device is not a kit and does not contain any electronic components. Construction of this device is substantially equivalent to the predicate device.

AIV Smart Label for Propofol is not intended to make contact with the patient.

The AIV Smart Label for Propofol is limited by the indications for use of the InfusO.R. pump.

The provided document, K142333, describes the AIV Smart Label for Propofol, an accessory for the InfusO.R. pump, and its substantial equivalence to a predicate device. The document primarily focuses on non-clinical testing to demonstrate performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of "acceptance criteria." However, based on the non-clinical testing performed and the claims of substantial equivalence, the implicit performance criteria and reported outcomes are:

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

• Sample Size: The document does not specify the exact sample size for the test set (number of Smart Labels tested). It generally refers to "devices" being subjected to various tests.
• Data Provenance: The testing was performed by AIV at their facility in Harmans, MD, USA. The data is prospective, generated specifically for this 510(k) submission.

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

There is no mention of experts being used to establish ground truth in the context of clinical or interpretative assessment. The "ground truth" for this device (a magnetic label accessory) primarily relates to its physical properties, functionality (pump recognition), and legibility for the user. These aspects were validated through engineering tests performed by AIV personnel.

4. Adjudication Method for the Test Set

Not applicable. The testing described is primarily functional and physical validation by engineering personnel, not an interpretative assessment requiring adjudication.

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

Not applicable. This device is a simple mechanical/magnetic accessory for an infusion pump, not an AI-powered diagnostic or interpretative tool that would involve human readers or MRMC studies.

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

Not applicable. This device is not an algorithm, nor does it have an "algorithm only" performance. Its function is to interface with the InfusO.R. pump and guide the human user.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical testing was based on:

• Technical Specifications: Conformance to pre-defined engineering and design requirements for the label's construction, material, content, and magnetic coding.
• Predicate Device Performance: The AIV Smart Label's performance (such as pump recognition and legibility after cleaning/storage) was compared to the expected performance of an "substantially equivalent" accessory, implying the predicate device's established functionality serves as a reference.
• InfusO.R. Pump Specifications: The performance (delivery accuracy) after label recognition is attributed to the host InfusO.R. pump, implying the pump's validated specifications form part of the "ground truth" for the overall system's function.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not involve a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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This device is an accessory for a syringe or infusion pump (not manufactured by AIV, Inc.). The healthcare worker connects the device to the corresponding pump. The patient uses the switch on the cable to signal the pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker.

Connects to designated syringe or infusion pump model used in hospital, ambulatory and home care environments.

AIV's Patient Pendant Bolus Cables are a replacement for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective syringe and infusion pumps. AIV does not manufacture the pumps. These Patient Pendant Bolus Cables are an accessory for the pump and are also available as a replacement part. These cables include a switch and are plugged into a mating connector on the syringe or infusion pump to allow the patient to request medication within the parameters entered into the syringe pump by the healthcare provider and the designed limits on the pumps.

The AIV Patient Pendant Bolus Cables use the same type of construction and have the same technological characteristics as the predicate device – the accessory supplied with the original pump. These are passive devices that contain no electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.

AIV Patient Pendant Bolus Cables use Biocompatible PVC for the cables, cable jackets and over molded connectors with an integral strain relief.

The provided document describes the predicate devices as "Patient Controlled Analgesia (PCA) Button Cables," and focuses on demonstrating that the AIV Patient Pendant Bolus Cables are substantially equivalent to these existing, legally marketed devices. It is explicitly stated that this device "is not sterile, has no software component, has no electronic components and is not a kit." Therefore, the details requested about clinical studies, MRMC studies, training/test sets, and ground truth are not applicable to this type of device and submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of patient numbers or data records. The testing described focuses on the physical devices themselves. The tests involved "each of the AIV Patient Pendant Bolus Cables models" with specific test patterns and programs. This implies testing each manufactured cable model rather than a statistical sample size of patient data.
• Data Provenance: The tests were conducted by AIV at their facility in Harmans, MD, USA. The testing is non-clinical, involving device verification and performance testing, not patient data. Therefore, the concept of "data provenance" related to patient data (e.g., country of origin, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable. The device is a simple mechanical accessory (a cable with a button). The "ground truth" for its operation is whether the button press is correctly registered by the connected pump and whether it withstands cleaning/storage. This would be verified through engineering tests rather than expert interpretation of complex data.

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

• This information is not applicable. The device validation involves objective pass/fail criteria for physical and functional performance, not subjective review requiring adjudication.

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 type of study is relevant for AI or diagnostic devices where human interpretation is involved. The AIV Patient Pendant Bolus Cable is a non-AI, non-diagnostic accessory.

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

• This information is not applicable. The device is a cable with a button; it does not contain an algorithm or software. Its function is to facilitate human-in-the-loop interaction (patient presses button) with the main infusion pump.

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

• The "ground truth" for this device's performance is its direct functional operation according to engineering specifications and its equivalence to predicate devices. This includes:
  • Functional Correspondence: Verification that when the button is pressed, the signal is sent, and when not pressed, no signal is sent.
  • Durability and Environmental Stability: Performance remains consistent after cleaning and storage cycles.
  • Material Biocompatibility: Conformance to biocompatibility standards (referenced in Section F).
  • Physical and Electrical Equivalence: Matching construction, operating voltage, and safety features of predicate devices.

8. The sample size for the training set

• This information is not applicable. There is no AI component or machine learning model that requires a training set.

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

• This information is not applicable, as there is no training set for this device.

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These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. AIV cables are limited by the Indications for Use of the connected recording/monitoring device.

AlV's Electrocardioaraph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes.

These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact.

The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.

The provided document describes the 510(k) summary for AIV's ECG Cables, Trunk and Patient Lead Wires, seeking substantial equivalence to existing devices. As such, the study described here is NOT an AI/ML device study. The acceptance criteria and "device performance" in this context refer to engineering specifications and compliance with recognized standards for medical devices, rather than an AI model's predictive accuracy.

Here's the information extracted and formatted according to your request, with clarifications due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML study. The evaluation was based on bench testing of the AIV cables. The sample size for these physical tests is not specified in the provided summary.
• Data Provenance: Not applicable in the sense of data origin for an AI model. This is a physical device and the "data" comes from bench testing of the manufactured cables.

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

• Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for these cables is compliance with engineering standards (ANSI/AAMI EC53 and EC53A) and functional equivalence to legally marketed predicate devices, assessed through bench testing. The evaluation was done by the manufacturer (AIV) and reviewed by the FDA.

4. Adjudication method for the test set

• Not applicable. There was no "test set" requiring adjudication in the AI/ML sense. Compliance was determined by meeting consensus standards and demonstrating equivalence to predicate devices through bench testing.

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. This is not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was performed.

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

• Not applicable. This is not an algorithm. The "standalone performance" for this device would be its ability to physically and electrically perform its intended function (signal conduction) when bench tested, which was stated to be "as intended."

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

• The "ground truth" for this device is based on compliance with recognized consensus standards (ANSI/AAMI EC53 and EC53A) for electrical and mechanical performance, and demonstrated functional and technological equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. There is no training set for this device.

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The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a thermistor temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor is displayed on a monitor/measuring system (not manufactured or supplied by AIV). The probe consists of a thermistor located in a metal tipped plastic shaft is attached to a plastic body that allows the protective sheath (not supplied component that actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some a heating resistor that allows a more rapid temperature measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AIV Clinical Electronic Thermometer:

Acceptance Criteria and Device Performance Study for AIV Clinical Electronic Thermometer

The provided document describes a 510(k) Premarket Notification for a replacement clinical electronic thermometer. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide extensive clinical performance data against specific acceptance criteria.

Based on the document, the "acceptance criteria" are primarily implicit in the demonstration of substantial equivalence to existing predicate devices. The study proving this substantial equivalence is limited to bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a replacement device, the "acceptance criteria" are largely derived from the characteristics and performance of the predicate devices. The document explicitly states that the AIV device uses "the same type of construction and have the same technological characteristics" as the predicate devices.

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 trial or a structured validation study with a defined dataset. The "study" referenced is bench testing.

• Data Provenance: The data provenance is not specified beyond "bench testing." It is not clinical data (patient data), so concepts like "country of origin" are not applicable in this context. It's an in-house prospective test by the manufacturer.

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

Not applicable. This submission is for a medical device (thermometer) and relies on bench testing and comparison to predicate devices, not on expert clinical interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as the testing is not based on expert review of ambiguous cases.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The AIV Clinical Electronic Thermometer is a direct measurement device, not an AI diagnostic tool that assists human readers.

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

Yes, in spirit, a standalone performance was done, in that the device's performance was evaluated independently through bench testing. However, it's not an "algorithm only" performance as the device is a physical electronic thermometer. The "standalone" evaluation here refers to the device itself performing its intended function (temperature measurement) without a human's interpretative cognitive task being assisted by AI. The human is involved in placing and operating the device, but the temperature reading itself is generated by the device.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be established by reference temperature standards and calibrated measurement equipment. While not explicitly detailed, standard engineering and metrology practices dictate that the thermometer's readings would be compared against highly accurate and traceable temperature sources to verify its performance specifications (e.g., accuracy, precision). This is essentially physics/engineering-based ground truth, not clinical or pathology-based.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electronic thermometer; it does not involve machine learning or AI algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM). The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

This document describes the 510(k) summary for Pulse Oximeter Adapter Cables from American IV Products, Inc. The submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, focusing on key characteristics like intended use, construction, and performance. The "reported device performance" reflects that these criteria have been met through testing and comparison.

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

• Sample Size for the Test Set: Not explicitly stated as a separate "test set" in the context of an AI/algorithm-driven device. For these types of accessories, the testing primarily involves bench testing and comparison to the physical and electrical characteristics of multiple predicate devices. The number of specific AIV part numbers tested is 13, each corresponding to a different OEM part number for various monitor systems.
• Data Provenance: The testing is primarily retrospective, comparing the AIV cables to existing OEM devices and standards. The data is generated from bench testing within the manufacturer's environment to ensure conformity and equivalence. The country of origin of the data is not specified but is inferred to be the manufacturer's location in the USA (Hanover, MD).

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

This type of device (adapter cables) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI diagnostic algorithm would. Instead, engineering and quality assurance personnel perform instrumental measurements and comparisons. The submission mentions "Director of Regulatory Affairs and Quality Assurance" (Gregory Falk), suggesting that qualified personnel within the company are responsible for overseeing the testing and ensuring compliance. Specific numbers or detailed qualifications of technical experts involved in the bench testing are not provided in this summary.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. Adjudication methods (e.g., 2+1) are typically used for interpreting ambiguous cases in diagnostic imaging or similar scenarios where human interpretation is a variable. For adapter cables, compliance is determined by meeting physical, electrical, and performance specifications through direct measurement and comparison, not by consensus among interpreters.

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

Not applicable. This device is an adapter cable, not an AI or diagnostic algorithm, so no MRMC study or AI assistance comparison would be performed.

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

Not applicable. This device is an adapter cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device Specifications: The technical and performance specifications of the legally marketed OEM pulse oximeter adapter cables.
• Consensus Standards: International (e.g., IEC 60601-1, IEC 60601-1-2) and national consensus standards for medical electrical equipment safety and electromagnetic compatibility.
• Functional Intent: The confirmed ability of the AIV cables to perform the intended function of connecting the sensor to the monitor to allow continuous SpO2 and pulse rate monitoring, without degrading the performance of the overall system.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a hardware accessory, not an AI or machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set or ground truth in the AI/ML sense for this device.

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These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

Acceptance Criteria and Device Performance

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These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors. The US transducers are used to detect the fetal heart rate using Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.

The provided document is a 510(k) Summary for a medical device (Transducers for Ultrasound Fetal Monitoring) and does not contain detailed information about a clinical study or specific acceptance criteria for performance metrics beyond general functional equivalence.

However, I can extract the relevant information that is present and indicate where specific details you requested are not available in this document.

Here's an attempt to answer your request based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document primarily focuses on demonstrating equivalence through design and testing of fundamental characteristics rather than a clinical trial with a defined test set of patients.
• Data Provenance: Not specified. Given the nature of the tests (acoustic output, biocompatibility, assembly design comparison), it's likely laboratory-based. No patient data or clinical study data is mentioned.

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

Not applicable. The "ground truth" for these types of engineering and material tests would be established through accredited laboratory methods and technical specifications, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. There's no indication of an adjudication method used. The "performance data" describes physical and material properties rather than clinical outcomes requiring expert review.

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. This device is a passive transducer for fetal monitoring, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-assistance evaluation is not relevant.

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

No. This device is hardware (transducer) and does not involve an algorithm for standalone performance evaluation in the context of an AI device.

7. The type of ground truth used

• Acoustic Output: Likely established through standardized acoustic power measurement techniques and equipment.
• Assembly Design: Established by expert engineering comparison against the predicate device's design and specifications.
• Biocompatibility: Established by adherence to recognized consensus standards (e.g., ISO 10993 series) through laboratory testing.
• Performance as Intended: Inferred equivalence based on the above tests and similarity to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable (no training set).

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These devices are intended to be used as replacement door assemblies for Baxter Flo-Gard 6201 and Baxter Flo-Gard® 6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.

AIV's pump door assemblies are replacements for similar doors manufactured by Baxter Healthcare Corporation for their Flo-Gard® 6201 and Flo-Gard® 6301 Volumetric Infusion Pumps. The door is part of a linear peristaltic pumping mechanism. The door assemblies are intended to be direct replacement for the predicate device door assembly.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIV Replacement Pump Head Door Assembly:

Acceptance Criteria and Device Performance

The core acceptance criterion for the AIV Replacement Pump Head Door Assembly is its performance in terms of flow volume accuracy.

Study Information

The provided document describes a bench testing study, but lacks detailed numerical results beyond the general statement of equivalence.

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

   • Sample Size: Not explicitly stated. The document refers to "Bench Testing" and "AIV devices," but does not provide the number of units tested.
   • Data Provenance: Not explicitly stated, but can be inferred as retrospective as it's a comparison to established predicate devices. The study was conducted by the manufacturer, American IV Products, Inc. (AIV). The country of origin of the data is likely USA, as the submitting company is based in Maryland.

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

   • Not applicable. This was a bench test comparing the functional performance of the AIV device to its predicate. Ground truth in this context would likely be established by validated test equipment and calibration standards, not expert human assessment.

3. Adjudication method for the test set:

   • Not applicable for this type of bench testing. Performance would be objectively measured using calibrated instruments against a defined specification.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a component of an infusion pump, and its performance is assessed via engineering bench tests, not human interpretation of medical cases.

5. Standalone (algorithm-only) performance:

   • Yes, a standalone performance evaluation was done in the sense that the AIV device was tested on its own (or in place of the predicate device component) to verify its functional performance. This is an engineering test, not an algorithm-only test in the context of AI/ML.

6. Type of ground truth used:

   • The ground truth for this study is the established performance specifications of the predicate device (Baxter Flo-Gard 6201 and 6301) and general engineering standards for flow rate accuracy. This is based on objective, quantifiable measurements.

7. Sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "design" and "materials" were presumably developed through engineering processes, prototyping, and testing, but not in the sense of a dataset for machine learning.

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

   • Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the design of the AIV device was the existing, legally marketed predicate devices and their known performance characteristics.

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