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The intended use of the Vista™ basic with fm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Vista™ basic and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.

The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.

The Vista™ basic with fm system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting.

The Vista™ basic is an electrical external infusion pump intended to provide accurate infusions of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Vista™ basic by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Vista™ basic with fm system introduces some additional features to aid the clinician in fluid delivery and maintenance.

These features include the addition of a barcode reader to minimize the potential for programming errors, an external power source to reduce the number of electrical outlets required at the bedside, and the convenience of a large interactive monitor that displays the status of all Vista™ basics being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input.

The infusion pump contains the following hardware assemblies: linear peristaltic pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord can be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of a 12V rechargeable battery. The display subassembly contains an LCD display and a kevpad used to input data into the pump as well as to present pump status and information to the user.

The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems.

The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data.

The software also provides communication abilities from external devices to the pump. This feature is only accessible by a trained Biomedical Technician. Programming of the pump is to be performed by trained Biomedical professionals.

This 510(k) submission describes the B. Braun Medical Inc. Vista™ basic with fm system, an infusion pump. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics beyond a general claim of substantial equivalence to predicate devices.

Instead, the document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The clinical applications of the device.
• Predicate Device Comparison: How this device is similar to existing, legally marketed devices (Horizon Outlook™ and Alaris Medley™ Patient Care System). This comparison focuses on design, material composition, components, manufacturing process, intended use, and labeling, as well as specific features.
• Claim of Substantial Equivalence: The primary purpose of the 510(k) submission, asserting that the new device is as safe and effective as predicate devices.

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

Here's what I can extract from the provided text regarding the device and its comparison to predicate devices, noting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on claims of "substantial equivalence" to predicate devices without listing specific performance metrics or acceptance criteria for the new device.

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

This information is not provided. The document makes no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to predicate devices rather than a de novo performance study with a test set.

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

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test set or study is detailed, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.

This information is not provided. The document does not describe any MRMC comparative effectiveness study.

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

This information is not applicable/not provided. The device in question is an infusion pump with a "fm system" (which includes features like a barcode reader and drug library for programming) and is not described as an AI algorithm that would have standalone performance in that context. Its "performance" would relate to factors like flow accuracy and safety alarms.

7. The Type of Ground Truth Used

This information is not provided. No specific test for performance against a ground truth is described. The basis for safety and effectiveness is stated as "substantial equivalence" to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not provided. Since no specific development or validation study with a "training set" (common for AI/machine learning devices) is described, this is not applicable. The device's software is mentioned, but its development process in terms of data sets is not detailed.

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

This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also not mentioned.

Summary of what is present:

The document serves as a 510(k) submission, asserting the "substantial equivalence" of the Vista™ basic with fm system infusion pump to two predicate devices: the Horizon Outlook™ and the Alaris Medley™ Patient Care System. The claim of equivalence is based on similarities in:

• Design
• Material composition (Injection Molded Thermoplastics for non-solution contact parts)
• Components
• Manufacturing process
• Intended use (accurate and continuous flow of parenteral and enteral fluids, medication error reduction)
• Labeling
• Specific features like control pump activities from a monitor, drug calculation abilities, drug library, dosing limits, communication ports, and visual displays (Digital LCD).

The submission explicitly states: "There are no new issues of safety or effectiveness raised by the Vista™ basic with fm system." and "There are technological differences between the subject and predicate device, however, these differences do not raise new issues of safety and effectiveness." This indicates that the device's acceptable performance is implicitly demonstrated by its similarity to already cleared devices, rather than through independent studies with specific performance criteria.

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The intended use of the Perfusor® compact with fm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Perfusor® compact and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.

The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.

The Perfusor@compact with fm system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting

The Perfusor® compact is a battery and AC powered transportable syringe delivery system intended to provide infusion of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Perfusor® compact by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Perfusor® compact with fm system introduces some additional features to aid the clinician in fluid delivery and maintenance.

These features include the addition of a barcode reader to minimize the potential for programming errors, an external power source to reduce the number of electrical outlets required at the bedside, and the convenience of a large interactive monitor that displays the status of all Perfusor compacts being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input. In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Inc. intends to introduce into interstate commerce the Perfusor® compact with fm system.

The infusion pump contains the following hardware assemblies: swivel-drive pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord can be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of four AA alkaline batteries. The display subassembly contains an LCD display and a keypad used to input data into the pump as well as to present pump status and information to the user.

The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems.

The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data.

The provided 510(k) summary for the Perfusor® compact with fm system does not contain information regarding a standalone study with acceptance criteria and a detailed analysis of device performance.

This 510(k) is a submission for substantial equivalence to predicate devices (Horizon Outlook™ and Alaris Medley™ Patient Care System) and focuses on demonstrating that the new device does not raise new issues of safety or effectiveness. The general approach for this type of submission is to compare the new device's characteristics and intended use to those of already cleared devices, rather than conducting new, detailed performance studies against specific acceptance criteria for a novel technology.

The document lists "Subject device system and software test plans" and "Subject device system and software hazard analysis," which indicate that testing was performed. However, it does not provide the results of these tests or the specific acceptance criteria used for them in this public summary.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sized used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
• Adjudication method: Not applicable as no such study is described.
• 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 infusion pump, not an AI-powered diagnostic tool for human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No detailed standalone performance study is described in this summary.
• The type of ground truth used: Not applicable as no such study is described.
• The sample size for the training set: Not applicable as no AI training set is mentioned for this device.
• How the ground truth for the training set was established: Not applicable as no AI training set is mentioned.

Summary of available information related to performance (implicit in 510(k) process):

The submission asserts that the differences between the subject device and the predicate devices "do not raise new issues of safety and effectiveness." This implies that any internal testing or validation performed by B. Braun Medical Inc. confirmed that the device performs as intended and is safe, similar to the predicate devices. However, the specific details of that testing and the acceptance criteria are not included in this 510(k) summary.

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