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The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.

The Z-800 Infusion System consists of the infusion pumps and approved external IV administration sets. The major modifications are as following: 1. Added a counter in software for cumulative volume of fluid infused in order to monitor pump utilization. The odometer feature enables pump display a reminder for user to service the pump once a preset volume limit is reached. 2. Implemented optional set based free flow protection. Modified set based free flow protection mechanism consists of a proprietary pinch clamp on the standard IV set tubing and an optional spring loaded clamp holder module on the pump. The pinch clamp can be manually opened for priming. The clamp holder is designed such that the pinch clamp is automatically closed once it is loaded into the clamp holder. Upon pump door close, the pump door activates the pinch clamp loaded in the clamp holder to open to allow flow go through. Upon pump door open, the spring in the clamp holder forces the pinch clamp to close. When the IV set is removed from the pump, the pinch clamp remains at closed position to avoid unintended free flow. A sensor on the clamp holder detects presence of the pinch clamp. "No Clamp" status can be displayed on pump screen to inform user that the clamp is absent. 3. Implemented optional Wi-Fi communication module for serial port to enable bidirectional communication through RF signal. A self-contained serial Wi-Fi convertor module is embedded into the Z-800 infusion pump to enable wireless communication. The Z-800 infusion pump sends serial command to the Wi-Fi convertor module. The Wi- Fi convertor module translates the serial communication command from the Z-800 infusion pump to RF signals and responsible for handling communication protocol with external devices. The serial Wi-Fi convertor enables the user to initiate a query on the pump for external information by entering partial patient identifier information as search criteria. External information returned from the query may include patient information, such as name, date of birth, and IV medication order. The patient and order information are presented to the healthcare professional during infusion programming process to be confirmed for association with the infusion. The Wi-Fi convertor also enables Z-800 infusion pump to publish infusion status data, with the associated patient and order identifiers, which can be utilized by external systems such as EMR. 4. Added an ESD/EMI shielding cap for serial port to enhance pump survivability under injection of Electromagnetic noise and Electrostatic Discharge. 5. Optimized pressure sensor zero point value determination process for better accuracy. 6. Optimized peristaltic plate to maximize durability of peristaltic module. 7. Optimized peristaltic cams in peristaltic module to maximize its durability. 8. Optimized rubber feet for increased durability.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for a Special 510(k) Device Modification for the Z-800 Infusion System. It focuses on device changes and comparison to a predicate device, rather than a clinical study with detailed performance metrics and ground truth establishment.

However, I can extract the general performance parameter for flow rate accuracy, which serves as an implicit acceptance criterion based on its comparison to the predicate device.

Here's an attempt to answer the questions based on the available information:

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

Based on the "Equivalency Matrix," the primary performance parameter stated is Flow Rate Accuracy.

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 describes engineering modifications and an equivalency comparison, not a detailed clinical study with a test set.

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 provided in the document. The type of device (infusion pump) typically relies on engineering and laboratory testing for performance validation, not expert-based ground truth for a test set in the way a diagnostic AI might.

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

This information is not provided in the document.

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 device is an infusion pump, which does not involve "human readers" or AI assistance in the context of diagnostic interpretation.

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

This information is not provided in the document in the context of a "standalone" performance study for an AI algorithm. The device itself is a standalone infusion pump, and its performance (e.g., flow rate accuracy) would have been evaluated independently in engineering tests, but these details are not given here.

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

For flow rate accuracy, the ground truth would be established through metrology and calibrated reference standards in a laboratory setting. This is implied by the nature of the device and the performance metric, but not explicitly stated as "ground truth" using those terms within the document.

8. The sample size for the training set

This information is not provided in the document. The document describes modifications to an existing medical device, not the development and training of a new AI algorithm where a "training set" would be relevant. The "optimization" mentioned (e.g., pressure sensor, peristaltic plate/cams) would typically involve engineering design iterations and testing, not machine learning training.

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

This information is not provided in the document, as there is no mention of a "training set" in the context of AI or machine learning.

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The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction of physician or other certified health care professional.

The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids. blood and blood products to a human patient under the direction of physician or other certified health care professional.

The Z-800 Infusion System consists of the Z-800 Infusion Pump and approved external IV administration sets. The scope of this 510K is to qualify CareFusion's blood administration sets (K882302) for use with the currently marketed Z-800 infusion pump system so as to extend the intended use of the Z-800 Volumetric Infusion Pumps to include intravenous administration of blood and blood products. The infusion pump remains the same as currently marketed Z-800 infusion pump, as in the predicated device Z-800 infusion system (K0717545).

The Z-800 infusion system contains the following components:

• The infusion delivery mechanism: Volumetric linear peristaltic pumping mechanism assembly.
• Approved IV administration sets include External IV sets for intravenous parenteral fluid delivery . and for intravenous blood and blood product delivery.
• . User Interface consists of a 128 X 64 dot matrix LCD display; a 14 key membrane keypad; a LED flow rate display; two device status indicator LEDs; power status indicator LEDs (AC & Battery); an audio speaker; an external alarm light accessory; an software alarm handler.
• The embedded software on the main CPU execute an infusion pump state machine, which monitors . the execution of currently programmed infusion as well as a collection of safety related alarm conditions.
• A watchdog timer is set at 50ms interval. Fail to satisfy the watchdog timer will cause both main . CPU and motor control CPU reset, pump device parks at a fail safe state, and an audible alarm to sound.
• Power supply consists of AC/DC power. Z-800 infusion pump is intended to be used as a pole . mounted pump. It contains a medical device grade switch power supply (input 100-240V 50-60Hz, 0-1.4A. output 15vdc) and a rechargeable 4700mA. 8X1.2 volt Nickel Metal Hydride battery pack. A fully charged new battery will power at least 8hr of continuous infusion (at 125mL/hr). A full battery charging time on a new battery is around 5hr. The battery charging circuitry has a dedicated controlling CPU, which manages the charging current as well as the battery safety monitoring. Redundant temperature sensor is embedded in the battery pack capable of shut off the charging current if battery pack temperature is above the safety threshold.
• . There is 128K flash EPROM memory which stores the embedded software along with 8K NVRAM for user specified configuration as well as preserving infusion parameters between power cycles.
• . Z-800 infusion pump uses linear peristaltic pumping mechanism driven by a step motor through driving belt. The ID/OD, wall thickness and the durometer of the IV set are specified by Zyno to the IV set manufacturers to ensure the accuracy specification of flow rate.
• . The user interface design requirement of the Z-800 pump is focused on simplicity and intuitiveness. The keypad contains 3 groups of keys: the navigation key group; the data entry key group; and the action key group. There is no numeric data entry keypad. All data entry kevs are scroll key. This design is to focus user's attention to the data entry results on the display while entering the infusion parameters, so as to mitigate data entry error caused by key bounce or user hitting the wrong keys,
• . The Z-800 infusion pump has an all metal casing to improve the durability of the pump and the integrity of the pumping/free flow protection mechanism. The pump door and the mating pump front panel are made in milled aluminum. The tubing guide cavity is designed to mitigate tubing loading error. If the tubing is not loaded correctly, the door can not be closed. Even user jam close the door, the mating pump door and the front panel will shut off the tubing to prevent free flow, and the drip sensor accessory will report no flow to alert user of misloaded tubine.
• . There is no known contraindication.

Here's an analysis of the provided text regarding the Z-800 Infusion System, focusing on acceptance criteria and the supporting study:

The provided document, K100705, is a 510(k) summary for the Z-800 Infusion System. This particular submission concerns qualifying CareFusion's blood administration sets for use with the already marketed Z-800 infusion pump to extend its intended use to include intravenous administration of blood and blood products.

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria and reported performance specifically for the new intended use (blood administration) are related to hemolysis testing.

Other general device performance specifications for the Z-800 Infusion Pump are found in the "Equivalency Matrix" (Table 1), establishing equivalence to predicate devices. These performance metrics include:

• Volume and Rate Accuracy: +/- 5%
• Occlusion Pressure Accuracy: Low: 4 psi, Medium: 16 psi, High: 30 psi (adjustable)
• Rate Range: 1 ml/hr to 999 ml/hr in 1 ml/hr increment
• Battery Life: 8 hours at 125 ml/hr

The document states that these general performance specifications of the Z-800 infusion pump remain the same as the currently marketed device.

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

• Sample Size: The document does not specify the exact number of blood samples or test runs performed for the hemolysis study. It mentions "production units" of the Z-800 infusion pump were used.
• Data Provenance: The hemolysis test was conducted by a "certified lab" according to "recognized Good Laboratory Practices" following an "FDA recognized ASTM standard." The blood used was "human blood." The document does not explicitly state the country of origin but implies a US context given the FDA submission. The study appears to be prospective as it was performed specifically to address the incremental risk of hemolysis identified during the risk analysis for the extended use.

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

This information is not applicable as the study described is a laboratory test (hemolysis testing) and not a clinical study involving experts establishing ground truth for diagnostic or clinical outcomes. The "ground truth" for the hemolysis test is objectively measured plasma free hemoglobin levels and statistical correlation, not expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies when multiple reviewers assess cases and discrepancies need to be resolved. The hemolysis test results are quantitative measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This is a medical device (infusion pump) and the study focuses on its physical performance and biological interaction (hemolysis), not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study was performed regarding the functional aspects of the physical device. The hemolysis test evaluates the device's interaction with blood without human intervention in the hemolysis measurement process itself. The broader device validation summarized in "Z-800 Validation Summary Report TR800-2010-02" (mentioned as Appendix E) would further demonstrate the standalone performance of the infusion pump (e.g., flow rate accuracy, occlusion detection) without considering human-in-the-loop aspects.

7. Type of Ground Truth Used

For the hemolysis testing, the ground truth was objective laboratory measurements of "plasma free hemoglobin level" and "correlation coefficient for the hemoglobin standard curve." These are quantitative, biologically derived measurements based on established ASTM standards and Good Laboratory Practices.

8. Sample Size for the Training Set

This information is not applicable. The Z-800 Infusion System is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are validated through engineering tests and quality control, not machine learning training.

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

This information is not applicable for the same reasons as #8.

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