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The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical and nonclinical environments, such as homes. The device is intended for subcutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.

The Halo II Ambulatory Infusion System includes an ambulatory infusion pump and administration set. It is used to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. This is a device modified from its predicate device Halo Ambulatory Infusion System (K140783). Modifications include allowing users to change battery therefore enabling pump use beyond 240 hours / 1500mL. The original motor was replaced with a longer life one to support extended pump life. Software was updated accordingly to realize the changes. The administration set remains exactly the same.

The Halo II Ambulatory Infusion Pump has a microprocessor controlled motor that drives a peristaltic pumping mechanism to deliver fluid at a controlled rate, same as the Halo ambulatory infusion pump (K140783) and CADD-Solis VIP ambulatory infusion pump (K11275).

The pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for the Halo II pump components are widely used in the medical industry.

The pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).

The Halo II Administration Set is exactly the same as Halo Administration Set (K140783). It is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient.

The administration set can be used with Halo II Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets (K120685), which can be used with Z-800 Infusion Pump or gravity infusion.

The provided text is a 510(k) premarket notification summary for the Halo II Ambulatory Infusion System. It details the device's substantial equivalence to previously marketed predicate devices.

However, the questions regarding acceptance criteria and study proving acceptance criteria for medical AI/ML devices typically refer to performance metrics for an algorithm (e.g., sensitivity, specificity, AUC) and clinical validation studies comparing the algorithm's performance, alone or with human users, to a ground truth.

The provided document describes a traditional medical device (an infusion pump), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," "sample size for training set," etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the Halo II Ambulatory Infusion System to its predicate devices through engineering and performance testing, safety standards compliance, and biocompatibility, as is standard for an infusion pump.

Therefore, I cannot fulfill the request as the provided text does not contain information about an AI/ML device or its associated performance study criteria.

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The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or 1500mL of infusion, whichever limit is reached first.

The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings.

Halo Ambulatory Infusion Pump: The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325). The Halo Pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for Halo Pump components are widely used in the medical industry. The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).

Halo Administration Set: The Halo Administration Set is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient. The Halo Administration Set can be used with Halo Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets(K120685), which can be used with Z-800 Infusion Pump or gravity infusion.

This document is a 510(k) summary for the Halo Ambulatory Infusion System, encompassing the Halo Ambulatory Infusion Pump and the Halo Administration Set. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established for each test based on relevant standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents. The document states that "All testing met pre-established specifications," and provides a summary table of the verification and validation tests performed.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for biocompatibility, number of pumps for volumetric accuracy). It only mentions that "Zyno Medical performed extensive verification and validation testing."

The provenance of the data is implicit: it was generated through the manufacturer's (Zyno Medical, LLC, Natick, MA, USA) own verification and validation testing, which is generally conducted under controlled, prospective conditions for a new device submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical studies, as clinical studies were "deemed unnecessary."

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

This information is not provided in the document. Given that the testing was primarily lab-based verification and validation against technical standards and safety requirements, clinical "experts" in the traditional sense for establishing ground truth on patient data were not involved as "Human clinical studies were deemed unnecessary." The "ground truth" for these tests would be the established performance specifications and regulatory standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple readers, which was not performed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Halo Ambulatory Infusion System." Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical medical device (infusion pump and administration set), not an algorithm or AI system. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established via:

• Technical Specifications and Regulatory Standards: Compliance with various international standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents related to infusion pumps and administration sets.
• Predicate Device Performance: The "Equivalency Matrix" tables (Table 1 and 2) compare the Halo system's features and performance parameters (e.g., volumetric accuracy) against legally marketed predicate devices, implying that the established performance of these predicates served as a benchmark for equivalence.
• Design Requirements and Hazard Analysis: The testing included verification against internal design requirements and findings from hazard analysis.

8. The Sample Size for the Training Set

This question is not applicable. The Halo Ambulatory Infusion System is a conventional medical device (infusion pump), not a machine learning or AI system that requires a "training set."

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

This question is not applicable as there is no training set for this type of device.

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Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. The major modifications are: 1) extended selection of interchangeable components manufactured by additional suppliers; 2) additional contract manufacturer for the device: 3) Gamma Irradiation as additional sterilization method.

The Zyno Medical Administration Set is an intravenous administration set used to deliver fluids from a container to a patient's vascular system.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion of Nonclinical Testing: "All nonclinical testing results successfully demonstrated that the Zyno Medical Administration Sets performed as intended. Conclusions drawn from the nonclinical testing is that the testing data demonstrated that the device is as safe, as effective, and performs as well as the legally marketed device cleared in K120685."

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

The document does not explicitly state the specific sample sizes for each of the nonclinical tests (Biocompatibility, Pyrogenicity, Chemical, Microbial Ingress, DEHP, Sterilization, Bench, Integration, and Aging Testing). It only states that "extensive verification and validation testing" was performed and that "All results successfully met acceptance criteria."

The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the data was retrospective or prospective. Given these are bench and lab-based tests for a medical device administration set, they are inherently prospective controlled tests conducted by the manufacturer.

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

This information is not provided. The nonclinical tests appear to rely on established testing methods and standards (e.g., ISO standards, FDA guidance documents) rather than subjective expert consensus for establishing ground truth. Compliance with these standards is the metric, not expert opinion.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple experts. Since no human clinical studies were performed, and the testing was nonclinical (bench, lab-based), an adjudication method is not applicable and therefore not mentioned.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Zyno Medical Administration Sets." The submission focuses on demonstrating substantial equivalence through nonclinical testing.

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

This question is not applicable to the Zyno Medical Administration Sets. This device is a physical medical administration set, not an AI algorithm or software device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance stands alone in its physical and functional testing.

7. The Type of Ground Truth Used

The ground truth for the nonclinical tests was based on established industry standards and regulatory guidance. For example:

• Biocompatibility: Likely ISO 10993 series.
• Sterilization: Compliance with relevant sterility assurance levels.
• Physical/Mechanical Testing: Adherence to performance specifications to ensure proper function and safety.
• Integration Testing: Successful operation with the Z-800 series infusion pumps, demonstrating compatibility and correct fluid delivery.
• Pyrogenicity, Chemical, Microbial Ingress, DEHP, Aging: Compliance with specific test methods and limits defined in relevant standards and guidance documents (e.g., "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]" and "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions").

8. The Sample Size for the Training Set

This question is not applicable. The Zyno Medical Administration Set is a physical medical device, not a machine learning or AI model that requires a "training set."

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

This question is not applicable, as there is no training set for a physical medical device.

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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 Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The Zyno Medical's I.V. Administration Set is a single use, latex-free, non-DEHP device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. Depending on configuration, the device may include the following components: tubing, protective cap(s), drip chamber (s) with spike, tubing, back check valve(s), needleless Y-site(s), slide clamp(s), roller clamp(s), pinch clamp(s), 0.22 micron filter or 1.2 micron filter, male luer lock (with cap), and pressure activated valve(s). Seven (7) representative administration sets and one (1) representative extension set are described in the application package to illustrate the device confiqurations.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Zyno Medical Administration Set (K120685).

Important Note: The provided text is a 510(k) summary for a medical device that is substantially equivalent to existing predicate devices. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving novel performance against specific, quantifiable acceptance criteria in a clinical study. Therefore, many of the typical "AI/software device" study questions (like MRMC, training sets, expert ground truth) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices and meeting relevant safety standards. There aren't specific numerical performance metrics (like sensitivity/specificity for a diagnostic AI) listed in the summary.

Study Details (Applicable to this type of device/submission)

This 510(k) is for a basic medical device (intravascular administration set), not an AI/software device. Therefore, the study conducted is primarily non-clinical bench testing for substantial equivalence. Clinical studies in the AI/software sense were not necessary or performed.

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

   • Sample Size: The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific number of units tested for the Zyno Medical Administration Set itself is not explicitly stated in the provided summary. This information would typically be found in the full 510(k) submission, not the summary.
   • Data Provenance: This refers to bench testing. The testing was conducted by or on behalf of Zyno Medical, LLC in Natick, MA, USA. It is prospective bench testing based on design specifications to confirm performance.

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

   • Not Applicable. For a physical device like an I.V. administration set, "ground truth" isn't established by human experts in the same way it would be for an AI diagnostic. Ground truth is derived from engineering specifications, industry standards, and measurable physical properties (e.g., flow rates, leak integrity, material strength).

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

   • Not Applicable. As there are no human interpretive "readings" involved, there's no adjudication method in play for the test set. Performance is objectively measured against specifications.

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:

   • Not Applicable. This is a physical medical device, not an AI or software-assisted diagnostic tool. No MRMC study was conducted.

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

   • Not Applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its physical properties and function are tested independently of a human "loop" for its intended use (fluid administration).

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

   • The "ground truth" for this device's testing is based on engineering specifications, recognized industry standards, and performance characteristics of legally marketed predicate devices. For example, ground truth for sterility is a sterile state, ground truth for material properties is adherence to chemical/physical specifications, and ground truth for functional performance (e.g., integrity, flow) is meeting pre-defined acceptable ranges.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

   • Not Applicable. See point 7.

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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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The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision of physician or other certified health care professional.

The Z-800 Infusion pump contains the filter assemblies. The electronics subsequently contains all of the electronics in the microprocessors that run the software. The electronics assembly also contains communications electronics. The pump has two microprocessors, one master processor which controls operation of the device, another pump processor which controls operation of the motor and sensors specific to the pump.

This document does not contain the information required to answer the request. The provided text is a 510(k) summary for an infusion pump, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and ground truth establishment.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance related to specific endpoints. The document provides a general intended use statement ("accurate delivery of parenteral fluids") and a comparison table of basic parameters (pump type, intended use) with predicate devices, but no quantified performance metrics or acceptance criteria are listed.
• Study details: There is no mention of a specific study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Comparative effectiveness or standalone performance studies: The document does not describe any MRMC comparative effectiveness studies or standalone algorithm performance studies. The approval is based on equivalence to existing devices.

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