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The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses. The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions.

This document is a 510(k) summary for the Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed performance data or study results typically found in an academic paper or a more comprehensive technical report that would directly answer your questions about acceptance criteria and how a study proves those criteria are met for an AI/ML device.

This submission is for a medical device (a stopcock) used in intravenous administration, not for an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance, are not applicable to this document. The "performance data" section in {3} merely states that the device "meets specified requirements" and is "substantially equivalent to the predicate devices" without detailing the specific criteria or the studies conducted.

To directly answer your request based on the provided text, the following information is available:

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

The document does not explicitly list acceptance criteria in a quantitative table format or detailed performance results. Instead, it makes a general statement:

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

Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no specific test set sample size or data provenance details are given.

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)

Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no expert ground truth establishment is described.

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

Not applicable or not provided.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable or not provided. The substantial equivalence is based on technological characteristics and functional performance compared to predicate devices, rather than a "ground truth" in the AI/ML sense.

8. The sample size for the training set

Not applicable or not provided. This is not an AI/ML device.

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

Not applicable or not provided. This is not an AI/ML device.

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The Texium™ Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Texium™ Syringe is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.

The Texium™ Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL or 60mL) permanently bonded to a closed male luer device (Texium™ Closed Male Luer, K053049). The Texium™ Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the Texium™ Syringe is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Texium™ Syringe is a passive device - it requires no cap and automatically seals upon disconnection.

The provided text is a 510(k) summary for the Texium™ Syringe, a medical device for handling hazardous fluids. This document is a regulatory submission before the device is marketed, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through detailed studies as one might find for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for a novel device performance study cannot be found in this document.

The document states: "The performance data indicate that the Texium™ Syringe meets specified requirements and is substantially equivalent to the predicate devices." However, it does not explicitly list those "specified requirements" as acceptance criteria in a table, nor does it detail the comprehensive studies with the level of information requested for AI/software.

This submission is about a physical device (a syringe) and its safety and effectiveness are established primarily through:

• Comparison to predicate devices: The bulk of the argument is that the Texium™ Syringe is "of comparable type and is substantially equivalent" to existing devices (Texium™ Closed Male Luer and Becton Dickinson Syringe) in terms of intended use and technological characteristics.
• Demonstration of basic performance: While not detailed, the "performance data" mentioned would likely refer to standard engineering and usability tests typical for a syringe, such as:
  • Leak-free operation (as it's a key intended use).
  • Material compatibility.
  • Sterility.
  • Flow rates/pressure limits.
  • Durability.
  • Compatibility with the SmartSite® Needle Free Valve port.

In summary, the document does not contain the information required to populate the requested table and answer the specific questions about acceptance criteria and detailed study methodology in the context of an AI/software device. This is because it is a filing type common for traditional medical devices showing substantial equivalence, not a detailed performance study for a novel algorithm.

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The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.

As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow the user to add drugs and fluids into the primary line without the use of a needle. This Traditional 510(k) Premarket Notification will add a new indication for the SmartSite Valve and qualified extension sets to allow use with low pressure devices up to 325psi. When used with a low pressure power injector, the SmartSite Valve must be secured to other devices with a luer lock connection and the other devices must also be rated for up to 325 psi. This new indication will require no changes to the current device design, materials, manufacturing processes, method of operation or basic scientific technology.

The provided document is a 510(k) summary for the Cardinal Health, Alaris® Products SmartSite Valve Sets with Additional Indication. It is a submission for a medical device and describes its intended use and performance data. However, it does not include the detailed information requested regarding specific acceptance criteria, study design elements (sample sizes, expert qualifications, adjudication methods), or detailed performance metrics.

Based on the provided text, here’s a summary of what can be extracted and an explanation of why other requested information is not available:

Acceptance Criteria and Reported Device Performance

The document states: "The performance data indicate that the Cardinal Health, Alaris Products SmartSite Sets with Additional Indication meets specified requirements and is substantially equivalent to the predicate device."

However, the document does not provide a table of acceptance criteria or specific reported device performance metrics. It focuses on demonstrating substantial equivalence to a predicate device (SmartSite Administration Sets, K960280) for a new indication (use with low-pressure power injectors up to 325 psi). The "specified requirements" are implied to be related to safety and functionality under the new indication, but the specific values or thresholds are not detailed.

Limitations in the Provided Document for Detailed Study Information

The document is a "Summary of Safety and Effectiveness" which often provides a high-level overview. It specifically mentions "Performance Data" but does not elaborate on the details of the studies conducted. Therefore, the following information is not present in the provided text:

• Sample sizes used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 administration set, not an AI-powered diagnostic or assistive tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned, but for a physical device, ground truth would likely refer to engineering specifications, stress testing results, and biological compatibility, rather than clinical diagnostic "ground truth."
• The sample size for the training set: Not applicable, as this is a physical device and not an AI/algorithm-based product that undergoes "training."
• How the ground truth for the training set was established: Not applicable.

Summary of What is Available:

• Device Name: SmartSite Needle Free Valve Administration Sets
• New Indication: Allows use with low pressure power injectors for which the maximum pressure setting is 325 psi.
• Predicate Device: SmartSite Administration Sets (K960280)
• Basis for Approval: Substantial equivalence to the predicate device and performance data indicating it "meets specified requirements."
• Nature of Study: While not explicitly detailed, the "Performance Data" section implies that tests were conducted to ensure the device's compatibility and safety under the new 325 psi pressure indication. These would typically be engineering and material science tests.

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The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.

The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.

The SML is a sealed male luer. The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.

The SML is a passive device – it requires no cap and automatically seals upon disconnection. An optional female cap will be provided for transport and an optional priming cap will be provided to allow the user to prime as necessary.

The Safety Male Luer (SML) is a unique male luer connector that is intended to be used with the currently marketed SmartSite® Needle Free Valve port and standard open female luers. The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products. Furthermore, the SML reduces environmental surface contamination of the work surface when used to reconstitute, dispense/transfer, administer, and dispose of hazardous or non-hazardous fluids when used in conjunction with SmarSite® Needle-Free Valve port.

The provided text describes the regulatory submission for the Alaris® Safety Male Luer (SML), focusing on its substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria and their results. The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly claims:

• "The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port."
• "The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer."
• "Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids..."
• "Furthermore, the SML reduces environmental surface contamination of the work surface..."
• "The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices."

These are statements of intended function and general conclusions, not specific, measurable acceptance criteria with corresponding performance data. The FDA letter confirms the device is "substantially equivalent" which often relies on demonstrating that the new device performs at least as well as a legally marketed predicate, rather than meeting novel, pre-defined quantitative acceptance criteria.

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

The document does not mention a specific "test set" in terms of patient data or clinical trials for device performance. The "performance data" mentioned is not described in detail. Given the nature of a 510(k) for a passive medical device, the "test set" likely consisted of in-vitro bench testing, rather than human subject data.

There is no information regarding:

• Sample size for any test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a passive mechanical device like a luer connector, "ground truth" would typically refer to objective measurements of leakage, sealing force, compatibility, etc., rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC study is mentioned. This type of study is typically relevant for interpretative devices (e.g., imaging devices analyzed by multiple clinicians), not for a passive mechanical connector.

6. Standalone Performance Study (Algorithm Only)

This concept is not applicable. The Alaris® Safety Male Luer is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The document implies the ground truth for performance was established through objective measurements and testing demonstrating the device's ability to prevent leakage and reduce spillage, thereby showing it "meets specified requirements." This would primarily involve:

• Mechanical testing (e.g., force to connect/disconnect, burst pressure, sealing integrity).
• Fluid leakage tests.
• Compatibility testing with specified predicate devices (SmartSite® Needle Free Valve port and standard open female luers).

It's likely based on bench testing and engineering validation rather than pathology, outcomes data, or expert consensus in a clinical setting.

8. Sample Size for the Training Set

This information is not provided and is not directly relevant for a physical medical device. "Training set" usually refers to data used to train an algorithm or AI model. For a mechanical device, iterative design and testing might occur, but it's not typically framed as a "training set."

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

Not applicable as there is no "training set" in the AI sense. Design validation and verification for a mechanical device involve testing prototypes against design specifications and relevant standards.

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The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.

I am sorry, but the provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. The document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with detailed acceptance criteria.

While it mentions "performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices," it does not elaborate on what those specific requirements or the performance data entail. Therefore, I cannot extract the information required for your request.

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The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.

The Alaris System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The Enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris System.

This document describes the Alaris System with Enhanced PC Unit, which is an infusion pump. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with acceptance criteria in the typical sense for a novel AI/software device.

Therefore, many of the requested categories for AI/software device performance studies (like sample size for test/training sets, ground truth establishment methods, MRMC studies, or standalone performance) are not applicable here as this is a medical device hardware upgrade focusing on equivalence to an existing device.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the way one would for an AI algorithm (e.g., "sensitivity > 90%"). Instead, it focuses on functional equivalence and meeting "specified requirements" through verification and validation activities.

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

• Sample Size for Test Set: Not applicable / Not provided. The evaluation appears to be based on engineering verification and validation activities comparing the upgraded unit to the predicate, rather than a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable. This is not a data-driven device; it's a hardware upgrade.

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

• Not applicable. Ground truth in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for this device would be its adherence to design specifications and safety/performance standards, verified through testing.

4. Adjudication method for the test set:

• Not applicable. There is no mention of an adjudication process for a "test set" in the context of clinical evaluation or expert review. Testing would likely follow a pre-defined protocol for hardware and software verification.

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-assisted diagnostic or therapeutic device. It is an infusion pump with an upgraded user interface and processor.

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

• Not applicable. This device is a hardware system, not an algorithm. Performance testing would be for the entire system, including its user interface.

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

• Not applicable in the typical sense. The "ground truth" for this device would be its conformance to engineering specifications, safety standards, and functional requirements, likely demonstrated through:
  • Design verification testing: Ensuring the device manufactured meets the design specifications.
  • Design validation testing: Ensuring the device meets user needs and intended use, likely involving usability and functional tests.
  • Comparison to predicate device: Demonstrating that the upgraded features (faster processor, increased memory, color screen) do not negatively impact the safety and effectiveness established by the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of the Study (Implied):

The "study" or rather, the basis for substantial equivalence, was a comparison of technological characteristics of the Alaris System with Enhanced PC Unit against its predicate device (Alaris System, K950419). It involved demonstrating that the upgrades (faster processor, increased memory, color screen) did not introduce new safety or effectiveness concerns and that the device continued to meet its "specified requirements." This would typically involve:

• Engineering bench testing: To verify the performance of the new processor, memory, and display.
• Software verification and validation: To ensure the upgraded software running on the new hardware functions correctly and consistently.
• Usability testing (implied): To ensure the color screen and faster interface maintain or improve usability without introducing errors.

The document states, "The performance information provided indicates that the Alaris System with Enhanced PC Unit meets specified requirements, and is substantially equivalent to the predicate device." This indicates that adequate testing was conducted to support these claims, though the specific details of those tests are not elaborated in this summary.

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A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand.

The provided document is a 510(k) summary for a medical device (Blood Hand Pump Set) and is not a study. Therefore, it does not contain detailed information about acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment typically found in a scientific study.

The document indicates that the device's substantial equivalence was determined based on its "technological characteristics" and "performance data" indicating it "meets specified requirements." However, it does not specify what those requirements are or how the performance data was generated beyond a general statement.

Here's an analysis based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The flow rate for hand pump compression administration "may be as much as twice that of gravity flow." (This is a characteristic, not a performance metric against a specific criterion). |

Missing Information:

• Specific quantitative acceptance criteria (e.g., minimum flow rate, pressure limits, material biocompatibility, sterility) are not provided.
• Actual measured performance values against these criteria are not given.

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

Missing Information:

• Sample Size: Not reported. The document does not describe any specific "test set" of data or how it was generated.
• Data Provenance: Not reported. It's unclear if any testing involved human subjects or was entirely bench testing, and if so, where it took place (country of origin). The document refers to "performance data" generally.
• Retrospective/Prospective: Not specified.

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

Missing Information:

• Not applicable. This type of device (blood administration set) does not typically involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI diagnostic device would. Its performance is assessed through engineering and biocompatibility testing. The "ground truth" for a device like this would be engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Missing Information:

• Not applicable for this type of device and submission.

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

Missing Information:

• Not applicable. This is a medical device for fluid administration, not an AI-assisted diagnostic tool for human readers. No human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Missing Information:

• Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical design and materials.

7. Type of Ground Truth Used

Missing Information:

• The document implies that the ground truth/basis for evaluation was adherence to engineering specifications, safety standards, and equivalence to predicate devices. It does not mention pathology, outcomes data, or expert consensus in a clinical sense for performance evaluation.

8. Sample Size for the Training Set

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

In summary: The provided 510(k) summary is a regulatory document demonstrating substantial equivalence, not a detailed scientific study. It focuses on comparing the new device's technological characteristics and overall performance to already cleared predicate devices rather than presenting detailed raw data, specific acceptance criteria values, sample sizes, or methodologies of internal validation tests. For medical devices like this, performance data typically refers to results from bench testing (e.g., flow rate tests, pressure resistance, sterility testing, material compatibility) and not clinical trial data involving "ground truth" from experts for diagnostic purposes.

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The SE Infusion System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The SE Infusion System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

The addition of the Medication Management System (MMS) to the SE Infusion System will allow wireless bi-directional communication with the Alaris Server and external devices. MMS is the combination of RF communication from the SE Infusion System to/from the Alaris Server and the Alaris Proprietary software called the Inter-Server Interface Protocol (ISIP). The ISIP allows for communication between the SE Infusion System, the Alaris Server, and external devices.

The SE Infusion System with MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and verification of infusion or monitoring parameters using MMS is performed by trained healthcare professionals prior to administration of medication(s).

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Cardinal Health, Alaris Products SE Infusion System with MMS. It primarily focuses on the device description, its intended use, and its substantial equivalence to a predicate device. The "Performance Data" section states broadly that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," but it does not provide any quantitative data, study design, or specific acceptance criteria.

Therefore, I cannot fulfill most of your request from the given information. Below is a response based on what can be extracted and a clear indication of what information is missing.

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

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not quantified in the provided text. The document only states that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device."

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 for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable as no specific test set and ground truth establishment is described in the provided text. The document mentions "trained healthcare professionals" for data entry and validation, but this pertains to the device's intended use in clinical practice, not a study's ground truth establishment.

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

• Not applicable as no specific test set and adjudication method is described.

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. The device is an infusion pump system with a Medication Management System (MMS) for automating programming parameters, not an AI diagnostic tool involving human readers interpreting cases.

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

• Not explicitly described as a standalone study in the context of an algorithm's performance. The device's primary function is to automate programming parameters, and it is intended for use by "trained healthcare professionals." The functionality of the MMS relies on communication and software, which could be considered algorithmic, but its performance is always in conjunction with a user.

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

• Not applicable as no specific ground truth for a study is described. The device's functionality is about accurately processing and delivering infusion parameters according to orders, validated by healthcare professionals.

8. The sample size for the training set

• Not applicable as no machine learning model or training set is described.

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

• Not applicable as no machine learning model or training set is described.

Summary of what is available from the text:

The provided text describes the Cardinal Health, Alaris Products SE Infusion System with MMS as a device intended to automate the programming of infusion parameters, thereby reducing manual steps. It communicates wirelessly with an Alaris Server using proprietary software. The document asserts that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," which is the Medley System with MMS (K030459). However, no specific performance data, acceptance criteria, or study details are provided to support this claim in the given excerpts. The review by the FDA (K043590) confirms substantial equivalence, allowing the device to be marketed.

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