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The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments.

The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap.

The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set.

The provided FDA 510(k) summary for the UTC 3mL Medication Cartridge (K230718) does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria related to algorithmic performance metrics (e.g., accuracy, sensitivity, specificity) for such a device. Instead, it concerns a physical medical device (a medication cartridge) and its substantial equivalence to a predicate device based on material, design, and performance testing for sterility, biocompatibility, and physical properties.

Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the performance data and acceptance criteria relevant to this specific device, as described in the 510(k) summary, and present them in a structured way that aligns with your request's format, even if the "performance" is mechanical/biological rather than algorithmic.

Here's the information based on the provided document, interpreting "acceptance criteria" and "device performance" in the context of a physical medical device clearance:

Device: UTC 3mL Medication Cartridge (K230718)
Type of Device: Infusion Pump Syringe (Accessory to an Infusion Pump)
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through conformance to recognized international standards and specific performance tests. The summary states that the tests "demonstrated to be in conformance with" or "met the USP acceptance criteria," indicating successful performance against these standards.

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 performance and biocompatibility tests. It only lists the standards followed. For medical device testing, sample sizes are typically defined by the specific test method within the referenced standards (e.g., ISO, ASTM, USP).

The data provenance is implied to be from laboratory testing conducted as part of the device development and regulatory submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical study data. These are bench/lab tests.

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

This concept is not applicable here as the "ground truth" for this physical device is established by objective engineering and biological test standards (e.g., whether a Luer taper fits correctly, whether a material is cytotoxic, whether packaging maintains sterility) rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical data review, especially in imaging studies, where expert disagreement needs resolution. For physical device performance tests, the outcome is typically an objective pass/fail against a standard.

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

Not applicable. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The UTC 3mL Medication Cartridge is a physical component, not an AI/ML algorithm used for interpretation.

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

Not applicable, as this is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective engineering and biological test standards and measurements. This includes:

• Physical dimensions and tolerances (e.g., Luer taper).
• Material properties (e.g., polypropylene).
• Biological responses (e.g., cytotoxicity, irritation, hemocompatibility through ISO 10993 series).
• Sterility assurance (e.g., Bacterial Endotoxin testing, ethylene oxide validation).
• Particulate assessment (USP ).
• Packaging integrity and shelf-life stability.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that requires a training set.

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

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

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The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to the pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) population.

Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.

The provided document describes the Elite Biomedical Solutions Dose Request Cord, an accessory for a syringe pump. The submission focuses on demonstrating substantial equivalence to a predicate device, the American IV Patient Pendant Bolus Cable (K120209), rather than presenting a study where a device's performance is measured against specific acceptance criteria in the context of improving human reader performance with AI.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device submissions) are not applicable or cannot be extracted from this document.

However, I can provide information based on the available performance data for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

This document describes non-clinical performance testing for a medical device accessory (a cable), not an AI/ML diagnostic system. Therefore, concepts like "test set" in the context of clinical data are not directly applicable.

• Sample Size for Test Set: Not specified in terms of patient data. The non-clinical testing likely involved a specific number of manufactured units of the Dose Request Cord, though this number is not detailed in the summary.
• Data Provenance: The data is from non-clinical laboratory testing performed by Elite Biomedical Solutions to verify the device's functional and safety characteristics. Country of origin for the testing is not specified but is implicitly tied to the submitter (Elite Biomedical Solutions, Cincinnati, Ohio, USA). This testing is prospective as it was performed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" for this device is its physical integrity and functional performance (e.g., button press accurately signals the pump, cable withstands a pull test, electrical insulation is sufficient). This is established through engineering and laboratory testing against established specifications and standards, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of clinical data. Testing involved objective measurements and validations against predetermined engineering and functional specifications.

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

No. This is a physical medical device accessory (cable), not an AI-powered diagnostic tool. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are not applicable.

6. Standalone Performance

Yes, in the sense of the device's intrinsic function. Non-clinical performance testing was conducted on the Dose Request Cord itself (and in conjunction with the compatible pump to verify its signaling function). The testing demonstrated that the device "performs as intended." The performance involves:

• Delivering a dose when the activation button is pressed.
• Not delivering a dose when the button is not pressed.
• Meeting construction, operational, cleaning, disinfection, and safety specifications.
• The accuracy of the dose itself being determined by the associated syringe infusion pump, confirming the cable's role as an accurate signaling accessory rather than a dosing mechanism.

7. Type of Ground Truth Used

The ground truth used for non-clinical testing comprises:

• Engineering Specifications: Design documents detailing required electrical, mechanical, and safety characteristics (e.g., cable length, operating voltage, double insulation).
• Functional Requirements: Specifications for how the device should operate (e.g., button press triggers signal, no signal when button not pressed).
• Test Standards: Compliance with relevant industry and regulatory standards for medical device accessories (e.g., IPX water intrusion, cleaning/disinfection validation methods).

8. Sample Size for the Training Set

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

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for such a set.

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The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial.

After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication Cartridge.

The provided text describes the regulatory clearance of the RG 3ml Medication Cartridge and outlines studies conducted to demonstrate its substantial equivalence to a predicate device, primarily focusing on non-clinical performance testing.

Here's an analysis based on your request, highlighting what information is available and what is not:

1. Table of acceptance criteria and the reported device performance

Important Note: The document specifies that "differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness." This implies that the acceptance criteria for the new device were primarily demonstrated through equivalency testing against established standards and the performance of the predicate device.

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

The document describes non-clinical performance testing for a medical device (a medication cartridge). Such tests typically involve specific numbers of units (samples) of the device and may use standardized test fluids or conditions. However, the exact sample sizes used for each test (e.g., how many cartridges for flow rate testing, how many animals for biocompatibility) are NOT specified in this document.

The data provenance is from non-clinical laboratory testing and is not tied to human subjects, countries of origin, or retrospective/prospective studies in the way clinical trials would be.

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

This information is not applicable to the type of testing described. The "ground truth" for non-clinical performance testing is established by recognized international standards (e.g., ISO, ASTM) and the specifications of the compatible medical device (the CADD-MS®3 Ambulatory Infusion Pump). These are objective measurements against defined criteria, not subjective expert interpretations.

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

This is not applicable to the type of testing described, as there is no subjective interpretation or consensus among experts required for the results of the performance tests. The tests yield objective measurements against predefined acceptance criteria.

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

An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human interpretation is involved, often with AI assistance (e.g., radiology images). This information is not applicable as the device is a medication cartridge, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical medical component, not a software algorithm.

7. The type of ground truth used

The ground truth used for evaluating the RG 3ml Medication Cartridge performance includes:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 7886-2 for flow rate, ASTM standards for packaging.
• Predicate Device Specifications: The CADD-MS®3 Ambulatory Infusion Pump's specifications for compatible cartridges and its performance characteristics served as a benchmark for comparison.
• Defined Acceptance Criteria: Each test had specific pass/fail criteria derived from these standards and specifications.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that requires a training set. The tests performed are engineering and biological validations, not algorithm training.

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

This is not applicable for the same reason as point 8.

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BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. The BlueStar® Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

BlueStar Rx is a modified version of the primary predicate (WellDoc BlueStar Rx cleared under K190013). BlueStar Rx maintains all of the features of the primary predicate and adds the titration of long-acting basal insulin doses for qualified type 2 diabetes patients who are not using bolus insulin. This long-acting basal insulin titration feature is included as part of the Insulin Adjustment Program (IAP) in BlueStar Rx. WellDoc BlueStar® as cleared under K190013, is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The system is intended to assist type 1 and type 2 diabetes patients to self-manage their disease. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal insulin titration for their qualified type 2 diabetes patients using the following two interfaces:

• Web based HCP interface for use by the providers to prescribe long-acting basal insulin doses for the qualified type 2 diabetes patients.
• Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan.
  The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only.
  BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

The document mentions "Performance testing" including "Software verification and validation," "Cybersecurity," and "Human Factors" testing. However, it does not specify sample sizes for any test sets, nor does it provide information about the data provenance (e.g., country of origin or whether it was retrospective or prospective).

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

The document mentions "intended user populations of patients and healthcare providers" for human factors testing, but does not specify the number or qualifications of experts used to establish ground truth for any of the performance tests.

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

The document does not specify any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or described in the provided text. The document refers to the device assisting self-management and providing calculated insulin doses, but not in the context of human reader performance improvement with AI assistance.

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

The document describes the "Insulin Adjustment Program (IAP)" which calculates appropriate long-acting basal insulin doses based on configuration by a healthcare provider. While the calculation itself is algorithmic, the system requires a "human-in-the-loop" for activation, configuration, and management by the healthcare provider, and the patient follows directions. Therefore, a purely standalone algorithm-only performance study in isolation from human interaction is not explicitly described in the context of the device's function. The performance testing focuses on software, cybersecurity, and human factors interaction with the system, implying a human-in-the-loop context.

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

The document does not explicitly state the type of ground truth used for the performance testing. For software verification and validation, ground truth would typically be derived from functional specifications and expected outputs. For human factors, it would likely involve observations and feedback from users regarding usability and clarity.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This is generally because the device is a rule-based system (an "Insulin Adjustment Program" that "calculates appropriate long-acting basal insulin doses based on configuration by a healthcare provider") rather than a machine learning model that requires explicit training data.

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

Since the document does not mention a training set, it does not describe how ground truth for a training set was established.

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The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients.
The product is intended to be used by qualified healthcare professionals.

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation'ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood components, Total Parenteral Nutrition (TPN), Lipids, and enteral fluids. The Perfusor® Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediativs, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. (only road ambulances).

The SpaceStation MRI is a movable MRI Rack System for the operation of up to four B.Braun Space Infusions Pumps in MRI rooms (faraday cage of antimagnetic materials) during MRI examinations of patients. The SpaceStation MRI does not include the Infusion Pumps, and it does not control the operation of the user-installed Infusion Pumps. Patients are moved from nursing units to the MRI area with infusing pumps which are placed in the SpaceStation MRI for the MRI scan.

The SpaceStation MRI is a RF-shielded housing which is mounted on the trolley. The mechanical construction of the housing makes it possible to position the system within the MRI room; it provides a shielded space and mechanical and electrical connections for up to four Space Infusion Pumps. A window in the door allows for direct viewing of the inserted infusion pumps, allowing all pump status and alarm conditions to be observed. The exterior housing provides IV line inlets and outlets, and knobs to release the infusion pumps.

The SpaceStation MRI (Unit) includes the SpaceStation with SpaceCover comfort and Magnet Indicator Tesla Spy 2010.

The SpaceCover comfort includes a large light display that shows the status and alarm condition of the pumps within the station as well as an audible alarm.

The Magnet Indicator Tesla Spy 2010 allows the operator to correctly position the SpaceStation MRI within the MRI room by measurement of the magnetic flux density. An optical and audible alarm is triggered if the station is too close to the MRI, exceeding the permitted flux density. The Trolley has an IV pole and provides a mount for the Safety Tether. The SpaceStation MRI is not connected to a network.

The Perfusor® Space Infusion Syringe Pump is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space Infusion Syringe Pump utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

The system is intended to provide intermittent or continuous delivery of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medicated for infusion as well as blood and blood products.

The Perfusor® Space Infusion Syringe Pump uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space Infusion Syringe Pump.

The Infusomat Space Volumetric Infusion Pump is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat Space Volumetric Infusion Pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat Space Volumetric Infusion Pump is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

The system created by using the administration sets with the Infusomat Space Volumetric Infusion Pump is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

This document describes the SpaceStation MRI (K191910), an MRI System Rack for B. Braun Space Infusion Pumps, and modifications to the Perfusor Space Infusion Syringe Pump (K062699) and Infusomat Space Volumetric Infusion Pump (K062700) to be MRI Conditional when used with the SpaceStation MRI.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally described as "pre-determined acceptance criteria was met in all testing" and conformance to various national and international standards. No specific quantitative targets are provided in the document for performance metrics like flow rate accuracy or alarm thresholds.

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

The document does not specify exact sample sizes for the test sets. All testing described is non-clinical performance testing, verified to be compliant with national and international standards. The provenance of the data is from the manufacturer, B. Braun Melsungen AG, based in Germany. The studies are prospective in nature, as they involve testing the physical devices in controlled environments for substantial equivalence determination.

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

No ground truth established by experts is mentioned as this is a device for infusion and an MRI rack, not an AI/diagnostic device that relies on expert interpretation of observational data. The performance is assessed against technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations. Device performance is determined by meeting pre-defined technical acceptance criteria in a laboratory setting.

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

No. This document does not mention any MRMC comparative effectiveness study. The devices are infusion pumps and an MRI system rack, not AI-powered diagnostic tools designed to improve human reader performance.

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

Not applicable. The SpaceStation MRI, Perfusor Space Infusion Syringe Pump, and Infusomat Space Volumetric Infusion Pump are physical medical devices, not algorithms. Their performance is assessed directly through non-clinical testing. The "Magnet Indicator Tesla Spy 2010" is an integrated component of the SpaceStation MRI, and its functionality was verified as part of the system.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these devices is established by technical specifications, national and international standards, and regulatory guidance documents (e.g., FDA's "Infusion Pumps Total Product Life Cycle" and "Applying Human Factors and Usability Engineering to Medical Devices"). The devices must meet these pre-defined, measurable criteria for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned as these are hardware devices and not AI/machine learning algorithms that require training data.

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

Not applicable, as there is no training set for these devices.

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The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority.

BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:

• Enterprise Director Portal
• HCP Service
• Patient Mobile Application
• Patient Web Portal

The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).

The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.

In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.

Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.

This document describes the WellDoc BlueStar and BlueStar Rx System, a software system for diabetes self-management. This 510(k) summary (K190013) references K162532 as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates). Instead, it states that the device's performance was evaluated through various non-clinical tests to demonstrate substantial equivalence to its predicate.

2. Sample Sizes used for the Test Set and Data Provenance

The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set or information regarding sample sizes, country of origin, or retrospective/prospective nature of data for clinical validation of device performance. The performance claim is based on non-clinical testing and substantial equivalence to a predicate device.

For the Human Factors testing, it mentions: "Human factors testing was conducted with the intended user populations of patients and healthcare providers." However, specific sample sizes for these user populations are not provided. The data provenance is not stated (e.g., country of origin, prospective or retrospective).

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

As there were no clinical tests and no explicit "test set" in the context of clinical performance evaluation (only non-clinical V&V and human factors), there is no information provided about experts establishing ground truth for a test set.

For the human factors study, "healthcare providers" were part of the intended user population, implying experts were involved as participants, but not in establishing ground truth in the traditional sense of diagnostic accuracy. Their qualifications beyond being "healthcare providers" are not detailed.

4. Adjudication Method for the Test Set

Since there was no clinical "test set" requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1, none) is 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 states "Clinical Tests: Not Applicable."

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

The document primarily focuses on the software system's functionality and its ability to process data, provide coaching messages, and calculate insulin doses. The "Software verification and validation" would assess the algorithm's standalone performance in terms of its intended functions. However, there isn't a separate, explicit study titled "standalone performance study" with specific metrics beyond the general software V&V. The human factors testing then evaluates it with human interaction. The insulin dose calculator performs its calculations algorithmically, and its "performance" is implicitly evaluated through software V&V and comparison to a well-understood linear decay model.

7. The type of ground truth used

For the software validation, the "ground truth" would be the expected output of the algorithms and software logic based on design specifications and established clinical models (e.g., for the insulin dose calculator, the "ground truth" is a correct calculation based on inputted parameters and a 'well-understood and accepted linear decay model'). For cybersecurity, the ground truth is adherence to security best practices and robustness against known vulnerabilities. For human factors, the ground truth is the usability and safety of the interface as determined by user interaction and expert review. No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is a software medical device, and the evaluation is primarily focused on verification and validation of its deterministic functions, safety, cybersecurity, and human factors, rather than a machine learning model that would require a distinct training set.

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

Since no training set is mentioned, the method for establishing its ground truth is not applicable.

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The Lockbox is intended to hold a Perfusor® Space PCA Infusion Pump and provide reasonably secure access to the medication syringe contained within.

The Lockbox is a lockable, clear plastic enclosure designed to house a B. Braun Perfusor® Space PCA Syringe Infusion Pump and secure it onto a vertical IV pole. The Lockbox consists of a two part polycarbonate enclosure consisting of a front housing and a rear housing. The rear housing has two guide rails which position the pump in the Lockbox. The left guiderail contains a detent which serves to hold the pump in place. The rear housing contains three openings, one to allow for the release of the pump from the detent in the left guide rail, one that allows for connection of the power and PCA cables, and slotted openings allowing for alarms to be heard while the infusion pump is in the Lockbox. A front housing is connected to the rear case by means of a full length hinge designed into the polycarbonate material. When closed, the Lockbox is secured by a keyed lock preventing access to the syringe contents contained within the infusion pump. A cut-out in the front housing provides a clinician direct access to the user interface keys and display screen. An aluminum pole clamp, designed to operate with a vertical IV pole is attached to the Lockbox. Once attached to the IV pole, the pole clamp can be locked to prevent the Lockbox from being removed from the pole.

The provided text describes a 510(k) summary for a medical device called the "Lockbox for the Perfusor® Space PCA Infusion Pump." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to AI or comparative effectiveness with human readers) are not applicable as this submission is for a Class II medical device, an "Infusion Pump Accessory," which emphasizes functional and safety testing to ensure it performs as intended and is substantially equivalent to existing devices.

However, I can extract the general acceptance criteria inferred from the performance testing summary and provide what information is available.

Acceptance Criteria and Device Performance

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

The document states that "In all testing, the pre-determined acceptance criteria were met." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance is reported qualitatively as meeting these unspecified criteria.

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

The document does not specify the sample size for any of the performance tests. The data provenance is internal B. Braun Medical Inc. testing, as these are non-clinical (engineering/functional) tests rather than clinical studies with patient data.

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

This question is not applicable. The "ground truth" concept is typically relevant for diagnostic or AI-driven devices where decisions are compared against expert consensus or pathological findings. For this device (an infusion pump accessory/lockbox), validation involves engineering and functional testing against design specifications and relevant standards, not expert interpretations of ground truth.

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

This question is not applicable for the same reasons as #3. Adjudication methods are used to establish a consensus ground truth when multiple experts provide differing interpretations, which is not the case for functional and physical testing of a lockbox.

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 question is not applicable. An MRMC study is relevant for diagnostic imaging devices, especially those incorporating AI assistance. The device in question is a physical lockbox for an infusion pump, which does not involve "human readers" or "AI assistance" in a diagnostic capacity.

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

This question is not applicable. The device is not an algorithm or an AI-driven system. It is a mechanical accessory.

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

For this device, the "ground truth" is implied by the design specifications, engineering standards (e.g., ASTM D4169-16, ISO 14971:2007), and the intended functionality (e.g., the lock working, the material not degrading, the pump fitting). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense usually applied to diagnostic devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this device is not an AI/machine learning model.

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

This question is not applicable for the same reason as #8.

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Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products to a patient's vascular system.
Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space.

Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in-line adapter, injection site assembly, check valve, pressure activated valve and blood chamber. Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

The provided text describes the 510(k) summary for "Sapphire Sets," which are administration sets intended for use with the Sapphire Infusion System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing the performance of an AI/ML-driven medical device. Therefore, a direct answer to the request regarding acceptance criteria and study proving performance for an AI/ML device, as outlined in the prompt, cannot be fully provided from this document.

The document discusses non-clinical tests for the infusion set components, assuring their material and functional integrity, and their compatibility with the Sapphire Infusion System. It does not refer to AI/ML device performance or associated studies like MRMC or standalone algorithm performance.

However, I can extract information related to the closest aspects from the document:

1. Table of acceptance criteria and reported device performance:

The document doesn't provide a typical "acceptance criteria vs. reported performance" table like one would expect for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it lists the types of non-clinical tests performed to demonstrate that the new Sapphire Sets perform as intended and meet applicable standards, confirming they are "acceptable."

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

This document does not specify a "test set" in the context of an AI/ML algorithm validating against a dataset. The testing described is for physical properties and functionality of medical device components. The document implies laboratory testing of device samples. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device submission.

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

Not applicable. Ground truth for an AI/ML algorithm involving expert review is not relevant to the physical and functional testing of an infusion set.

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

Not applicable. This is not an image-based or diagnostic AI/ML device where adjudication methods for ground truth would be used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is for evaluating human performance (e.g., radiologists) with and without AI assistance, which is not applicable to an infusion set.

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

No. This document is not about an AI/ML algorithm.

7. The type of ground truth used:

The 'ground truth' for the Sapphire Sets relates to established engineering standards (e.g., ISO standards for material properties, leakage, tensile strength, flow rate accuracy) and biological safety tests. It's based on objective, quantitative measurements and adherence to recognized industry standards, rather than expert consensus on diagnostic interpretations or clinical outcomes in the way an AI/ML model's performance would be assessed.

8. The sample size for the training set:

Not applicable. This document is not about an AI/ML algorithm.

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

Not applicable. This document is not about an AI/ML algorithm.

In summary: The provided document is a 510(k) premarket notification for a medical device (infusion sets) demonstrating substantial equivalence to predicate devices, primarily through engineering and material testing, and compliance with established standards. It does not describe the evaluation of an AI/ML medical device as outlined in the prompt's detailed questions.

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The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have Type 2 Diabetes. The system is intended to assist Type 2 Diabetes patients to self-manage their disease, as cleared under K100066. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® -BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a HCP.

BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:

• Enterprise Director Portal
• HCP Service
• Patient Mobile Application
• Patient Web Portal

The Enterprise Director application is used for administrative purposes (unchanged since cleared under K100066). The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).

The Patient Web Portal and the Patient Mobile application have a similar feature set (unchanged since cleared under K100066). Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications is stored in the database and can be retrieved for display in either applications require the initial web- or mobilebased registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.

In BlueStar® Rx, the patient web portal and mobile application also provide an insulin dosing calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The insulin dose calculator is restricted to prescription-use only.

Furthermore, as cleared under K16225 (reference device), BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. These modifications do not change the fundamental scientific technology of the device.

The provided documentation is a 510(k) summary for the WellDoc BlueStar® and BlueStar® Rx systems. It describes the device, its indications for use, and a comparison to predicate devices, but does not appear to contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria.

Instead, the document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices (K100066 and K162225) based on intended use, design, materials, and overall performance characteristics. The "Non-Clinical Performance Data" section mentions "Software Verification, Software Validation, Human Factors Testing" as data provided to support substantial equivalence, suggesting these activities were performed. However, it does not provide the specific acceptance criteria for these tests or the detailed results that would allow for a table of acceptance criteria versus reported device performance.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

Information Not Available in Document: The document does not provide a specific table of acceptance criteria or quantifiable performance metrics beyond stating that "Verification, validation and human factors testing showed that the system can be used by a layperson without HCP oversight, meets its requirements and functions as intended." It does not list target accuracy, specificity, sensitivity, or other predefined benchmarks with corresponding measured values.

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

Information Not Available in Document: The document does not specify the sample size used for the mentioned "Software Verification, Software Validation, Human Factors Testing" or the provenance of any data used in these tests.

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)

Information Not Available in Document: The document does not mention the use of experts to establish ground truth for any test set. The focus is on software functionality and human factors for a self-management diabetes system, not diagnostic accuracy requiring expert interpretation.

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

Information Not Available in Document: The document does not describe any adjudication methods, as no expert-based ground truth establishment is mentioned.

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

Information Not Available in Document: An MRMC comparative effectiveness study is not mentioned. The device, an AI-powered diabetes self-management system, isn't described in a way that suggests "human readers" or "AI assistance" in the context of image interpretation or similar diagnostic tasks. Its function is to provide coaching messages and an insulin dose calculator.

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

Information Available:
The device ("WellDoc BlueStar®" and "WellDoc BlueStar® Rx") is a "stand-alone software system" intended for use by both patients and healthcare providers. The document states that "software intended for use on mobile phones or personal computers" and that the system "provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends." BlueStar® Rx also "includes an insulin dose calculator." These descriptions imply standalone algorithm performance in generating coaching messages and calculating insulin doses based on input data. The "human factors testing" mentioned confirms that the system is designed to be used by a layperson, indicating that the core functionality operates somewhat independently, though the system is meant to support self-management with HCP oversight (for Rx version).

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

Information Not Available in Document: The document does not specify the type of ground truth used for any testing. Given the nature of the device (diabetes management, coaching, insulin calculation), "ground truth" would likely relate to the correctness of calculations or the appropriateness of coaching messages, which might be assessed against clinical guidelines or pre-defined rules rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Information Not Available in Document: The document does not provide any information about a training set size or methodology. It's unclear if machine learning/AI techniques that require explicit training sets were used in a manner that necessitated reporting such a detail in this K162532 summary, as the "AI" aspect is described more generally as providing "coaching messages... based on real-time blood glucose values and trends."

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

Information Not Available in Document: As no training set is mentioned, the method for establishing its ground truth is also not provided.

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Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

The document describes a 510(k) premarket notification for Hospira Sapphire Sets, an accessory for infusion pumps. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text. Many of the requested details about acceptance criteria and study specifics are not explicitly stated in this type of regulatory document, which focuses on demonstrating equivalence rather than a full clinical trial.

1. Table of acceptance criteria and the reported device performance:

The document outlines a series of tests performed to establish substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to the predicate device. Specific numerical acceptance criteria are generally not provided in this summary. Instead, it states that "All testing is acceptable."

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

• Sample Size: The document does not specify the sample sizes used for any of the tests (biocompatibility, particulate contamination, leakage, tensile strength, or flow rate accuracy).
• Data Provenance: The tests were conducted to demonstrate substantial equivalence of the "Hospira Sapphire Sets," which are described as a "combination of Hospira IV set components with the Sapphire Cassette." The testing was performed for the new device as part of the 510(k) submission. It relates to the safety and performance of the device itself and its interaction with the Sapphire Infusion System. This would be considered prospective testing conducted by the manufacturer for regulatory submission. Country of origin of the data is not specified, but the applicant is Hospira, Inc. in Lake Forest, Illinois, USA.

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

This is not applicable to this type of device submission. The "ground truth" for infusion pump accessories, in this context, is established through adherence to recognized international standards (e.g., ISO) and engineering performance specifications. There is no concept of expert "ground truth" establishment in the way it might apply to diagnostic AI or imaging devices.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs independent review to establish a consensus ground truth. For an infusion set, performance is measured against objective physical and chemical standards.

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 is not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where human "readers" (e.g., clinicians interpreting images) are part of the diagnostic process and their performance might be augmented by AI. The Hospira Sapphire Sets are infusion pump accessories, not diagnostic imaging devices or AI-powered tools for interpretation.

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

This is not applicable. The device is an infusion set, not an algorithm or an AI-powered system. The tests described are for the physical and functional performance of the medical device itself.

7. The type of ground truth used:

The "ground truth" for the performance claims of the Hospira Sapphire Sets is based on adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 1135-4) and the engineering specifications and performance characteristics demonstrated to be "acceptable" through the conducted tests. It's essentially "compliance with established safety and performance benchmarks."

8. The sample size for the training set:

This is not applicable. The device is a physical medical device (infusion set), not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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