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The BD Alaris™ Pump Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through intravenous, intra-arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults.

The BD Alaris™ Pump Infusion Set is designed to interface with the BD Alaris™ Pump Module or to be used for gravity infusion. The BD Alaris™ Pump Infusion Set is a single-use infusion set that is available in various configurations of the following components: fluid container spike, vent cap, drip chamber, pump segment assembly, roller clamp and/or pinch clamp, SmartSite™ Y-sites, check valve and male luer lock connector. The drip chamber cap located at the proximal end of the infusion set and the male luer lock cap located at the distal end of the infusion set maintain sterility of the fluid path prior to use. The spike located on the proximal end of the drip chamber is inserted into a fluid container. The infusion set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic.

The BD Alaris™ Pump Infusion Sets are infusion sets used by healthcare professionals for administering fluids and medications. The device's performance was evaluated through non-clinical design verification testing, including functional, bench, system, and biocompatibility tests. No clinical data was included in the submission.

Here is a summary of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test performed. It generally refers to "Design verification testing" and "Performance testing completed on the subject device." The testing would have been conducted internally by CareFusion/BD.

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

Not applicable, as this was a non-clinical premarket notification (510(k)) for a medical device (infusion set), not an AI/software device requiring expert interpretation of results for ground truth establishment. The "ground truth" here is defined by engineering standards, physical measurements, and biological compatibility test results.

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

Not applicable, as this was not a study involving human reader interpretation or clinical adjudication.

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. No MRMC study was conducted as this device is an infusion set, not an AI or imaging device requiring human-in-the-loop performance evaluation.

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

Not applicable. This is a medical device, not a software algorithm. The "standalone performance" would be the device functioning according to its specifications, which was evaluated through the functional and performance tests.

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

The "ground truth" for the non-clinical testing was based on:

• Established engineering and performance standards: e.g., ISO 8536-4 for gravity flow rate, AAMI TIR101:2021 for flow rate and bolus accuracy.
• Biocompatibility standards: e.g., ISO 10993 series and USP .
• Sterilization and shelf-life standards: e.g., ISO 11137 series and ASTM standards.
• FDA guidance documents: for various aspects like microbial ingress and general infusion pump lifecycle.
• Internal protocols: where specific external standards might not cover all aspects.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. It consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, spike, drip chamber, flow regulator, flexible tube, conical fitting, and injection needle/intravenous needle. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile and single use.

The provided document is a 510(k) summary for a medical device (Infusion Sets for Single Use with Needles) and does not describe a study involving an AI/Machine Learning device that utilizes a test set, expert readers, or ground truth in the way a diagnostic AI would.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device by comparing technical characteristics and performance standards. The "acceptance criteria" and "study" described here refer to non-clinical performance testing to ensure the device meets specified engineering and safety standards, rather than evaluating diagnostic accuracy of an AI model.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, number of experts for ground truth, MRMC studies, effect size of AI assistance, standalone performance, and training set details) are not applicable to this 510(k) submission.

Here's an interpretation of the document's content in a way that aligns with your request as much as possible, focusing on the quality and performance testing described:

Device: Infusion Sets for Single Use with Needles (K221069)

Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing for Substantial Equivalence Determination. This is not an AI/ML diagnostic performance study.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like infusion sets, acceptance criteria are typically defined by recognized international and national standards. The "performance" is demonstrated by showing compliance with these standards.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of infusion sets tested for flow rate, sterility, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." Regulatory standards often dictate minimum sample sizes for such tests, but these are not enumerated in the summary.
• Data Provenance: The testing was conducted by Sichuan Prius Biotechnology Co., Ltd. (China). The data represents laboratory testing results performed on the manufactured devices. The studies are by nature prospective, as they are specifically conducted to support the 510(k) submission for the new device.

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

• This concept is not applicable. For non-clinical performance and biocompatibility testing, "ground truth" is established by adherence to validated international standards and test methods (e.g., ISO, ASTM, USP). The expertise lies in the qualifications of the testing laboratories and personnel conducting these specific, standardized tests (e.g., chemists, material scientists, engineers, microbiologists). The document does not specify how many or the qualifications of the testing personnel, as it's assumed to be part of standard quality system requirements for medical device manufacturing and testing.

4. Adjudication Method for the Test Set

• This concept is not applicable. Performance testing results are either compliant with the specified standard and acceptance criteria or they are not. There is no "adjudication" in the sense of reconciling differing expert opinions or interpretations, as would be the case in subjective diagnostic AI assessments.

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, nor is it a diagnostic imaging device that involves human reader interpretation. No MRMC study was performed.

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

• Not applicable. This is not an algorithm or AI device. The device itself (infusion set) functions independently of human interpretation concerning its core performance metrics (e.g., flow rate, sterility, tensile strength).

7. The type of ground truth used

• Ground Truth: For this type of device, "ground truth" is defined by established international and national standards, regulatory requirements, and validated test methods. Compliance with these standards (e.g., ISO for biological evaluation, physical properties; ASTM for material properties, package integrity; USP for sterility, pyrogens) indicates that the device performs as intended and is safe. The document repeatedly states, "Comply with ISO X," "meets the requirements of ISO Y," or "test result can meet the requirements."

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device which undergoes compliance testing rather than AI model training.

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

• Not applicable, as there is no training set.

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The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The proposed device consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, drip chamber, drip tube, flow regulator, flexible tube, and conical fitting. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile, single use.

The provided document is a 510(k) Summary for a medical device (Infusion Sets for Single Use) and not a study describing the acceptance criteria and performance of an AI/ML powered device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, and training set details cannot be extracted from this document.

The document discusses the substantial equivalence of the proposed device to a predicate device, focusing on material, physical characteristics, and compliance with various ISO and ASTM standards relevant to infusion sets (e.g., sterilization, biocompatibility, seal strength, flow rates). It explicitly states:

• No clinical study is included in this submission. This means there is no data on human-in-the-loop performance, standalone algorithm performance, or the benefits of AI assistance.
• The device being reviewed is a physical medical device (Infusion Sets for Single Use), not an AI/ML algorithm or system.

Therefore, I cannot fulfill your request using the provided text.

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The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use. The proposed devices include 32 models.

This document describes a 510(k) premarket notification for "Infusion Sets for Single Use." This is a medical device application that demonstrates "Substantial Equivalence" to a predicate device. This type of submission relies on non-clinical testing to support its claims, rather than clinical studies with human participants. Therefore, several of the requested categories are not applicable (N/A) to this document.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it refers to conformity with established international and US standards for medical devices. The "reported device performance" is implicitly that the device conforms to these standards, making it "substantially equivalent" to the predicate device and safe for its intended use.

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: The document does not specify the exact sample sizes used for each individual non-clinical performance and biocompatibility test. It simply states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests, typical sample sizes are relatively small and determined by the specific ISO/ASTM standard.
• Data Provenance: The testing was conducted as part of the submission by Jiangsu Suyun Medical Materials Co., Ltd. from China. The types of tests (Performance Testing, Biocompatibility Testing, Sterility, Shipping and Shelf-life) are generally performed prospectively in a lab setting rather than being retrospective analyses of existing data. The specific country of origin for the data acquisition (i.e., where the labs are located) is not explicitly stated beyond the sponsor's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is N/A. For non-clinical device testing, "ground truth" is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, USP). The "experts" are the qualified laboratory personnel performing the standardized tests, and their qualifications are in conducting these specific test methods, not in clinical interpretation.

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

This is N/A. Adjudication methods are typically relevant for clinical studies or studies involving subjective human assessment (like image interpretation). Non-clinical performance and biocompatibility tests are objective measurements against predefined criteria in standards, not subject to individual interpretation requiring adjudication.

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 N/A. This submission is for a physical medical device (infusion sets), not an AI/software device that involves human readers or image interpretation. No MRMC study was performed.

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

This is N/A. This submission is for a physical medical device, not an algorithm or AI device.

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

The "ground truth" for this device's performance and safety is based on established international and national standards and test methods. For example, the ISO 8536 series for infusion equipment, ISO 10993 series for biocompatibility, and various USP and ASTM standards define the accepted methods and criteria for assessing device attributes like flow rate, mechanical integrity, material safety, and sterility.

8. The sample size for the training set

This is N/A. This is a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set.

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

This is N/A. As mentioned above, there is no training set for a physical medical device.

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The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.

The Precision Infusion Filter for Single Use is intended to be used with administration sets for removal of particulate matter during the administration of fluids or medications.

The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.

The purpose of this submission was to introduce new products into interstate commerce. This is a bundled submission which includes Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use and Extended Infusion Sets for Single Use.

Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system under the action of gravity. The proposed devices are comprised of protective cap, closure-piercing device, air vent, drip chamber, precision filter, flexible tubing, injection site, flow regulator, clamp, conical fitting, burette and needle tube. The devices are provided sterile and single use.

Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The proposed devices are comprised of protective Cap and precision filter. The devices are provided sterile and single use.

Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration. The proposed devices are comprised of protective Cap, flexible tubing, conical fitting and precision filter. The devices are provided sterile and single use.

This document describes various infusion sets and filters, but it does not describe a study involving an AI device. The document is for a 510(k) premarket notification for medical devices (infusion sets and filters), focusing on demonstrating substantial equivalence to predicate devices, not on AI performance. Therefore, I cannot provide an answer based on the provided text.

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The devices are indicated for the delivery of fluids from a container to a patient's vascular system.

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.

I am sorry, but the provided text does not contain the information required to answer your request. This document is a 510(k) premarket notification summary for medical devices (infusion sets). It outlines the device description, indications for use, comparison to predicate devices, and non-clinical test conclusions to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance beyond general compliance with ISO standards.
• Details about a specific study proving the device meets acceptance criteria, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on this text.

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These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.

The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.

The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asante Conset™ and Asante Comfort™ Subcutaneous Infusion Sets:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The following verification testing was performed on the modified sets" and then lists the criteria, followed by a conclusion that the new products are "substantially equivalent." It does not explicitly provide the numerical results for the modified sets, but the substantial equivalence claim implies that the acceptance criteria were met.

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

The document does not explicitly state the sample size used for the verification testing (Flow, Leak, and Pull tests). The data provenance is also not specified (country of origin, retrospective or prospective).

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

This information is not applicable and not provided. The study involves performance testing of a medical device (infusion sets) against engineering specifications, not a clinical diagnostic assessment that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves objective engineering measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and not provided. This is a 510(k) submission for an infusion set, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

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

This information is not applicable and not provided. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (Flow, Leak, Pull) is established by the specified acceptance criteria (e.g., minimum flow rate, no leaks, minimum pull force). These are objective engineering specifications derived from the predicate devices' performance and industry standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable and not provided, as there is no training set for this device.

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Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.

Hospira infusion sets are intended for use as gravity sets or with dedicated Hospira Infusion Pumps. Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components. These components including the back check valve which is the subject of this submission may be shared across Hospira set families and used with sets designed for gravity or other pump platforms.

The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.

Acceptance Criteria and Device Performance

The Hospira Infusion Sets with an alternate fixed diaphragm Back Check Valve were evaluated against various performance characteristics, primarily focusing on biocompatibility and sterility. The acceptance criteria are implicitly defined by the successful "Pass" result for each test.

Study Details

1. Sample Size used for the test set and the data provenance:
   The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for cytotoxicity, sensitization, etc.). It only states that the "Hospira Infusion sets with an alternate Back Check Valve passed all specified test requirements."
   The data provenance is not explicitly stated as country of origin, nor is it explicitly mentioned whether the data is retrospective or prospective. However, given this is a 510(k) submission for a modified device, the testing would typically be prospective for the modified component.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The tests performed are laboratory-based performance and safety tests, not clinical evaluations requiring expert consensus on a 'ground truth' in the context of diagnostic algorithms.

3. Adjudication method for the test set:
   Not applicable, as the tests are laboratory-based performance and safety tests with objective pass/fail criteria according to international standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This submission is for a physical medical device (infusion set) and not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a physical medical device.

6. The type of ground truth used:
   The ground truth for the device's performance is established by the specified international standards (ISO series) for biocompatibility and sterility. For the back check valve performance, it's assessed against "reduction of backflow" and "user needs and design inputs for an Infusion set." These are objective, measurable criteria defined by regulatory and engineering standards.

7. The sample size for the training set:
   Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, for the same reason as above.

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The Sof-set and Polyfin families of infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a Medtronic MiniMed infusion pump and reservoir.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Polyfin Infusion Set" and related models. It explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.

A 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. This process does not typically involve detailed studies to establish new acceptance criteria or quantify device performance against specific metrics in the way a PMA (Premarket Approval) or a clinical trial for a novel device would. The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria as you've requested.

The information you are asking for, such as sample size, ground truth establishment, expert qualifications, and specific performance metrics, is usually found in detailed scientific reports, clinical trial summaries, or design validation documents that are submitted to the FDA as part of the 510(k) but are not typically included in the public-facing clearance letter itself.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria because this information is not present. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data against new acceptance criteria.

The information you've requested typically comes from the technical documentation and studies submitted to the FDA, which are not included in this summary letter.

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These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Not Found

The provided text is a 510(k) summary for an infusion set and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria and results in the way one would expect for an AI/ML device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not mentioned in this document because it describes a medical device (infusion set) for which performance is typically verified through engineering testing against specifications, rather than clinical studies involving ground truth establishment by experts as seen in diagnostic AI/ML applications.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Verification testing confirmed the product meets their specifications." It does not provide numerical acceptance criteria or specific performance metrics.

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

• Sample Size: Not specified. The document refers to "Verification testing" without detailing the sample size for these tests.
• Data Provenance: Not applicable. The "tests" would be engineering/bench tests of the physical device, not data from a human population.
• Retrospective/Prospective: Not applicable.

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

• Number of Experts: Not applicable. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant for the performance verification of an infusion set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This document describes an infusion set, which is a physical device.
• Effect size of human reader improvement: Not applicable.

6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• The term "ground truth" as typically used for AI/ML devices is not applicable here. Performance was likely confirmed against engineering specifications using physical measurements and tests (e.g., flow rate, material compatibility, durability).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for an infusion set, which is a physical medical device. The 510(k) process primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. For such devices, performance data typically comes from engineering and bench testing to ensure the product meets its pre-defined specifications, rather than from clinical studies involving human data and expert ground truth establishment that is characteristic of AI/ML diagnostic or prognostic devices. Therefore, most of the questions derived from an AI/ML context are not relevant to this specific submission. The key performance statement is general: "Verification testing confirmed the product meets their specifications."

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