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The BD FlowSmart™ Set/MiniMed™ Pro-Set™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

The subject infusion set is a single use infusion administration set intended to be used for 48-72 hours. The product is intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing is connected on one end to the medication reservoir of an infusion pump and on the other end to the patient, attached to the skin by an adhesive base. The plastic catheter of the device contains a proprietary side-port. It is a single-use sterile device.

The provided document is a 510(k) summary for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set. It describes bench performance and biocompatibility studies conducted to demonstrate substantial equivalence to a predicate device (K160651).

Here's the breakdown of the requested information:

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

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

The document does not specify the exact sample sizes for each bench study. It only states that "BD has verified the modifications of the subject device through bench performance and biocompatibility studies." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective), but these are bench tests conducted by BD, likely in their own facilities.

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. The studies described are bench performance tests (e.g., strength, integrity), not studies involving human interpretation or clinical outcomes that would require expert ground truth establishment.

4. Adjudication method for the test set

This information is not applicable as the studies were bench tests, not clinical studies requiring adjudication of human performance or expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The submission is for an intravascular administration set, and the studies described are bench performance tests to demonstrate substantial equivalence to a predicate device, not an AI-based diagnostic or assistive device that would involve human readers.

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

This information is not applicable. The device is a physical infusion set, not an algorithm.

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

The "ground truth" for the bench tests is defined by the technical specifications and standards (e.g., "Equivalent to predicate device," "Testing in accordance with ISO 10555-1:1995") for each physical characteristic being tested. It's a quantitative measurement against predefined criteria.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set. The studies are for a physical medical device.

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

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

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The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

Here's a breakdown of the acceptance criteria and study information for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ based on the provided document.

It's important to note that this document is a 510(k) summary for a medical device seeking substantial equivalence, not a standalone clinical study report for an AI algorithm. Therefore, the information will be geared towards demonstrating this equivalence for a physical medical device, not AI performance. Many of the requested AI-specific details (like MRMC studies, training set ground truth, number of experts for ground truth establishment) are not applicable or provided in this type of submission.

Acceptance Criteria and Reported Device Performance

The document doesn't present explicit quantitative acceptance criteria for specific device performance metrics in a table. Instead, it relies on demonstrating that the "results of these tests were found to be acceptable and demonstrated that the subject infusion set met requirements for its intended use and is substantially equivalent to its predicate device." This implies the acceptance criteria are implicitly defined by the standards and predicate device performance.

The "reported device performance" is a general statement of meeting the requirements and demonstrating substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Details

Given this is a 510(k) for a physical medical device, the concept of "test set" and "training set" as typically used for AI algorithms does not directly apply in the same way. The "testing" refers to non-clinical bench testing and adherence to standards.

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

   • Sample Size: Not explicitly stated as a number of "samples" in the context of a dataset. The testing was performed on representative samples of the device components and finished product to demonstrate compliance with the referenced ISO standards.
   • Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (BD) or contracted testing facilities. There is no mention of country of origin for data in the sense of patient data, as this is bench testing. The studies are prospective in the sense that the testing was performed on new device designs to evaluate their performance.

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

   • Not Applicable. For a physical device's non-clinical testing, "ground truth" is not established by human experts in the way it is for diagnostic image interpretation. The "ground truth" or reference standard for biocompatibility, functional performance, and sterilization is the established parameters and thresholds defined by the international ISO standards (e.g., specific chemical leaching limits, flow rate tolerances, sterility assurance levels). These standards are developed by expert committees, but not in the context of individual case "ground truth" adjudication.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, often involving multiple human readers interpreting medical images or clinical data. This document describes non-clinical laboratory testing of a physical device where results are measured against defined engineering specifications and international standards, not against human interpretations requiring adjudication.

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:

   • No. This is a physical medical device (an infusion set), not an AI algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

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

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

   • Standards-Based Specifications and Prior Validated Methods. The "ground truth" for non-clinical testing is based on:
     • Defined specifications: Engineering and design requirements for the device.
     • Compliance with international standards: ISO 10993 (biocompatibility), ISO 10555-1 and ISO ID26 (functional performance), ISO 11135-1 (sterilization).
     • Comparison to predicate device: The predicate device is considered safe and effective, and the new device must perform equivalently.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

   • Not Applicable. As there is no training set in the AI sense, this question is not relevant.

Summary of Device and Approval Context:

This 510(k) submission is for an intravascular administration set (BD FlowSmart™ Set/MiniMed™ Pro-Set™). The device is substantially equivalent to a previously cleared predicate device (K153257). The "acceptance criteria" and "studies" are focused on demonstrating that the new device, despite a minor change in adhesive material, meets all relevant safety and performance standards (biocompatibility, functional performance, sterilization) and performs identically to its predicate. The detailed AI-specific questions are not relevant for this type of medical device submission.

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The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

The BD FlowSmart™MiniMed™ Pro-Set™ infusion set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

This document, a 510(k) summary for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set, describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria and device performance in the format of AI/ML device studies. Therefore, many of the requested fields cannot be directly answered.

Here's an analysis based on the provided text, highlighting what is available and what is missing:

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

The document does not explicitly state acceptance criteria in a quantitative table for specific performance metrics like accuracy, sensitivity, or specificity, as would be common for AI/ML device evaluations. Instead, it states that "Results of these tests were found to be acceptable and demonstrated that the subject infusion set met requirements for its intended use and is substantially equivalent to its predicate device."

The testing included:

• Device material biocompatibility: ISO 10993 (Biological evaluation of medical devices)
• Device functional performance:
  • ISO 10555-1 (Sterile single use intravascular catheters)
  • ISO ID26 (Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps)
  • ISO 11135-1 (Sterilization of healthcare products)

Since this is a physical medical device (infusion set) and not an AI/ML diagnostic or predictive tool, the "performance" here refers to meeting standards for safety, biocompatibility, and intended mechanical/fluidic function. The document does not provide specific numerical performance results against these standards.

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

This information is not provided in the document. The testing described is non-clinical (biocompatibility and functional performance), likely involving laboratory testing of materials and device prototypes, rather than testing on patient data.

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

This information is not applicable as the device is a physical infusion set, and the "ground truth" concept as typically applied to AI/ML for diagnostic tasks does not apply here. The testing involves adherence to established international standards for medical devices.

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

This information is not applicable for the type of non-clinical testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an infusion set, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. The device is a physical infusion set, not an algorithm.

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

This information is not applicable in the context of AI/ML device evaluation. For this infusion set, "ground truth" would be defined by the specifications and performance requirements outlined in the referenced ISO standards (e.g., material compatibility as per ISO 10993, fluidic integrity as per ISO 10555-1). Compliance with these standards serves as the benchmark.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" as this is not an AI/ML device.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set. It declares substantial equivalence to a predicate device (K150059 - BD FlowSmart™ Set) based on non-clinical testing. This testing focused on:

• Device material biocompatibility: According to ISO 10993
• Device functional performance: According to ISO 10555-1, ISO ID26 (related to infusion pumps), and ISO 11135-1 (sterilization).

The conclusion states that the analysis and testing demonstrate the subject device is substantially equivalent to its predicate device. This type of submission relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device, especially when technological changes (like different adhesive material or tubing configuration) are not significant enough to alter fundamental principles or intended use.

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