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Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

All Orbit micro Infusion Sets are used for the subcutaneous delivery of fluids and medication from an external infusion pump. All Orbit micro Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. All Orbit micro Infusion sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base. The subject devices use a stainless steel indwelling cannula instead of the Teflon cannula in the predicate devices.

This document describes the 510(k) submission for the Orbit®micro Infusion Set. This is a medical device and not an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices, such as those related to accuracy, sensitivity, specificity, MRMC studies, or ground truth establishment based on expert consensus/pathology, are not applicable here.

The provided text details the performance testing conducted to demonstrate the substantial equivalence of the Orbit®micro Infusion Set to a predicate device (K130468). The acceptance criteria are essentially the specifications that the device must meet, and the "results" column indicates whether these criteria were passed.

Here's the information as requested, adapted to the context of a medical device rather than an AI system:

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

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

The document does not specify the exact sample sizes used for each performance test. The tests are physical/mechanical property tests of the device components and entire system, not tests on biological or imaging data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for an AI/ML context. The tests were conducted by Ypsomed AG, a Swiss company.

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

Not applicable. Ground truth for these types of device performance tests is established by adherence to international standards (e.g., ISO) and engineering specifications, often measured by calibrated equipment, rather than requiring expert human interpretation.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation.

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 a medical device, not an AI system. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm. The performance tests ("standalone") refer to the device's inherent mechanical and material properties.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established engineering principles, international standards (like ISO 9626, ISO 10555-1, ISO 8536-8, ISO 10993-1), and the predefined specifications set by the manufacturer to ensure the device performs as intended and is safe. This isn't "expert consensus," "pathology," or "outcomes data" in the context of diagnostic accuracy, but rather compliance with physical and biological requirements through standardized testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that requires a training set.

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

Not applicable. No training set for an algorithm was used.

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Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Orbit Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. These sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base.

The Orbit Infusion Set is intended for the subcutaneous delivery of fluids and medication from an external infusion pump. The device aims to demonstrate substantial equivalence to the predicate device, Talon Infusion Set (K033290), by meeting performance and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study concluded that "The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product."

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

The document does not explicitly state the sample size used for each specific test. The data provenance is described as "relevant assessments specified in the following international and internal standards and protocols." This suggests that the tests were conducted in a controlled laboratory environment according to established engineering and medical device standards. There is no mention of country of origin of the data, or if it was retrospective or prospective human subject data, as these are technical performance tests on the device itself.

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

Not applicable. The ground truth for these performance tests is based on the specified engineering and medical device standards, which are objective measurements. Expert consensus or clinical interpretation of data is not required to establish ground truth for these types of device performance criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical outcomes where ambiguity might exist. For objective performance tests with clear pass/fail criteria based on standards, an adjudication method is not relevant.

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 submission is for a medical device (infusion set) and not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The ground truth for the performance tests is based on objective measurements defined by international and internal engineering/medical device standards. For example, "Material strength per ISO 9626," "No leak when subjected to pumping pressures up to 20psi," and "No separation...when subjected to a minimum force of 10N (ISO 10555-1, Annex B)."

8. The sample size for the training set

Not applicable. This is a physical medical device being evaluated against engineering and safety standards, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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