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ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.

The ACCU-CHEK® Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

This 510(k) summary describes a re-submission for an existing device, the ACCU-CHEK® Ultraflex infusion set. The submission is for minor design modifications due to a transfer of manufacturing to a new manufacturer, Unomedical A/S. As such, the study conducted is primarily for functional equivalence rather than a full de novo clearance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "in vitro functional testing" and "Biocompatibility testing" but does not specify the sample sizes used for these tests. The data provenance is implied to be from the manufacturer (Roche Diabetes Care AG and Unomedical A/S) but no country of origin for the test data is explicitly stated. The studies are essentially retrospective in the sense that they are to re-validate an existing product with minor modifications.

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

Not applicable. This device is an infusion set, and the "ground truth" for its performance is based on engineering specifications and laboratory testing, not expert interpretation of medical images or clinical outcomes that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation is based on functional and biocompatibility testing against predefined specifications, not on expert adjudication of clinical data.

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

No. This type of study is not relevant for an infusion set as it's not a diagnostic imaging or interpretive aid where human readers' performance is being evaluated. The document explicitly states: "Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the ACCU-CHEK® Ultraflex infusion set."

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The functional and biocompatibility testing represents a standalone evaluation of the device's physical and material properties against specifications, without human intervention in the device's functional assessment. It's not a software algorithm, but the principle of standalone evaluation applies to the hardware.

7. The Type of Ground Truth Used

The ground truth used is based on predefined engineering specifications and biocompatibility standards. The device is tested to ensure it meets these established technical and safety requirements.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense. The "training" for such a device would be its initial design and manufacturing process validation.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the device's design and manufacturing is established through engineering design principles, material science, and regulatory standards for medical devices of this type.

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