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The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.

The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump. The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose). The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following: - Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen - Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only) The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis. There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE.

Here's an analysis of the provided text regarding the DANA Diabecare® II Insulin Pump and SUPERLINE Infusion Sets, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, detailed study report with extensive acceptance criteria and performance statistics like a PMA. Therefore, some of the requested information (especially quantitative data, training set details, or complex study designs like MRMC) is not explicitly present or as detailed as one might expect in a scientific publication.

Acceptance Criteria and Reported Device Performance

The document describes several performance tests and their outcomes, which serve as the acceptance criteria for ensuring the modifications made to the device still meet safety and effectiveness standards.

Additional Information on the Study (if available)

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

   • The document does not explicitly state the sample sizes for the burst, bioburden, insulin potency, or shelf-life testing. These would typically be determined by statistical methods or regulatory guidance for such tests.
   • The data provenance (e.g., country of origin, retrospective/prospective) is not specified. Given the manufacturer is from Korea, it's likely the testing was performed there or by a contract lab; however, this is not confirmed in the text. This is a design verification activity, not a clinical trial.

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

   • This question is not applicable to the described performance testing. The "ground truth" for burst, bioburden, and insulin stability tests is typically established through objective measurements against defined chemical, physical, and microbiological standards, not relying on expert interpretation in the same way as, for example, image interpretation in a diagnostic device.

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

   • This question is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where there might be disagreement. These are objective engineering and laboratory tests.

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:

   • This is not applicable as this device is an insulin pump and infusion set, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.

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

   • Not applicable as this is a medical device (pump and infusion sets), not a standalone algorithm or AI. While the pump has software with algorithms, the "standalone" performance here relates to the device's functional integrity (e.g., accurate insulin delivery, absence of leaks), not an AI's interpretative power.

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

   • For the described tests:
     • Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and validated laboratory test results (e.g., cytotoxicity assays, sensitization tests).
     • Burst Testing: Ground truth is the physical presence or absence of leakage under specified pressure.
     • Bioburden Testing: Ground truth is the microbiological count meeting sterility assurance levels.
     • Insulin Potency Assay: Ground truth is the measured concentration/activity of insulin remaining relative to a control or baseline, determined by validated chemical assays.
     • Shelf-Life Testing: Ground truth is the maintenance of all specified performance criteria (e.g., sterility, dimensional stability, material integrity, functional operation) over the stated period.
   • These are all objective, laboratory-based measurements against established scientific and regulatory standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no "training set." The development of the device involves engineering design, material selection, and verification testing.

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

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

In summary: The provided 510(k) summary focuses on demonstrating the safety and effectiveness of the physical device modifications through performance testing against established engineering and regulatory standards (e.g., biocompatibility, physical integrity, stability). It does not involve AI or diagnostic interpretations, thus many of the questions related to AI/algorithmic performance, human readers, and ground truth in that context are not relevant to this submission.

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