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The DANA Diabecare® IIS is an external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.
The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump.
The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels.
The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log.
DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.

The provided document is a 510(k) summary for the DANA Diabecare® IIS Insulin Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that are typically found in studies for diagnostic or AI-driven medical devices.

Instead, the "Performance Testing" section states: "Module and system verification and validation testing was performed on the modified software for the DANA Diabecare® IIS insulin pump. The verification and validation testing confirmed that all new and modified subroutines performed as designed and conformed to the software requirement specifications. The modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. A risk analysis was also performed in accordance with the requirements of Medical Device Directive 93/42/EEC and ISO 14971 which confirmed that the modified DANA Diabecare® IIS insulin pump is safe and effective for its intended use for the subcutaneous delivery of insulin for the treatment of diabetes mellitus."

This indicates that the "acceptance criteria" were related to software requirements and safety standards, not statistical performance metrics against a medical ground truth in the way a diagnostic AI would be evaluated. The "study" mentioned is the internal verification and validation testing and risk analysis, which confirmed compliance with these engineering and regulatory standards.

Therefore, many of the requested elements for a deep learning/AI device evaluation cannot be extracted from this document because it describes an insulin pump, not an AI or diagnostic tool.

Here's a breakdown of the information that can be extracted and an explanation for why other requested information is not present:

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

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

• Not Applicable / Not Provided: This device is an insulin pump, not a diagnostic AI system that uses patient data for a "test set" in the common AI sense. The "verification and validation testing" would have involved internal software testing and hardware testing, not a clinical study on a patient test set in the same way.

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)

• Not Applicable / Not Provided: Ground truth in the context of an insulin pump's software validation would relate to whether the code executed correctly and met specifications, not to clinical diagnoses requiring expert medical review.

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

• Not Applicable / Not Provided: As above, this concept does not apply to the software verification and validation of an insulin pump.

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: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

• Not Applicable / Not Provided: The device is an insulin pump; its function is to deliver insulin, not to provide an algorithm-only diagnostic output. Its performance is inherent in its operation, which is always with a human user in the loop providing inputs and monitoring. The "algorithm" here refers to the pump's control software, not a diagnostic AI.

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

• Software Requirements Specifications / Engineering Standards: The "ground truth" for the performance testing of the pump's software would have been the predefined requirements and specifications outlined during its development, as well as relevant safety and performance standards (e.g., ISO 14971, Medical Device Directive 93/42/EEC).

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI system that undergoes "training" on a data set. Its software is programmed and validated.

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

• Not Applicable / Not Provided: As above, the concept of a training set and its ground truth does not apply to this type of device.

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