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The Disetronic Pen P100 is indicated for the injection of insulin into the body

The Disetronic Pen P100 is a reusable device that provides a method of accurately iniecting a selected dose of insulin from an insulin cartridge supplied by other manufacturers, through a single lumen hypodermic needle. The device can be used by health professionals or for self-iniection by the patient. The device is similar in appearance and size to a ballpoint pen. It is cylindrical in shape and has a retractable dosage knob at the top that resembles the 'clicker' used to extend and retract the tip of a ballpoint pen beyond its housing.

The internal mechanisms used to set and activate the injection are the same across the product line. Each pen operates in the following manner. After the cartridge is loaded into the barrel and the needle is attached, the user pushes a button on the side of the pen opposite the digital display. This releases a spring-loaded 'knob' at the top of the pen. The knob is then rotated in a clockwise direction which increments the digital display to show the dose to be delivered. The needle cap is removed and the needle is inserted into the injection site. The knob at the top of the pen is depressed which advances the plunger to displace the chosen dose. After the injection, the needle is removed from the pen and discarded.

The provided text is a 510(k) summary for the Disetronic Pen P100. This document focuses on demonstrating substantial equivalence to previously marketed devices and does not contain the detailed study information typically associated with acceptance criteria for a novel AI/software device. The device in question is a reusable insulin injection pen, a mechanical device, not an AI, software, or imaging device subject to the types of studies outlined in your request.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to aspects that are not relevant to a mechanical device submission like this.

However, I can extract the information that is present and indicate where the requested information is not applicable to this type of device.

Acceptance Criteria and Device Performance for Disetronic Pen P100

Based on the provided 510(k) summary, the "acceptance criteria" are not explicitly defined in a quantitative table with performance metrics as one might expect for a diagnostic or AI device. Instead, the performance is evaluated against a recognized standard for such mechanical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states that the device was "tested using the methods specified in the draft ISO standard, ISO 11608," but does not detail the number of devices or injections tested.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary for a mechanical device conformance to an ISO standard.

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

• Not Applicable. For a mechanical device conforming to an ISO standard, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The performance is assessed against the physical and functional specifications defined in the standard.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, which is not relevant for testing a mechanical injection pen's conformity to an ISO standard.

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 mechanical device, not an AI or diagnostic tool. MRMC studies are used to evaluate diagnostic accuracy and the impact of AI assistance on human reader performance, which is not relevant here.

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

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

7. The type of ground truth used

• Standards-based Conformance: The "ground truth" in this context is the requirements and test methods specified in the draft ISO standard, ISO 11608, for "Pen-injectors for Medical Use." The device's performance is measured against these established engineering and functional benchmarks.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set for this mechanical device.

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