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The device is indicated for the injection of insullin into the body.

The Disetronic Injection Pen is a reusable devices that provides a method of accurately injecting a selected dose of insulin from a fluid cartridge through a single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient. The device is similar in appearance and size to a ball point pen, hence the description. It is cylindrical in shape and has a retractable dosage know at the top that resembles the "clicker" used to extend and retract the tip of a ball point pen beyond its housing.

The internal mechanisms used to set and activate the injection are identical across the oroduct line. Each pen operates in the following manner. After the cartndge 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 sonng loaded 'knob' at the top of the pen The knob is then twisted in a clockwise direction which increments the digital display to show the dose to be delivered. The needle can 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 Pen models are differentiated in that different models of pens differ in the amount of drug represented by each incremental click of the dose setting mechanism. These differences are determined by differences in the threaded rod and nut mechanism of each model which determines the distance, and therefore the dose each click of the dosage knob represents.

The provided text describes the Disetronic Injection Pen, which is a reusable device for accurately injecting insulin. The document primarily focuses on its substantial equivalence to previously marketed devices and its conformity with an ISO standard, rather than presenting a detailed study with acceptance criteria and device performance results in the format requested.

However, based on the provided text, we can infer some information relating to the performance data and the study mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The statement refers to "testing using the methods specified in the ISO standard," which implies that the testing was conducted in accordance with the standard's guidelines, but specific details are not provided.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The validation primarily relies on conformance to an ISO standard.

4. Adjudication Method

There is no mention of an adjudication method as the evaluation is based on conformance to a technical standard rather than subjective assessments by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission focuses on device performance against an engineering standard, not human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states, "The device conforms with the requirements when tested using the methods specified in the ISO standard, ISO 11608-1, 'Pen-injectors for Medical Use - Part 1. Requirements and Test Methods.'" This indicates a standalone assessment of the device's functional performance against established technical specifications.

7. Type of Ground Truth Used

The ground truth used is conformance to the technical specifications and test methods outlined in ISO 11608-1, "Pen-injectors for Medical Use - Part 1. Requirements and Test Methods." This is a regulatory/standard-established ground truth for device functionality and safety.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of submission (510(k)) for a medical device generally focuses on validation and performance testing, not on machine learning model training.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established. The focus is on the device's compliance with established engineering standards.

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