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The B-D insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin in the treatment of diabetes.

The B-D Insulin Pen Injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin. The pen injector uses a cartridge of insulin (supplied by others) and a single use, detachable and disposable pen needle (sold separately).

The B-D Pen Ultra™ Assembly consists of three (3) main mechanical assemblies:

• A dose setting mechanism in the upper body,
• An injection mechanism in the center body, and
• An interlocking mechanism in the center body.

The B-D Pen Ultra™ Assembly also consists of three (3) sub-assemblies

• The window/upper body sub-assembly,
• The half-nut/plunger sub-assembly, and
• The cap/clip sub-assembly.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B-D PEN ULTRA device:

Device: B-D PEN ULTRA 1.5 ml and 3.0 ml Versions

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size (i.e., number of pens tested) for the test set. It mentions "pens were tested" and refers to "ALL data points collected across all test conditions" but provides no concrete number.

Data Provenance: The study was a prospective design verification study conducted by the manufacturer, BECTON DICKINSON CONSUMER PRODUCTS. There is no information regarding the country of origin of the data provided in this summary, but the company is based in Franklin Lakes, New Jersey, USA.

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

This information is not applicable as the device is a mechanical insulin pen injector, not an AI or diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is the precise mechanical dose delivery and functional integrity, measured by instruments and observations against a standard.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involved objective mechanical and environmental testing, not subjective human assessment needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is not relevant for a mechanical medical device like an insulin pen injector. MRMC studies are typically used for diagnostic or AI-assisted interpretation tasks where human readers' performance is being evaluated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in essence. The performance assessment of the B-D Pen Ultra was a standalone device performance study. The device's ability to accurately deliver insulin and maintain functionality under various conditions was tested independently, without a human-in-the-loop component influencing its core mechanical operation.

7. The Type of Ground Truth Used:

The ground truth was established based on predefined technical specifications and proposed international standards (Draft ISO Standard ISO-11608-1) for dose accuracy and functional performance. This involved objective measurements of insulin dose delivery and visual/functional inspections after various challenge conditions.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI development. The device's design and manufacturing processes are likely informed by engineering principles and previous product iterations, but not a dataset used for model training.

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

This information is not applicable as there is no training set for a mechanical device.

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