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The NovoPen Echo* is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses Penli ill " 3 mL cartridges of Novo Nordisk insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in half unit increments, from a Novo Nordisk 3.0 mL insulin cartridge. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected. The pen-injector is intended for use with Novo Nordisk 3.0 mL insulin cartridges and single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk).

The provided text describes the NovoPen Echo® insulin delivery device and its 510(k) summary. However, it does not contain the detailed acceptance criteria and study information as requested. The document states that the device meets design requirements and complies with ISO 11608-1, and that Human Factor testing documented its safety. It also mentions a shelf life.

Here's a breakdown of what is present and what is missing from your request:

What is present (to a limited extent):

• Acceptance Criteria Mention: The document states that "The results of design verification testing has documented that the NovoPen Echo® meets all its design requirements and complies with the requirements specified in ISO 11608-1 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods." This implies that the acceptance criteria are based on ISO 11608-1, but the specific numerical criteria or performance targets are not listed. It also mentions that "Human Factor testing has documented that the NovoPen Echo" is safe to use."
• Study Mention: "Design verification testing" and "Human Factor testing" are mentioned as studies performed.
• Device Performance Mention: It states the device "meets all its design requirements and complies with the requirements specified in ISO 11608-1" and "is safe to use." Specific performance metrics are not given.

What is largely missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The text mentions meeting ISO 11608-1, but doesn't detail the requirements from that standard or the specific performance results in a table format.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific "test set" or "ground truth" derived from experts for performance metrics is detailed. The human factors testing likely involved users, but specifics are absent.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is a medical device (insulin pen), not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
7. The type of ground truth used: Not applicable for device performance in the context of ISO standards. For human factors, "safety" is the ground truth, assessed by user interaction.
8. The sample size for the training set: Not applicable for a mechanical device.
9. How the ground truth for the training set was established: Not applicable for a mechanical device.

Table of Acceptance Criteria and Reported Device Performance (Based only on the provided text, heavily inferred):

In summary, the provided 510(k) summary is a high-level document confirming that testing was done and the device met requirements set by an international standard (ISO 11608-1) and human factors principles. It does not elaborate on the specific details of those tests, such as sample sizes, ground truth establishment methods, or the specific numerical performance results.

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