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The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.

The TactiPen is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of U-100 insulin from a single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient. The pen-injector uses 3.0-mL cartridges of U-100 insulin and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose. The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-mL ISO type A cartridges (supplied separately), which meet ISO 11608-3: 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods.

Here's a breakdown of the acceptance criteria and study information for the Haselmeier GmbH TactiPen (K083457), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The 510(k) summary for the TactiPen (K083457) is very concise regarding performance data. It primarily relies on demonstrating conformity to an existing international standard rather than presenting specific numerical performance metrics from a proprietary study.

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

• Sample Size: Not explicitly stated. The summary simply says, "The TactiPen has been demonstrated to perform as intended" and "conforms to the requirements when tested using the methods specified in the ISO Standard." ISO 11608-1:2000 itself would specify required sample sizes for various tests.
• Data Provenance: Not explicitly stated, but the testing was conducted by Haselmeier GmbH, a Swiss company (Zurich, Switzerland is listed as the address). It can be inferred that the data is prospective, generated specifically for this submission.

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

• Not applicable. The performance data is based on conformance to an engineering standard (ISO 11608-1:2000) for mechanical and functional aspects of the pen injector, not on expert clinical review or interpretation of data to establish a "ground truth" in a diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the evaluation is against a technical standard, not a diagnostic or clinical "ground truth" that would require adjudication.

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

• No. This type of study is not relevant for a medical device like a pen injector. MRMC studies are typically used to evaluate the effectiveness of diagnostic aids or tools that assist human readers (e.g., radiologists interpreting images). The TactiPen is a drug delivery device, not a diagnostic or interpretive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes (in essence). The "performance data" provided is for the device itself, functioning independently. There isn't an "algorithm" in the AI sense, but the device's mechanical performance is evaluated without human intervention determining its 'output.' The evaluation is on the device's ability to precisely dial and deliver doses according to specifications.

7. Type of Ground Truth Used

• Technical Standard Compliance: The "ground truth" is defined by the technical requirements and test methods outlined in ISO 11608-1:2000. The device's performance is compared directly against these established engineering and functional benchmarks.

8. Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."

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

• Not applicable, as there is no training set for this device.

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