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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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The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous selfadministration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.

The Haselmeier Pen 8 is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of medication from 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 medication and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose (0.08 mL).

The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use PPart 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, with the following dimensions:

Overall cartridge length including aluminum cap: 63.9 mm+/- 0.3 mm Outside Cartridge Diameter: 11.94 mm MAX. Inner Cartridge Diameter: 9.65 mm +/- 0.1 mm measured at open end. Maximum eccentricity of aluminum cap: 0.33 mm

The provided text describes a 510(k) Premarket Notification for the Haselmeier Pen 8, a reusable pen-injector. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not available in the provided document. The document primarily details the device's design, intended use, and its conformance to a recognized standard.

Here's an attempt to answer the questions based only on the provided text, while noting what information is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) submission for substantial equivalence based on conformance to an international standard, explicit acceptance criteria in the form of specific performance metrics (e.g., accuracy percentages, sensitivity/specificity, etc.) for a novel AI device are not defined. Instead, the "acceptance criteria" are implied by the requirements of the referenced ISO standard and the demonstration that the device "performs as intended."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document states that the device "conforms to the requirements when the methods specified in the ISO Standard," implying testing was done according to that standard, but specific sample sizes, data provenance (country of origin, retrospective/prospective), or details of the test set are not mentioned.

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

• Not applicable/Not provided. This device is a mechanical pen-injector, not an AI/diagnostic device that requires expert-established ground truth for a test set. The validation would involve physical and mechanical testing against the ISO standard.

4. Adjudication method for the test set

• Not applicable/Not provided. This concept is typically relevant for studies involving human interpretation or AI output, where disagreements between experts or AI predictions need resolution. For a mechanical device conforming to an ISO standard, adjudication in this sense is not part of the described testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, not performed. An MRMC study is relevant for evaluating the impact of AI assistance on human readers (e.g., radiologists interpreting images). This device is a mechanical pen-injector, not an imaging or diagnostic AI tool.

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

• Not applicable. This device is a mechanical pen-injector, not an algorithm or AI system.

7. The type of ground truth used

• Physical and mechanical measurements/engineering specifications. The "ground truth" for this device would be its adherence to the specified dimensions, dose accuracy, durability, and other functional parameters as defined by ISO 11608-1:2000. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set

• Not applicable/Not provided. This is a mechanical device, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned or relevant here.

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