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

The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.

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, 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 document is a 510(k) Premarket Notification for the Haselmeier Pen, an autoinjector. It states that the device has been demonstrated to perform as intended and is substantially equivalent to legally marketed devices. However, it does not contain specific acceptance criteria, detailed study results, or information regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed performance study against explicit criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what information can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document states "The Haselmeier Pen has been demonstrated to perform as intended," implying internal testing, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/not specified. The document does not describe the establishment of ground truth for a test set in the context of expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/not specified. There is no mention of an adjudication method as no expert review for a test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device (autoinjector), not an AI diagnostic tool involving human readers.

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

• Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" would relate to the device's mechanical function, which is described as "perform[ing] as intended," but specific test results are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/not specified in the sense of clinical ground truth for a diagnostic AI. For a mechanical device, "ground truth" would implicitly be its ability to accurately deliver a dose, be compatible with cartridges/needles, and function reliably. The document states the pen is compatible with ISO standards (ISO 11608-2 and ISO 11608-3) for needles and cartridges, implying these standards serve as the "ground truth" or performance benchmark for compatibility.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

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

• Not applicable.

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