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GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.

GO-PEN® is an assembly of a durable pen-shaped dosing unit with a special disposable sterile reservoir that fits into the dosing unit. The GO-PEN® device can only be used with NovoLog® U-100 insulin aspart for injection. The user is intended to fill up the disposable reservoir with 1.3 mL of insulin from a 10 ml vial and mount it on the dosing unit. The GO-PEN® device allows the user to set the desired dose from 1 to 60 Units in 1 Unit increments using the dial feature. Once the GO-PEN® disposable reservoir is filled, it can be used over a period of up to 3 days at room temperature (max. 30°C/86°F) for multiple injections of precise doses of insulin. When the reservoir is empty or the time has been exceeded, the reservoir must be discarded, and a new sterile reservoir is used for the next filling. GO-PEN® is used with standard single-use hypodermic needles with a luer lock which are supplied separately by the user.

Based on the provided FDA 510(k) Clearance Letter for the GO-PEN®, here's an analysis of the acceptance criteria and study information:

The document focuses on non-clinical (bench) testing to demonstrate substantial equivalence, rather than clinical studies with human participants. Therefore, several of the requested categories related to human studies (e.g., sample size for test sets/training sets in a clinical context, expert ground truth, MRMC studies, standalone performance with humans) are not applicable or not provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to ISO 11608-1:2022 and specific design specifications. The reported performance indicates that the device passed these requirements.

• Standard Atmosphere
• Cool Atmosphere
• Warm Atmosphere
• Free Fall
• Dry Heat
• Cold Storage
• Damp Heat
• Cyclical (Temperature cycling)
• Vibration
• In-Use Lifetime Test (Life-cycle test for 5 years)
• Simulated Transport
• Aging to Expiration (Functional Stability) | Passed dose accuracy requirements after all specified preconditioning conditions. |
  | Last Dose Accuracy | As defined in ISO 11608-1:2022 | Passed. |
  | Fluid Leakage (into dosing mechanism) | As defined in ISO 11608-1:2022 | Passed. |
  | Leakage (during injection) | As defined in ISO 11608-1:2022 | Passed. |
  | Visible Particles in Reservoir | As defined in ISO 11608-1:2022 | Passed. |
  | Break Loose and Glide Force | As defined in ISO 11608-1:2022 | Passed. |
  | Biocompatibility (Durable Pen – intact skin contact) | Meets ISO 10993-1:2018; evaluated for in-vitro cytotoxicity. Materials excluded from Attachment G of FDA guidance also evaluated. | Exterior materials tested and evaluated accordingly. |
  | Biocompatibility (Reservoir – externally communicating) | Meets ISO 10993-1:2018; evaluated for in-vitro cytotoxicity, skin irritation, material mediated pyrogenicity, and sensitization. | Materials of construction evaluated accordingly. |
  | Usability/Human Factors | Critical tasks (filling/labeling reservoirs, injecting, handling) passed without mistakes; user interface did not adversely impact performance or usability. | Confirmed all critical tasks passed without mistakes. |
  | Luer Testing | As defined in ISO 80369-7 and 80369-20 for:
• Dimensions
• Fluid leakage
• Sub-atmospheric pressure leakage
• Stress cracking
• Resistance to separation from axial load
• Resistance to separation from unscrewing
• Resistance to overriding | Passed all luer lock testing requirements. |
  | Insufficient Remaining Dose (IRD) Feature | Complies with ISO 11608-1:2022, §5.6(k) method (4). | Complies (pen displays un-injected dose after emptying reservoir). |
  | Life Cycle (Durable Pen) | 3 years once use begins (bench tested for 5 years). | Tested for a 5-year life-cycle; stated use life is 3 years once use begins. |

Study Proving Device Meets Acceptance Criteria

The study described is a non-clinical bench testing program.

1. Sample Size used for the Test Set and the Data Provenance:

   • Sample Size: The document does not specify the exact number of GO-PEN® devices or components used for each bench test. Regulatory submissions typically use statistically relevant sample sizes for each test to achieve confidence in the results, though specific numbers aren't listed here.
   • Data Provenance: The testing was conducted by or on behalf of GO-Pen ApS, located in Lyngby, Denmark. The nature of these are prospective tests performed specifically to support this regulatory submission, based on established international standards.

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

   • This is not applicable as the "ground truth" for bench testing involves adherence to objective physical and engineering standards (e.g., ISO, precise measurements) rather than expert human interpretation of data. The "experts" would be the engineers and technicians conducting the tests and interpreting results against the standard's pass/fail criteria.

3. Adjudication Method for the Test Set:

   • Not applicable in the sense of expert consensus for clinical data. Adjudication is automated based on whether measured parameters fall within the acceptable ranges defined by the ISO standards.

4. 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:

   • No. This is a medical device (insulin pen), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI performance metrics are not applicable.

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

   • This is not applicable as the GO-PEN® is a mechanical medical device, not an algorithm or AI. Its "standalone performance" is its mechanical function as tested in the bench studies.

6. The Type of Ground Truth Used:

   • For bench testing, the ground truth is defined by international consensus standards (e.g., ISO 11608-1:2022, ISO 80369-7, ISO 80369-20, ISO 10993-1:2018) and the device's own pre-defined engineering specifications derived from these standards. Metrics like dose accuracy are objectively measured against these established limits.

7. The Sample Size for the Training Set:

   • Not applicable. As a mechanical medical device undergoing non-clinical bench testing, there is no "training set" in the context of machine learning or AI.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set."

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