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NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.

This document is a 510(k) premarket notification for the NovoFine® hypodermic single lumen needle, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K173479).

Based on the provided text, there is no information regarding acceptance criteria for a device's performance that would typically be measured through sensitivity, specificity, accuracy, or other similar metrics. This document is for a medical device (hypodermic needle), and the "performance" discussed relates to its mechanical and material properties, rather than diagnostic accuracy or algorithmic performance.

Therefore, the following information cannot be extracted from the provided text, as it describes a different type of evaluation:

1. A table of acceptance criteria and the reported device performance (in terms of clinical outcomes or diagnostic metrics).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Instead, the document details non-clinical performance testing to demonstrate the device's physical and material properties meet established standards, thereby supporting its substantial equivalence to a predicate device.

Here's the relevant information that can be extracted concerning the device's characteristics and testing:

Device Acceptance Criteria and Performance (Non-Clinical/Engineering):

The document describes material and mechanical specifications that the device must meet, demonstrating its substantial equivalence to the predicate device. These are more akin to engineering specifications rather than clinical performance metrics.

Study Information (Non-Clinical/Engineering):

• Non-Clinical Tests Performed: The device underwent non-clinical performance testing to support the determination of substantial equivalence.
• Testing Standards:
  • ISO 10993-1: 2018 (Biological evaluation of medical devices)
  • DS EN/ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
  • ISO 11608-2: 2012 (Needle-based injection systems for medical use)
  • ISO 9626: 2016 (Stainless steel needle tubing for the manufacture of medical devices)
  • Particulates per ISO 11040-4:2015 (Prefilled syringes)
  • ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices for shelf-life validation)
• Biocompatibility Tests: In vitro cytotoxicity, intracutaneous reactivity, skin sensitisation, acute systemic toxicity, and haemocompatibility (haemolysis).
• Functional Compatibility: Tested with a list of pen injectors (e.g., Autopen® 24, FlexPen®, Ozempic®, etc.) to demonstrate connectivity and maintenance of dose accuracy.
• Package Integrity Testing: Conducted after environmental conditioning and simulated transportation in accordance with ISTA 3A, on final, packaged, and sterile devices.

The document does not describe a clinical study measuring diagnostic performance or AI algorithm effectiveness, as it pertains to a physical medical device.

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