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Indications for Use: NovoFine® Plus 32 G 4 mm needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

NovoFine® Plus 32 G 4 mm needle 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.

The provided document is a 510(k) premarket notification for a medical device, the NovoFine® Plus 32G 4 mm needle, and details why it is substantially equivalent to a previously cleared predicate device (NovoFine® Plus 32G 4 mm ETW cleared under K133738). This type of submission focuses on demonstrating equivalence rather than establishing new performance criteria for novel devices.

Therefore, the document does not contain information about acceptance criteria for a novel device, nor a study proving a device meets such criteria. Instead, it focuses on demonstrating that minor changes to an existing, already cleared device do not introduce new safety or effectiveness concerns, and that the updated device performs similarly to the predicate.

Here's an analysis of the provided text in relation to your request:

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

   • Not Applicable. The document provides a "Side by side comparison of the subject device and predicate device" (Table 1 on page 7). This table compares specifications like outer diameter, inner diameter, length, gauge, and material composition between the current device (K202005) and the predicate device (K133738). It also lists existing standards that apply to both. However, these are device specifications and standards compliance for an equivalent product, not new acceptance criteria established for a novel device and corresponding performance data from a specific study against those criteria.
   • For example, it states "Inner diameter: Minimum 0.146 mm" for the subject device and "0.145-0.16 mm" for the predicate. This is a specified parameter, not an acceptance criterion with a calculated performance output from a study.

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

   • Not provided. The document states "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards" (page 8). It also mentions "functional compatibility according to ISO 11608-2:2012 with all leading pen injectors available on the market." However, it does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

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. This question typically pertains to studies involving expert review for diagnostic or screening devices where a "ground truth" is established by human experts (e.g., in medical image analysis). The NovoFine® Plus is a hypodermic needle; its performance is assessed through engineering and biocompatibility testing against established standards, not expert-adjudicated clinical outcomes.

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

   • Not Applicable. As explained above, this device and its clearance process do not involve expert adjudication methods typically seen in AI/diagnostic device studies.

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 device for drug delivery, not a diagnostic or AI-assisted interpretation device, so MRMC studies are not relevant.

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

   • Not Applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.

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

   • Not Applicable. The "ground truth" for this device's performance would be compliance with manufacturing specifications, established engineering standards (like ISO 11608-2:2012 for needle-based injection systems, and ISO 10993-1 for biocompatibility), and functionality testing (e.g., flow rate, bond strength, sterility). This is not typically referred to as "ground truth" in the context of clinical outcomes or expert consensus.

8. The sample size for the training set

   • Not Applicable. This is a physical device, not an AI model, so there is no "training set."

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

   • Not Applicable. As above, there is no "training set" or corresponding ground truth establishment process for this type of device.

In summary, the provided document is a 510(k) submission for substantial equivalence of a hypodermic needle. It describes product specifications and compliance with established ISO standards, but it is not a study that establishes new acceptance criteria for a novel device or provides detailed performance data against such criteria in the way your request outlines for AI or diagnostic devices. The closest information available is the comparison table of specifications between the subject device and the predicate device, implying that the acceptance criteria are met by conforming to these specifications and relevant ISO standards.

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