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This device is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin. Syringe with plunger for general medical uses. The Insulin syringes are intended for insulin injection.

The Devon Standard Syringe is a sterile, single use, disposable syringe with attachable hypodermic needle. The Devon Standard Syringe consists of a syringe barrel, a plunger rod, piston, nozzle cap and a single lumen hypodermic needle. The Insulin syringes are used for the injection of U100 insulin only and have scale lines in insulin units.

The provided text does not contain information about acceptance criteria or specific study details that would allow for a comprehensive answer to your request. The document is a 510(k) summary for a medical device (Devon Standard Syringe, Hypodermic Needle, and Insulin Syringe) and primarily focuses on establishing substantial equivalence to predicate devices.

Here's what can be extracted based on your request, and what is missing:

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

• Missing. The document states: "The Devon Standard Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics." However, it does not list specific acceptance criteria (e.g., force to depress plunger, leakage rates, accuracy of markings) or report quantitative device performance against those criteria.

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

• Missing. The document does not provide details on the sample size used for any testing, nor does it specify the provenance of the data (country, retrospective/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 where expert interpretation is needed to establish ground truth, such as in image analysis or diagnostic accuracy studies. For a syringe, the "ground truth" would be objective physical measurements and adherence to functional standards, not expert interpretation.

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

• Not Applicable. Similar to point 3, adjudication methods are relevant for studies involving human interpretation where consensus or arbitration is needed to resolve discrepancies. This is not typically applied to the performance testing of a physical device like a syringe.

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 type of study relates to AI-assisted diagnostic tools and involves human readers. The Devon Standard Syringe is a physical medical device, not an AI diagnostic tool.

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

• Not Applicable. This question also pertains to AI algorithm performance.

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

• The "ground truth" for a syringe's performance would be objective measurements and adherence to internationally recognized standards. The document implicitly states this by mentioning "internationally recognized standards for syringe performance and labeling characteristics." This would include things like:
  • Dimensional accuracy
  • Fluid leakage (seal integrity)
  • Force required to depress plunger
  • Accuracy of volume markings
  • Sterility
  • Biocompatibility (if applicable)

8. The sample size for the training set

• Missing. This device is a physical product, not an AI algorithm that requires a training set of data.

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

• Missing. Not applicable for this type of device.

In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to existing devices. It confirms that the device meets "internationally recognized standards" but does not detail the specific acceptance criteria, test methodologies, sample sizes, or personnel involved in validating those claims. These details would typically be found in more extensive design control and risk management documentation, which is not part of this summary.

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