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TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.

The proposed device has 2 models depending on the diameter of the needle.

The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.

Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)

The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.

Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."

Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:

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

   • The document does not specify exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
   • Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing data.

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 as this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.

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

   • Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.

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 not an AI/ML device. "Clinical studies were not required to support substantial equivalence."

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

   • Not applicable. This is not an AI/ML device.

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

   • For the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device with a training set.

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

   • Not applicable. This is not an AI/ML device.

In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.

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