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Disposable syringe for insulin administration, for the patient with diabetes.

Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel, Piston, Plunger, Needle, Needle cover or protector.

This document describes the acceptance criteria and study results for the "Insulin syringe with integrated needle DL®" (proposed device), demonstrating its substantial equivalence to a predicate device (Disposable Insulin Syringe, K162180).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards (ISO series) and national standards (MGA, NOM). The "Specifications" column represents the acceptance criteria, and the "Insulin syringe with integrated needle DLPJECT®" column represents the reported device performance.

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 extensively references international ISO standards (e.g., ISO 9626:2016, ISO 7864-1:2016, ISO 8537:2016, ISO 10993 series) and national standards (MGA, NOM-137-SSA1-2008, ASTM D4109-22). These standards typically specify the number of samples required for each test. For instance:

• ISO 10993 (Biocompatibility): Tests like cytotoxicity, irritation, sensitization, acute, subacute, and subchronic toxicity, and pyrogenicity often involve in-vitro (cell cultures) or in-vivo (animal models like Wistar rats) testing with specific animal group sizes outlined in the respective ISO parts. For example, Pyrogens in Table 3 mentions "The sum of the temperature increments of the test animals is 0.26 °C so the sample is considered apyrogenic," implying in-vivo testing.
• Physical/Performance Tests (e.g., Dimensions, Cannula adhesion, Hermeticity): These are typically performed on a statistically significant number of production samples according to the specific test methods outlined in the cited ISO standards. While exact numbers are not explicitly stated in this summary, the compliance with these standards implies that the required sample sizes were met.

The data provenance is not explicitly stated as "country of origin." However, the tests are conducted in accordance with international (ISO) and potentially national (MGA, NOM from Mexico, given the submitter's address) standards, suggesting these tests were performed in certified laboratories adhering to these guidelines. The studies appear to be prospective as they are testing the newly developed "Insulin syringe with integrated needle DL®" against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of medical device (insulin syringe) does not typically involve human expert "ground truth" establishment in the same way an AI diagnostic algorithm might. The "ground truth" for the performance and biocompatibility tests is based on objective measurements and established scientific protocols as defined by the international standards (ISO) and regulatory guidelines (MGA, NOM, ASTM). The "experts" involved would be the certified laboratory technicians and scientists performing these tests and interpreting the results against the defined specifications. Their qualifications would be in analytical chemistry, microbiology, toxicology, materials science, and medical device testing, following Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) principles. The number of such professionals is generally defined by the laboratory's quality system and standard operating procedures for each test.

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

Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in subjective assessments for diagnostic devices (e.g., radiologists reviewing images). For this type of device, which relies heavily on objective physical, chemical, and biological testing, traditional adjudication methods are not applicable. The "adjudication" is inherent in the test methodology itself:

• Compliance with numerical specifications: If a measurement falls within the specified range, it passes.
• Qualitative observations: For tests like "Finish" (absence of defects) or "Cytotoxicity" (reactivity grade), trained personnel make observations and record results based on predefined criteria in the standard. If a result is deemed "Non-cytotoxic" or "Passes the Test" according to the standard's interpretation guidelines, it meets the criterion.
  The reporting of results as "Complies," "Passes the Test," or specific measurement within tolerance indicates that the results were directly compared to the acceptance criteria without a separate adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The "Insulin syringe with integrated needle DL®" is a physical medical device, not a diagnostic imaging or AI software product, so such a study would not apply.

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

No, a standalone (algorithm-only) performance study was not done. This concept is also specific to AI/software as a medical device (SaMD) where an algorithm makes a determination independently. The device here is a physical syringe. Its "standalone" performance refers to its intrinsic physical and biological properties as tested against the standards.

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

The ground truth for this device's evaluation is primarily established through:

• International Standards and Regulatory Specifications: The core ground truth is defined by the detailed requirements and test methods of standards like ISO 9626, ISO 7864, ISO 8537, ISO 10993 series, MGA, NOM, and ASTM. These standards define acceptable material properties, dimensions, performance characteristics, and biological compatibility limits.
• Objective Measurement and Analytical Testing: Laboratory tests provide objective data (e.g., dimensional measurements, force required for cannula adhesion, chemical residue levels, cell reactivity grades, animal physiological responses) which are quantitatively or qualitatively compared to the predefined acceptance criteria from the standards.
• Biological Endpoints: For biocompatibility, endpoints like cell viability (cytotoxicity), skin reactions (irritation/sensitization), and animal physiological responses (pyrogenicity, acute/subchronic toxicity) serve as the ground truth indicators as interpreted against the ISO 10993 series.

8. The sample size for the training set

This device does not involve machine learning algorithms, thus there is no "training set" in the context of AI. The "training" in the manufacturing process refers to process validation and quality control, ensuring that the manufacturing process consistently produces devices meeting specifications. The exact numbers of units produced and tested during process validation are not provided, but they would be governed by internal quality systems and relevant manufacturing standards.

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

As there is no AI training set for this physical device, this question is not applicable. The "ground truth" for the device's design and manufacturing process would refer to the adherence to verified design specifications, material inputs, and validated manufacturing procedures, all established through engineering principles, regulatory requirements, and quality management systems.

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