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ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.

ANTHOGYR has developed cartridge syringes which are substantially equivalent to legally marketed and FDA cleared predicate devices. Intraligamental syringes ERGOJECT and MINIJECT are syringes for every kind of anesthesia, especially intraligamental and intraseptal that requires high pressure. ANTHOGYR intraligamental syringes feature an ergonomic handle constructed of thermoplastic resin and have a leverage factor of three (ERGOJECT) or five (MINIJECT) to make it easier to use and an anti-reverse, non-ratcheting mechanism that prevents the plunger from slipping during injection. Aspirating dental cartridge syringes ANTHOGYR developed a full range of dental cartridge syringes including: Self aspirating syringe (ISO 9997 Type 2b - Aspiration under the effect of strength produced by the bending of a diaphragm in the cartridge), Aspirating syringe (ISO 9997 Type 2a -Aspiration under the effect of strength produced by the receding of the button in relation to the needle) and dental syringes without aspiration (ISO 9997 Type 1).

The Anthogyr Cartridge Syringes, K040671, received 510(k) clearance based on substantial equivalence to predicate devices, rather than a study demonstrating meeting specific acceptance criteria for performance metrics like sensitivity or specificity. This type of clearance relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.

Here's an breakdown of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not applicable for this 510(k) submission. Acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy) and their reported performance are typically required for diagnostic devices or devices with measurable output that directly impacts clinical decisions. For device types like cartridge syringes, the submission focuses on functional equivalence, material safety, and adherence to relevant standards.

Instead of a typical performance table, the submission indicates compliance with relevant standards:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a separate test set for performance evaluation in the typical sense of a diagnostic or algorithmic device. Compliance with the ISO standards listed above would involve testing of representative samples of the manufactured syringes to ensure they meet the standard's requirements for design, materials, and functional aspects (e.g., proper fit of cartridges, smooth injection, resistance to sterilization). The specific number of devices tested to demonstrate compliance is not detailed in this summary.
• Data Provenance: The document does not specify the origin of any data (e.g., country of origin, retrospective/prospective). It implicitly refers to internal testing by Anthogyr to ensure compliance with the mentioned ISO standards.

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

This is not applicable. For a device like a cartridge syringe, "ground truth" in the context of expert review for diagnostic accuracy is not relevant. Compliance with engineering standards and functional specifications does not typically involve expert clinical review of test results for a ground truth determination.

4. Adjudication method for the test set

This is not applicable. As there is no clinical "ground truth" established by experts, an adjudication method for conflicting expert opinions is not relevant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated and compared. Cartridge syringes are instruments, and their effectiveness is assessed through their mechanical function and safety, not through human reader interpretation performance.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable. This device is a physical, mechanical instrument and does not incorporate any algorithms or AI component.

7. The type of ground truth used

The "ground truth" in this context is adherence to established mechanical, material, and functional specifications outlined in the international standards (NF EN ISO 9997 and ISO 13402). This can be thought of as a "conformance to standard" ground truth, verified through engineering and quality control testing, rather than a clinical ground truth like pathology or outcome data.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a device that learns from data.

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

Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.

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