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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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The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.

The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneously. The device consists of an injector and a luer adapter to provide a means of filling the device using a standard slip lock syringe. The device is powered by a proprietary charge system wholly contained in the distal portion of the device.

The provide submission does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical diagnostic or AI/ML device submission would. This 510(k) submission is for a physical medical device—a needle-free injection system—and its approval is based on demonstrating substantial equivalence to a predicate device rather than performance against a set of predefined acceptance metrics for accuracy, sensitivity, or specificity.

Instead, the submission focuses on:

• Device Description: Detailing the components and function of the "Mini-Ject Needlefree Injection System."
• Substantial Equivalence: Comparing the proposed device to a legally marketed predicate device (Biojector 2000) based on intended use, system configuration, materials, packaging, sterility, shelf life, and fill adapter. The goal is to show that the new device is as safe and effective as the predicate.
• Intended Use Statement: Clearly defining the purpose and user population for the device.

Based on the information provided, here's how to address your questions in the context of this device type:

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

No explicit acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) are provided for this needle-free injection system in the document. The regulatory pathway here is demonstrating "substantial equivalence," not meeting quantitative performance targets in the same sense as an AI/ML or diagnostic device.

The "performance" is implicitly demonstrated through the comparison table, showing that:

The main "study" proving the device meets the (implicit) acceptance criteria is the comparison to the predicate device, asserting that its fundamental technology, materials, and intended function are comparable, and any differences (like being fully disposable and fixed volume/route) do not raise new questions of safety or effectiveness.

Regarding your other questions, they are largely not applicable to this type of 510(k) submission for a physical, non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of diagnostic performance or AI model evaluation is mentioned. Device testing would have been conducted for aspects like sterility, material compatibility, dose delivery accuracy, and shelf life, but details on sample sizes for such engineering/bench tests are not provided in this summary document.

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 is not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 physical injection device, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to successful fluid delivery, sterility, and material safety, which are confirmed through engineering tests and material specifications, not clinical outcomes or expert consensus on a diagnostic interpretation.

8. The sample size for the training set
Not applicable. This device does not have a "training set" as it's not an AI/ML product.

9. How the ground truth for the training set was established
Not applicable.

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This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.

The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).

The provided text is related to a 510(k) submission for a medical device called the "Miniject Syringe." However, it is a regulatory document focused on establishing substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and device performance based on the input provided. The document primarily identifies the device, its intended use, and its substantial equivalence to previously marketed devices (K823536 Intralig and K802483 Ligmaject). There is no mention of a clinical or performance study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

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