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The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

NOV Aguard™ is a sharps injury protection device with a passively activated safety shield. The NOV Aguard™ product has a female luer connector, compatible with a luer-lock syringe, on one side and a stainless steel cannula on the other. A shield is mounted around the cannula. This product is packaged in a rigid container sealed by a Tyvek lid to facilitate sterilization. The product is removed from the package and connected to a luer-lock syringe simultaneously; this is accomplished when attaching the syringe, turning it in a clockwise direction. During this process, the shield is automatically moved to a position where the cannula tip is exposed so that the user can easily see it. An injection is given using the standard common technique. Inserting the cannula into the patient displaces the shield causing the shield legs to move apart and act like a spring. Upon removal, the spring force of the shield legs forces the shield over the tip of the cannula into a locked position.

The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.

The provided text describes a 510(k) submission for the NOVAguard™ Safety Needle, asserting its substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria. Therefore, the information requested in the prompt based on "acceptance criteria" and a "study that proves the device meets the acceptance criteria" is largely not present in the provided document.

Here's an analysis based on the information available and what is not present:

Missing Information:
The document does not provide:

• A table of specific acceptance criteria (e.g., minimum performance thresholds for parameters like activation force, shield engagement time, etc.).
• Reported device performance against such specific criteria.
• Details of a standalone study specifically designed to prove acceptance criteria (e.g., a performance study with a test set, ground truth, expert readers, etc.). This document focuses on demonstrating substantial equivalence to already approved predicate devices.
• Sample sizes for a test or training set in the context of performance evaluation.
• Data provenance for such tests.
• Citations of experts, their qualifications, or adjudication methods for establishing ground truth for performance.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on how ground truth for training or test sets was established.

Information that can be inferred or is partially present:

The document asserts the device's safety and effectiveness implicitly through its comparison to predicate devices, and through general quality control measures.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The "acceptance criteria" here are inferred from the claims of the 510(k) submission regarding its similarity to predicate devices and general regulatory compliance rather than explicit metrics from a performance study.

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

• Sample Size: Not specified for any performance testing. The submission relies on demonstrating substantial equivalence, not novel performance data from a specific test set.
• Data Provenance: Not applicable in the context of a performance study test set. The biocompatibility testing likely involved laboratory tests following international standards.

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

• Not applicable. The document does not describe a performance study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication method is described.

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 device is a physical medical device (safety needle), not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not applicable. This is a physical device.

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

• For biocompatibility: Ground truth was established by adherence to FDA General Program Memorandum #G95-1 and ISO-10993 testing results.
• For manufacturing quality: Finished products are tested against "required release specifications." The specific criteria for these specifications are not detailed in the summary but would constitute the "ground truth" for manufacturing quality.
• For functional aspects (e.g., safety shield activation, luer-lock compatibility): Implied to be verified through engineering and functional testing, comparing favorably to predicate devices, though specific "ground truth" methodologies are not described.

8. The sample size for the training set:

• Not applicable. No "training set" in the context of a machine learning algorithm is mentioned.

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

• Not applicable.

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