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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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The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The Needle-Trap™ Needle Safety devices are substantially equivalent to the current marketed products

This 510(k) submission for the Needle-Trap™ / Needle Safety Label (K073206) is a pre-market notification for a medical device that claims substantial equivalence to previously marketed devices. It does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for an AI/software as a medical device (SaMD) submission.

Instead, the submission focuses on demonstrating that the device (a syringe anti-needle stick accessory) has similar technological characteristics and performance to existing, legally marketed predicate devices. The "Performance Data" section in the 510(k) summary explicitly states: "Verification and Validation testing confirmed the products meet their specifications." However, it does not provide details on these specifications, acceptance criteria, or the study results themselves.

Therefore, many of the requested items related to a performance study (especially for AI/SaMD) cannot be extracted from this document, as this is a much older and different type of device submission.

Here's an attempt to address your points based on the provided text, while highlighting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided documents. The verification and validation testing mentioned would have used a sample, but the size is not disclosed.
• Data Provenance: Not specified. This type of device (physical accessory) generally undergoes bench testing and possibly human factor studies, rather than relying on patient data in the same way an AI device would.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable or not specified. For a physical device like this, ground truth would typically be established through engineering specifications, material testing, and functional performance tests rather than expert interpretation of data.
• Qualifications: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. This typically applies to studies where multiple readers assess cases, which is not described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in these documents. This type of study is relevant for diagnostic imaging or similar AI applications where human readers' performance is augmented.

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

• Standalone Study: Not applicable. This device is a physical accessory, not an algorithm. Its function is to cover a needle after use, preventing needle sticks. Its performance is inherent to its mechanical design and materials, not a standalone algorithmic output.

7. The Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated as "ground truth" in these documents. For a device like this, the "ground truth" would likely be defined by engineering specifications, functional requirements (e.g., ability to reliably cover the needle, resistance to accidental re-exposure), and safety standards (e.g., ISO standards for sharps injury prevention devices). Performance would be measured against these predefined specifications.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or ground truth in that context.

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The VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.

The VACUTAINER® Brand Blood Collection Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The syringe contains dry calcium-balanced lithium heparin (approximately 50 IU per mL of whole blood) derived from porcine intestinal mucosa, as the anticoagulant. Calcium chloride has been added to the formulation to provide a calcium-balanced lithium heparin solution, specifically allowing the measurement of ionized calcium and magnesium. The calcium chloride solution binds to the heparin prior to blood collection allowing electrolytes such as ionized calcium and magnesium in the blood to be measured without interference from the heparin (calcium-balanced).

VACUTAINER Brand A-LINE Kit: Contains a specifically designed syringe only for aspiration of blood samples from arterial lines.

VACUTAINER Brand PRESET™ Kit: Contains a specifically designed syringe (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling.

VACUTAINER Brand DRIHEP® PLUS Kit: Contains a specifically designed syringe (may include needle) with a self-venting membrane, (which seals automatically upon blood contact), and low plunger resistance which permits preset, aspiration, and natural fill sampling. Plunger auto-stop avoids overfill and leakage.

Please Note: The needle component may be one of two configurations. The needle may be a single lumen hypodermic needle or a SafetyGlide™ Needle, a single lumen hypodermic needle with a hinge safety mechanism.

The provided text describes the 510(k) summary for the VACUTAINER® Brand Blood Collection Syringe. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device conformance. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance metrics against defined acceptance criteria.

Therefore, I cannot provide a complete answer to all your questions from the given text. I will extract what information is available and note where specific details are missing.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance

The document states that "Three separate performance studies (anticoagulant & hemolysis, analytical, and clinical) were done to show the performance and equivalence of the principal device with the new calcium-balanced lithium heparin anticoagulant to the predicate devices currently marketed in the United States." It concludes that "All results from the three studies show equivalence between the principal device and the predicate device."

Missing Information:

• Specific quantitative acceptance criteria (e.g., "pH measurement should be within X units of the reference method").
• Reported device performance values for these criteria.
• The actual results of the "anticoagulant & hemolysis, analytical, and clinical" studies. The document only reports "equivalence" without detailing the specific findings.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

Study Details

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only indicates the studies were conducted to show equivalence to predicate devices marketed in the United States.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not applicable. This device is a blood collection syringe, not an AI-assisted diagnostic tool involving human readers.

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

• Standalone Performance: Not applicable. This device is a medical device (syringe), not an algorithm.

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

• Ground Truth Type: Not explicitly stated. The studies focused on demonstrating "equivalence" in anticoagulant & hemolysis, analytical, and clinical performance, implying comparisons to established reference methods or predicate device performance. For example, "analytical studies" would likely compare measured values (pH, blood gases, electrolytes) to a gold standard analytical instrument.

The sample size for the training set:

• Sample Size: Not applicable. This device is a physical product (syringe), not an algorithm that requires a training set.

How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable.

In summary, the provided 510(k) summary (K981922) for the VACUTAINER® Brand Blood Collection Syringe mainly focuses on establishing substantial equivalence to existing predicate devices based on the description of the device, its intended use, and general statements about performance studies ("anticoagulant & hemolysis, analytical, and clinical") showing equivalence. It does not provide the detailed quantitative data, sample sizes, or specifics about ground truth establishment that would typically be found in a comprehensive study report for certain types of medical devices, especially AI/ML-based ones.

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