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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 TERUMO® SurGuard2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The SurGuard2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes fall within the 18 to 30gauge range and the needle lengths are 3/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard2™ Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 1. 3,5, and 10cc/ml.

The provided document is a 510(k) premarket notification for the TERUMO® SurGuard2™ Safety Needle. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and performance data for the new device.

Therefore, many of the requested elements (sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, specific ground truth types) are not applicable or extractable from this type of regulatory submission, as it relies on the established performance of predicate devices.

However, I can extract the acceptance criteria as implied by the testing performed and describe how the document implies the device meets these criteria through substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Substantial Equivalence)

The TERUMO® SurGuard2™ Safety Needle, as described in this 510(k) submission (K051865), demonstrates its compliance by proving substantial equivalence to existing legally marketed predicate devices. This means that the acceptance criteria are implicitly met if the new device performs equivalently to the predicates in key areas. The study demonstrating this is essentially a comparison study against the predicates across various specifications and performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Description:

The study to "prove the device meets the acceptance criteria" is implicitly the 510(k) submission itself, which functions as a comparative effectiveness study against predicate devices to establish substantial equivalence. The manufacturer asserts that the performance of the SurGuard2™ Safety Needle is substantially equivalent to the legally marketed predicate devices (K031453, K040531, K023271, K771205).

The performance tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, etc.) were conducted, and the document states, "None of the data raises any new issues of safety and effectiveness." This implies that the results of these tests were within acceptable ranges, or comparable to the predicate devices, thereby meeting the unstated acceptance criteria.

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

• Sample Size: Not explicitly stated for each test. The document mentions "The following tests were performed on the SurGuard2™ Safety Needle" and "The following tests were performed on the Terumo Philippines 1cc/ml syringe," but does not provide specific quantities of devices tested for each parameter.
• Data Provenance: The manufacturing entity is Terumo (Philippines) Corporation, and the submission is prepared by Terumo Medical Corporation (USA). The origin of the test data is implied to be from testing performed on devices produced by Terumo (Philippines) Corporation. The data is reported as part of a retrospective comparison to previously cleared predicate devices.

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

• Not Applicable. This is a 510(k) submission for a medical device (hypodermic needle and syringe), not a diagnostic or AI-driven system requiring expert ground truth for image interpretation or similar. The "truth" is established by physical measurement, engineering standards, and biological testing, not expert consensus in a clinical sense.

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

• Not Applicable. As above, this type of adjudication method is generally for clinical endpoints or diagnostic interpretations, which are not relevant to the physical and functional tests described for this device.

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 document pertains to a physical medical device (needle/syringe), not a digital health or AI software product.

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

• Not Applicable. This is a physical medical device.

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

• The "ground truth" for the performance tests would be defined by established engineering standards, material science properties, and validated test methods for medical devices (e.g., force measurements against specific thresholds, leak rates against defined limits, visual inspections against specifications). For biocompatibility, it's defined by ISO-10993 standards and their associated testing protocols. For sterility, ANSI/AAMI/ISO 11137-1994 provides the ground truth for validation.

8. The sample size for the training set:

• Not Applicable. This refers to a manufactured medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document leverages the substantial equivalence pathway for regulatory clearance. It asserts that the TERUMO® SurGuard2™ Safety Needle meets acceptance criteria because it is identical or critically similar in materials, design, intended use, technology, and performance to previously cleared predicate devices, and any differences raise no new issues of safety or effectiveness. The various tests listed confirm that the device's measured parameters align with expectations for devices of its type and prior clearances.

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