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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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The SURGUARD2™ SAFETY NEEDLE device for 26 to 30gauge needles 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 withdraw 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. 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 are 26gauge to 30gauge and the needle lengths are 3/8" (9mm) to 1" (13mm). 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 as a safety needle only or as a safety needle with attached Terumo syringe.

The Terumo SURGUARD2™ Safety Needle is an existing device (K031453) that the manufacturer is trying to expand to cover 26-gauge to 30-gauge needles. The safety and effectiveness of these additional needle sizes are being demonstrated through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in a quantitative table format. Instead, it states that tests were performed and implies successful completion by declaring substantial equivalence. However, we can infer the tested parameters and the general intention, which is to demonstrate performance comparable to the predicate device and ensure safety.

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

• Sample Size: The document does not specify the exact sample size for each performance test (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study). It only states that "The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles."
• Data Provenance: The data is prospective, generated specifically for this 510(k) submission by Terumo Medical Corporation in Elkton, Maryland, USA. The testing was conducted to prove the safety and effectiveness of the extended product line.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a medical needle, and the "ground truth" is established through engineering and biological performance testing, not expert interpretation of outputs like images.

4. Adjudication Method for the Test Set:

Not applicable for this type of device and testing. Performance data is generated directly from physical tests, not through expert adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI/algorithm-based diagnostic device where human reader performance would be a relevant metric.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, Biocompatibility, Sterility) are all standalone evaluations of the device's physical and biological properties. There is no human-in-the-loop component in these specific tests determining the core performance of the safety mechanism.

7. Type of Ground Truth Used:

The ground truth used is based on:

• Engineering Specifications/Standards: For tests like Activation Force, Deactivation Force, and Puncture Resistance, the ground truth is the measured physical property against predefined engineering limits or industry standards for safety needles.
• Simulated Clinical Scenarios: For the Simulated Use Study, the "ground truth" would be the observed successful activation and prevention of needlestick injuries under controlled, simulated conditions.
• Biological Standards: For Biocompatibility, the ground truth is compliance with ISO-10993 standards, demonstrated through specific in-vitro and/or in-vivo tests.
• Sterilization Standards: For Sterility, the ground truth is achieving a specified Sterility Assurance Level (SAL) through a validated process according to ANSI/AAMI/ISO 11137-1998.

Essentially, the ground truth is derived from objective, measurable physical, chemical, and biological properties and adherence to established regulatory and industry standards for medical devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process are established through engineering principles.

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

Not applicable, as there is no training set for this type of device. The design and validation are based on established engineering, manufacturing, and regulatory compliance practices.

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