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The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.

The provided text describes the 510(k) summary for the TERUMO® Needle, a hypodermic single lumen needle. The focus of this document is to demonstrate substantial equivalence to previously cleared devices rather than to present a de novo study with detailed acceptance criteria and performance metrics for a new device.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria and performance studies, such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable to this type of submission. This document primarily relies on the equivalency of the new device to existing devices based on several performance tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the format typically seen for novel device efficacy studies. Instead, it states that:

• Performance Tests Performed:
  • Protector Pit
  • Adhesive Hold
  • Conical Fitting
  • Seal Strength
• Outcome Statement: "None of the data raises any new issues on safety and effectiveness." This implies that the device met the internal specifications and standards set by Terumo (Philippines) Corporation for these tests, which are presumably deemed equivalent to those of the predicate devices. However, the specific numerical acceptance thresholds and the quantitative results are not disclosed in this summary.

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

• Sample Size: Not specified. The document only mentions that performance tests were "performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation."
• Data Provenance: The device is manufactured by Terumo (Philippines) Corporation. The data would therefore originate from their internal testing. It's a prospective internal test for the new device variant to confirm its manufacturing quality and performance against established specifications.

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

• This is not applicable. The performance tests listed are mechanical and material engineering tests (e.g., strength of adhesive, fit of conical parts, seal integrity). These do not typically involve human expert interpretation or "ground truth" establishment in the way that diagnostic imaging or clinical decision support AI devices would. The "ground truth" for such tests would be defined by engineering specifications and objective measurements.

4. Adjudication method

• Not applicable, for the same reasons as #3.

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 medical device (a hypodermic needle), not an AI algorithm or a diagnostic imaging system. Therefore, MRMC studies are not relevant.

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

• For the listed performance tests (Protector Pit, Adhesive Hold, Conical Fitting, Seal Strength), the "ground truth" would be established by engineering specifications and objective measurements against industry standards (e.g., ISO standards for Luer connectors) and the manufacturer's internal quality control criteria, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design and manufacturing processes are informed by established engineering principles and prior experience with similar devices, not by a data-driven training process.

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

• Not applicable, as there is no training set.

In summary, the 510(k) process for a device like a hypodermic needle heavily relies on demonstrating equivalence to predicate devices through design, materials, intended use, and a set of standard performance and safety tests. The detail of these tests, while crucial for the submission, is often summarized at a high level in the public 510(k) summary, with the most critical information being the confirmation that "None of the data raises any new issues on safety and effectiveness," thereby establishing substantial equivalence.

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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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