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The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Terumo SurGuard®3 Safety Hypodermic Needle [hereinafter referred to as "SurGuard 3 (Short Sheath 2)"] consists of a hypodermic needle with a hinged safety sheath attached to the connector hub which can be attached to either a luer slip or luer lock syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheathcollar which are simultaneously activated when 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, using the finger, thumb, or surface activation.

The document describes the Terumo SurGuard®3 Safety Hypodermic Needle and its modifications. However, the provided text does not contain detailed information about acceptance criteria and a study that comprehensively proves the device meets those criteria in the format requested.

Specifically, the document states:

• "No deviations from recognized consensus ISO standards were identified, except where the design of the device resulted in a modified method or acceptance criterion." (page 10)
• "The device complies with the acceptance criteria established based on the predicate, as shown in the table below: Table 5.6: Performance Testing per Internal Standards" (page 10)
• "Performance testing demonstrates that the new Terumo SurGuard®3 Safety Hypodermic Needle conforms to the recognized consensus ISO standards (ISO 7864 and ISO 23908) and meets internal standards acceptance criteria." (page 10)

This indicates that acceptance criteria were established and met, but the specific numerical criteria for each test and the detailed results demonstrating conformance are not provided. The results are summarized as "Meets acceptance criteria" or "Meets standard."

Additionally, the document explicitly states:

• "This 510(k) does not include data from clinical tests." (page 11)

Therefore, much of the requested information regarding study details (sample size, data provenance, ground truth establishment, expert involvement, MRMC studies) is not available in the provided text.

Here's a summary of what can be extracted or inferred:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified, but generally, such performance testing is conducted by the manufacturer (Terumo (Philippines) Corporation). The nature of the tests (mechanical, sterilization, biocompatibility) suggests laboratory testing rather than human subject data. Retrospective/Prospective is not applicable in this context.

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

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria, not expert interpretation of outputs.

4. Adjudication method for the test set

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria.

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

• No. This is a medical device (hypodermic needle) and not an AI/imaging device. The document explicitly states: "This 510(k) does not include data from clinical tests." (page 11)

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

• No. This is a medical device (hypodermic needle) and not an AI/imaging device.

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

• For the physical and mechanical performance tests, the "ground truth" would be the established specifications, engineering tolerances, and requirements set forth by ISO standards (ISO 7864, ISO 23908, ISO 11137-1, ISO 14971) and the manufacturer's internal standards.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device.

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

• Not applicable as this is not an AI/machine learning device.

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