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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 Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.

The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.

The provided text describes a 510(k) submission for a medical device, the Terumo® Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a study of the device's diagnostic performance or algorithm effectiveness. As such, many of the requested categories for acceptance criteria and study details are not relevant or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's performance testing against a recognized standard, which serves as its primary acceptance criteria in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "testing" and "data" but does not quantify the sample sizes used for each specific test (e.g., how many syringes were tested for dimensional accuracy, or how many batches for sterility).
• Data Provenance: The device is manufactured by Terumo Europe N.V., in Belgium. The submission states the device "was tested in accordance with EN ISO 7886-1 (1993)", suggesting the testing was performed, or overseen, by the manufacturer or a certified testing facility in relation to its European operations. The description is of the device's inherent physical and material properties, rather than clinical data from human subjects. It's a laboratory/engineering performance study, not a clinical study.

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

• Not applicable. This document describes laboratory and engineering performance testing against established international standards. There is no "ground truth" established by human experts in the sense of clinical diagnoses or interpretations. The "truth" is defined by the objective pass/fail criteria of the scientific/engineering standards.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical studies with human review, which is not what this document describes. Performance is assessed against quantitative metrics and methods specified within the referenced ISO/EN standards.

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 manual syringe, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

• Not applicable. This device is a manual syringe, not an algorithm.

7. The type of ground truth used:

• For the performance testing, the "ground truth" is defined by the objective, quantitative criteria and test methods specified in the referenced international standards (e.g., EN ISO 7886-1, EN ISO 10993 series, EN 550, ISO 11135, EN 556-1). This includes measurements of physical properties, chemical residual levels, and biological responses.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" for this device.

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