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The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (

The TERUMO Surshield-PUR Safety I.V. Catheters are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term use (

The provided text is a 510(k) Summary for the TERUMO Surshield-PUR Safety I.V. Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment (which are common for AI/ML device submissions) are not present in this K100282 document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., minimum flow rate, maximum needle stick rate, specific tensile strength values) and the reported device performance against those criteria are not explicitly listed in the provided summary. The summary focuses on stating that the device met whatever criteria were used to establish substantial equivalence.

Missing:

• Specific numerical acceptance criteria for various performance metrics.
• Quantifiable reported performance data for the device against these criteria.

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

The document does not detail specific "test set" sample sizes, as it doesn't describe a typical diagnostic performance study. It mentions the catheter's types and specifications but not a test set for performance evaluation in the context of diagnostic accuracy.

Missing:

• Sample size for any test set.
• Data provenance (e.g., country of origin, retrospective/prospective).

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

As this is a medical device (intravascular catheter) and not a diagnostic device relying on image interpretation or similar expert-dependent outputs, there's no mention of experts establishing a "ground truth" for a test set. Evaluation would typically involve engineers and biocompatibility specialists, not clinical experts for ground truth in the AI/ML sense.

Missing:

• Number of experts.
• Qualifications of experts.

4. Adjudication Method for the Test Set

Since there's no mention of experts or a "test set" in the context of diagnostic ground truth, there is no adjudication method described.

Missing:

• Adjudication method (e.g., 2+1, 3+1, none).

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

This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI. This is a medical device (catheter) and does not involve human readers interpreting cases.

Missing:

• Information on MRMC study.
• Effect size of human readers improvement with AI.

6. Standalone (Algorithm Only) Performance

This concept is not applicable to an intravascular catheter, which is a physical device, not an algorithm.

Missing:

• Information on standalone performance.

7. Type of Ground Truth Used

For an intrusive medical device like a catheter, "ground truth" would relate to its physical and biological performance (e.g., integrity, biocompatibility, flow rates, ease of insertion, safety mechanism activation). These are established through engineering tests, material analysis, and possibly bench and animal testing, rather than "expert consensus" on diagnostic cases or pathology. The document indicates that testing was "in accordance with the consensus standards and design control requirements." This implies standards for device performance, not clinical ground truth in the diagnostic sense.

Partial Answer:

• Type of Ground Truth: Established by adherence to "consensus standards and design control requirements" for physical, mechanical, and safety performance of the catheter. This would involve objective measurements and tests for criteria such as flow rate, cannula strength, safety mechanism activation, etc.
  Missing: Specific details of these ground truth determinations per standard.

8. Sample Size for the Training Set

The concept of a "training set" is for AI/ML models. This device is a physical product, not an AI/ML model, so there is no training set.

Missing:

• Sample size for the training set.

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

Similarly, this is not applicable for a physical medical device.

Missing:

• How ground truth for the training set was established.

In summary, the K100282 document focuses on demonstrating substantial equivalence of a physical medical device (intravascular catheter) to existing predicate devices. It states that performance testing was done according to standards, but does not provide granular details about specific acceptance criteria or performance results, nor does it involve the type of diagnostic study (with test sets, ground truth panels, and AI/ML metrics) that would typically be associated with the requested information points.

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