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To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.

The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.

The provided K062435 document describes a 510(k) premarket notification for a "Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters." This device is a repair kit for existing medical catheters, and the submission focuses on demonstrating substantial equivalence to a predicate device, the Pourchez Retro Repair Kit (K022644).

Given the nature of this submission (a repair kit for existing catheters, demonstrating equivalence to an existing repair kit), the "study" conducted is a series of bench tests rather than a clinical trial involving human or animal subjects that falls under a typical AI/ML performance study. The focus is on physical and material characteristics.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment for AI, expert involvement, MRMC studies, standalone AI performance) are not applicable to this type of device and submission. The "acceptance criteria" and "device performance" in this context refer to the physical and mechanical properties tested during bench validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 'Bench Testing' for physical test data."

However, Section 18 "Bench Testing" is not included in the provided excerpts. Therefore, the specific acceptance criteria and the quantitative reported performance values are not available here. We can infer that the general acceptance criterion would be that the repair kit's performance in these physical tests is equivalent to or not worse than the predicate device.

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

• Sample Size: Not specified in the provided document. For physical bench testing, sample sizes vary depending on the specific test and statistical requirements.
• Data Provenance: The tests were conducted "in-house" by Spire Biomedical, Inc. (manufacturer), likely at their facility in Bedford, MA, USA. This is a retrospective evaluation based on laboratory testing of the device prototypes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For physical bench testing of a medical device repair kit, "ground truth" is typically established by engineering specifications, material standards, and benchmark performance of predicate devices, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are relevant for subjective assessments, such as image interpretation or clinical outcomes, typically involving multiple human readers. Bench testing involves objective measurements against established technical specifications.

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 not an AI/ML-driven diagnostic or assistive tool for human readers. It's a physical medical device repair kit.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• For physical tests: Engineering specifications, material standards, and benchmark performance data of the predicate device (Pourchez Retro Repair Kit K022644).
• For biocompatibility: Adherence to recognized biocompatibility standards (e.g., ISO 10993 series) for medical devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set." The repair kit itself is the "device," designed and manufactured according to specifications.

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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