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To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.

The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing exists. The repair kit components are made from Delrin.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This device is a Catheter Repair Kit with Replacement Connector (K101261). It is essentially a repair kit for specific hemodialysis catheters, designed to replace damaged Luer-lock connectors or extensions.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria (e.g., specific tensile strength values, leak rates, etc.) and corresponding reported device performance. Instead, it states that the device "met all predetermined acceptance criteria derived from the above mentioned references." The references listed are:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term & Long-Term Intravascular Catheters; March 16, 1995
• ISO 10555-1:1995/Amd 1:1999, Amd 2:2004; Sterile, single-use intravascular catheters, Part 1. General requirements
• AAMI/ANSI/ISO 10993-1:2003; Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
• ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock Fittings
• AAMI/ANSI/ISO 11135-1:2007, Sterilization of Health Care Products - Ethylene Oxide –Part 1: Requirement for the development, Validation and Routine Control of a Sterilization Process for Medical Devices.

The general performance statement is: "Design validation was conducted on the subject Catheter Repair Kit with Replacement Connector configuration and yielded acceptable results."

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

The document does not specify exact sample sizes for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generically states: "Tests were performed on sterilized, finished devices."

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

This type of information is not applicable to this device. This is a physical medical device (a catheter repair kit), and its performance is evaluated through non-clinical bench testing against established engineering and medical device standards, not through expert review of diagnostic images or clinical data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As the device performance is evaluated using non-clinical, objective testing (e.g., mechanical strength, leak tests, biocompatibility), there is no "adjudication method" in the sense of human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. This device is a repair kit for a catheter, and its effectiveness is determined through physical and material property testing, not human reader performance.

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

Not applicable. This is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is irrelevant here. Its performance is inherent in its design and manufacturing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and medical device standards (e.g., ISO and AAMI standards) and in-house protocols that specify acceptable measurable parameters for catheter components regarding mechanical integrity, fluidic performance (e.g., Luer-lock fit), biocompatibility, and sterilization efficacy.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the physical testing of a medical device like a catheter repair kit.

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

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth established in the context of data for an algorithm. The "ground truth" for its design and manufacturing is adherence to established regulatory and engineering standards.

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