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The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter.

The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.

This document, K961155, is a 510(k) premarket notification for the SoloPak Peripheral Intravenous Catheter Insertion Tray. It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-based assessments.

The document is a submission stating that the SoloPak Peripheral Intravenous Catheter Insertion Kits are substantially equivalent to predicate devices (Clinicathr Procedural Tray and Per-Q-Cath Tray). The safety and effectiveness are based on the kits utilizing similar and equivalent designs, materials, and components as legally marketed products, and sterilization according to AAMI guidelines.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness studies or human reader improvement data.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

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The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

The SoloPICC and SoloMidline catheters are sterile, non-pvrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peelтм peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.

Here's an analysis of the provided text in the context of acceptance criteria and a device study:

Based on the provided 510(k) summary (K954428) for the SoloPICC and SoloMidline Peripheral Intravenous Catheters, there is no specific study described that establishes explicit acceptance criteria with numerical performance targets and then proves the device meets those targets.

This document is a 510(k) premarket notification summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with defined acceptance criteria.

The core of this submission revolves around the assertion of substantial equivalence to predicate devices (Luther Medical Products, Inc. L-Cath® Intravenous Placement Unit (K801575) and Medical Profiles, Inc. Peripheral Intravenous Catheter (K914378)). The argument is that because the SoloPICC and SoloMidline catheters utilize similar and equivalent designs, materials, and components as the predicate devices, they are therefore safe and effective when used as intended.

Let's break down why most of the requested information cannot be found in this specific document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as numerical targets. The implicit acceptance criterion is "substantial equivalence" to the predicate devices in terms of materials, design, and manufacturing processes, along with meeting general safety standards (sterilization, LAL testing).
• Reported Device Performance: No specific numerical performance metrics (e.g., success rates, complication rates, dwell times) are reported for the SoloPICC or SoloMidline catheters in comparison to a defined threshold. The performance is implied to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document does not describe a clinical performance study with a test set. It's a submission based on equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment is described because no specific performance study is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

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 physical medical catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not Applicable. This device is a physical medical catheter, not an algorithm.

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

• Not Applicable. No clinical ground truth is established or discussed as part of a performance study in this document. The "ground truth" for this 510(k) is primarily the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/algorithm device that requires a training set.

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

• Not Applicable. As above, not an AI/algorithm device.

In summary:

The provided document is a 510(k) Premarket Notification Summary focused on demonstrating substantial equivalence, not a detailed clinical study report defining explicit acceptance criteria or proving device performance against those criteria. The "proof" relies on the assertion that the new device is fundamentally similar in materials, design, and manufacturing processes to already legally marketed (predicate) devices. Specific performance data, sample sizes, expert involvement, or adjudication methods for a new study are not provided.

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