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The Merit Low Profile Companion Sheath is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The Low Profile Companion Sheath is a sterile, disposable device consisting of (a) a coil reinforced shaft with and the distal end; (b) a hemostasis valve with a side port and (c) a tapered tip dilator with snap-fit hub at the proximal end.

(a) Shaft. The coil reinforced, multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lument through which devices can be passed. A hydrophilic coating is applied to the entire outer surface of the shaft. A radiopaque marker made of platinum iridium is embedded 5mm from the dista At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection of the hemostasis valve.

(b) Hemostasis valve. A removable hemostasis valve is thread onto the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve housing is connected to a side port leading to a three-way stopcock valve. The sideport is used for flushing the introducer sheath.

(c) Dilator. The dilator made of a polypropylene blend contains a full-length round lumen to allow placement over a guidewire. The distal end of the dilator is configured as a tapered tip that extends about 2 cm beyond the end of the dilator is fully inserted through the sheath.

The Low Profile Companion Sheath is a prescription medical device that is used only in healthcare facilities and hospitals. The device is placed in patients for up to 24 hours.

This is a 510(k) summary for a medical device called the "Low Profile Companion Sheath." This document describes the device and claims substantial equivalence to a previously cleared device (predicate device). For such submissions, the acceptance criteria and study information provided generally focus on demonstrating that the new device performs comparably to the predicate or meets established performance specifications. The details for acceptance criteria and studies are typically more concise than for novel device approvals.

Here's an analysis of your requested information based on the provided text:

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

Based on the text, the acceptance criteria are implicitly tied to meeting "predetermined specifications" for the "changed dimensions of the device." The specific numerical acceptance criteria are not explicitly provided in this summary, but the general categories of tests and their successful outcome are stated.

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

The document does not explicitly state the sample size used for the design verification tests. It mentions "design verification tests" were performed. The "data provenance" (country of origin, retrospective/prospective) is also not specified, as these are typically bench-top engineering tests rather than clinical studies.

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)

This is a technical device submission, not an AI/diagnostic software submission where expert adjudication is common for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" here is defined by engineering specifications and physical measurements.

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

As this is a technical device submission involving engineering measurements and performance testing, an "adjudication method" in the context of expert review for diagnostic accuracy is not applicable and not mentioned. The tests would likely be performed by qualified engineers/technicians according to established protocols.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is relevant for diagnostic software (often AI-powered) where human interpretation is involved. This submission is for a physical medical device (catheter introducer sheath). Therefore, such a study was not performed and is not applicable to this device.

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

This refers to AI algorithm performance. Since this is a physical medical device, there is no AI algorithm involved, and thus no standalone performance was evaluated in this context.

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

For the design verification tests, the "ground truth" would be the predetermined engineering specifications and physical measurements for the device's dimensions and characteristics. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This question refers to the training of an AI algorithm. Since this is a physical medical device and does not involve an AI algorithm, there is no "training set."

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

Again, this question is relevant for AI algorithm development. As there is no AI algorithm or training set for this physical medical device, this information is not applicable.

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