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The 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Set is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Set consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" quidewire. The 14Fr Low Profile Introducer Set is kitted with an 0.035" access quidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14 Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14 Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

This document describes the FDA's 510(k) clearance for the Abiomed 14Fr Low Profile Introducer Set. The information provided heavily focuses on the comparison to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a quantitative format, nor does it detail a clinical study with human patients, as the clearance was based on bench testing and substantial equivalence to predicate devices.

Let's break down the available information based on your request:

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

The document broadly states that the device "met the acceptance criteria," but it does not specify what those criteria are in a numerical or categorical table format for each test. Instead, it lists the types of tests performed.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified for each individual bench test. The document mentions "Performance testing (bench) was completed," but doesn't detail the number of units tested for each specific test.
• Data Provenance: The document does not specify the country of origin of the data. The study was a retrospective evaluation based on bench testing, as it states "No clinical data were required to demonstrate substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as there was no test set involving human data or expert review to establish ground truth in the traditional sense for medical imaging or diagnostic devices. The acceptance was based on engineering and biocompatibility bench testing.

4. Adjudication method for the test set:

• Not applicable. There was no human-reviewed test set requiring adjudication in the context of this 510(k) submission.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical cases, which was not part of this clearance process.

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

• Not applicable. This device is a physical medical introducer set, not an AI algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The performance evaluated was the device's physical and functional attributes through bench testing.

7. The type of ground truth used:

• The "ground truth" for this device's performance was established via engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1). For example, "leak testing" would have a pre-defined maximum allowable leak rate as its ground truth, based on engineering requirements for a safe and effective introducer.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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INTENDED USE:

The Impella XR Sheath Set is intended to facilitate femoral access to the vascular system.

INDICATIONS FOR USE:

The Impella XR Sheath Set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.

The Impella XR Sheath Set is a sterile, single-use, prescription device. The Impella XR Sheath Set consists of an introducer sheath (Impella XR Introducer Sheath) and a tapered sheath dilator (Impella XR Dilator) which is compatible with a 0.035" guidewire. The Impella XR Sheath Set is kitted with a 0.035" access quidewire and a supplemental dilator in the Impella XR Sheath Kit for convenience to help facilitate insertion.

The Impella XR Introducer Sheath consists of a sheath hub with a three-way stop cock and flush port at its proximal end and an expandable sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stop cock and flush port, a butterfly (suture pad), and connects with the dilator hub. The sheath body has an insertion profile of 10 Fr and expands after removal of the dilator to allow the insertion of the Impella 2.5 catheter. The sheath body also features a hydrophobic coating to aid in the insertion of the introducer sheath.

The Impella XR Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub.

The provided document describes the Impella XR Sheath Set, a medical device for introducing catheters, and its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and study details typical of an AI/ML medical device submission. Specifically, it does not include:

• A table of acceptance criteria with reported device performance for an AI/ML algorithm.
• Sample sizes for test sets, data provenance, or details about ground truth establishment by experts for AI/ML performance evaluation.
• Information on MRMC comparative effectiveness studies or standalone AI algorithm performance.
• Details regarding training set size or how ground truth was established for a training set (which are relevant to AI/ML devices).

The document is for a traditional catheter introducer device, and the performance testing mentioned (Visual Inspection, Dimensional Verification, Packaging, Sterilization, Shelf Life, Biocompatibility, and a GLP animal study) relates to the physical and biological characteristics of this type of hardware, not to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text.

If this were an AI/ML device submission, the requested information would typically be found in dedicated sections describing the clinical validation study, often including sensitivity, specificity, AUC, and other performance metrics against established acceptance criteria, along with detailed methodologies for data collection, expert review, and ground truth generation.

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The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.

The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.

Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:

Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)

This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."

The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:

2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device testing.)
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: N/A (This is not an AI-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)

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