The Vessel Dilator is a device used over a quide wire to dilate the opening in a vessel in preparation of percutaneous entry of a catheter. The device may be used separately or in conjunction with a sheath introducer. The device consists of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist in dilation. The hub proximal end has a female luer lock configuration An optional hub collar may be used to attach the dilator to an introducer. The device is available in sizes 4F through 15F and is supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits,trays, or packs.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called a "Vessel Dilator." It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The information provided focuses on:

Biocompatibility: Stating that "Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests."
Material Testing: "The device meets the requirements of the USP XXIII physicochemical tests for plastics."
Tensile Strength: "Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device."

These are engineering and material compliance statements, not clinical performance acceptance criteria or studies in the way you've outlined with terms like "test set," "ground truth," "MRMC study," or "standalone performance."

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.

Here's how I can address what is available:

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and hemocompatibility tests.	Biocompatibility has been established by the listed tests. (Implies positive outcome without specific performance metrics).
Material Compliance	Meets requirements of the USP XXIII physicochemical tests for plastics.	Device meets the requirements of the USP XXIII physicochemical tests for plastics. (Implies positive outcome without specific performance metrics).
Mechanical Performance	(Implicit: Tensile strength at least equivalent to predicate device; explicitly stated improvement)	"Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device." (Specific metrics not provided).
Equivalence to Predicate	Identical in design, function, intended use, and similar in composition to predicate device, and performs at least as well as the legally marketed predicate.	Device is identical in design, function, and intended use, similar in composition. Performance testing shows improved tensile strength, leading to the conclusion it "performs at least as well."

The remaining questions cannot be answered from the provided text as they relate to clinical study design and performance, which is not present in this 510(k) summary.

Sample size used for the test set and the data provenance: Not applicable; no clinical test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical ground truth described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set described.
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 instrument, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable; no clinical ground truth described.
The sample size for the training set: Not applicable; no training set described.
How the ground truth for the training set was established: Not applicable; no training set described.

Summary

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K963388

MAR I I 1997

510 (k) SUMMARY

ADMINISTRATIVE -

Maxxim Medical, Inc., Argon Division Submitter: 1445 Flat Creek Road Athens, TX 75751 (903) 675-9321

Contact Person: Eddie Monroe

Date of Preparation: August 26, 1996

DEVICE NAME 11.

Proprietary Name: None

Common Name: Vessel Dilator

Classification Name: Vessel Dilator for percutaneous catheterization

PREDICATE DEVICE III.

Vessel Dilator component of Introducer for PTCA Guiding Catheters; K891022; Argon Medical.

IV. DEVICE DESCRIPTION

of the device has been established by cytotoxicity, Biocompatibility intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests. The device meets the requirements of the USP XXIII physicochemical tests for plastics.

V. INTENDED USE

To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.

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VI. COMPARISON TO PREDICATE ()EVICE

The Vessel Dilator is identical in design, function and intended use, and similar in composition, to the Vessel Dilator component of the Introducer for PTCA Guiding Catheters (Argon Medical; K891022). Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device

Accordingly, Maxxim Medical, Inc., Argon Division, concluded that the Vessel Dilator is safe and effective for intended use and performs at least as well as the legally marketed predicate device.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).