(129 days)
The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.
The Merit MAK® (Mini Access Kit) utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred.
The Merit MAK® consists of the following components:
One (1) 4F or 5F Coaxial Introducer/Dilator Pair
One (1) 21 gauge Introducer Needle
One (1) 0.018" (0.46mm) Guide Wire
Two new versions of guide wires will be offered:
Stainless Steel Wire with Palladium Tip
Nitinol Wire with Palladium Tip
The provided text describes a 510(k) premarket notification for the Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire. However, it does not include detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications in the way one would describe a study proving a device meets acceptance criteria for an AI/CADe device.
The document focuses on demonstrating substantial equivalence to a predicate device (the Merit MAK with platinum tip guide wire [K031691]) through comparison of technological characteristics and safety/performance tests. It explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, a "battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device."
Without the specific "battery of tests" and their corresponding acceptance criteria, it's impossible to create the requested table and answer many of the questions. The document is for a medical device (guide wire, dilator/introducer sheath), not an AI/CADe device, thus many of the questions regarding AI-specific studies (MRMC, standalone algorithm, training set, etc.) are not applicable.
Therefore, this response will highlight the information that is available and explicitly state what is not found in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table specifying distinct acceptance criteria for each test and the corresponding quantitative performance of the Merit MAK with Palladium Tip Guide Wire. It generally states that a "battery of tests was performed...and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device," but the specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance
Not explicitly stated for any specific test. The document refers to "a battery of tests" but does not quantify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to the type of device and study described. This device is a physical medical instrument, and its evaluation relies on engineering, biocompatibility, and functional tests, not interpretation of images by experts for ground truth establishment.
4. Adjudication method for the test set
Not applicable, as there's no clinical trial or expert review described for establishing ground truth in the context of an AI/CADe device.
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
No. This is not an AI/CADe device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/CADe device.
7. The type of ground truth used
Not explicitly defined in the context of expert consensus, pathology, or outcomes data. For a physical medical device like this, "ground truth" would relate to validated engineering specifications, material properties, and functional performance benchmarks (e.g., tensile strength, lubricity, flexural properties, biocompatibility), which are assessed through laboratory testing rather than medical "ground truth" as typically understood for diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe device.
Summary of Study (as described in the document):
The study performed was a series of safety and performance tests to demonstrate substantial equivalence of the Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire to a predicate device (Merit MAK with platinum tip guide wire, K031691). The basis for acceptance criteria was "protocols based on the requirements of industry standards and guidances." The specific tests and their detailed results validating these criteria are not included in the provided text. The overall conclusion was that the device "meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device."
§ 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).