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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."

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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) 4 French or 5 French Coaxial Introducer/Dilator Pair .
• One (1) 21 gauge Introducer Needle ●
• One (1) 0.018" (0.46mm) Guide Wire . Three versions of guide wires will be offered:
  • Stainless Steel Wire and Tip .
  • Stainless Steel Wire with Platinum Tip .
  • Nitinol Wire with Platinum Tip .

The document provided is a 510(k) Premarket Notification for a medical device (Merit MAK - Mini Access Kit). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for a device that uses AI or for which clinical studies with human readers are conducted in the same way as AI software.

Therefore, many of the requested categories (e.g., AI performance, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and submission.

However, I can extract the information relevant to the acceptance criteria and the study performed to demonstrate safety and effectiveness for a traditional medical device like this one.

Here's the breakdown of the available information:

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

The document states: "Bench testing was conducted on the Merit® MAK in order to ensure device safety and effectiveness for its intended use." and "Performance data demonstrates that the Merit® MAK is substantially equivalent to the predicate device and/or met the acceptance criteria as defined in design verification and validation protocols."

However, specific acceptance criteria values and the detailed reported performance results are not provided in this summary document. The summary only concludes that the device "met all acceptance criteria of the testing performed."

Therefore, a table with specific criteria and results cannot be generated from the given text.

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

This information is not applicable as the studies mentioned are "bench testing" on the device itself, not clinical studies involving patient data or test sets in the context of AI.

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 information is not applicable as the studies are "bench testing," not clinical studies that require expert-established ground truths for interpreting images or data.

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

This information is not applicable for the same reasons as above.

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 such study was done or is applicable for this type of device (a vessel dilator/introducer sheath). This is a physical medical device, not an AI-powered diagnostic tool.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the "bench testing" mentioned, the "ground truth" would be established by engineering specifications, international standards, and in-house protocols for performance (e.g., tensile strength, flow rates, dimensions, material compatibility). These are objective measurements rather than interpretations requiring expert consensus or pathology. The document states: "Bench testing was conducted according to international standards and guidance documents as well as in-house protocols."

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above.

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