(93 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) 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.
§ 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).