(169 days)
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.
However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.
Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.
The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.
Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance (for a physical medical device):
The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implicit via test type) | Test Performed | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Dilator Effective length | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Dilator Outer Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Inner Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Mechanical Properties | Insertion Force | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Pushability and Kink Test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Shaft Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hub Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Bend | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Fracture | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Material/Surface Characteristics | Particulate test | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Lubricity test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Biocompatibility | Cytotoxicity | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Sensitization | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Irritation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Acute Systematic Toxicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Pyrogenicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hemolysis | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Partial Thromboplastin Time | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Heparinized Blood Platelet and Leukocyte Count | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Complement Activation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Extract Particulates | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Design Validation | Clinician feedback assessment | Not specified, but implied satisfactory as part of overall acceptability statement. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
- Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of AI/SaMD ground truth establishment.
- For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.
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 type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI/SaMD performance, which is not the subject of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.
8. The sample size for the training set:
- Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this document does not describe an AI algorithm or its training set.
§ 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).