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The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

The NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip). different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff). enable users to gain vascular access.

Here's a breakdown of the acceptance criteria and study information for the NM1 Coaxial Microintroducer Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device was tested to ISO 11070, indicating that the device met the requirements of this standard for tensile strength and dimensional accuracy. Specific numerical values for criteria or performance were not provided in the 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document refers to "non-clinical test performed."
• Data Provenance: Not explicitly stated. The document indicates "non-clinical testing," which typically means laboratory or bench testing, not human-patient data from a specific country. This would be considered retrospective in the sense that no new patient data was collected.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the evaluation involved non-clinical, bench testing (Tensile Testing and Dimensional Verification) against an ISO standard, not expert review of clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved non-clinical, bench testing against an ISO standard, which would not involve an adjudication method in the traditional sense. The standard itself would define the pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, and the document describes a physical medical device (introducer set) evaluated through non-clinical bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

Yes, a standalone performance evaluation was done. The performance data presented (tensile testing and dimensional verification) assesses the device's physical and mechanical characteristics in a standalone manner, without human interaction being a variable in the performance assessment itself. The "human-in-the-loop" concept is not directly applicable to this type of device and testing.

7. The Type of Ground Truth Used:

The ground truth used was compliance with an industry standard: ISO 11070: "Sterile, Single-Use Intravascular Catheter Introducers." This standard defines the acceptable performance characteristics for devices of this type.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not an AI or algorithm-based system that requires a "training set" for machine learning. The "training set" concept does not apply here.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

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The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip), different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff), enable users to gain vascular access.

This 510(k) summary reports on a medical device (NMI Coaxial Microintroducer Set) which is not an AI/ML device. Therefore, acceptance criteria and study data related to AI/ML device performance are not applicable. The provided document details the substantial equivalence of the NMI Coaxial Microintroducer Set to a predicate device based on non-clinical performance and technological characteristics.

However, based on the provided text, I can extract the following information about the device's testing and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the testing performed to demonstrate substantial equivalence, rather than a specific set of acceptance criteria with numerical targets. The "acceptance criteria" are implied by the standards used and the conclusion of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., tensile testing, leak testing). It only states that tests were performed "in accordance with" the specified ISO standards. These standards typically outline appropriate sample size requirements for the tests.
• Data Provenance: The data is from non-clinical tests performed by the manufacturer (Navilyst Medical, Inc.). This is not patient data, so concepts like country of origin or retrospective/prospective are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This device is evaluated based on non-clinical performance data (material properties, mechanical integrity, etc.) against established engineering standards (ISO). There is no "ground truth" in the clinical sense established by human experts for these types of tests.

4. Adjudication Method for the Test Set:

• Not Applicable. As the evaluation is based on objective non-clinical tests against engineering standards, there is no need for an adjudication method involving human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an AI/ML or image-based diagnostic device. An MRMC study is not relevant or performed for this type of medical device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Not Applicable. This is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant. The "performance" here refers to the physical device's characteristics.

7. Type of Ground Truth Used:

• Benchmark Standards and Engineering Specifications: The "ground truth" for this device's performance is derived from established international standards (ISO 11070, ISO 594-2, ISO 10993-1) and the manufacturer's own design specifications, which are compared to those of the predicate device. The goal is to demonstrate that the device performs equivalently to the predicate and meets safety and performance standards.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set.

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