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For percutaneous entry of peripheral vessel using the Seldinger technique.

NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - .045", Length: 20 cm - 500 cm, Tip: Straight, Shapable or Preshaped, Flexibility: Soft through Stiff, Coil Length: 2 cm - 30 cm. NOTE : None of these guidewires are for PTCA use.

This document describes the regulatory submission for the Lake Region Manufacturing (LRM) Core and Coil Assembly (CCA) Guidewire. It presents information regarding the device's characteristics, safety, and effectiveness, primarily through comparative testing against a predicate device.

Here's an analysis of the provided text, structured according to your request:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds with specific numerical values for each test. Instead, it describes "prescribed specification limits" which the device met. The reported device performance is that all test results were within these prescribed specification limits.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Size: For each product qualification test, 30 samples were selected. Since there were three groups of LRM wires and two groups of Flexmedics product, and at least 200 samples of each size were produced (600+ total LRM samples), the 30 samples for each test were drawn from these larger production batches.
   • Data Provenance: The study was prospective as LRM samples were manufactured following current processes, and Flexmedics products were purchased (presumably new for the purpose of the study). The country of origin for the data is implicitly the United States, as LRM is based in Chaska, MN, and the submission is to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document describes engineering and biocompatibility testing for a medical device. There is no mention of human "experts" establishing a "ground truth" in the context of clinical or diagnostic performance. Instead, the ground truth for the engineering tests would be established by validated test methods and established engineering specifications. For biocompatibility, the ground truth is determined by the specific laboratory assays and their established pass/fail criteria.

3. Adjudication method for the test set:

   • Not applicable. This is a technical performance and biocompatibility study, not a study involving human interpretation or adjudication of results in the traditional sense of clinical imaging or diagnostics.

4. 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, an MRMC comparative effectiveness study was not done. This submission is for a guidewire, which is a physical medical device, not an AI or diagnostic system involving human readers.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for the engineering tests (e.g., dimensional, flexibility, kink resistance, torsional integrity, pull test, 3-point bending) is based on established engineering specifications and validated measurement techniques.
   • The "ground truth" for biocompatibility tests (e.g., cytotoxicity, hemolysis, systemic toxicity, intracutaneous, implantation, sensitization, pyrogen) is based on standardized laboratory assays and their predetermined pass/fail criteria, as recommended by FDA's General Program Memorandum #G95-1 and ISO-10993.

7. The sample size for the training set:

   • Not applicable. This document describes the manufacturing and testing of a physical medical device. There is no AI component or "training set" in the context of machine learning. The "training" for the device would be the manufacturing processes themselves.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of AI/machine learning. The manufacturing processes and material specifications are the "ground truth" for the device's production.

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NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - . 045" Length: 20 cm - 500 cm Tip: Straight, Shapable or Preshaped Flexibility: Soft through Stiff Coil Length: 2 cm - 30 cm NOTE: None of these guidewires are for PTCA use.

The provided text describes comparative testing for guidewires, focusing on their substantial equivalence to predicate devices and biocompatibility. However, it does not describe a device that uses an AI algorithm or a study that utilizes features like experts, ground truth, or MRMC studies typically associated with AI/ML medical devices.

Therefore, the following information cannot be extracted from the given text:

• 1. A table of acceptance criteria and the reported device performance: While various tests were performed, specific acceptance criteria values are not provided, only that "All test results were within prescribed specification limits."
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "For each test, there were 30 samples selected" for comparative testing, and "at least two hundred (200) samples of each size (600+ total samples)" were produced. Data provenance (country of origin, retrospective/prospective) is not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device study.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The ground truth for the physical tests would be the measurement results against engineering specifications.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
• 9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the provided text regarding the closest equivalent to acceptance criteria and study findings:

The document describes product qualification tests and biocompatibility tests performed to demonstrate substantial equivalence of new guidewires (with NiTi core and platinum coil) to predicate guidewires (Flexmedics products).

Acceptance Criteria and Device Performance (Summary based on text):

Study Information:

• Study Purpose: To demonstrate substantial equivalence of guidewires with NiTi core and platinum coil to predicate Flexmedics guidewires and assess biocompatibility.
• Test Set Description:
  • Comparative Test Data: LRM guidewires (produced following current manufacturing processes) and Flexmedics guidewires (purchased complete in packaging). Both were sterilized prior to testing.
  • Biocompatibility Testing: Samples of the new guidewire type.
• Sample Size for Test Set:
  • Comparative Test Data: "at least two hundred (200) samples of each size (600+ total samples)" were produced. For each specific test, "30 samples selected."
  • Biocompatibility Testing: Not explicitly stated, but implies sufficient samples for each of the listed tests.
• Data Provenance (Comparative Test Data): LRM samples were manufactured, and Flexmedics products were purchased. No country of origin or explicit retrospective/prospective status stated, but based on the context of premarket notification, it is prospective testing for regulatory submission.
• Type of Ground Truth Used (Comparative Test Data): Engineering specifications/design criteria and comparison to predicate device performance.
• Type of Ground Truth Used (Biocompatibility): Standardized biological evaluation methods (ISO-10993) and established criteria for biological responses (e.g., Grade 0 for cytotoxicity, no hemolysis, etc.).

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