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Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)

The provided text is related to a 510(k) premarket notification for a medical device called "Hi Torque Connect Guidewire." This document focuses on demonstrating the substantial equivalence of a modified device to a previously cleared predicate device, rather than presenting a study of an AI algorithm's performance or a diagnostic device.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific ground truth types) are not applicable to this type of regulatory submission, as it deals with a physical medical device and its mechanical/material properties.

However, I can extract the acceptance criteria and performance data related to the device's physical properties.

Here's an analysis based on the information provided:

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

The document states that a design change involved a new PTFE coating for the guidewire. The performance testing was conducted to demonstrate the equivalence of the modified design to the existing design and to ensure the new coating does not adversely affect performance.

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

• Sample Size: The document does not specify the exact sample sizes (number of guidewires or test repetitions) for each bench test. It generally refers to "bench tests" being carried out.
• Data Provenance: The tests were "In vitro bench tests." The company, Lake Region Medical Limited, is located in Ireland. Therefore, the testing was likely conducted in Ireland or by designated testing facilities on behalf of the Irish manufacturer. The data is prospective as it was generated specifically for this 510(k) submission.

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

This is not applicable. The "ground truth" here is the performance of the guidewire against established engineering and material specifications, and comparison to the predicate device. This is determined by quantitative bench testing, not expert interpretation.

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

This is not applicable as the tests are quantitative bench tests, not qualitative assessments requiring adjudication.

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

This is not applicable. This is a physical medical device (guidewire), not an AI algorithm for diagnostic imaging or similar application.

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

This is not applicable. This is a physical medical device.

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

The "ground truth" for this medical device's performance is based on established engineering and material specifications, as well as the performance characteristics of the previously cleared predicate device (K112381, cleared Nov 3, 2011). The tests also referenced the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". This is a combination of:
* Engineering Specifications: Defined product specifications for the guidewire's physical and mechanical properties.
* Predicate Device Performance: Performance data from a legally marketed device used as a benchmark for substantial equivalence.
* Regulatory Guidance: Adherence to recognized testing methods and performance expectations outlined in FDA guidance.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable.

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Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)

This document is a 510(k) summary for the Hi Torque Connect Guidewire. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Tensile Strength
• Torque Strength
• Outer Diameter measurement
• Torque Response
• Catheter Compatibility
• Coating Adherence/Coating Integrity
• Particulate Testing
• Tip Flexibility |
  | Biocompatibility Tests | No specific numerical acceptance criteria are given, but the device must demonstrate biological safety based on ISO 10993-1. | The device's biological safety has been established through biocompatibility testing carried out in compliance with ISO 10993-1.
  Specific tests performed:
• Cytotoxicity Study (Qualitative and Quantitative)
• Irritation Test (Intracutaneous Injection, ISO 10993-10)
• Sensitisation Test (Kligman Maximisation, ISO 10993-10)
• Acute Systemic Toxicity Test (Systemic Injection, ISO 10993-11; ISO-Rabbit-Pyrogen)
• Haemocompatibility Test (Haematology: Haemolysis, In-vitro Haemocompatiblity Assay; Coagulation: Prothrombin Time Assay (PT), Unactivated Partial Thromboplastin Time Assay (UPTT); Thrombosis: In Vivo Thrombogenicity in Dogs; Complement Activation; Lee & White Coagulation Assay) |

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

The document does not explicitly state the sample sizes used for the mechanical or biocompatibility testing. The data provenance is not specified beyond indicating "in vitro bench tests" and reference to FDA guidance. Given the nature of a 510(k) submission for a medical device of this type, the testing would generally be conducted in a controlled laboratory environment. This would be considered prospective testing for the purpose of regulatory submission. The country of origin for the testing itself is not stated, but the submitter is Lake Region Medical Limited, Ireland.

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

Not applicable. This is a medical device (guidewire) premarket notification (510(k)) that focuses on engineering performance and biocompatibility rather than diagnostic accuracy or clinical outcomes that typically involve expert consensus on ground truth. The "ground truth" for these tests are the established scientific and engineering principles, and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Test results are compared against predefined specifications and regulatory standards, not expert adjudication.

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

Not applicable. This is not a diagnostic imaging device or an AI algorithm intended for interpretation, so MRMC studies are not relevant. This submission focuses on the safety and performance of a physical medical device.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical guidewire, not a standalone algorithm.

7. Type of Ground Truth Used

For the performance testing, the "ground truth" is based on:

• Established engineering specifications and standards: These define acceptable ranges for tensile strength, torque strength, dimensions, etc.
• Predicate device performance: The new device must perform "comparably" to legally marketed predicate devices.
• Regulatory guidance: Specifically, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995" for mechanical tests, and ISO 10993-1 for biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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