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The TightRail and TightRail Mini Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects

The TightRail and TightRail Mini Rotating Dilator Sheaths are intra-operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation sheath. Each rotating dilator sheath is packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter, or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the dilation sheath. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. For the TightRail the diameter sizes range from 9 French (F) to 13 F with a nominal effective length of 47.5cm. For the TightRail Mini, the diameter sizes range from 9 French (F) to 11 F with a nominal effective length of 15.5 cm.

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets the acceptance criteria as requested. The document is a 510(k) summary for the Spectranetics TightRail and TightRail Mini Rotating Dilator Sheaths, which details their technological characteristics and testing performed for substantial equivalence to a predicate device.

Specifically:

• No acceptance criteria: The document lists various tests performed (e.g., Dimensional Verification, Tri Coil Tensile Test, etc.), but it does not provide specific acceptance criteria or thresholds for these tests.
• No device performance metrics: While it states "the subject device met all requirements as identified in the risk analysis," it does not report specific device performance metrics in a quantitative manner or in relation to defined acceptance criteria.
• No information on "AI" or "human readers": This device is a medical instrument (dilator sheath), not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of AI, human readers, MRMC studies, effect sizes of AI assistance, or standalone algorithm performance.
• No ground truth, training/test sets, or expert details: For a medical device like this, which is an interventional tool, the concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, expert consensus on images) is not directly relevant in the context of this 510(k) summary. The summary focuses on device functionality, materials, and mechanical performance rather than diagnostic accuracy. Consequently, there is no information about training sets, test sets, data provenance, number of experts, or adjudication methods for establishing ground truth.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K142546) based on similar design and performance without requiring preclinical or clinical data for this specific submission because the changes were considered minor (material of the trigger pin). The testing performed was generally for design verification and validation, ensuring the device functions as intended and safely, rather than evaluating diagnostic accuracy against a ground truth.

Therefore, I cannot fulfill the request to provide the table or the detailed information regarding acceptance criteria and study particulars in the context of an AI-driven device.

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The TightRail and TightRail Mini Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

The TightRail and TightRail Mini Rotating Dilator Sheaths are mechanical, intra- operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal, thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail is 47.5 cm. The nominal effective length of the TightRail Mini is 15.5 cm.

The provided text describes a 510(k) premarket notification for the TightRail and TightRail Mini Rotating Dilator Sheaths, focusing on establishing substantial equivalence to previously cleared predicate devices. The information provided does not align with the typical structure of reporting acceptance criteria and a study proving device performance in the context of AI/ML devices or diagnostic accuracy studies. This document pertains to a physical medical device and its mechanical/material performance, not an AI system.

However, interpreting the request in the context of physical medical device validation as presented, here's an attempt to extract relevant information, acknowledging the limitations for your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in a strict pass/fail quantifiable manner for each test. Instead, it lists types of tests conducted to ensure safety and effectiveness, and then broadly states that the device "met all specifications" and was "substantially equivalent." Therefore, the table below will generalize the 'acceptance criteria' based on the purpose of each test.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for any of the individual tests. The document only lists the types of tests performed.
• Data Provenance: The document does not specify the country of origin for any test data. The tests are "Design Verification and Validation Testing" and "Biocompatibility" tests, which are typically conducted in a laboratory setting by the manufacturer or a contracted lab. It does not mention retrospective or prospective studies in the typical clinical trial sense.

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

This question is not applicable in the context of this device and testing. The tests described are primarily engineering, mechanical, and material science evaluations, along with biocompatibility assessments. They do not involve human interpretation of clinical data or images that would require expert consensus for "ground truth."

4. Adjudication method for the test set:

Not applicable. There's no indication of clinical data interpretation requiring adjudication. Performance is assessed against defined engineering and biological standards.

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. This is a physical medical device (dilator sheath), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. (See point 5).

7. The type of ground truth used:

The "ground truth" for this type of device and its mechanical/biocompatibility testing would be established by:

• Engineering specifications and standards: For dimensional, tensile, torsional, axial, and durability tests.
• International standards (e.g., AAMI TIR:28-2009): For sterilization validation.
• ISO standards for biocompatibility: For cytotoxicity, sensitization, hemolysis, etc.
• Pre-defined pass/fail criteria: Based on the device's intended use and safety profile.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The "training" for the device would be its manufacturing process.

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

Not applicable. (See point 8).

Summary of what's not in the document but relevant to your questions:

The provided document describes a traditional 510(k) for a physical medical device that facilitates percutaneous dilation. The validation focuses on engineering specifications, material compatibility, and sterilization efficacy to demonstrate substantial equivalence to predicate devices, especially after a change in the drive mechanism for rotation. It does not involve AI/ML technology, diagnostic image interpretation, or clinical efficacy studies that would require expert ground truth, MRMC studies, or training/test sets in the computational sense. The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."

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The TightRail Mini Rotating Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

The TightRail Mini Rotating Dilator Sheaths is an intra-operative device. The device consists of a proximal handle drive mechanism with a distal dilation sheath. The sheath is packaged with an outer support sheath. The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the sheath. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 11 F. The nominal effective length of the effective length of the TightRail Mini is 15.5 cm (6.1").

The provided text describes a 510(k) submission (K141131) for the Spectranetics TightRail Mini Rotating Dilator Sheath. This is a medical device for percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. The device is a modification of an existing predicate device (TightRail Device K140047), with the primary change being a shorter working length.

Given that this is a 510(k) submission for a Class II device that is substantially equivalent to a predicate device, the regulatory pathway relies heavily on demonstrating performance through design verification and validation testing, not necessarily clinical studies with human subjects or a direct measure of AI performance.

Therefore, many of the requested categories for AI-based device evaluations (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not explicitly detailed in this type of submission. The "acceptance criteria" here relate to engineering and performance specifications for the device itself, rather than diagnostic accuracy or AI algorithmic performance metrics.

I will populate the table and answer the questions based on the information available and note when information is not provided due to the nature of the device and submission type.

Acceptance Criteria and Device Performance

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

Note: All tests marked with an asterisk () are leveraged from the predicate device K140047, indicating the subject device is considered to have the same performance characteristics for these aspects.*

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

This document describes technical and biological verification testing for a physical medical device, not a software algorithm or AI. Therefore, there isn't a "test set" in the context of data used for an algorithm. The testing described (e.g., dimensional verification, tensile tests, biocompatibility tests) would involve physical samples of the device components or final product. The document does not specify the number of samples used for each test individually or their geographical origin, but rather states that these tests were conducted to validate and verify the device. These are generally prospective tests conducted by the manufacturer.

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 is not applicable. This is a physical medical device, not an AI or diagnostic imaging device that relies on expert interpretation to establish ground truth for a test set. Ground truth for these tests would be objective measurements against engineering specifications (e.g., dimension, force, chemical analysis).

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

Not applicable for this type of physical device testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data for diagnostic purposes.

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. This is not an AI-assisted diagnostic device. A comparative effectiveness study against human readers would not be relevant.

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

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

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

For the listed design verification and validation tests, the "ground truth" would be established by:

• Engineering specifications and standards: For dimensional verification, tensile/torsional/axial load tests, corrosion resistance, radio-detectability.
• Established biological testing protocols: For biocompatibility tests (cytotoxicity, sensitization, hemolysis, thrombogenicity, etc.), adherence to defined test methods and acceptance criteria from standards (e.g., ISO 10993 series).
• Simulated conditions: For simulated use testing, package integrity, and simulated distribution, performance is assessed against defined environmental stresses and functional requirements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a comprehensive set of Design Verification and Validation testing. This testing demonstrates that the TightRail Mini Rotating Dilator Sheath performs as intended and is as safe and effective as its predicate device (TightRail Device K140047).

The core of the "proof" for this 510(k) submission lies in demonstrating substantial equivalence to the predicate device. This was achieved by:

• Identifying the technological characteristics of the predicate device and confirming the subject device shares these, with the only significant change being the shorter working length.
• Performing new tests specific to the subject device (e.g., Dimensional Verification of TightRail Mini Working Length).
• Leveraging existing test data from the predicate device (K140047) for a wide range of tests including mechanical properties (tensile, torsional, axial load tests), material characteristics (radio-detectability, corrosion resistance), functional performance (simulated use testing), long-term stability (2-year tests), packaging, sterilization equivalency, and extensive biocompatibility testing. The justification for leveraging this data is that the subject and predicate devices are otherwise identical in technological characteristics.

The conclusion drawn from this combination of new and leveraged testing was that "The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This formed the basis for the FDA's determination of substantial equivalence.

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