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The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

1. Drive Assembly
2. Dilation Extension Selection (DES) Assembly
3. Motor Drive Handle
4. Outer Sheath Accessory
5. Fish Tape Accessory
   The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. As such, it does not contain the detailed information typically found in a clinical study report or a validation study for an AI-powered medical device.

Specifically, this document describes a mechanical device (a motorized dilator sheath) and its validation through engineering and performance testing, not an AI algorithm. Therefore, most of the requested information regarding AI device acceptance criteria, human reader studies, ground truth establishment, and training/test set details is not applicable to this submission.

The document states: "Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the approval was based on demonstrating equivalence in mechanical and performance characteristics to a previously cleared device, not on the performance of a novel AI algorithm.

However, I can extract the relevant "acceptance criteria" and "study" information that is present in the document, which pertains to the engineering and performance testing of this mechanical device.

Acceptance Criteria and Study for the TightRail Guardian Motorized Dilator Sheath (Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or precise reported performance values in a table format. Instead, it lists the types of design verification and validation testing performed to ensure the device met its specifications and performed comparably to its predicate. The implicit acceptance criterion for all these tests is that the device demonstrated performance equivalent to or better than the predicate, and met all engineering specifications for safety and effectiveness.

Since this is not an AI/software device, the following points are not applicable (N/A) based on the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No test set of patient data/images for an AI algorithm). Testing was engineering-based on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts for images/data for AI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A (No AI, no human reader study).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No ground truth as defined for diagnostic AI). The "ground truth" for this mechanical device is proper functioning according to engineering specifications and safety standards.
8. The sample size for the training set: N/A (No training set for an AI algorithm).
9. How the ground truth for the training set was established: N/A (No training set for an AI algorithm).

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Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal atteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System and Philips Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies:

• 1. Catheter Subassembly
• 2. Motor Drive Unit (MDU) Subassembly
     The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System or Philips Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system or Philips Laser System is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

This document is a 510(k) premarket notification for the Turbo-Power (2.0mm and 2.3mm) Laser Atherectomy Catheters. It describes a modification to an existing device (a new Printed Circuit Board Assembly and firmware) and aims to demonstrate substantial equivalence to a predicate device.

Therefore, the study design described is a design verification and validation testing for the modified device, rather than a clinical trial or large-scale comparative effectiveness study typical for new medical device approvals. The acceptance criteria and the study performed are focused on confirming that the modified device functions as intended and meets the safety and performance requirements established for the original device.

Here's an analysis based on the provided text:

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

The document broadly states that "Functional testing was performed to confirm the devices with the new PCBA meet the relevant product requirements." and "The following testing was conducted to verify that the subject device met all acceptance criteria as required by the risk analysis that was performed." However, a specific table detailing individual acceptance criteria and corresponding reported device performance values (e.g., pass/fail for specific tests, quantitative measurements within certain tolerances) is not provided in this summary. The categories of testing performed are listed:

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

• Sample Size: The document does not specify the exact sample size (number of modified devices) used for the functional, software, and medical electrical safety testing. It mentions "devices with the new PCBA" in plural, implying more than one unit, but no specific number.
• Data Provenance: The testing was conducted by The Spectranetics Corporation, based in Colorado Springs, Colorado, USA. The data is prospective as it involves new testing on the modified device.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective human interpretation, such as image reading in AI/diagnostic device studies. For this submission, which focuses on engineering verification of a physical device modification, the "ground truth" is established by the device's technical specifications and engineering requirements. Therefore, no external experts (like radiologists) were used to establish a "ground truth" in the diagnostic sense. The "experts" would be the internal engineers and quality personnel responsible for defining and executing the test protocols and assessing compliance. Their qualifications are implicitly assumed to be appropriate for device testing and validation.

4. Adjudication method for the test set:

Not applicable in the context of this device modification verification. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth for diagnostic studies. For engineering and safety testing, passing or failing a test is typically based on predefined objective criteria, not subjective interpretation 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:

No, an MRMC comparative effectiveness study was not done. This document is for a medical device modification (a laser atherectomy catheter) and not an AI/CADe device where human reader improvement with AI assistance would be relevant. The submission aimed to demonstrate substantial equivalence of the modified device to its predicate, focusing on maintaining existing performance and safety.

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

Not applicable. This is not an algorithmic device. The "performance" here refers to the physical and electrical function of the catheter and its associated components, not the output of a diagnostic algorithm.

7. The type of ground truth used:

The "ground truth" for this device modification is based on engineering specifications, functional requirements, and safety standards. The tests performed verify that the modified device continues to meet these objective, predefined criteria. It does not involve "expert consensus, pathology, or outcomes data" in the traditional sense of validating a diagnostic or AI-based device.

8. The sample size for the training set:

Not applicable. This is a medical device modification, not a machine learning or AI algorithm development. Therefore, there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for an AI algorithm.

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