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The Turbo Elite devices are indicated for use in the treatment of infrainguinal stenosis and occlusions. When used in conjunction with the Turbo Booster and/or as an accessory to the Turbo Tandem System, the devices are indicated for atherectomy of infrainguinal arteries.

The 0.014" and 0.018" Over-the-wire (OTW) Turbo Elite laser catheters are also indicated for use as an accessory to the use of the Turbo Tandem System in the treatment of femoropoplited artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Spectranetics Turbo Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014", 0.018", and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo Elite catheters compatible with 0.014" and 0.018" quidewires.

The Turbo-Tandem Laser Guide Catheter with Laser Atherectorny Catheter (Turbo-Tandem System) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectomy catheter. The Turbo-Tandem System is designed to be used to directionally ablate infrainguinal concentric lesions in vessels 5mm or greater at or above the knee. The Turbo Tandem Laser Guide Catheter with Laser Atherectorny Catheter is available in two sizes; a 7F and 8F with a 2.0mm equivalent laser catheter embedded in the system. New indication clearance is only being requested for the Turbo-Tandem 7F catheters.

The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, 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.

Acceptance Criteria and Study Details for Spectranetics Turbo-Tandem System and Turbo Elite Laser Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on seeking a new Indication for Use (IFU) based on clinical evidence, rather than presenting specific numerical acceptance criteria for a device performance test where the device's output is measured against a predefined standard. The clinical study (EXCITE trial) compared the device combination (ELA+PTA) against another treatment (PTA alone) to demonstrate non-inferiority for safety and superiority for effectiveness for the new indication.

Device Effectiveness (Primary Effectiveness Hypothesis):

Device Safety (Primary Safety Hypothesis):

Note: The document does not provide specific numerical thresholds or percentages for "superiority" or "non-inferiority" for these clinical endpoints. It only states that the hypotheses were met.

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

• Test Set (Clinical Data): The EXCITE trial
  • Sample Size: Not explicitly stated as a number of patients, but referenced as "a prospective randomized controlled trial performed respectively in a 2:1 randomization scheme."
  • Data Provenance: Prospective, randomized controlled trial. The country of origin of the data is not specified in the provided text.

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

This type of information is generally not applicable to clinical trials comparing medical device efficacy and safety directly in patients. The "ground truth" in this context is based on clinical outcomes (e.g., freedom from TLR, occurrence of MAE) observed in patients following treatment, as assessed by clinical investigators and defined trial endpoints, rather than expert consensus on a diagnostic image or interpretation. The trial would have been monitored by a Data Safety Monitoring Board (DSMB) and events adjudicated by independent committees, but the roles and qualifications of such individuals are not detailed here.

4. Adjudication Method for the Test Set

The document mentions that the EXCITE trial involved a "primary safety hypothesis" and "primary effectiveness hypothesis" and that "freedom from a major adverse event (MAE)" was defined. Clinical trials typically have independent clinical events committees (CECs) to adjudicate endpoints like MAE and TLR to ensure consistency and minimize bias. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed in this summary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic devices or imaging interpretation by different human readers. The EXCITE trial was a clinical trial comparing the effectiveness and safety of a treatment device (laser atherectomy with PTA) against another treatment (PTA alone), not a study of human readers' performance.

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

No, a standalone study (algorithm only) was not done. The "device" in question is a physical medical device (laser ablation catheter and system) used by a physician during a procedure, not a diagnostic algorithm or AI system. The EXCITE trial evaluated the performance of the device in conjunction with human intervention (the procedure).

7. Type of Ground Truth Used for the Test Set

The ground truth for the clinical effectiveness and safety endpoints in the EXCITE trial was based on clinical outcomes data from patients, specifically:

• Freedom from Target Lesion Revascularization (TLR): A clinical outcome representing the need for a repeat revascularization procedure of the treated lesion.
• Freedom from Major Adverse Events (MAE): A composite clinical outcome including all-cause death, major amputation in the target limb, or target lesion revascularization (TLR).

These are direct patient-level clinical events, not expert consensus on images or pathology results in the typical sense of AI/image analysis studies.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here, as the device is a physical medical instrument, not a machine learning algorithm that underwent a training phase. The EXCITE trial was a clinical validation study to support a new indication for use.

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

As noted above, there was no "training set" in the context of developing an algorithm. Therefore, the establishment of ground truth for a training set is not relevant to this submission.

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The LexiPliant™ Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.

The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.

The provided text is a 510(k) summary for the LexiPliant™ Dilator Sheath Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested sections about study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with explicit notes about when information is not available:

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

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a clinical context (e.g., success rate of lead removal). Instead, it lists various engineering and biological tests conducted to demonstrate substantial equivalence to a predicate device.

Note: The document states "The results of design verification and validation testing demonstrate that the subject device is as safe and clinically effective as the predicate device" and that the testing results "demonstrated that the subject device is as safe and clinically effective as the predicate device." This implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.

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

The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."
Therefore, there were no clinical test sets or data provenance as typically understood for a clinical study. The "test set" consists of the physical devices themselves and materials used in the listed engineering and biocompatibility tests. The specific sample sizes for each of these engineering and lab tests are not provided in this summary.

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)

Not applicable. No experts were used to establish ground truth because there was no clinical study. The testing performed was largely engineering and lab-based, overseen by product developers and quality assurance personnel.

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

Not applicable. No clinical test set or adjudication process as described.

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 device is a physical medical instrument (dilator sheath), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

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

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

Not applicable. For the engineering and biocompatibility tests, the "ground truth" would be the established scientific and engineering principles, test standards (e.g., AAMI TIR:28-2009 for sterilization), and comparison to the predicate device's characteristics, as measured by laboratory equipment and procedures, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. As there was no AI/algorithm, there was no training set.

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

Not applicable. As there was no AI/algorithm, there was no training set or ground truth for it.

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