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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 TightRail Mechanical 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 Mechanical Dilator Sheaths are mechanical, intra-operative devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are 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 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 provided text describes a 510(k) summary for the "TightRail™ Mechanical Dilator Sheath Set." This premarket notification asserts that the device is substantially equivalent to a legally marketed predicate device, focusing on design verification and validation testing rather than presenting formal acceptance criteria with specific performance metrics.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be typical for independent studies. Instead, it lists various "Design Verification and Validation Testing" categories, implying that the device was tested to "meet all specifications" and "demonstrated that the subject device is as safe and clinically effective as the predicate device."

• No explicit table of acceptance criteria or quantitative performance is provided in the document. The acceptance is based on demonstrating substantial equivalence to a predicate device through a series of verification and validation tests.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated. The "Simulated Use Bench Top" test would have involved a certain number of devices or iterations, but the specific sample size is not detailed for any of the listed tests.
   • Data Provenance: The tests are described as "Design Verification and Validation Testing" and "Simulated Use Bench Top," implying in-house laboratory testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense. These are engineering and performance tests, not clinical data from patients.

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

   • Not applicable. This is not a study involving expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these engineering tests would be the established performance specifications for the device itself and comparison to the predicate.
   • "Physician Simulated Use" is mentioned, which implies input from physicians, but the number or specific qualifications are not detailed, nor is it a method for establishing "ground truth" in the typical sense of a diagnostic study.

3. Adjudication method for the test set:

   • Not applicable. This is not a clinical study involving human readers or interpretation where adjudication methods (like 2+1 or 3+1) would be used. The tests described are engineering and performance validation tests.

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. This is a medical device for percutaneous dilation, not a diagnostic imaging AI device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant to this submission.

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

   • No. This is a mechanical medical device, not a software algorithm.

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

   • For the engineering and performance testing, the "ground truth" would be established engineering specifications, industry standards (e.g., AAMI TIR:28-2009 for sterilization), and the performance characteristics of the legally marketed predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

Summary of Device Acceptance Criteria and Study:

The acceptance criteria for the TightRail Mechanical Dilator Sheath Set were met through a series of Design Verification and Validation Tests. These tests aimed to demonstrate that the device met all its specifications and was substantially equivalent to the predicate device (Cook® Medical Evolution® Mechanical Dilator Sheath Set, K061000).

The types of tests conducted included:

• Dimensional Verification
• Axial Loading of Tip Assembly and Outer Sheath
• Tensile and Torsional Testing on the Tri-Coil
• Simulated Use Bench Top
• Radiopacity
• Corrosion Resistance
• Physician Simulated Use
• Simulated Distribution (Shipping and Environmental Conditioning)
• Shelf Life Verification Testing (6 months, including Dimensional Verification, Axial Loading, Simulated Use Bench Top, Package Integrity)
• Sterilization (Product adoption equivalency per AAMI TIR:28-2009)
• Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, C3a and SC5b-9 Complement Activation, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity Ames Test, Material Mediated Pyrogenicity)

The submission explicitly states, "Preclinical and clinical data were 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 acceptance of this device was based purely on non-clinical, engineering, and laboratory performance testing, establishing equivalence to a previously cleared device.

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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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The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm.

The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.

The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.

The provided document is a 510(k) summary for the Spectranetics 0.035" compatible, 2.3mm and 2.5mm TurboElite Atherectomy Catheters. It is not a study report that details specific acceptance criteria and the results of a clinical or analytical study in the way typically expected for AI/ML device evaluations.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K071227) by showing that the new devices have comparable intended use, patient population, mode of operation, materials, packaging, biocompatibility, sterilization, and shelf-life. The "studies" mentioned are primarily device integrity testing to support this claim of substantial equivalence.

Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable or cannot be extracted from this specific document, as it describes a different type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the device integrity testing (listed above) performed by Spectranetics. The purpose of these tests was to support the claim of substantial equivalence to the predicate device (K071227). The conclusion states that "All device integrity tests...met the specified requirements," leading to the determination of substantial equivalence.

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

• Sample Size for Test Set: This document does not provide specific sample sizes (e.g., number of catheters, number of tests for each category) for the device integrity testing. This information is typically found in detailed test reports, not a 510(k) summary.
• Data Provenance: Not specified. The studies are described as "device integrity testing" and "in vitro," implying laboratory-based testing rather than clinical data from human subjects or specific geographical regions.

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. This submission is for a medical device (catheter) and relies on engineering and performance testing, not on expert adjudication of diagnostic images or clinical assessments to establish "ground truth" in the context of an AI/ML device.

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

• Not Applicable. As above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads) and is not part of the device integrity testing described here.

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 study was not done. This study is focused on the physical and performance characteristics of a catheter, not the comparative effectiveness of human readers, with or without AI assistance, in a diagnostic context.

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

• Not Applicable. This is a hardware device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

• The "ground truth" in this context refers to the specified requirements or design specifications for the device's physical and functional performance (e.g., dimensional tolerances, leak pressure limits, tensile strength minimums, laser output parameters). The device integrity tests were conducted to verify that the manufactured devices met these engineering specifications.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device's regulatory submission. This is not an AI/ML device.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandem® System (Laser Guide Catheter with Laser Atherectomy Catheter) is a laser atherectomy catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser atherectorny catheter. Specifically, the guiding catheter portion of the Turbo-Tandem® System includes an angled biasing tip to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel.

The incorporated laser catheter of Turbo-Tandem® System is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) guidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter has a radiopaque marker bands at the distal tip. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing.

The guiding catheter portion of the Turbo-Tandem® System is comprised of a handle with an incorporated flush port, a braided shaft with hydrophilic coating, and a biasing tip with two radiopaque marker bands. The handle features a six-position locking mechanism to position the laser catheter on the ramp of the biasing tip.

The Turbo-Tandem® System is provided sterile and is intended to be single-use.

The provided text describes the 510(k) summary for the Spectranetics 8Fr Turbo-Tandem® System, which is a percutaneous guide catheter with a laser atherectomy catheter. The submission seeks to demonstrate substantial equivalence to a predicate device, the Spectranetics 7Fr Turbo-Tandem® System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that Spectranetics performed "device integrity testing." However, it does not specify any sample sizes for these tests (e.g., number of devices tested for dimensional, functional, or performance tests).

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. Given that the tests are described as "in vitro" and "device integrity testing," it implies laboratory-based testing rather than clinical data from human subjects.

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

The document does not mention the use of experts to establish ground truth for the test set. The tests performed are engineering and performance-based tests on the device itself, not assessments requiring clinical expert interpretation.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the "tests" described are for device integrity and performance, not for clinical outcomes or diagnostic accuracy requiring human expert consensus.

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

No MRMC comparative effectiveness study is mentioned. The study described focuses on demonstrating substantial equivalence of the 8Fr device to the 7Fr predicate device through device integrity and performance tests, not through human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

This device is a physical medical device (a catheter system), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for the device integrity tests would be the engineering specifications and performance parameters defined by Spectranetics for the device. The tests determine if the device's physical and functional characteristics meet these predefined specifications. It is not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

The document does not mention a "training set" as this is a physical medical device and not a machine learning model. The study described involves testing the physical device against predefined engineering requirements to demonstrate substantial equivalence to a predicate device.

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

As there is no "training set" for an AI or machine learning model, this question is not applicable. The "ground truth" for the device's expected performance in the integrity tests would be established by the device's design specifications and manufacturing standards.

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Indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandem™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser atherectorny catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The Turbo-Tandem System is designed to directionally ablate infrainguinal concentric and eccentric lesions in vessels 5mm or greater at or above the knee. The Turbo-Tandem System is not designed to be used in total or sub-total occlusions. In the event of a total or sub-total occlusion a pilot channel is recommended. The guiding catheter portion of the Turbo-Tandem™ System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem™ System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a 0.014" (0.35mm) quidewire compatible lumen and has a fiber optic surface area similar to a 2.0mm laser catheter. The laser catheter is connected to the Spectranetics CVX-300® Excimer Laser System by means of an optical coupler and tail-tubing catheter portion of the Turbo-Tandem™ System is comprised of a handle with an incorporated flush port, proximal coupler, tail tubing, strain relief tubing, braided shaft with a hydrophilic coating, two radiopaque marker bands in the distal tip with a platform, and one radiopaque marker band at the distal end of the laser catheter.

The provided text describes a 510(k) premarket notification for the Spectranetics Turbo-Tandem™ System, a laser atherectomy catheter. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects commonly associated with clinical performance studies involving AI or expert review.

The submission focuses on establishing substantial equivalence to a predicate device, primarily through device integrity testing, rather than clinical performance evaluation against predefined criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

No information is provided about a "test set" in the context of clinical performance, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned were "device integrity testing."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. The submission does not describe a study involving expert review or the establishment of ground truth for a clinical dataset. The "ground truth" seems to be implied by successful device integrity testing against internal requirements.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication by experts is described.

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

Not applicable. No MRMC study or comparison of human readers with or without AI assistance is mentioned. This device is a physical medical device, not an AI-based diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be successful device integrity testing against internal specifications and engineering requirements, demonstrating functional and safety equivalence to the predicate device. There is no mention of clinical ground truth like pathology, outcomes data, or expert consensus related to patient outcomes for this 510(k) submission.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Summary of what the document does provide:

• Device Type: Laser atherectomy catheter system.
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Spectranetics first generation Turbo Tandem System K091299).
• Basis for Equivalence: Device integrity testing.
• Conclusion: Device integrity tests met specified requirements, supporting substantial equivalence.

The provided document is typical for a 510(k) for a physical medical device where the primary focus is on engineering and performance testing to demonstrate equivalence rather than a clinical trial or AI performance validation.

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The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.

The provided 510(k) summary for the VisiSheath Dilator Sheath indicates that it is a Class II medical device and that there are no established performance standards under Section 514 for these types of devices. Therefore, the information provided does not include specific predetermined acceptance criteria or a detailed study proving the device meets such criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission relies on functional testing to demonstrate performance.

Here's a breakdown of the available information based on your request:

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

Since specific numerical acceptance criteria (like sensitivity/specificity targets) are not provided, this table will reflect the general statement made in the submission.

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

The document does not specify the sample size for the functional testing conducted ("device functional testing"). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) as the tests described are laboratory-based functional tests, not clinical studies with patient data.

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

This information is not applicable. Functional testing typically relies on engineering specifications and direct measurement, rather than expert judgment for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable as the testing involves functional measurements against specifications, not human 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 such study was conducted or reported. This device is a physical medical instrument (dilator sheath), not an AI-powered diagnostic tool, so MRMC studies and AI-related performance metrics are irrelevant.

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

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

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

For functional testing, the "ground truth" would be the engineering specifications and design requirements for the device's physical properties and performance (e.g., tensile strength, flexibility, dimensions, radiopacity, ability to dilate tissue).

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, meaning there is no "training set" in the context of machine learning or AI.

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

This is not applicable as there is no training set for this device.

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Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study that validates the device against such criteria. The document is a 510(k) submission for a Quick-Cross Extreme Support Catheter, primarily focusing on its substantial equivalence to previously approved predicate devices.

Therefore, I cannot populate the table or answer the questions as the information is not present in the provided text.

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Indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.

The information primarily describes a 510(k) premarket notification for a medical device (Spectranetics Turbo-Tandem™ System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML-based diagnostic device.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this document. The provided text details the device, its intended use, and its comparison to predicate devices through device integrity testing.

Here's a breakdown of the available information based on your request, highlighting where information is absent or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document states, "Performance standards do not currently exist for these devices. None established under Section 514." Instead of formal acceptance criteria, the study aimed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for the premarket notification was that the device integrity test results met "specified requirements," which implies internal company specifications.
• Reported Device Performance: "All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements."

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

• Not Applicable: This document describes device integrity testing, not a clinical study involving a "test set" of patient data for an AI/ML diagnostic device. The "test set" here refers to the device itself being subjected to various integrity tests. The sample size for these engineering tests is not specified, but it would typically involve a certain number of manufactured units.
• Data Provenance: The data provenance is from internal Spectranetics Corporation testing in the USA. The study is retrospective in the sense that the testing was performed, and the results were then compiled for the submission.

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

• Not Applicable: This type of information is relevant for AI/ML diagnostic devices where expert review is needed to establish ground truth from medical images or clinical data. For device integrity testing, the "ground truth" is established by engineering specifications and objective measurements, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic studies. This is not relevant for basic device integrity testing.

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

• Not Performed: An MRMC study is designed to assess the performance of human readers, often with and without AI assistance, on a set of cases. This study is about confirming the physical and functional equivalence of a medical device (catheter system), not evaluating human reader performance or AI's impact on it.

6. Standalone (Algorithm Only) Performance Study

• Not Performed: This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance evaluated here is that of the physical device.

7. Type of Ground Truth Used

• Engineering Specifications and Objective Measurements: For device integrity testing, the "ground truth" refers to established engineering standards, design specifications, and objective measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).

8. Sample Size for the Training Set

• Not Applicable: This type of study does not involve a "training set" in the context of machine learning.

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

• Not Applicable: There is no training set for an AI/ML algorithm in this context.

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