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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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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 guidewire 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.

The provided text describes the regulatory clearance for the TightRail Guardian Motorized Dilator Sheath and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered device evaluation.

The document is a 510(k) summary for a medical device (a motorized dilator sheath), outlining its intended use, design, and comparison to predicate devices for regulatory clearance. It focuses on demonstrating substantial equivalence to existing devices, not on evaluating the performance of an AI/ML model.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (as it relates to AI/ML metrics).
• Sample size and data provenance for an AI/ML test set.
• Number of experts and qualifications for establishing ground truth in an AI/ML context.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI vs. without AI assistance.
• Standalone algorithm-only performance.
• Type of ground truth used for an AI/ML model.
• Sample size for the training set of an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

The document lists various Design Verification and Validation Testing performed, such as Simulated Use Testing, Human Factors Evaluation, and Biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance metrics for an AI/ML algorithm.

The statement "Preclinical and clinical data was not required to demonstrate substantial equivalence" further indicates that this is a traditional medical device clearance, not one involving extensive clinical trials or AI/ML performance evaluation studies against specific acceptance criteria for diagnostic/prognostic accuracy.

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The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.

The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2.

The provided text describes the CavaClear Laser Sheath, a laser-powered device used for the retrieval of IVC filters that have failed previous removal methods. While the document details various aspects of the device's testing and clinical performance, it does not pertain to an AI/ML powered medical device. Therefore, information typically associated with AI/ML device acceptance criteria, such as training and test set data, ground truth establishment by experts, adjudication methods, and MRMC studies, is not present in this document.

The acceptance criteria and the study proving the device meets these criteria are based on traditional medical device evaluation metrics, focusing on safety and effectiveness in a real-world clinical setting.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the lack of AI-specific details:

Acceptance Criteria and Device Performance for CavaClear Laser Sheath

The acceptance criteria for the CavaClear Laser Sheath are defined by two primary performance goals: a safety endpoint and an efficacy endpoint. These goals were based on meta-analysis of existing literature for IVC filter retrieval procedures.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a retrospective analysis of real-world evidence from multiple medical centers.

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

   • Total Subjects: 265
   • Single-Center Experience (Test Set 1): 139 subjects
   • Multi-Center Experience (Test Set 2): 126 subjects from 6 sites
   • Data Provenance: United States (US), retrospective. Data was collected from medical records between March 2012 and February 2021.

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

   • The document states that "All site reported complications were independently adjudicated to assess relatedness to use of the laser and to evaluate the appropriate severity classification based on the current SIR guidelines."
   • Number of Experts: Not explicitly stated, but implies at least one independent adjudicator.
   • Qualifications of Experts: Not explicitly stated, but "adjudicated... based on the current SIR guidelines" implies experts familiar with interventional radiology and complication grading (e.g., interventional radiologists, vascular surgeons).

3. Adjudication Method for the Test Set:

   • "All site reported complications were independently adjudicated."
   • The specific method (e.g., 2+1, 3+1) is not detailed, but it was an independent review process based on SIR (Society of Interventional Radiology) grading guidelines for complications.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This study evaluated the performance of a physical medical device (laser sheath) in performing a medical procedure, not an AI/ML algorithm requiring human reader performance evaluation.

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

   • Not applicable, as this is not an AI/ML algorithm. The device's performance is inherently linked to human operation by trained medical professionals within a clinical setting.

6. The Type of Ground Truth Used:

   • The ground truth for safety (complications) and efficacy (technical success) was established through clinical judgment and independent adjudication of real-world patient outcomes, based on medical records and SIR grading guidelines. Technical success was defined based on practitioners' clinical judgment and reported as such.

7. The Sample Size for the Training Set:

   • Not applicable in the context of AI/ML training. The "training" for this device refers to human medical professional training on its use, not algorithmic training data.

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

   • Not applicable as there is no algorithmic training set. The "ground truth" for human training would be established through established medical protocols, clinical best practices, and expert consensus on effective and safe procedural techniques. The document mentions a required training program for users.

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The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure.

The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft.

The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.

Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (Bridge Occlusion Balloon). It discusses the device's indications for use, comparison to a predicate device, and the basis for its substantial equivalence.

However, it does not contain details about a study that proves the device meets specific acceptance criteria based on performance data. Specifically, the document states:

• "No preclinical or clinical data was needed to support this submission."
• "The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years."

This indicates that any "test data" referred to is related to shelf-life and packaging changes, not a performance study of the device itself with acceptance criteria for a new or modified functionality. There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

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Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries 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. 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) guidewirecompatible lumen. The PTFE guidewire 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 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 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.

The provided text describes a 510(k) premarket notification for Spectranetics, Inc.'s Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheters, seeking substantial equivalence to a predicate device (K172687).

This document does not contain information related to an AI/ML powered medical device and therefore does not have the answers to questions 1-9. The device described is a physical medical device (laser atherectomy catheter) with minor design modifications (improved battery clip and battery pull tab), not an AI/ML algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets the acceptance criteria based on the provided text. The traditional medical device testing mentioned (Motor Drive Unit Lifetime Test, Motor Drive Unit Functionality Test, Pull Tab Isolation Test) are specific to the physical catheter's mechanical performance, not the performance of an AI/ML model.

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

The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The 2.0mm and 2.3mmTurbo-Power Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are used to ablate lesions with reference vessel diameters of ≥3.0mm. 2.0mm and 2.3mm Turbo-Power 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) guidewirecompatible 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 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 is used to photoablate multiple morphology lesions which mav 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.

The provided text is a 510(k) summary for the Spectranetics Turbo-Power Laser Atherectomy Catheters. The document states that "New clinical data was not required to demonstrate substantial equivalence," and much of the testing was "leveraged from the predicate Turbo-Power (2.3mm)" and summarized within this submission (which is not fully provided). Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment for a new study are not available in the provided text because a new extensive clinical study for this specific 510(k) was not conducted.

However, based on the information provided, here's what can be inferred or directly stated:

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

The document lists types of performance data collected but does not provide specific acceptance criteria or quantitative performance results in a table format.

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

• Test Set Sample Size: Not specified for any new testing. Much of the data was leveraged from predicate devices. For pre-clinical GLP studies, the sample size is not disclosed.
• Data Provenance: Not specified for any new testing. The phrase "pre-clinical GLP studies" suggests controlled laboratory or animal studies, not human clinical trials.

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, as new clinical data requiring expert-established ground truth was not explicitly detailed or required. The testing involved "Design Verification and Validation Testing" and "Pre-clinical GLP studies," which typically don't involve expert ground truth in the same way clinical imaging studies do.

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

Not applicable, as new clinical data requiring adjudication was not explicitly mentioned or required.

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 MRMC study was mentioned. This device is a physical medical device (laser atherectomy catheter), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

This question is not applicable to a physical medical device like a laser atherectomy catheter. The device itself performs the intended function, often with human operation.

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

For the pre-clinical GLP studies, the ground truth would likely be based on direct observations, measurements of tissue effects, and safety endpoints within the experimental setup, rather than expert consensus on diagnostic images or pathology. The document does not provide details.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

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

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

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The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

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 femoropopliteal 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" guidewires.

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 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.

The provided text is a 510(k) summary for a medical device (Spectranetics Turbo-Elite Laser Atherectomy Catheters). It focuses on establishing substantial equivalence to a predicate device and expanding indications for use. While it mentions a clinical study (ABLATE), it does not provide acceptance criteria in the form of a table with specific device performance numbers, nor does it detail all the specific information requested in the prompt regarding the study's methodology for acceptance testing as if it were an AI/ML device.

However, I can extract the information that is present and indicate where information is missing based on the prompt's requirements.

Missing Information Acknowledgment:
The document does not include details typically found in studies proving an AI/ML device meets acceptance criteria, such as:

• A table of specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy thresholds for an AI/ML diagnostic device).
• Information on test set sample size for AI validation.
• Data provenance for AI training/test sets.
• Number/qualifications of experts for AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness study results (AI vs. without AI).
• Standalone performance for an algorithm.
• Ground truth type for AI (e.g., pathology, outcomes data).
• Training set sample size for AI.
• How ground truth for the training set was established for AI.

This is because the device described, the "Spectranetics Turbo-Elite Laser Atherectomy Catheters," is a physical medical device (a laser catheter) and not an AI/ML software device. The clinical study mentioned (ABLATE) is designed to demonstrate the safety and effectiveness of the physical device for its intended use in treating infrainguinal stenosis and occlusions, not to validate an AI/ML algorithm's performance against specific metrics.

Based on the provided text, here is the available information related to the clinical study and device performance, rephrased to fit the prompt's structure where possible, and explicitly noting missing AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the primary safety and effectiveness endpoints of the ABLATE clinical study for the physical device, not an AI/ML algorithm.

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 (Test Set): Not explicitly stated numbers of patients in the ABLATE clinical study.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The ABLATE study is referred to as a "clinical study," which typically implies a prospective design for gathering safety and effectiveness data for device approval.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: The "Angiographic Core Lab" is mentioned for assessing reduction in percent stenosis, implying expert (likely interventional cardiologists or radiologists specializing in vascular imaging) review, but no specific qualifications or numbers are provided.

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

• Not specified.

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. This is a physical device, not an AI/ML system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not conducted. The study evaluated the direct impact of the laser atherectomy catheter.

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

• No. This is a physical device, not an AI/ML algorithm. Standalone algorithm performance is not applicable.

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

For the physical device, the "ground truth" for effectiveness and safety endpoints included:

• Clinical Outcomes Data: Major Adverse Events (MAE) and Target Lesion Revascularizations (TLR) are clinical outcomes.
• Angiographic Assessment: "Mean reduction in percent stenosis at the time of the procedure by Angiographic Core Lab assessment" serves as a measure of the device's immediate effectiveness against a measurable anatomical change.

8. The sample size for the training set

• Not applicable. This is a physical device undergoing a clinical trial for safety and effectiveness, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a physical device approval, not an AI/ML algorithm.

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

The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.

The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is 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) guidewirecompatible 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 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 is used to photoablate multiple morphology lesions which mav 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.

The provided document is a 510(k) summary for the Spectranetics Turbo-Power (2.0mm) Laser Atherectomy Catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria, nor does it include information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The document mentions that various tests were conducted to validate and verify that the subject device met all acceptance criteria, as required by the risk analysis. These tests included:

• Design Verification and Validation Testing: Simulated Use Testing, Functional Testing, Physical Testing, Laser Testing.
• Sterilization: Product adoption equivalency per AAMI TIR:28-2009.
• Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity - Ames Test, Material Mediated Pyrogenicity.
• Pre-clinical Data: A pre-clinical GLP study was conducted to compare usability and procedural safety of the Turbo-Power (2.0mm) and Turbo-Power (2.3) laser catheters.

The document does not provide the specific acceptance criteria for these tests or the reported performance values against those criteria in a table format. It only states that the device "met all acceptance criteria." It also explicitly states that new clinical data was not required to demonstrate substantial equivalence, which means there isn't a human-in-the-loop or standalone study with clinical outcomes described here.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that testing was performed and the device "met all acceptance criteria," but it does not specify what those criteria were or the actual performance results in a quantifiable manner.

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

• Cannot be provided. The document mentions "Simulated Use Testing," "Functional Testing," "Physical Testing," "Laser Testing," and a "pre-clinical GLP study." However, it does not specify sample sizes for any of these tests or the data provenance (e.g., retrospective/prospective, country of origin). The pre-clinical study involved an "Ovine Model," indicating animal data.

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/Cannot be provided. This question typically applies to studies involving human interpretation or clinical endpoints. The document describes engineering, biocompatibility, and animal (ovine model) studies. It does not mention any studies where human experts established ground truth for a test set.

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

• Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving human assessment or interpretation, which are not detailed 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. The document explicitly states "New clinical data was not required to demonstrate substantial equivalence." An MRMC study would fall under clinical data. This device is a physical catheter, not an AI system.

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

• Not applicable. This device is a physical catheter, not an algorithm or AI system. Its performance is evaluated through engineering, biocompatibility, and pre-clinical animal studies, not standalone algorithmic performance.

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

• Cannot be fully specified. For the engineering tests, ground truth would likely refer to engineering specifications and performance benchmarks. For the biocompatibility tests, it would be established standards (e.g., ISO standards for cytotoxicity, sensitization). For the pre-clinical GLP study using an ovine model, ground truth would have been based on observations and measurements from the animal subjects related to usability and procedural safety as defined by the study protocol.

8. The sample size for the training set

• Not applicable. The document describes a medical device (catheter), not an AI system that requires a "training set."

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

• Not applicable. Same as point 8.

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The TightRail Sub-C 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 Sub-C 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 Sub-C is 15.5 cm.

The provided text describes a medical device, the "TightRail Sub-C Rotating Dilator Sheath," and its premarket notification (510(k)) to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria for a new, standalone device performance claim. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not available in this document because it pertains to the evaluation of a software algorithm or AI, which is not the subject of this medical device submission.

Here's a breakdown of the available information:

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

The document lists various design verification and validation tests performed to ensure the subject device met specifications and was substantially equivalent to its predicate. These are not acceptance criteria in the sense of a clinical trial's primary endpoints and statistical measures, but rather engineering and safety parameters.

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

• Not Applicable. This document describes engineering and biocompatibility testing for a physical device, not an algorithm being tested on a "test set" of data. No clinical studies were required or performed to demonstrate substantial equivalence 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:

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

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. This is a physical medical device, not an AI or software algorithm requiring an MRMC study.

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

• No. This is a physical medical device, not an algorithm.

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

• Not Applicable. For the engineering tests, "ground truth" would be established by validated measurement techniques, standards, and established laboratory protocols, rather than expert consensus on medical images or pathology.

8. The sample size for the training set:

• Not Applicable. This document describes a traditional 510(k) submission for a physical device, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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