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The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions in native peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

• 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
• 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (175cm Working Length)
• 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
• 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . (275cm Working Length)
• Safe-Cross RF System Console with Display and Footswitch .

The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within OCK mpat on the connector is alles. The RF connector is connected to the RF output on the vessol of havigation practical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Ice orosing 'Are wided in a separate peel pouch. The packaged RF Crossing Wire 1 on. 71 Torquer is provided oxide) and non-pyrogenic, and is intended for single use only.

The provided text is a 510(k) summary for the Safe-Cross® Radio Frequency Total Occlusion Crossing System. This type of document is for regulatory clearance based on substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through clinical studies. Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance) is not available in these FDA submission documents.

Here's a breakdown of what can be extracted from the document based on the request:

Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

• Same components and technological characteristics as the predicate device.
• Bench testing and software verification/validation conducted to qualify changes.
• Intended Use: Facilitating placement of devices in vascular interventions in native peripheral arteries with total occlusions (not for carotid arteries). This is the same as the predicate. |

Study Information:

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on bench testing and software verification/validation, not a clinical test set with human data for performance evaluation in a clinical context.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical performance studies (e.g., expert consensus on medical images) is not relevant here, as there isn't a clinical test set being evaluated in that manner.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no clinical test set requiring adjudication.

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: Not applicable. The device is a physical catheter system, not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an algorithm. Bench testing and software verification/validation were performed on the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated in terms of clinical ground truth. The "ground truth" for this submission would be defined by engineering specifications and functional performance metrics established during bench testing and software validation. These are evaluated against predetermined thresholds or against the performance of the predicate device.

7. The sample size for the training set: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that sense.

8. How the ground truth for the training set was established: Not applicable, for the same reason as above. If "training set" were interpreted as the data used for the design and development of the device, then the "ground truth" for design would be derived from clinical needs, engineering principles, and performance requirements for a device of this type.

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The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

• 175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
• 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
• Safe-Cross RF System Console with Display and Footswitch .

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The I he modified Sale-Cross RF Bystein is simmal nt a Y-Site hub that houses the optic proximal end of the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the imput on the console to anow the medical proceed to the RF couput on the digit vessel for havigation purposes. The re-over to provide discrete RF energy to the distal console: - This anoving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Kr Crossing Wire is packaged warate peel pouch. A rorquer is provided the oxide) and non-pyrogenic, and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Safe-Cross® Radio Frequency Total Occlusion Crossing System:

It's important to note that the provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial results with specific acceptance criteria in the way a PMA (Pre-Market Approval) or novel device application might. Therefore, the information available is focused on comparison to a previously cleared device and internal testing, which may not align with the standard format for reporting clinical study results to establish acceptance criteria for a new, unique claim.

Based on the provided document, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note on "Acceptance Criteria": In a 510(k), explicit "acceptance criteria" are often internal to the manufacturer's design controls and testing protocols. The public summary typically states that these criteria were met rather than detailing the specific numerical targets. The primary "acceptance criterion" for the FDA in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.

Detailed Study Information:

The document describes several types of studies performed, but it focuses on demonstrating substantial equivalence to a predicate device (K032031, also the Safe-Cross Radio Frequency Total Occlusion Crossing System). It does not present a traditional clinical study with explicitly defined acceptance criteria, sample sizes for test sets in human patients, or ground truth established by independent experts for a novel device claim.

Here's a breakdown based on the categories requested:

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

• Test Set (Human Data): Not applicable for a typical "test set" as understood in machine learning or a de novo clinical trial. This 510(k) relies on non-clinical data and comparison to a predicate device.
• Data Provenance:
  • Bench Testing: In vitro, conducted by the manufacturer (IntraLuminal Therapeutics, Inc.).
  • Animal Studies: In vivo, conducted by the manufacturer. No country of origin is specified for the animal studies, but the company is US-based.
  • Retrospective/Prospective: The testing described (biocompatibility, bench, animal, software validation) would be considered prospective for the purpose of demonstrating substantial equivalence for this modification, but it's not a prospective human clinical trial.

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

• This information is not provided as the submission does not detail an independent expert review process for a "test set" in the context of human data. The "ground truth" for this submission is based on engineering specifications, biocompatibility standards, and the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of an adjudication method as there's no "test set" of human cases with independent expert interpretation forming a ground truth.

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 performed. This device is a catheter guide wire system aiding in physical navigation, not an AI-powered diagnostic or assistive tool for human readers interpreting medical images.

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

• Not applicable. This is a medical device (catheter guide wire system) that requires human operation; it is not a standalone algorithm. The "software validation testing" mentioned is for the integrated console, not for an independent diagnostic algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: For bench and animal testing, the "ground truth" would be successful adherence to predefined engineering specifications, performance targets, and safety criteria relevant to the device's intended function and comparison to the predicate.
• Predicate Device Performance: The overarching ground truth is the established safety and effectiveness profile of the predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System cleared under K032031). The modified device aims to maintain or improve upon this.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device and its modifications, not a machine learning model requiring a "training set."

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

• Not applicable, as there is no training set for an algorithm in this context.

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The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

• 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
• 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
• 0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
• Safe-Cross Console with Display and Footswitch .

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR inout on the console to allow the medical practitioner to visualize structures within the wessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.

The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

The provided text describes a 510(k) submission for a medical device modification (Safe-Cross® RF TO Crossing System). This document is primarily focused on demonstrating substantial equivalence to a predicate device through biocompatibility, bench, and animal testing.

It does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The submission is for a modification to a catheter guide wire, which is a physical medical device, not an AI/ML system. Therefore, the questions related to AI/ML device performance metrics, sample sizes for AI/ML models, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document.

The document discusses "performance requirements of the device specifications" and "intravascular performance requirements in an animal model," but these are general statements about the device's physical function and safety, not specific quantitative acceptance criteria for an AI/ML algorithm.

Without the requested information from the provided text, I cannot complete the table or answer the specific questions about AI/ML device acceptance criteria and study details.

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The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

• 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
• 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
• Safe-Cross RF System Console .
  The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
  The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

This 510(k) summary (K033708) describes a medical device, the Safe-Cross® Radio Frequency Total Occlusion Crossing System, which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through performance and bench testing, rather than a clinical study involving human patients.

Therefore, many of the requested categories, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not directly applicable or reported in this type of submission.

Here's a breakdown of the available information:

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

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 for Test Set: Not applicable / Not specified for human testing. The testing was primarily in vitro bench testing and software testing.
• Data Provenance: Not applicable for human data. The testing was conducted by the manufacturer, IntraLuminal Therapeutics, Inc., likely at their facilities (Carlsbad, CA, USA). The nature of the testing (bench and software) is prospective for the device under evaluation.

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 relies on in vitro bench testing and software testing, not expert-adjudicated clinical data to establish ground truth.

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

• Not applicable. No clinical adjudication method was used as this was not a human study.

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 device (catheter guide wire system), not an AI/software product, and therefore, no MRMC study was conducted.

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

• Not applicable. This is not an algorithm-only device. The performance data refers to the physical device's characteristics and functionality. The "standalone" performance here refers to the device's ability to function according to specifications in a controlled, non-human environment. The "bench testing" represents this form of standalone evaluation.

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

• The "ground truth" for this submission is based on the device's predetermined engineering specifications and performance requirements. The bench testing and software testing confirmed that the modified device met these specifications, which serve as the "ground truth" for its safety and performance claims in this context.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" as this is not a machine learning or AI-driven device.

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

• Not applicable. No training set or ground truth for a training set was used.

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