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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 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 modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The The modified Bate-Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and 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 mible on the console to anow and more connector is connected to the RF output on the vessel for navigation purposes. al 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 the Safe-Cross® Radio Frequency Total Occlusion Crossing System (K050916), a catheter guide wire system. The summary focuses on its substantial equivalence to a predicate device and safety testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.

Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth types for AI performance evaluation is not available in the provided document, as it pertains to a mechanical medical device rather than an AI/ML system.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a mechanical device, the "acceptance criteria" are related to safety and performance requirements rather than statistical metrics against a benchmark. The document states:

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

• Sample Size: Not specified for biocompatibility, bench testing, or animal studies. The text only mentions "modified 0.014" RF Crossing Wires" for biocompatibility and "an animal model" for in vivo.
• Data Provenance: Not specified (e.g., country of origin). Both bench and animal studies are mentioned as "in vitro" and "in vivo," respectively, but whether they are retrospective or prospective is not stated, though animal studies are typically prospective.

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

• Not applicable/Not specified. This information is typically relevant for AI/ML studies where human experts establish ground truth. For this mechanical device, "ground truth" would be the direct measurement of physical properties or biological response in laboratory or animal settings, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth labeling in AI/ML studies. For device testing involving physical and biological measures, standard scientific protocols for data collection and analysis would be followed.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic technologies, particularly AI systems, with human readers. The Safe-Cross® system is an interventional device, not a diagnostic one.

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

• Not applicable. The device is a physical, interventional medical device and does not involve an AI algorithm operating "standalone."

7. The Type of Ground Truth Used:

• Bench Testing: Engineering specifications and physical measurements are the "ground truth" for bench testing.
• Biocompatibility: Standardized biological tests (e.g., cytotoxicity, sensitization, irritation) results compared against acceptance criteria for biological safety.
• Animal Studies: Observed physiological and pathological responses in an animal model—e.g., successful crossing of occlusions, lack of vessel damage, proper system function.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above, there is no training set.

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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 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)
• Safe-Cross RF System 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 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 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.

Acceptance Criteria and Device Performance

This 510(k) summary focuses on modifications to a previously cleared device. Therefore, the acceptance criteria are primarily demonstrated through verification that the modified device maintains the safety and performance of the predicate device and meets established design specifications. Specific numerical performance metrics or acceptance criteria are not explicitly detailed in the provided text as they would be in a submission for a novel device.

Study Details

The provided document describes studies conducted to support the substantial equivalence claim for the modified Safe-Cross® Radio Frequency Total Occlusion Crossing System.

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

• Test Set (Bench Testing): Not explicitly stated. The document mentions "Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications." This implies a set of tests were conducted, but the number of devices or iterations tested is not provided.
• Test Set (In Vivo Animal Studies): Not explicitly stated. The document mentions "In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model." The number of animals or specific experimental design details are not given.
• Data Provenance: The studies were conducted by IntraLuminal Therapeutics, Inc., likely at their facilities or through contracted labs. The data would be prospective, as it was generated specifically for this 510(k) submission. No country of origin for the data is specified beyond the company's location in Carlsbad, CA, USA.

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

• Not applicable/Not explicitly stated. For biocompatibility, bench testing, and animal studies, "ground truth" is typically established by objective measurements, scientific standards, and observation by qualified scientific personnel (e.g., toxicologists, engineers, veterinarians, or principal investigators) according to established protocols. The document does not specify the number or qualifications of experts beyond the company's internal R&D and QA teams.

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

• Not applicable/Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human interpretation of data (e.g., image reading). For the types of studies described (biocompatibility, bench, animal), results are generally objective and determined by predefined pass/fail criteria or statistical analysis, not by human adjudication of nuanced findings in the same way.

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 performed. This device is a medical instrument (catheter guide wire system), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in data interpretation.

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

• No. This device is a medical instrument, not an algorithm or software-only device. Its function intrinsically requires human operation.

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

• Biocompatibility: Ground truth is established by adherence to recognized standards (e.g., ISO 10993 series) and biological safety assessments based on specific tests (e.g., cytotoxicity, sensitization, irritation).
• Bench Testing: Ground truth is established by design specifications, engineering tolerances, and mechanical/electrical performance standards. Measurements are compared against these predefined criteria.
• In Vivo Animal Studies: Ground truth is established through direct observation of device function, physiological responses, and potentially histological examination in animal models, evaluated against expected normal biological function and safety parameters.

8. The sample size for the training set:

• Not applicable. The devices described are hardware medical devices, not AI models that require a "training set" in the computational sense. The "training" of the device is through design, manufacturing, and quality control processes.

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

• Not applicable, as there is no "training set" in the context of an AI model for this hardware medical device.

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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 ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The 0.018" Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the 0.018" Safe-Cross Deflecting Catheter is 135cm. The shaft deflecting segment maximum outside diameter is 4.3Fr at a use pressure of 10atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires.

The 0.018" Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.

The provided text is a 510(k) summary for a medical device (Safe-Cross® Deflecting Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with precise acceptance criteria and performance metrics. Therefore, many of the requested data points (e.g., sample sizes for test and training sets, expert qualifications, specific performance metrics against acceptance criteria, MRMC studies, standalone algorithm performance) are not included within this type of regulatory submission.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the device performs similarly to the predicate device and meets established safety and performance requirements for its intended use. Specific quantitative performance targets are not explicitly stated for parameters like sensitivity, specificity, or reader improvement, as would be common for AI/diagnostic software. Instead, the focus is on the device's physical and functional characteristics.

2. Sample Sizes and Data Provenance for Test Set

• Sample Size: Not specified. The document mentions "Biocompatibility and performance testing," but does not detail the number of units tested or whether human subjects were involved (unlikely for this type of 510(k) for a catheter enhancement). These tests are typically benchtop or in vitro, and sometimes an in vivo animal study, but the specifics are not provided.
• Data Provenance: Not specified. Given the nature of a 510(k) for mechanical changes to a catheter, the data would primarily be from internal laboratory/bench testing. It is not clinical data from patients or countries of origin in the way typical of AI models. It is entirely retrospective on the device itself.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts/Qualifications: Not applicable in the context of this device. Ground truth for a physical medical device like a catheter is established through validated engineering specifications, material science, and performance testing against industry standards, not through expert consensus on images or clinical outcomes.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. There is no concept of "adjudication" in the sense of reconciling expert opinions for establishing ground truth for a physical device's specifications.

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

• MRMC Study: No. This is a physical medical device (catheter), not an AI algorithm or diagnostic imaging tool that would involve human readers interpreting cases with or without AI assistance.

6. Standalone Performance Study

• Standalone Performance: Yes, in an engineering and functional sense. The "performance testing" described in the document is a standalone evaluation of the device's physical and functional characteristics (e.g., integrity, flow capacity, deflection mechanism, guidewire compatibility) according to its design specifications. It is not an "algorithm-only" performance in the context of AI.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on engineering specifications and established industry standards for catheters (e.g., material strength, dimensions, coating integrity, sterility validation) and comparison to the performance of the predicate device. It is not pathology, expert consensus on imaging, or patient outcomes data directly.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set" of data.

9. How Ground Truth for Training Set was Established

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

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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 percutaneous interventions in native coronary arteries with total occlusions.

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:

• 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
• Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
• Safe-Cross RF Generator with Footswitch and Interface Cable .
  The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. 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 Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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 sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

The provided text describes the Safe-Cross Radio Frequency Total Occlusion Crossing System, a medical device, and its regulatory submission. It mentions human clinical studies were conducted to verify the device's safety and performance, but it does not provide specific acceptance criteria or detailed results of those studies in a quantifiable manner.

Therefore, I cannot populate the table or answer all of your questions directly from the provided text.

However, I can extract the information that is present and indicate where information is missing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states a general conclusion that the device performs as intended and does not pose unacceptable risks, but it does not provide the specific numerical acceptance criteria (e.g., "successful crossing of occlusion in X% of cases") or the achieved performance metrics (e.g., "successful crossing in Y% of cases").

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

• Sample Size for Test Set: Not specified. The document only states "Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System."
• Data Provenance: Prospective human clinical studies. The country of origin is not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document does not detail how the outcomes of the clinical studies were assessed or by whom.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study Done?: Not applicable. This device is a guidewire system, not an imaging or diagnostic AI requiring human reader comparison. The "clinical studies" mentioned are likely efficacy and safety trials demonstrating the device's ability to cross occlusions.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study Done?: Not applicable in the context of an "algorithm only" study. This is a physical medical device (guidewire system) operated by a human, not a standalone AI algorithm. The device's performance inherently involves human interaction.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for performance and safety would be established through clinical outcomes observed during the human clinical studies, likely including successful occlusion crossing, procedural success rates, and the incidence of adverse events, as assessed by the treating physicians and study investigators.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The development and testing would involve bench testing and animal studies prior to human clinical trials.

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

• How Ground Truth for Training Set Was Established: Not applicable as there is no "training set" in the AI sense. For the development and pre-clinical stages, "ground truth" for design and performance would be established through engineering specifications, bench testing results (e.g., force required to cross simulated occlusions, RF power output, durability), and animal study observations (e.g., successful crossing in animal models, tissue effects). These would typically be compared against predetermined design requirements and safety parameters.

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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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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 (RF) Total Occlusion (TO) Crossing System consists of a 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-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
• Safe-Cross RF Generator with Footswitch and Interface Cable .
  The Safe-Cross RF Crossing Wires are similar to the predicate guidewires in construction and intended use. 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 Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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 sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

The provided text describes the Safe-Cross Radio Frequency Total Occlusion Crossing System, but it does not contain acceptance criteria for the device or a dedicated clinical study report outlining specific performance metrics against such criteria.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, and predicate devices.
• Device Description: Components of the system (crossing wires, OCR Unit, RF Generator) and their function.
• Intended Use: Facilitating placement of devices in vascular interventions for total occlusions in native iliac and superficial femoral arteries.
• Technological Characteristics: Similarity to predicate devices.
• Biocompatibility and Performance Data: Mentions that biocompatibility testing, in vitro bench testing, and in vivo animal studies were conducted, and that results "satisfy safety and performance requirements of the device specifications" and "do not raise unanticipated safety issues."
• Clinical Studies: States that human clinical studies were conducted to "verify the safety and performance characteristics..." and concluded that the device "performs as intended and does not involve unacceptable risk to the patient."
• Conclusion: The system is "substantially equivalent" to predicate devices.
• FDA K031842 Clearance Letter: Confirms clearance and reclassification.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide specific details about a study that proves the device meets those criteria, as this information is not present in the provided text.

The document implies that general safety and performance criteria were met through bench, animal, and human clinical studies, but it does not quantify these criteria or provide the results in a comparative format.

Based on the provided text, the following sections cannot be answered with specific details:

• 1. A table of acceptance criteria and the reported device performance (Not provided).
• 2. Sample sized used for the test set and the data provenance (Not provided, beyond "human clinical studies" in general).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not provided).
• 4. Adjudication method (Not provided).
• 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 provided; this device is a guidewire system, not an AI diagnostic tool involving human readers).
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not provided; this device is a guidewire system, not an algorithm).
• 7. The type of ground truth used (Not specified beyond "safety and performance in human subjects").
• 8. The sample size for the training set (Not provided).
• 9. How the ground truth for the training set was established (Not provided).

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The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guidewires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The Safe-Cross Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The effective length of the Safe-Cross Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guidewires.

The Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE". "Non-Pyrogenic" and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device called the "ILT Safe-Cross® Deflecting Catheter." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive performance studies against pre-defined acceptance criteria for efficacy or diagnostic performance. Instead, the "acceptance criteria" here refer to the functional performance requirements of the device and its biocompatibility, which are typically met through bench testing and standard biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly list "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI-based device's performance. Instead, it discusses the device's functional characteristics and how its performance was evaluated against these.

• Effective length: 135-140 cm
• Shaft nominal O.D.: 2.5 F (0.033")
• Max O.D. of deflecting segment: 3.5 F (0.045") at 10 atm
• I.D. at tip: 0.016"
• Accommodates 0.014" guidewires |
  | Sterility | Device must be sterile. (Implicit) | "The packaged units are sterilized with ethylene oxide gas. The device is provided 'STERILE'." |
  | Pyrogenicity | Device must be non-pyrogenic. (Implicit) | "'Non-Pyrogenic'" |

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 refers to "bench studies" and "biocompatibility testing." These types of studies typically involve a set number of manufactured devices tested against engineering specifications and biological safety standards. However, the exact sample sizes for these tests are not specified in the provided text. The data provenance is also not specified, though it would originate from the manufacturer's testing facilities. These were likely prospective tests performed on newly manufactured devices.

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 as the device is a medical catheter, not a diagnostic device relying on expert interpretation of data or images to establish ground truth for performance. The "ground truth" for this device's performance would be objective measurements against engineering specifications and standard biocompatibility assay results.

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

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation of medical data where there's a need to resolve discrepancies between multiple readers.

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

An MRMC study was not done. This device is a physical catheter, not an AI or imaging-based diagnostic system. Therefore, there's no concept of human readers or AI assistance in its direct use or evaluation in the context of this 510(k) submission.

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

This is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Measurements of physical dimensions, flexibility, pushability, torqueability, and other mechanical properties against pre-defined design criteria.
• Standard Biocompatibility Test Results: Objective results from assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) performed according to international standards (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

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