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The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

The Houdini® Cross Support Catheter is a single use, bi-lumen intravascular catheter intended for percutaneous use. The Houdini® Cross Support Catheter is intended for use in the iliac. femoral, ilio-femoral and popliteal arteries. It is designed for use in conjunction with a standard commercially available off the shelf (OTS) 0.014" - 0.018" quidewire (not included) to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the Houdini® Cross Support Catheter provides the option of distal anchoring as well as physician-controlled extension of the inner shaft (up to 2 cm) to support the OTS guidewire during advancement.

The effective length of the Houdini® Cross Support Catheter is a nominal 100 cm. The inner lumen accommodates an OTS 0.014" - 0.018" spring-tipped guidewire. The inner lumen shaft allows for visualization under fluoroscopy due to the radiopague stainlesssteel design and additionally allows for continuous clinician control of the OTS guidewire for appropriate positioning.

If distal anchoring is desired, the Houdini® Cross Support Catheter requires the use of a commercially available OTS manual inflation device (not included). Once positioned within 2 cm of the user's target location, the catheter is inflated to 6 atm using diluted radiopaque contrast media to anchor the distal end of the catheter in the blood vessel. For additional support of the quidewire, the clinician may extend the location of the inner lumen shaft up to 2 cm distally without the need to reposition the anchoring balloon.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Houdini Cross Support Catheter." It focuses on demonstrating the device's substantial equivalence to previously cleared predicate devices.

Based on the provided text, the document describes the acceptance criteria and study proving the device meets those criteria primarily through a comparison to a predicate device and extensive bench/simulated use testing, rather than a clinical study involving human patients or AI performance metrics.

Therefore, I will extract relevant information where available and state "Not Applicable" or "Information not provided in the document" for aspects that are typically found in studies for AI/diagnostic devices but not for a catheter's 510(k) submission focused on substantial equivalence.

Here's the breakdown of the information requested:

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

The document does not present explicit "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device and satisfying functional and safety requirements through engineering bench testing and simulated use.

The "criteria" are implicitly tied to meeting the performance characteristics of the predicate device and established international standards (e.g., ISO 10555-1, ISO 10993-1). The "reported performance" is a general statement that the device "satisfies" these requirements.

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

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or clinical images, as this is a 510(k) for a medical catheter based on engineering and simulated use testing. For bench testing, samples of the physical device were used, but the exact number of units tested for each specific test is not provided.
• Data Provenance: The data provenance is from laboratory bench testing and simulated use. No patient data (retrospective or prospective) from specific countries or populations is mentioned because a clinical study with patients was not required for this type of device and submission.

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 document pertains to a medical catheter, not a diagnostic device or AI algorithm requiring expert interpretation of medical images or patient data to establish ground truth. Ground truth for device performance is established through engineering specifications, validated test methods (e.g., ISO standards), and comparative performance with predicate devices.

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

• Not Applicable. As there is no clinical test set requiring expert interpretation for ground truth, there is no adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This document is for a medical catheter, not an AI algorithm or a diagnostic device that would involve human readers or AI assistance.

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

• Not Applicable. This is not an AI algorithm.

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

• The "ground truth" for the device's performance is established through:
  • Engineering Specifications: The device is designed to meet specific physical and performance parameters (e.g., diameter, length, pressure resistance, guide wire compatibility).
  • International Standards: Compliance with ISO standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility) where the "ground truth" is adherence to these established safety and performance benchmarks.
  • Predicate Device Performance: The predicate device serves as a benchmark for "ground truth" in terms of expected functionality and safety. The new device must demonstrate that its performance characteristics are substantially equivalent.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of an AI algorithm thus there is no "training set" in the machine learning sense.

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

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

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The XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Score LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score LP catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in the one catheter length (150 cm), and longitudinal scoring element length (23cm).

The provided text is a 510(k) summary for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter. It focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional/safety testing, rather than an AI-driven medical device requiring a study with acceptance criteria for a new clinical indication or improved diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic context, a study proving the device meets that criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.

The "acceptance criteria" referred to in the document are for bench testing to validate and verify that the device is substantially equivalent to a predicate device, focusing on physical and functional characteristics of the catheter. This is different from the type of acceptance criteria and study design you're asking for, which typically apply to AI/software as a medical device (SaMD) or diagnostic devices that provide clinical information or assist human readers.

To be specific, the document explicitly states:
"The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria."
The listed tests are all bench tests (e.g., Biocompatibility, Kink Radius, Tensile Testing, Retrieval Force Testing, Device Recovery, Accessory PTA Balloon Catheter burst pressure, Torque, Cycling, Scoring Capability Assessment).

In summary, the provided text does not describe the type of study and acceptance criteria you've requested for an AI-driven or diagnostic device.

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The XO Cross is a support catheter intended to guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross Support Catheter is identical to the predicate device in that it is a single-lumen support catheter designed to support a guidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 15cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.

The provided text describes the submission for a 510(k) premarket notification for the XO Cross Support Catheter, which is a revised version of a previously cleared device. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

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

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

The document does not present a table of specific acceptance criteria with corresponding performance statistics for the device in terms of clinical outcomes or diagnostic accuracy. Instead, it details that "Verification & Validation activities were performed on the subject XO Cross Support Catheter to demonstrate substantial equivalence to the predicate device."

The closest the document comes to "acceptance criteria" and "reported performance" is in the context of the functional/safety testing and biocompatibility testing. For these, the acceptance criteria are generally "passed" or "met/exceeded" internal requirements and ISO standards.

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 does not provide details on a 'test set' in the context of clinical data or patient outcomes. The testing described is primarily pre-clinical (biocompatibility, engineering design verification). Therefore, information on sample size and data provenance for a clinical test set is not available.

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)

This information is not applicable to the provided document. The submission is for a medical device (support catheter), not an AI/diagnostic software. Ground truth, in the sense of expert consensus on imaging or pathology, is not part of this type of submission. The "ground truth" for the engineering and biocompatibility tests would be the established scientific methods and standards (e.g., ISO 10993-1, ISO 10555-1) and internal specifications.

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

This information is not applicable. There is no clinical 'test set' involving human interpretation or adjudication for this device submission.

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

This information is not applicable. The device is a physical support catheter and not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical support catheter, not an algorithm.

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

The "ground truth" for the evaluations performed is based on:

• International Standards: ISO 10993-1 for biocompatibility and ISO 10555-1 for catheter design verification.
• Internal Requirements: Transit Scientific's in-house specifications for design verification tests (e.g., radiopacity, tip ID, tensile, lubricity, durability, particulate, integrity, coaxial).

8. The sample size for the training set

This information is not applicable. The document does not describe the development of an AI algorithm with a training set. The descriptions relate to physical device design and manufacturing.

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

This information is not applicable. As there is no AI algorithm or training set discussed, this question is not relevant to the provided content.

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