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The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

The ENABLER-P Catheter System is comprised of the ENABLER-P Catheter, the ENABLER Pressure Control Unit (PCU), and accessories including a sterile cover, syringe, manifold and extension tube.

The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire 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 ENABLER-P Catheter, using a distal balloon, can provide distal anchoring and support the advancement of the guidewire.

The ENABLER Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon.

The provided 510(k) summary for the EndoCross ENABLER-P Catheter System describes a device intended for use in the peripheral vasculature. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.

This document is for a traditional medical device (catheter system) and the regulatory pathway is focused on demonstrating "substantial equivalence" to predicate devices, rather than establishing performance against pre-defined metrics in a clinical study with a ground truth.

Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types/establishment for training sets) are not applicable to this specific 510(k) submission.

Here's a breakdown based on the information provided and what is implied by a traditional medical device submission:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. The submission emphasizes "substantial equivalence" to predicate devices rather than meeting specific quantifiable performance criteria like sensitivity, specificity, or accuracy that would be found in an AI/ML device submission. The performance assessment is qualitative, stating that "Performance test results indicate that the device satisfies functional performance requirements when used as indicated."

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 device is a catheter system, and its performance is evaluated through bench testing and in vivo studies, not typically against a "test set" of clinical data in the way an AI/ML algorithm would be. The document mentions "in vitro bench studies, and in vivo studies" but does not provide specific sample sizes or data provenance for these studies in the context of a "test set."

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. Ground truth in the context of expert consensus on clinical data is not relevant for this type of traditional device submission. Performance is assessed through engineering tests and non-clinical studies.

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

• Not Applicable. Adjudication methods for a "test set" are not relevant here as the performance evaluation is not based on interpreting clinical data where human expert disagreement would need resolution.

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. MRMC studies are specific to evaluating diagnostic systems, particularly AI/ML-assisted ones. This is a catheter system, not a diagnostic AI.

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

• Not Applicable. This is a physical medical device (catheter system), not an algorithm.

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

• Not Applicable. For a physical device like this, "ground truth" would relate to engineering specifications, material properties, and biological responses (e.g., biocompatibility). The document states: "Biocompatibility test results indicate that the device is biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated." This suggests that the "ground truth" is defined by pre-determined engineering and biological standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

• Not Applicable. See point 8.

Summary of the Study (as described in the 510(k) document):

The submission for the ENABLER-P Catheter System relies on "Biocompatibility testing, in vitro bench studies, and in vivo studies" to demonstrate the device's characteristics. The primary argument for clearance is Substantial Equivalence to legally marketed predicate devices (ENABLER-P Catheter manufactured by Endocross, Medtronic Everest 20cc Inflation Device, and Angiometrx Metricath System). The rationale is that the device has the "same intended use" and "similar technological characteristics" as the predicates, and that "[a]ny differences in technological characteristics or principles do not raise new questions of safety or efficacy."

Therefore, the "study" proving the device meets its requirements is essentially the set of these non-clinical tests and the comparative analysis against the predicate devices to establish substantial equivalence under the 510(k) pathway. Specific performance metrics, acceptance criteria, or clinical study endpoints as would be required for an AI/ML device are not detailed as they are not typically part of this type of submission.

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The ENABLER-P 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 ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire 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 ENABLER-P Catheter can provide distal anchoring and support the advancement of the guidewire. The ENABLER-P Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.

The provided text describes the 510(k) summary for the EndoCross ENABLER-P Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with specific acceptance criteria related to disease detection or diagnosis based on imaging or other data.

Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission, as it concerns a physical medical device (a catheter) and its mechanical/biocompatibility performance, not an AI or diagnostic algorithm.

Here's an analysis based on the provided text, indicating where information is not applicable (N/A):

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

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: Not explicitly stated for performance testing. The text mentions "in vitro bench studies and animal studies" but does not quantify the sample sizes for these studies.
• Data Provenance: Not explicitly stated. The applicant, EndoCross Ltd, is located in Israel, but the location of the studies is not specified. The studies are likely prospective, as they are conducted to evaluate the new device.

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)

• N/A. This device is a catheter, not a diagnostic or AI device that requires expert-established ground truth for interpretation. Performance is assessed through engineering bench tests, animal studies, and biocompatibility testing.

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

• N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in diagnostic studies. This is a physical device with objective performance metrics (e.g., tensile strength, burst pressure, maneuverability in a model, biocompatibility assay results).

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. This is a physical medical device (catheter), not an AI or diagnostic tool. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device. "Standalone performance" in the context of AI applies to algorithms making decisions independently, which is not relevant for a catheter's performance evaluation.

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

• The "ground truth" for this device's performance relies on objective measurements from in vitro bench testing (e.g., mechanical properties, functional operation in models) and biological responses observed in biocompatibility tests and animal studies. It's not a diagnostic ground truth like pathology.

8. The sample size for the training set

• N/A. There is no "training set" in the context of evaluating a physical medical device like a catheter. This term applies to machine learning algorithms.

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

• N/A. As there is no training set, this is not applicable.

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The ENABLER-P 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 ENABLER-P Support Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire 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 ENABLER-P Support Catheter can provide distal anchoring and support the advancement of the guidewire.
The ENABLER-P Support Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The ENABLER-P Support Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices.

The provided text describes a 510(k) summary for a medical device, the ENABLER-P Support Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device would.

Therefore, the information regarding acceptance criteria, study details like sample size, ground truth, expert involvement, and comparative effectiveness studies (MRMC, standalone) as requested for an AI/ML device is not applicable to this 510(k) submission.

The document indicates that the device's substantial equivalence was established through:

• Biocompatibility testing: Results indicated that the device materials are biocompatible.
• In vitro bench studies: These studies were conducted to evaluate performance characteristics.
• Animal studies: These were also conducted to evaluate performance characteristics.

The conclusion is that "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." However, specific numerical acceptance criteria and reported performance metrics are not detailed in this summary.

In summary, for the ENABLER-P Support Catheter, the following information is not available in the provided text, as it is typical for a 510(k) pathway for a conventional medical device rather than an AI/ML device requiring clinical performance metrics:

1. Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence based on material and functional characteristics rather than specific quantifiable performance metrics against pre-defined clinical acceptance criteria.
2. Sample size used for the test set and data provenance: No "test set" in the context of an AI/ML algorithm is mentioned. The studies were biocompatibility, in vitro bench, and animal studies, for which sample sizes are not detailed.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI/ML model is not relevant here.
4. Adjudication method for the test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI/ML diagnostic tool meant to assist human readers.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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