(154 days)
The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.
The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature.
The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.
The provided document is a 510(k) premarket notification for a medical device, specifically a peripheral dilatation catheter. It details the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, this type of submission focuses on demonstrating equivalence rather than proving device performance against specific acceptance criteria for a new clinical claim or an AI algorithm.
Therefore, the requested information regarding acceptance criteria, study details for proving the device meets those criteria, and specifics about AI algorithms, ground truth, experts, and multi-reader studies cannot be fully extracted from this document. This document describes a traditional medical device (a catheter) and its mechanical/physical performance, not an AI-powered diagnostic or therapeutic device.
Here's a breakdown of what can be extracted and why other parts cannot:
What can be extracted (and partially inferred):
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Acceptance Criteria (Implied): The document states that "The new balloon sizes met all of the verification/validation acceptance criteria." While explicit numerical acceptance criteria are not listed, the types of performance tests performed serve as the basis for these criteria.
- Balloon compliance
- Balloon burst pressure
- Balloon fatigue
- Shaft resistance (Torque Test)
- Bond strength
- Catheter dimensions
- Deflation time
- Guide wire and introducer compatibility
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Study Proving Acceptance Criteria: The document mentions "bench testing" was performed. This refers to in-vitro (laboratory) testing, not human clinical trials or observational studies for typical AI device evaluation.
Information that CANNOT be extracted from this document, as it pertains to a different type of device (AI/diagnostic) and study design:
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A table of acceptance criteria and the reported device performance: While the types of tests are mentioned, the actual numerical acceptance criteria (e.g., "burst pressure > X atm") and the specific reported performance results are not included in this summary. It only states they "met all... criteria."
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Sample size used for the test set and the data provenance: This refers to patient data for AI algorithms. The "sample" here refers to physical catheter units tested in a lab, not a patient test set. The document does not specify the number of catheters tested for each bench test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a physical device like a catheter. Ground truth in this context would be engineering specifications and measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for bench testing of a physical device.
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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 not for an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the catheter, the "ground truth" for the bench tests would be established by validated test methods, engineering specifications, and industry standards, measured using calibrated equipment. This is not "expert consensus" in the diagnostic sense, nor is it pathology or outcomes data.
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The sample size for the training set: Not applicable. This device does not use a "training set" in the machine learning sense.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
This document describes the 510(k) clearance for the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter, which is a physical medical device. The submission focuses on demonstrating substantial equivalence to predicate devices for a line extension (new balloon diameter and lengths).
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Bench Tests Performed) | Reported Device Performance |
|---|---|
| Balloon compliance | Met all verification/validation acceptance criteria |
| Balloon burst pressure | Met all verification/validation acceptance criteria |
| Balloon fatigue | Met all verification/validation acceptance criteria |
| Shaft resistance (Torque Test) | Met all verification/validation acceptance criteria |
| Bond strength | Met all verification/validation acceptance criteria |
| Catheter dimensions | Met all verification/validation acceptance criteria |
| Deflation time | Met all verification/validation acceptance criteria |
| Guide wire and introducer compatibility | Met all verification/validation acceptance criteria |
(Note: Specific numerical criteria and performance values are not provided in this summary document, only the confirmation that the device "met all of the verification/validation acceptance criteria" for each listed test.)
2. Sample size used for the test set and the data provenance:
The document refers to "bench testing" performed on the modified catheter. The specific sample size (number of catheters tested) for each bench test is not provided. Data provenance is from in-vitro (laboratory) testing conducted by the manufacturer, Natec Medical Ltd. It is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of physical device bench testing, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by an expert consensus process involving human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, this was not done. This study is for a physical medical device (catheter), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for the bench tests would be defined by the engineering specifications, design requirements, and relevant industry standards against which the physical performance (e.g., burst pressure, dimensions) of the catheter units were measured and compared.
8. The sample size for the training set:
Not applicable. This device does not have a "training set" as understood in machine learning.
9. How the ground truth for the training set was established:
Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).