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510(k) Data Aggregation
(80 days)
ANGIOJET ULTRA AVX THROMBECTOMY SET
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text describes a 510(k) submission for the AngioJet® Ultra AVX® Thrombectomy Set, which is a medical device and not an AI/ML software device. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.
However, I can extract the relevant acceptance criteria and study information available for this medical device from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | o Cytotoxicity (ISO 10993-5) | Testing performed, results provide assurance of conformity. |
| O Sensitization (ISO 10993-10) | Testing performed, results provide assurance of conformity. | |
| o Intracutaneous Reactivity (ISO 10993-10) | Testing performed, results provide assurance of conformity. | |
| o Acute Systemic Toxicity (ISO 10993-11) | Testing performed, results provide assurance of conformity. | |
| o ASTM Hemolysis (ISO 10993-4) | Testing performed, results provide assurance of conformity. | |
| o Material Mediated Pyrogen (ISO 10993-11) | Testing performed, results provide assurance of conformity. | |
| o Physiochemical (ISO 10993-18) | Testing performed, results provide assurance of conformity. | |
| Design Verification | o Operation Pressure | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. |
| o Net Evacuation | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Infusion rate | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Extended Use | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Dimensional testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o System leak testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Contrast Injection | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Guide Wire Passage | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Mechanical Integrity testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| Overall Equivalence | Substantially equivalent to predicate device (K082382 AngioJet Ultra AVX Thrombectomy Set) | Based on similarities in functional design, materials, indications for use, and principles of operation. |
2. Sample size used for the test set and the data provenance
The document states that "Bench and laboratory testing was performed" for biocompatibility and design verification. It does not specify a "test set" in the context of patient data or a specific sample size for a test set. This device is a physical medical device, not an AI/ML algorithm that processes data.
3. 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 AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this device's non-clinical testing. The "ground truth" for the device's performance is established by meeting predefined engineering and biocompatibility specifications through bench and lab testing.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for human review of AI outputs or image interpretation, which is not the nature of this 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
Not applicable. This device is a thrombectomy set, a physical medical instrument, not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used
For biocompatibility, the ground truth is established by the specifications defined in the ISO 10993 standards. For design verification, the ground truth is established by engineering specifications for operational pressure, evacuation, infusion rate, dimensions, leak thresholds, etc.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(115 days)
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.
The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set, indicating its substantial equivalence to a predicate device. It briefly mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned." However, the document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria, as requested.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
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1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document only generally states that "Bench and biocompatibility testing supported" certain aspects.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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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 provided.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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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 device is an embolectomy catheter, not an AI diagnostic tool, so an MRMC study is not applicable in this context.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is an embolectomy catheter, not an AI algorithm. Its performance is inherent to its physical design and function, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, beyond general "Bench and biocompatibility testing."
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8. The sample size for the training set: Not applicable for this type of device, as it's not an AI model requiring a training set.
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9. How the ground truth for the training set was established: Not applicable for this type of device.
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(48 days)
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on functional and safety testing. However, it does not detail specific acceptance criteria or a dedicated study with performance metrics in the format requested.
Therefore, I cannot provide the information in the requested table format regarding acceptance criteria and device performance based solely on the provided text. The document refers generally to "bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a broad statement and does not specify the quantitative criteria or the results of such tests.
Furthermore, the document does not contain information about:
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set (as this is not an AI/ML device per the document).
- How ground truth for the training set was established.
This document is a regulatory submission for a medical device (thrombectomy set) based on substantial equivalence to predicate devices, not an AI/ML-based device requiring detailed performance metrics and ground truth establishment in the way the prompt implies.
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