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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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(165 days)
ANGIOJET ULTRA POWER PULSE KIT
The AngioJet® Ultra Power Pulse® Kit is intended for use only with AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.
AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red. The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids. The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set.
This document is a 510(k) summary for the AngioJet Ultra Power Pulse Kit. It describes the device, its intended use, and a comparison to a predicate device, as well as performance data.
Here's the 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 state acceptance criteria in a quantitative manner (e.g., "X% accuracy," "Y mm deviation"). Instead, it outlines the types of tests performed to demonstrate substantial equivalence to a predicate device. The "acceptance" is implied by the successful completion of these tests, confirming that the new device material (DEHP-free tubing) performs equivalently to the previous version.
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Physiochemical, Pyrogenicity, Hemolysis) | Passed/Conformed to ISO 10993 standards. (Verified new device material is substantially equivalent to predicate devices.) |
| Mechanical Integrity (Clamp open/close, Leak, Component separation) | Passed/Conformed to requirements. (Verified new device material is substantially equivalent to predicate devices.) |
| Functional Design Equivalence | Demonstrated similar functional design to the predicate. |
| Indications for Use Equivalence | Demonstrated same intended use as the predicate. |
| Principles of Operation Equivalence | Demonstrated similar principles of operation to the predicate. |
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 specific sample sizes for the bench and laboratory testing. It just states that "Bench and laboratory testing was performed." There is no information about the country of origin or whether the data was retrospective or prospective.
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 type of information is not relevant or provided in this document. The testing described is primarily mechanical and biocompatibility, which typically relies on laboratory standards and instrumental measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing did not involve expert adjudication in the context of clinical or diagnostic performance.
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 catheter kit, not an AI-powered diagnostic system. No MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" would be established by the respective ISO 10993 standards and their defined limits for various biological responses. For mechanical integrity, the "ground truth" would be the engineering specifications and performance requirements for the device components (e.g., force required for clamp actuation, acceptable leak rates).
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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(11 days)
ANGIOJET ULTRA DVX THROMBECTOMY SET
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from :
- upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
- . upper extremity peripheral veins ≥ 3.0mm in diameter,
- ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
- A-V access conduits > 3.0mm in diameter and o
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
This document (K113428) is a 510(k) premarket notification for a medical device called the AngioJet Ultra DVX Thrombectomy Set. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through extensive clinical studies like those for novel AI/ML devices or entirely new technologies.
Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission as it relates to a device with limited design changes from its predicate.
Here's an analysis based on the provided document, addressing what is present and noting what is absent:
Acceptance Criteria and Study for AngioJet Ultra DVX Thrombectomy Set (K113428)
The device is a PIVOTAL device in so much that it is a modified version of an existing device. The acceptance is based on equivalency to a device that has already established safety and efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are not framed as specific performance metrics against an outcome (e.g., disease detection accuracy), but rather as a demonstration of equivalent performance and safety compared to its predicate devices despite a minor design change. The design change involved making the distal section more robust for guide wire use.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from Submission) |
|---|---|
| Functional Equivalence (after design modification) | Bench testing was performed to support a determination of substantial equivalence. The device maintains similar functional design, materials, indications for use, and principles of operation to the predicate. |
| Safety - Catheter Operational Characteristics | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Leakage | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Guide Wire Compatibility | Testing performed (directly related to the design modification); results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a key test given the design change. |
| Safety - Tracking | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Extended Use | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Hemolysis Ratio | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Distal Emboli | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This is a critical safety consideration for thrombectomy devices. |
| Safety - Catheter Tip Temperature | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). |
| Safety - Mechanical Integrity (tensile, compression, torque) | Testing performed; results "provide assurance that the proposed device conforms to the requirements for its intended use." (Specific numerical results not provided in summary). This confirms the new design's mechanical robustness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in this 510(k) summary. The testing refers to "bench testing" which typically involves a set number of units or iterations of the device in a laboratory setting. This is not a clinical study involving patient data.
- Data Provenance: N/A. The data comes from internal bench testing (laboratory experiments) conducted by the manufacturer, MEDRAD, Inc. It is not patient data from a specific country, nor is it retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. Since this involves bench testing of a device rather than interpretation of medical images or patient outcomes, there are no "experts" establishing a "ground truth" in the clinical sense. The ground truth for bench tests is typically established by engineering specifications, validated test methods, and measurement against known standards.
4. Adjudication Method for the Test Set
- N/A. No adjudication method is applicable as this is bench testing, not an assessment requiring consensus among human interpreters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is compared. This device is a mechanical thrombectomy device, and its performance is evaluated through engineering bench tests, not comparative reading studies.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- N/A. This device is a physical medical device (catheter and pump set), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and hydraulic functions.
7. The Type of Ground Truth Used
- For this device, the "ground truth" for the bench testing is defined by engineering specifications, physical measurements, and compliance with industry standards relevant to catheter performance, mechanical integrity, and biological interactions (e.g., hemolysis). It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- N/A. There is no "training set" as this is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- N/A. Not applicable, as there is no training set for this type of device.
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(65 days)
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
- . Upper and Lower extremity peripheral arteries > 3 mm in diameter
- . Upper extremity peripheral veins > 3 mm in diameter
- Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
- . AV access conduits > 3 mm in diameter and
- . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
- Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
- Upper extremity peripheral veins > 3 mm in diameter .
- lleofemoral and lower extremity veins > 3 mm in diameter .
- . A V access conduits > 3 mm in diameter and
- For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are 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 bloodstream where the catheter is positioned.
The provided text is a 510(k) summary for the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets. This document outlines the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in clinical trials for new medical device approvals or AI/CAD performance assessment.
Instead, the provided text describes an administrative change to a previous 510(k) clearance and the original 510(k) submission which focuses on demonstrating substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and principles of operation, supported by bench and biocompatibility testing.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document focuses on regulatory clearance through substantial equivalence, not on novel performance evaluation against specific metrics like sensitivity, specificity, etc., usually associated with acceptance criteria for new or AI-powered devices.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided: The document does not define specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or similar quantitative metrics) for the device's performance in breaking apart and removing thrombus. It also does not report specific device performance statistics against such criteria. The "Supporting Information" section mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions," but it doesn't detail performance metrics or acceptance criteria for these tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided: The document does not describe a clinical "test set" in the context of diagnostic or AI performance evaluation. The testing mentioned is "Bench and biocompatibility testing," which are typically laboratory-based and do not involve patient data in the same way as a clinical test set for AI/CAD. Therefore, data provenance (country, retrospective/prospective) for such a test set is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided: No "ground truth" establishment by experts for a clinical test set is mentioned. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial evaluating diagnostic accuracy against a gold standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided: No clinical test set or adjudication process is 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:
- Cannot be provided: This device is a mechanical thrombectomy set, not an AI or imaging diagnostic aid for which an MRMC study comparing human readers with and without AI assistance would be relevant. The document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided: This device is a physical medical device (catheter) used by a medical professional. It is not an algorithm, so the concept of "standalone performance" for an algorithm is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided: As no clinical test set for diagnostic accuracy is described, no ground truth type is specified. The assessment here is about the device's physical properties and intended function (breaking apart and removing thrombus), likely evaluated through engineered performance tests and simulations, rather than diagnostic "ground truth."
8. The sample size for the training set:
- Cannot be provided: This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Cannot be provided: Not applicable as there is no AI algorithm or training set discussed.
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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:
-
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.
-
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.
-
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.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: This device is an embolectomy catheter, not an AI diagnostic tool, so an MRMC study is not applicable in this context.
-
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.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, beyond general "Bench and biocompatibility testing."
-
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.
-
9. How the ground truth for the training set was established: Not applicable for this type of device.
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(14 days)
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm 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.
This is a premarket notification (510(k)) for a medical device, the AngioJet Ultra Spiroflex VG Thrombectomy Set, not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance metrics, sample size for AI test sets, expert ground truth, MRMC studies, or training set details) is not applicable or present in this document.
The document describes the device, its intended use, and states that it underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, and comparative testing to demonstrate appropriate functional and performance characteristics.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Design | Similar to predicate devices |
| Materials | Similar to predicate devices |
| Indications for Use | Similar to predicate devices |
| Principles of Operation | Similar to predicate devices |
| Mechanical Testing | Passed (demonstrated appropriate functional and performance characteristics) |
| Biocompatibility | Passed |
| Sterility | Passed |
| Comparative Testing | Passed (demonstrated appropriate functional and performance characteristics) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "Representative samples of the devices underwent bench testing."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was laboratory/bench-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. Testing involved engineering and analytical methods.
4. Adjudication method for the test set:
- Not applicable. Testing was based on engineering and performance standards, not expert adjudication of diagnostic outcomes.
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 is not an AI/ML device; an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a thrombectomy set, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation would be defined by established engineering specifications, material standards, sterility standards, and functional performance benchmarks consistent with the predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable; this is not an AI/ML 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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(47 days)
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter.
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm 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.
I am sorry, but the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the AngioJet Ultra XMI, XVG, and Spiroflex Thrombectomy Sets, indicating they are substantially equivalent to previously cleared predicate devices.
The "Functional and Safety Testing" section states that "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." However, it does not provide details on:
- Specific acceptance criteria (e.g., minimum thrombus removal efficacy, max embolization rate).
- Quantitative results of these tests against acceptance criteria.
- The sample size used for the test set.
- Data provenance.
- The number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Training set sample size or how ground truth for it was established.
Without this information, I cannot complete the table or answer the specific questions about acceptance criteria and study details.
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(24 days)
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
This document is a 510(k) summary for the AngioJet Ultra DVX Thrombectomy Set, which is a medical device intended to remove thrombus from peripheral arteries and veins. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and study details.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." (No specific performance metrics are reported) |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The document mentions "representative samples" for bench testing.
- Data provenance: Not specified. These are likely internal lab tests (bench testing) and not human clinical data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. The document describes bench testing, not a study involving ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable. As above, this was bench testing, not a study requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
- No. The document does not mention an MRMC comparative effectiveness study. It states "comparative testing to demonstrate appropriate functional and performance characteristics" but this refers to comparison with predicate devices, not human readers with and without AI assistance.
- Effect size: Not applicable, as no such study was performed.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- The device is a physical thrombectomy set used in a medical procedure, not an AI algorithm. Therefore, a standalone (algorithm only) study is not applicable. The bench testing performed could be considered a form of standalone performance evaluation for the physical device.
7. Type of ground truth used:
- For the described bench testing, the "ground truth" would be established by the physical and chemical properties measured during mechanical, biocompatibility, and sterility tests. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.
8. Sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI model.
In summary:
This 510(k) notification focuses on demonstrating substantial equivalence of the AngioJet Ultra DVX Thrombectomy Set to predicate devices based on functional design, materials, indications for use, and principles of operation, supported by bench testing. It does not provide the detailed information about acceptance criteria or a study with expert-adjudicated ground truth and clinical performance metrics that would be typically found for diagnostic AI devices.
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(78 days)
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
The AngioJet Ultra XPEEDIOR Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥ 3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Ultra XPEEDIOR Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra XPEEDIOR Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text is a 510(k) summary for the AngioJet Ultra XPEEDIOR Thrombectomy Set, indicating that Possis Medical, Inc. considers the device to be substantially equivalent to previously cleared predicate devices.
However, the document does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes for testing, ground truth establishment methods, expert qualifications, or comparative effectiveness studies (MRMC) with specific effect sizes.
The "Functional and Safety Testing" section (page 4) broadly states: "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a general statement about the types of tests performed but lacks any specific results or details that would allow for filling out the requested table and information.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided.
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