Search Results

The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are 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
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 a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.

Here's an analysis of the provided text based on your request:

It's important to note that the provided document (K091593) is a 510(k) summary for medical devices (AngioJet® Ultra DVX® and Xpeedior® Thrombectomy Sets). It describes hardware devices, not a software/AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI device's performance metrics (like accuracy, sensitivity, specificity) and a ground truth established by experts are not directly applicable here.

Instead, this summary focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, material comparisons, and similar indications for use.

Let's break down why most of your requested points cannot be directly answered from this document, and what can be inferred:

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

• Acceptance Criteria (for a hardware device in 510(k)): The acceptance criteria here are implicitly related to demonstrating that the device performs as intended and is as safe and effective as its predicate devices. This is achieved through various forms of testing.
• Reported Device Performance: The document states: "Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics."

Lack of Specifics for AI-focused questions:

The remaining questions (2-9) are designed for evaluating AI/software performance in a diagnostic or predictive context. This document, being for a physical medical device, does not contain the information needed to answer them.

• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an AI algorithm here. Bench testing uses representative device samples.
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. No ground truth established by experts for AI output here.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. An MRMC study is for evaluating human performance, often with and without AI assistance. This device is a tool, 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 hardware device.
• 7. The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks against which the bench testing is measured.
• 8. The sample size for the training set: Not applicable. This is not an AI algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The K091593 document describes a medical device (a thrombectomy set), not an AI algorithm. Therefore, the detailed questions about acceptance criteria, test sets, ground truth, and expert evaluation pertinent to AI or software are not addressed in this type of submission. The "study" proving its acceptance is the "mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics" and comparison to predicate devices, but the specifics of that testing are not provided in this summary.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device