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Evacuate air and/or fluid from the chest cavity or mediastinum
Help re-establish lung expansion and restore breathing dynamics
Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Not Found

The provided text is an FDA 510(k) clearance letter for the "Atrium eDrain Chest Drainage System." It does not contain information about acceptance criteria, device performance, study details, ground truth, or sample sizes for an AI/ML powered device. The letter is a regulatory document confirming clearance for a traditional medical device (a powered suction pump) and references general manufacturing and labeling requirements.

Therefore, I cannot extract the requested information from this document.

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The Atrium Graduated Wall Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Atrium Graduated Wall Flixene IFG Graft

The provided document is a 510(k) premarket notification letter from the FDA regarding a vascular graft device, not an AI/ML medical device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies.

The document discusses the substantial equivalence of the "Atrium Flixene IFG Vascular Graft" to a predicate device and its indications for use in arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access.

To provide the requested information, a document describing a study conducted on an AI/ML medical device would be necessary.

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Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.

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The input provided is a 510(k) clearance letter from the FDA for a surgical mesh device, Atrium C-QUR RPM Mesh. This document is related to medical device regulation and describes the process of obtaining clearance for a physical medical device (surgical mesh), not a software-as-a-medical-device (SaMD) or an AI-based diagnostic tool.

Therefore, the concepts of "acceptance criteria," "study," "sample size for test set," "ground truth," "MRMC study," "standalone performance," and "training set" as described in the prompt are not applicable to this type of device and document. These criteria are specifically for evaluating the performance of AI algorithms or diagnostic tools, which rely on data analysis and interpretation.

The provided document simply states that the Atrium C-QUR RPM Mesh is substantially equivalent to legally marketed predicate devices. This equivalence is typically established through preclinical testing (e.g., biocompatibility, material properties) and/or sometimes clinical use data if a novel feature is introduced, but not through the type of performance study outlined in the prompt for AI/diagnostic software.

In summary, none of the requested information regarding acceptance criteria, study details, and AI-specific performance metrics can be extracted from this document because it pertains to a physical surgical mesh, not an AI device.

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The ClearWay™ RX NB is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Atrium ClearWay™ RX NB Catheter." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States that the device is a Class II medical device.
• Lists the product's indications for use.
• Outlines FDA regulations and compliance information.

Therefore, I cannot provide the requested information based on the input document.

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The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a vascular graft, which primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities. It does not include details about device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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For localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

ClearWay OTW catheter

I apologize, but the provided text is a 510(k) clearance letter from the FDA for the Atrium Medical Corp. ClearWay OTW catheter. This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device and does not contain information about acceptance criteria or specific study data to prove the device meets those criteria.

Therefore, I cannot extract the requested information, such as acceptance criteria tables, sample sizes, expert qualifications, or details about standalone or MRMC studies, because this information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report or a technical performance specification.

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The Atrium C-Qur TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.

The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.

The provided text describes a 510(k) premarket notification for a medical device modification, the Atrium C-Qur™ OVT Mesh. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a novel device.

Therefore, many of the requested elements for a detailed study on device performance and acceptance criteria are not explicitly available in the provided text. The document states "Results of verification testing indicate that the product meets the established performance requirements" but does not detail what those requirements are, what performance was reported, or the methodology of the verification testing.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified. The document refers to "verification testing" but does not indicate if this involved human clinical data, animal studies, or bench testing on the device. Therefore, information regarding "country of origin of the data," "retrospective or prospective" is not available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set. This is a 510(k) for a device modification, relying on substantial equivalence to a predicate device.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring adjudication 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

• Not applicable. This document pertains to a surgical mesh, not an AI-assisted diagnostic or interpretive device that would involve human readers or comparative effectiveness studies with AI assistance.

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

• Not applicable. This is not an algorithmic or software device.

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

• Not applicable, as no clinical ground truth determination is described in the context of this 510(k). The "performance data" mentioned likely refers to bench testing to confirm physical properties or functional aspects of the modified mesh.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Not applicable, as no training set is relevant to this device.

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Atrium C-QUR V-Patch™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a surgical mesh device, the "Atrium C-QUR V-Patch™ Mesh". It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding artificial intelligence or device performance compared to specific metrics.

The 510(k) process for a Class II device like surgical mesh typically relies on demonstrating substantial equivalence to a predicate device through evidence such as:

• Similar materials
• Similar design
• Similar manufacturing process
• Similar intended use
• Performance data (e.g., mechanical testing, biocompatibility in animal models) demonstrating the new device performs as safely and effectively as the predicate.

However, the provided text does not contain any of these specific study details or acceptance criteria tables. It is a regulatory clearance letter, not a study report or a summary of performance data.

Therefore, I cannot provide the requested information from the provided input regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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Atrium ProLite S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

Not Found

This document is a 510(k) clearance letter from the FDA for the Atrium ProLite S Mesh. It confirms that the device is substantially equivalent to a predicate device for specific indications of use (hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material).

However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter is a regulatory approval based on demonstrating substantial equivalence, not a summary of a performance study with specific metrics and methodologies.

Therefore, I cannot provide the requested information based on the provided text. The document is solely an FDA clearance letter and does not include the details of a performance study.

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To evacuate air and/or fluid from the chest cavity or mediastinum.

To help re-establish lung expansion and restore breathing dynamics.

To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Atrium Medical Corporation Express™ Chest Drain

This document is solely a 510(k) clearance letter for the Atrium Express Chest Drain. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the requested table and information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive premarket notification submission that details the performance data.

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