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Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.

Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:

• . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
• . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
• . Tapered end
• . Thin or standard wall thickness

The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.

The provided text is a 510(k) premarket notification for a medical device (vascular grafts) and does not contain information related to an A.I./algorithm-driven device or study. Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an A.I. device from this text.

The document focuses on demonstrating substantial equivalence of the Advanta VXT and Flixene Vascular Grafts to previously cleared predicate devices, primarily through non-clinical bench testing. It explicitly states: "There were no clinical studies of the modified device." and "The Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices in the fundamental scientific technology of the device. The design verification and validation testing established that the Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices."

As such, I cannot provide:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for a test set or data provenance for an AI/algorithm.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication methods for an AI/algorithm test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth for an AI/algorithm.
8. Sample size for a training set for an AI/algorithm.
9. How ground truth for a training set was established for an AI/algorithm.

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· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

This document describes a 510(k) premarket notification for Atrium Medical Corporation's Auto transfusion (ATS) Chest Drains, specifically the Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, and Express Dry Seal Chest Drain. The filing argues for substantial equivalence to previously cleared predicate devices (K043140 and K043582).

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics. This 510(k) submission is focused on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical trials.

The performance is implicitly described as being equivalent to the predicate devices and that the device "performs as well as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No dedicated "test set" in the context of clinical performance evaluation is mentioned for the modified device. The document states, "There were no clinical studies of the modified device."
• Data Provenance: Not applicable for a new clinical study. The submission relies on the established safety and performance of the predicate devices and extensive non-clinical testing of the modified devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a new clinical test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

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 an auto transfusion chest drain, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K043140 and K043582), as well as compliance with relevant voluntary standards and successful completion of non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. The device is not an AI/ML algorithm.

Summary of Acceptance Criteria and "Study" (Non-Clinical) Proving Equivalence:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. The "study" that proves this involves a comprehensive non-clinical assessment, outlined as follows:

Acceptance Criteria (Implied for Substantial Equivalence):

• Same Intended Use: The modified devices must have the same indications for use as the predicate devices.
• Similar Technological Characteristics: The modified devices must operate on the same fundamental scientific technology and have similar features. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
• Similar Materials: The major materials of construction must be the same or demonstrably equivalent in terms of safety and biocompatibility.
• Performance: The modified devices must perform as well as the predicate devices.
• Safety: The risks associated with the intended use must be acceptable and compatible with a high level of protection of health and safety.

"Study" (Non-Clinical Testing) Proving Equivalence:

The document states that Atrium Medical's development process required the completion of the following non-clinical activities:

• Specification Review: Ensuring the designs meet predefined criteria.
• Performance Testing: Verifying the functional aspects of the device.
• Biocompatibility Testing: Evaluating the device's interaction with biological systems (e.g., ISO 10993 series).
• Sterility Testing: Confirming the device is sterile and maintains sterility.
• Stability Testing: Assessing the device's ability to maintain its properties over time (shelf life).
• Design Validation: Ensuring the device meets user needs and intended uses.

These non-clinical tests, along with compliance with voluntary standards (Section 9, though not provided in the excerpt), are the basis for demonstrating that the modified devices are safe and effective and perform as well as the predicate devices, thereby supporting the claim of substantial equivalence. The submission also relies on the low complaint rates and reportable events of the predicate devices over the last 5 years as evidence of acceptable clinical safety and performance.

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C-QUR Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QURTM Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides. The C-QUR Mesh family is available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.

The provided document is a 510(k) premarket notification from the FDA regarding surgical mesh devices (C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document specifically states: "This submission does not contain technological changes for subject devices. C-QUR Mesh has the same technological characteristics as previously cleared C-QUR Mesh devices (K050311, K082748, K090909, K100076, K110110 and K121070). The subject devices differ only from the predicate devices in the indications for use, contraindications, and MR compatibility in the labeling." It also states, "The mesh materials used to construct the Atrium C-QurTM Mesh have not been modified and remain the same as those described in predicate C-QUR Mesh devices."

The document focuses on demonstrating substantial equivalence based on existing, previously cleared devices and labeling changes, rather than presenting a new performance study to prove the device meets acceptance criteria. Therefore, the information required to answer the prompt directly is not available within this document. The document is essentially a regulatory filing affirming that these updated versions of the C-QUR mesh family do not represent a new device that requires a de novo performance study, but rather are equivalent to those already on the market.

Based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria, because such information is not present. This document is a regulatory approval based on substantial equivalence, not a report of a new performance study.

Therefore, I cannot populate the table or provide details about sample size, expert involvement, or ground truth establishment for a new performance study of this device. The document explicitly states that there are no technological changes and that the device characteristics are the same as previously cleared predicates.

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ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.

ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.

I am sorry, but based on the provided document, I cannot adequately answer your request. The document is a 510(k) summary for surgical mesh devices (ProLite Mesh, ProLite Ultra Mesh, and ProLoop Mesh Plug) and focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's why I cannot provide the requested information:

• No Acceptance Criteria or Performance Study: The document explicitly states, "This submission does not contain technological changes for subject devices. ProLite, ProLite Ultra and ProLoop have the same technological characteristics as previously cleared ProLite Family devices (K930669 and K002093). The subject devices differ only from the predicate devices in the indications for use and contraindications in the labeling." This means no new performance studies were conducted or acceptance criteria defined for these specific devices in this submission because their core technology and performance are considered identical to their predicate devices. The submission focused on labeling changes.
• No Clinical Study Data: Consequently, there is no information regarding:
  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or training sets.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used or how it was established.

This 510(k) is essentially seeking approval for updated labeling for existing devices, leveraging the prior approvals of the predicate devices. Therefore, the detailed study information you're asking for would likely be found in the original 510(k) submissions for the predicate devices (K930669 and K002093), not in this document.

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The Atrium Flixene IFG 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 is a 510(k) clearance letter from the FDA for a vascular graft. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

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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.

Not Found

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 CentriFX 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 is a 510(k) premarket notification for a medical device (Atrium CentriFX Mesh) and does not contain information related to the acceptance criteria or study details as one would find for an AI/ML medical device. This document is related to a surgical mesh, which is a physical implant, not a software algorithm.

Therefore, I cannot provide the requested information.

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