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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

The provided document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed External Fixation Devices. It declares substantial equivalence to predicate devices but does not contain specific acceptance criteria or a study proving that the device meets such criteria.

The document states:
"Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
"Vanguard Reprocessed External Fixation Devices are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics."

Based on the provided text, I cannot complete the requested table and details because the information is not present. The document focuses on demonstrating substantial equivalence based on the identical technological characteristics and intended performance to predicate devices rather than providing detailed acceptance criteria and a study with specific performance metrics.

Therefore, the questions cannot be answered from the provided text.

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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.

External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

Rods. Rails and Modular Rails ~ Straight rods and rails are external fixation devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.

Rings and Ring Segments ~ Rings and ring segments are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.

Ring-to-Rod/Rail Clamps ~ Ring-to-rod/rail clamps are utilized to connect a Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or ring-to-wire clamps u Ring-to-Fin of Ring-to-Wire Or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.

Rod/Rail-to-Screw Clamps ~ Rod/Rail-to-screw clamps are utilized to 8 Rour Ran-to-Screw - Califfer - Califfer - Station raily affixed to the bone. connect an excential rination fail to a proscrews that are anchored in the bone.

DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.

Rail-to-Rail Couplings ~ Rail-to-Rail couplings are multi-element . Components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.

Rod-to-Rail Couplings ~ Rod-to-Rail couplings are multi-element . Kou-to-Kan - Couplines
components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.

Rod-to-Rod Couplings ~ Rod-to-Rod couplings are multi-element 제 Device components used to connect one rod to another in a range of positions Description defined by the individual clamp configuration. They are designed to (continued) denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rail-to-Clamp Couplings ~ Rail-to-clamp couplings are multi-element 트 components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rod-to-Clamp Couplings ~ Rod-to-clamp couplings are multi-clement 8 components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Clamp-to-Clamp Couplings ~ Clamp-to-clamp couplings are multi-element 해 components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel.

The provided text is a 510(k) summary for Vanguard Reprocessed External Fixation Devices. It describes the devices, their indications for use, and declares substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification, Product Codes.
• Predicate Devices: Listing the original equipment manufacturers and their trade names.
• Indications for Use: What the reprocessed devices are intended for.
• Contraindications: When the devices should not be used.
• Device Description: Detailed breakdown of components like rods, rings, clamps, and couplings, including materials (anodized aluminum, stainless steel, carbon fiber).
• Technological Characteristics: Stating that the reprocessed devices are essentially identical to OEM devices and perform as intended after cleaning, packaging, and performance testing.
• Conclusion: A declaration of substantial equivalence to predicate devices.
• FDA Approval Letter: Confirming the 510(k) clearance.
• Catalog Pages: Listing specific models, their descriptions, and materials.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement based on the provided text.

The statement "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective" is a summary conclusion, but the actual data, methods, acceptance criteria, or results of these tests are not present in this document. This kind of detailed study information is often found in the full 510(k) submission, which is typically much more extensive than the public summary.

Ask a specific question about this device

Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used non-invasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight and curved rods, rod-to-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-to-rod, and ring-to-pin clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

The provided text describes a 510(k) summary for VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES but does not contain acceptance criteria for device performance nor any study details that prove the device meets such criteria.

The document primarily focuses on:

• Identification of the device: Vanguard Reprocessed External Fixation Devices, along with its classification, common name, and product code.
• Predicate devices: Listing of original equipment manufacturers (OEM) and third-party reprocessors for comparison.
• Indications for Use and Contra-indications: Specifies the medical conditions the device is intended to treat and situations where it should not be used.
• Device Description: Detailed explanation of the components of external fixation systems (rods, couplings, rings, clamps) and their materials.
• Technological Characteristics: States that the reprocessed devices are "essentially identical" to OEM devices and perform the same.
• Test Data (mentioned, but not detailed): A generic statement that "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, no specific acceptance criteria or results from these tests are provided.
• Conclusion: A declaration of substantial equivalence to predicate devices based on the information provided.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or specific study information because this information is not present in the provided document.

Ask a specific question about this device

External fixation components are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

External skeletal fixator systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins, may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, or other means of internal fixation. External fixator elements consist of components such as straight and curved rods, tubes, rodto-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-torod, and ring-to-pin clamps.

Vanguard receives previously used external fixation devices from healthcare facilities. These devices are cleaned, inspected, tested, repackaged and returned to the healthcare facility.

It is important to note that the provided text is a 510(k) Summary of Safety & Effectiveness for reprocessed external fixation devices, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (like ground truth establishment for training, MRMC studies, effect size of human improvement with AI, standalone performance of an algorithm) are not directly applicable.

However, I can extract the relevant information regarding the general device, its acceptance criteria, and the study proving it meets those criteria based on the provided document.

Here's the analysis of the acceptance criteria and the study for the Vanguard Reprocessed External Fixation Devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size for the "performance, sterilization and packaging validations." It generically refers to "reprocessed devices."
• Data Provenance: The devices are "previously used external fixation devices from healthcare facilities." This implies the data/devices for testing are retrospective (they were used previously) and likely originate from healthcare facilities within the United States (given the FDA submission).

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

This question is not applicable as this is a medical device reprocessing submission, not an AI/ML diagnostic device. Ground truth, in the context of AI/ML, refers to a definitively correct diagnosis or measurement. For this device, "ground truth" would be the established performance and safety of the original (OEM) devices, and the study aims to show equivalence of the reprocessed devices. The document does not describe the use of experts to establish a "ground truth" in this AI/ML sense.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts establishing ground truth or evaluating performance. This document describes engineering and validation testing of a reprocessed physical device, not an interpretative task requiring multi-reader adjudication.

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 question is not applicable. An MRMC study is relevant for diagnostic or interpretive AI systems where human readers' performance with and without AI assistance is compared. This submission pertains to physical medical devices, not an AI system.

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

This question is not applicable. This refers to the standalone performance of an AI algorithm, which is not what this submission is about.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is effectively the established safety and performance profile of the original equipment manufacturer (OEM) devices. The study aims to demonstrate that the reprocessed devices maintain that same safety and performance, making them "substantially equivalent." There isn't a "ground truth" established from pathology or outcomes data specifically for the reprocessed devices in this submission in the way it would be for a diagnostic tool.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI/ML model. This document describes the re-processing and testing of physical medical devices, not the development of an AI algorithm.

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

This question is not applicable for the same reason as above. There is no AI/ML training set mentioned or implied in this submission.

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