Search Results

The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The TRUREPAIR™ Bone Graft Substitute is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant.

The provided text is a 510(k) summary for the TRUREPAIR Bone Graft Substitute. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PolyGraft BGS) through comparison of intended use, materials, available shapes, sizes, packaging, shelf life, and sterilization.

The summary states: "Performance testing conducted includes bench and animal studies that demonstrate substantial equivalence to the PolyGraft BGS." However, it does not provide details about these studies, such as their design, sample sizes, specific performance metrics, or results against any defined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided document.

The document indicates that the device's substantial equivalence is based on its similarity to a legally marketed predicate device, rather than a direct study demonstrating its performance against specific acceptance criteria.

Ask a specific question about this device

PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the PolyGraft™ BGS Cement Restrictor. It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure. However, the document does not contain or reference any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Specific performance metrics for the device.
• Clinical study details like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on regulatory approval, specifically indicating a warning that the device is not intended for spinal indications and that its safety and effectiveness in the spine have not been established. It also outlines general FDA regulations and requirements.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.

PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.

The provided text describes the PolyGraft™ BGS, a resorbable bone void filler, and its 510(k) summary (K040047). However, the document does not contain the specific information required to complete all sections of your request, such as a table of acceptance criteria, detailed device performance metrics, or information about AI/algorithm performance. The device described is a physical medical device, not an AI/algorithm-based diagnostic tool.

Therefore, many of the requested fields related to AI/algorithm performance, ground truth establishment for AI, sample sizes for test/training sets in an AI context, and expert adjudication are not applicable or cannot be extracted from this document.

Here's a breakdown of the information that can be gleaned from the provided text, addressing your questions to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the PolyGraft™ BGS is "substantially equivalent in design, function and performance to the PolyGraft™ BGS cleared as K030288." This implies that the acceptance criteria are met by demonstrating equivalence to a predicate device.

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

• Sample Size: The document mentions a "rabbit metaphyseal defect study." However, the exact number of rabbits or lesions used in this study is not specified.
• Data Provenance: The study was an "in vivo comparison" using rabbits, which is a prospective animal study. The country of origin of the data is not specified, but the applicant is based in San Antonio, Texas, USA.

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

The document mentions "histologically showed bone formation" but does not specify the number or qualifications of experts who assessed these histological results.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It notes "histologically showed bone formation similar to the predicate device," implying a comparative assessment, but not a formal adjudication process amongst multiple readers/experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study conducted was an in vivo animal study comparing a device variant to a predicate device. This is not applicable to a physical bone graft substitute.

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

No, this device is a physical bone void filler, not an algorithm or AI. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth was established through histological analysis of bone formation in a rabbit model.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The studies were for performance and safety demonstrations.

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

As above, the concept of a "training set" is not applicable for this type of medical device. The "ground truth" for the performance studies was established through histological assessment in the animal model.

Ask a specific question about this device