(340 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per Study) |
|---|---|
| Biocompatibility (materials used) | Demonstrated biocompatibility by independent certified laboratories. |
| Degradation rate in simulated body fluid | Showed degradation rate substantially equivalent to predicate devices. |
| Bone formation (in vivo) | Histologically showed bone formation similar to the predicate device (PolyGraft™ BGS alone) at different endpoints, particularly when combined with autogenous blood products. |
| Performance when combined with autogenous blood products | Demonstrated that the addition of autogenous blood products (like platelet rich plasma) does not alter the performance of the device and supported expanded indications. |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.