(264 days)
The PolyGraft™ TCP 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 PolyGraft™ TCP 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.
PolyGraft™ TCP is manufactured using a blend of poly(D,L-lactide-coglycolide), tricalcium phosphate, polyglycolide fibers and surfactant. The PolyGraff™ TCP will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text is a 510(k) summary for the PolyGraft™ TCP device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (PolyGraft™ BGS, K030288).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., a certain percentage of degradation, specific mechanical strength thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated biocompatibility of materials by independent certified laboratories. |
| Degradation rate | Degradation testing in simulated body fluid at 37°C showed the degradation rate is substantially equivalent to predicate devices. |
| Design, Function, Intended Use | Substantially equivalent to PolyGraft™ BGS (K030288). |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a distinct "test set" in the context of clinical or performance data for the PolyGraft™ TCP device itself. The evidence presented focuses on in vitro testing for degradation and biocompatibility.
- Data Provenance:
- Country of Origin: Not specified for the in vitro testing.
- Retrospective or Prospective: The in vitro degradation testing is inherently prospective laboratory testing. Biocompatibility assessment would also be laboratory-based.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The document describes in vitro laboratory tests (biocompatibility, degradation) rather than human-interpreted data requiring expert consensus for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints requiring expert review, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. An MRMC comparative effectiveness study is not mentioned. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The PolyGraft™ TCP is a resorbable bone void filler.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance Done: Yes, in a sense. The described testing (biocompatibility, degradation rate) is performed directly on the device material itself, without human intervention as part of its function to deliver a diagnostic or interpretive result. The "performance" here is the material's inherent properties and behavior.
7. Type of Ground Truth Used
- Type of Ground Truth: For the in vitro studies, the "ground truth" is established by standard laboratory methods and control conditions.
- Biocompatibility: Established by "independent certified laboratories" according to recognized standards.
- Degradation: Established by in vitro testing in a "simulated body fluid at 37 ℃" with comparison to predicate devices.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires training data in the conventional sense. The "training" for this type of device involved formulation development and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. No "training set" or "ground truth" in the context of AI/ML algorithms is mentioned for this device. The development process would have involved material science principles and iterative testing to achieve the desired properties, but not in the framework of machine learning.
§ 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.