(89 days)
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
AlloFuse Plus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor and formulated into a paste or putty-like consistency.
The carrier is a solution of polvethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).
This is a 510(k) premarket notification for the AlloFuse Plus Paste and Putty, which are resorbable calcium salt bone void filler devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials.
The provided document does not contain a traditional table of acceptance criteria and reported device performance in the manner one would expect for a diagnostic or AI-driven medical device. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence and meeting established manufacturing and biological safety standards for tissue-based products.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Evidence |
|---|---|---|
| Technological Equivalence | Device design, materials of construction, and function are the same as previously cleared predicate devices (K070751, K050642). | The proposed device is stated to be "the same device in design, materials of construction and function as the previously cleared devices of 510(k) Notification K070751 cleared 15-Oct-2007 and K050642 cleared 05-Dec-2005." This is supported by a contractual agreement with IsoTis Orthobiologics for an exclusive license to manufacture and market. |
| Biological Safety - Viral Inactivation | Processing methods for Demineralized Bone Matrix (DBM) and cancellous chips, as well as final product sterilization (electron beam), demonstrate significant viral inactivation potential for a wide range of human viruses. | "The methods for processing the DBM and cancellous chips contained in AlloFuse Plus were evaluated for their viral inactivation potential as well as the electron beam sterilization process for final product. A select panel of viruses representing various virus types, sizes, shapes, and genomes was evaluated. Both the DBM processing method (demineralization), the proprietary cleaning process for the cancellous bone and the sterilization process were determined to provide significant viral inactivation potential for a wide range of potential human viruses." |
| Biological Safety - Osteoninductive Potential | The product exhibits osteoinductive potential. | "AlloFuse Plus Paste and Putty have been shown to have osteoinductive potential in athymic rats. Every lot of final product is tested via an in vivo assay to ensure osteoinductive potential of the final product." (Note: The document explicitly states this should not be interpreted to predict clinical performance in humans). |
| Biological Safety - Endotoxin/LAL | The product meets endotoxin/LAL requirements. | "Product safety and effectiveness is adequately supported by the substantial equivalence information and test data including osteoinductive potential, viral inactivation and endotoxin/LAL provided in this Premarket Notification." (This is a summary statement, specific data is not provided in the excerpt). |
| Osteoconductivity | The device is osteoconductive. | "The proposed and predicate devices are osteoconductive..." (This is a declarative statement of characteristic, not a test result). |
2. Sample Size Used for the Test Set and Data Provenance
- Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes was evaluated." The exact number of viruses and the specific experimental setup (e.g., how many replicates, sample sizes per condition) are not specified in this document. This is a laboratory-based study, not a human clinical test.
- Osteoinductive Potential: The test set involves "athymic rats." The exact number of rats used in the initial validation is not specified. For ongoing lot testing, it states "Every lot of final product is tested via an in vivo assay."
- Data Provenance: The studies are laboratory and animal studies conducted for regulatory submission purposes. The geographic origin of the lab or specific animal facility is not mentioned. These are prospective, controlled laboratory/animal studies designed to evaluate specific biological characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish "ground truth" in the context of human clinical data or image interpretation for this device. The evaluations described (viral inactivation, osteoinductivity, endotoxin/LAL) are laboratory or animal-based analyses typically performed by trained scientists and technicians specializing in those respective fields (e.g., virologists, histologists, toxicologists). These are not studies that require expert adjudication of clinical outcomes or images.
4. Adjudication Method for the Test Set
Not applicable. The studies described are laboratory and animal experiments with objective readouts (e.g., viral titer reduction, bone formation presence, endotoxin levels), not studies requiring human rater 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
Not applicable. This is not an AI-driven or diagnostic device. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Viral Inactivation: The "ground truth" would be established by standard virological assays (e.g., cell culture infectivity assays) to quantify viral reduction logs.
- Osteoinductive Potential: The "ground truth" is typically established by histological examination of tissue sections from the athymic rat implants to confirm the presence of new bone formation (ectopic bone).
- Endotoxin/LAL: The "ground truth" is measured quantitatively using Limulus Amebocyte Lysate (LAL) assay, against established limits.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context refers to the development and optimization of the manufacturing process (demineralization, cleaning, formulation) that enables the described performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense. The process parameters (e.g., demineralization time, temperatures, concentrations) for manufacturing DBM and the final product are established through extensive research and development work, guided by scientific principles and iterative testing to achieve desired product characteristics (e.g., demineralization, retention of growth factors, sterility, rheology). This involves rigorous process validation, where various parameters are tested and optimized to consistently produce a product meeting specifications.
§ 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.