(60 days)
AFT is intended for use as a bone void filler in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.
AFT is intended for single patient use only.
AFT is composed of human demineralized bone matrix, human non-demineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
This 510(k) premarket notification for the AFT Allograft Filler Tube does not include detailed acceptance criteria or a dedicated study section with the type of quantitative performance data you're requesting. Instead, it relies on demonstrating substantial equivalence to predicate devices and general safety/effectiveness information.
Here's a breakdown of what is available based on your request, and where the document falls short:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductivity | AFT is osteoconductive. |
| Osteoinductivity Potential | Demonstrated in an athymic mouse model. Every lot of final product will be tested for this potential. |
| Biocompatibility | Established through long history of safe and effective clinical use of materials, and laboratory testing per ISO 10993. |
| Sterility | Single-donor processed using aseptic techniques and tested per current USP . |
| Viral Inactivation (DBM component) | DBM processing methods provide significant viral inactivation potential for a wide range of model viruses. |
| Viral Inactivation (CBM component) | CBM processing methods provide some viral inactivation potential for a wide range of model viruses (less than DBM, but risk of disease transmission remains low due to multiple safeguards). |
| Function and Intended Use | Same as predicate devices (OSTEOSET® and Exactech Resorbable Bone Paste). |
| New Bone Growth Support | In vivo testing in the athymic mouse model demonstrated that AFT materials can effectively support new bone growth in osseous defects. |
Important Note: The document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects." This highlights that while animal data is presented, it's not considered directly predictive of human clinical outcomes for this specific aspect. There are no quantitative metrics (e.g., specific percentages, measurements of new bone formation) presented as acceptance criteria or performance results within this document.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document refers to "in vivo testing in the athymic mouse model" for osteoinductivity potential and new bone growth support.
- Sample Size: The exact sample size ("n") for the athymic mouse model study is not provided in this document.
- Data Provenance: The athymic mouse model is an animal model. The country of origin for the data is not specified, though the sponsor is in Edison, NJ, USA. The data is presented as a result of experimentation, making it prospective data within the context of the animal study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided. Given that the listed "performance" data comes from an animal model, the concept of "ground truth" derived from human clinical experts is not directly applicable in the same way as it would be for a diagnostic device. Any assessment of the animal study results would presumably be done by researchers/pathologists specializing in histology and bone biology, but their number and qualifications are not disclosed.
4. Adjudication Method for the Test Set:
- This information is not provided. Again, for an animal study focused on biological endpoints, a formal clinical adjudication method (like 2+1) is typically not used in the same context as for human diagnostic device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI devices where human readers interpret medical images. The AFT Allograft Filler Tube is a bone void filler product, not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone (algorithm only) study was not done. This concept is also not applicable to a bone void filler. The device itself is the "algorithm" in a sense, and its performance is assessed via biological outcomes (like bone growth), not through an AI algorithm's independent interpretations.
7. Type of Ground Truth Used:
- For the athymic mouse model: The ground truth would likely be based on histopathological examination (e.g., histology slides showing new bone formation, cell differentiation) and potentially radiographic analysis (e.g., assessment of bone density or defect filling in animal models). The document mentions "in vivo testing" and "osteoconductive," implying biological assays.
8. Sample Size for the Training Set:
- This information is not applicable/not provided. The AFT device is a biological product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The components (DBM, CBM, sodium hyaluronate) have an "established history of safe and effective clinical use," which could be considered analogous to a large historical dataset informing their safety, but not a "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established:
- This information is not applicable/not provided for the same reasons as #8. The "ground truth" for the raw materials is their known biological and chemical properties, and their established clinical safety and effectiveness through prior research and clinical use.
In summary, this 510(k) notification focuses on demonstrating substantial equivalence, biocompatibility, sterility, and potential for osteoinductivity/new bone growth based on animal models and an established history of safe use for its components, rather than providing quantitative performance metrics typical of a diagnostic AI device or a direct clinical trial with a defined acceptance criteria table.
§ 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.