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510(k) Data Aggregation
(260 days)
FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities 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. FIBERGRAFT® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.
FIBERGRAFT® Aeridyan™ Matrix product is composed of 4585 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the Aeridyan™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.
This document describes the Prosidyan, Inc.'s FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute. The acceptance criteria described in the document are based on demonstrating substantial equivalence to predicate devices, focusing on physical and chemical properties, functional performance in animal studies, and biocompatibility.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Assumed based on evidence) | Reported Device Performance |
|---|---|---|
| Physical and Chemical Properties | In vitro functionality and bioactivity | Confirmed in vitro functionality and bioactivity. (Note: in vitro bioactivity results have not been correlated to clinical performance). |
| Biocompatibility | Meet ISO 10993 standards. Similar composition and intended use to clinically used bioactive glass materials. | Demonstrated by ISO 10993 testing. Composed of the same bioactive glass material and used for the same type and duration of patient as predicates. |
| Sterility | Sterile product | Sterile. (Mentioned in comparative table) |
| Packaging & Stability | Acceptable packaging, shelf life, and real-time aging. | Packaging evaluations, shelf life testing, and real-time aging testing performed with passing results. |
| Endotoxin Content | Meet endotoxin limits of established guidelines. | Bacterial endotoxin testing (LAL method) showed the device meets endotoxin limits. |
| Functional Performance (Posterolateral Spine Study) | Substantially equivalent performance to predicate devices and positive controls in critical sized cancellous bone in a rabbit posterolateral spine fusion model, evaluated by radiographic, histomorphometric, and biomechanical data. No new types of safety or effectiveness concerns. | The animal study demonstrated that FIBERGRAFT® Aeridyan Matrix performs substantially equivalently to the FIBERGRAFT® BG Matrix predicate device and positive controls, with no new safety or effectiveness concerns, through 26 weeks of follow-up. |
| Functional Performance (Extremities and Pelvis Study) | Substantially equivalent performance to predicate and reference devices in critical-sized defects in a rabbit femoral condyle model, evaluated by radiographic, histological, and histomorphometric data. No adverse impact on performance from minor technological differences. | The animal study demonstrated that FIBERGRAFT® Aeridyan Matrix performs substantially equivalently to the BG Matrix predicate and NovaBone MacroFORM reference devices, with no adverse impact on performance from minor technological differences, through 26 weeks of follow-up. |
| Overall Substantial Equivalence | Same intended use, similar indications, technological characteristics, and principles of operation as predicate/reference devices. Minor technological differences do not raise new safety or effectiveness issues. | Performance testing demonstrated that the device functions as intended and meets the requirements of Class II bone void fillers compared to predicate and reference devices. Minor technological differences do not raise new issues of safety or effectiveness, thus establishing substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set 1 (Posterolateral Spine Study):
- Sample Size: 71 skeletally mature rabbits.
- Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
- Test Set 2 (Femoral Condyle Defect Study):
- Sample Size: 44 skeletally mature rabbits.
- Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
- Other tests (Biocompatibility, physical/chemical, etc.): Sample sizes for these in vitro tests are not specified but would typically follow ISO standards. Data provenance is implied to be laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for the animal studies. The evaluation relied on objective measures:
- Radiographic data
- Histomorphometric data
- Biomechanical data (for posterolateral spine study)
- Histological data (for femoral condyle study)
4. Adjudication Method for the Test Set
Not applicable, as ground truth was established by objective measurements in animal models (radiographic, histomorphometric, biomechanical, histological data), not through expert review or consensus.
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 conducted. The studies described are animal studies comparing the device's performance to predicate devices and positive controls through objective biological and physical measurements, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The FIBERGRAFT® Aeridyan™ Matrix is a physical bone graft substitute, not an algorithmic or AI-based device. Therefore, the concept of "standalone algorithm performance" doesn't apply.
7. The Type of Ground Truth Used
The ground truth used in the animal studies was objective biological and physical measurements:
- Radiographic data: Imaging evidence of bone healing and fusion.
- Histomorphometric data: Quantitative analysis of tissue morphology, including bone formation, graft resorption, and new bone growth.
- Biomechanical data: Measurement of the mechanical strength of the fused/healed bone (for the spine study).
- Histological data: Microscopic examination of tissue structures (for the femoral condyle study).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical bone graft substitute, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(60 days)
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
The provided text is a 510(k) summary for the FIBERGRAFT® BG Matrix Bone Graft Substitute. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device performance study.
Instead, the document details performance testing for a bone graft substitute, which involves:
- Physical and chemical property evaluation studies.
- Functional performance animal studies (specifically, a rabbit study comparing the device to a predicate and controls).
- Biocompatibility tests (ISO 10993).
- Packaging evaluations, shelf life, and real-time aging testing.
- Bacterial endotoxin testing.
The document states that the rabbit study evaluated device performance using "radiographic, histological, histomorphometric, and biomechanical data" and concluded that the device performs "substantially equivalently to the predicate device and positive control."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is for a medical device (bone graft substitute), not an AI/ML algorithm.
If you can provide a document describing a clinical study or performance evaluation for an AI/ML medical device, I would be happy to help answer your questions according to the format you've provided.
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