(401 days)
DynaGraft® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. DynaGraft® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.
DynaGraft II is derived from selected donated human bone tissue that has been processed into particles. The demineralized bone matrix (DBM) is combined with a hydrogel carrier and formulated to a gel or putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the DynaGraft II device:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of document focuses on demonstrating equivalence rather than providing exhaustive details of standalone clinical trials for novel devices. As such, some of the information requested in your prompt (e.g., specific acceptance criteria for performance metrics, detailed statistical findings from a comparative effectiveness study, or precise sample sizes for human readers in an MRMC study) is not explicitly present in this summary.
1. Table of Acceptance Criteria and the Reported Device Performance
| Assessment Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viral Inactivation | Suitable viral inactivation potential of processing methods for a wide range of potential human viruses. (Implied: Demonstrated inactivation of all tested viruses to an acceptable safety margin.) | Methods for processing DBM were evaluated against a select panel of viruses (various types, sizes, shapes, genomes). Testing "demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses." |
| Osteoinductivity (In Vitro) | The in vitro assay for alkaline phosphatase activity of myoblast cells should correlate with the in vivo athymic rat model and predict in vivo osteoinductivity with at least 95% confidence. (Implied: Each lot of DBM must pass this in vitro assay.) | The in vitro assay (measuring alkaline phosphatase activity of myoblast cells compared to controls) "has been validated against the in vivo athymic rat model and predicts with at least 95% confidence the in vivo osteoinductivity of the test material." "Each lot of DBM incorporated in the DynaGraft II is evaluated for osteoinductive potential using an in vitro assay." 67 out of 67 test lots that passed the in vitro assay also passed the in vivo athymic rat assay. |
| Product Performance (In Vivo) | Demonstration of safe and effective performance when used as a bone void filler in orthopedic applications (e.g., bone graft extender, bony void filler in extremities, spine, and pelvis). (Implied: Radiographic and histological findings consistent with new bone ingrowth and integration.) | "Performance of DynaGraft II DBM has been evaluated in rabbit and sheep models by radiographic and histological methods for the indications specified in the Premarket Notification." "Clinical studies using DynaGraft II DBM Putty and Gel have been performed demonstrating acceptable outcomes." These data "substantiate DynaGraft II Putty and Gel safety and effectiveness for the indications presented." |
| Substantial Equivalence | DynaGraft II must be similar in design, materials of construction, and function to its predicate devices (AlloMatrix® DBM Putty and InterGro® DBM). It must also be osteoconductive and provide an environment for new bone ingrowth, be provided sterile, and for single patient use. The differences between the proposed device and predicates must not raise new questions of safety or effectiveness, or raise them but be adequately supported. | DynaGraft II and its predicate devices are "similar in design, materials of construction and function." Both are osteoconductive and provide an environment for new bone ingrowth. Both are sterile and for single patient use. The "only difference" (the inert carrier) is stated to meet AATB requirements, and safety/effectiveness are supported by product quality, validation, materials data, and test results. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Viral Inactivation (Test Set): A "select panel of viruses" was used, representing "various virus types, sizes, shapes, and genomes." The exact number of viruses is not specified.
- Data Provenance: Not explicitly stated, but implies laboratory testing performed by the manufacturer.
- Osteoinductivity (In Vivo Correlation Test Set): 67 test lots of DBM were assessed.
- Data Provenance: Not explicitly stated, but implies laboratory and animal (athymic rat) testing.
- Product Performance (Animal Models): Conducted in "rabbit and sheep models." The specific number of animals or cases is not provided.
- Data Provenance: Animal studies.
- Product Performance (Clinical Studies): "Clinical studies using DynaGraft II DBM Putty and Gel have been performed." The number of patients/cases is not specified.
- Data Provenance: "Clinical studies" implies human data, but details like country of origin or prospective/retrospective nature are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given the nature of the studies (viral inactivation, in vitro osteoinductivity, animal models, and general "clinical studies" for "acceptable outcomes"), it's unlikely that "experts to establish ground truth" (in the sense of independent clinical review of images/data) would be explicitly detailed in this type of submission. The ground truth for the non-clinical studies would typically be based on established biological assays, histological analysis, and radiographic interpretation by trained personnel. For "clinical studies," the "acceptable outcomes" would likely have been determined by primary investigators.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the studies, formal adjudication methods (like 2+1 or 3+1 for imaging studies) are not described. For the osteoinductivity assay, the "correlation" against a positive and negative DBM control suggests a comparative methodology rather than expert adjudication of individual samples.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not explicitly mentioned or described. The document refers to "clinical studies" demonstrating "acceptable outcomes," but these are not detailed as MRMC studies comparing human readers with and without AI assistance. The device is a bone void filler, not an AI-powered diagnostic tool, so such a study would not typically be applicable.
- Effect Size: Not applicable, as no such study was described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. DynaGraft II is a medical device (bone void filler), not an algorithm or AI system. Its performance is inherent to the material properties and biological activity, not an algorithmic output.
7. The Type of Ground Truth Used
- Viral Inactivation: Based on standard virological assays to detect viral clearance/inactivation levels.
- Osteoinductivity (In Vitro): Alkaline phosphatase activity in myoblast cells, with positive and negative DBM controls. This assay was then validated against an in vivo athymic rat muscle pouch model (a biological standard for osteoinductivity, where bone formation in the muscle pouch is the ground truth).
- Product Performance (Animal Models): Radiographic and histological methods for assessing new bone formation, integration, and other healing parameters.
- Product Performance (Clinical Studies): "Acceptable outcomes," which can refer to a variety of clinical endpoints such as fusion rates, pain reduction, functional improvement, lack of complications, etc. The specific outcome data is not provided in detail.
- Substantial Equivalence: Comparison to legally marketed predicate devices based on design, materials, function, and regulatory compliance.
8. The Sample Size for the Training Set
Not applicable. DynaGraft II is a manufactured device, not an AI model that requires a training set. The "training" for the device's development involves material science, biological research, process optimization, and manufacturing controls.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.
For the development and optimization of the device itself, the "ground truth" during R&D would be established through a variety of methods:
- Material characterization: Chemical and physical tests to confirm composition and properties.
- Biocompatibility testing: In vitro and in vivo tests to ensure the material is not toxic or harmful.
- Process validation: Ensuring manufacturing processes consistently produce DBM with desired properties, including osteoinductivity. This relies on established biological assays (like the in vitro osteoinductivity assay validated against the athymic rat model) as a "ground truth" for material efficacy.
§ 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.