(131 days)
Integra MOZAIK™ Osteoconductive Scaffold - Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Putty is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Putty is resorbed and replaced with bone during the healing process.
The Integra MOZAIK Osteoconductive Scaffold - Putty is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Integra MOZAIK Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Integra MOZAIK Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
Integra MOZAIK Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
The provided document is a 510(k) Premarket Notification for the Integra MOZAIK™ Osteoconductive Scaffold - Putty. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific performance acceptance criteria through the types of studies typically performed for novel AI/software devices.
Therefore, the information requested in categories 1-9 is largely not applicable or not detailed in this document because the regulatory pathway chosen (510(k)) for this device (a physical resorbable bone void filler) does not require a clinical trial with specific performance metrics against pre-defined acceptance criteria in the same way an AI-powered diagnostic device might.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative acceptance criteria in this 510(k) submission. The primary "acceptance criteria" here is Substantial Equivalence to the predicate device (VITOSS® Scaffold Foam Bone Graft Matrix, K032288) in terms of function and intended use. | Animal Study Results: The device "has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone." This demonstrates the intended biological function and resorption profile. |
Compatibility with Characterization Studies & Performance Testing: The document states that these results, in conjunction with product characterization studies and performance testing, affirmed that the device is equivalent to its predicate. While specific data points for these tests are not provided, they would likely include material properties, sterility, biocompatibility, and perhaps mechanical strength suitable for its intended use as a void filler. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "an animal study." The number of animals, species, and specific experimental design are not detailed.
- Data Provenance: Not specified. Assuming the animal study was conducted by or for the manufacturer, it's likely domestic (USA) but not explicitly stated. The study type was prospective in nature, as it involved implanting the device and observing its performance over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Experts for Ground Truth: Not specified. For an animal study evaluating bone growth and resorption, ground truth would typically be established by veterinary pathologists or bone histomorphometry experts, but their number and qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/specified. This type of adjudication is typically used in clinical trials or reader studies for diagnostic devices, not for a biological implant performance study. The animal study would involve scientific observation and analysis.
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
- MRMC Study: No, this document does not mention an MRMC comparative effectiveness study. This type of study is relevant for AI-powered diagnostic imaging devices, not for a physical bone void filler.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: Based on the description, the ground truth for the animal study would be histopathology/pathology (evaluating bone growth and resorption through tissue analysis) and potentially imaging (e.g., radiography or micro-CT) for assessing bone formation, and gross observation for overall healing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, this question does not apply.
Summary of Device Performance and Equivalence Claim:
The crucial performance information provided in the 510(k) is:
- Animal Study: The device "has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone." This is the key functional performance evidence.
- Product Characterization Studies and Performance Testing: These were also conducted to further support the claim of equivalence.
The core of this 510(k) is the demonstration of substantial equivalence to the predicate device, VITOSS® Scaffold Foam Bone Graft Matrix (K032288), in terms of intended use and function, supported by the animal study and product characterization. The FDA's clearance (DEC 20 2006) indicates they agreed with this assessment of substantial equivalence.
§ 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.