(98 days)
The Integra MOZAIK Osteoconductive Scaffold - Strip 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 Strip 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 Strip is resorbed and replaced with bone during the healing process.
The Integra MOZAIK™ Osteoconductive Scaffold – Strip is a resorbable bone void filler made from a porous highly purified collagen matrix that high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Integra MOZAIK Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure of the Integra MOZAIK Strip quickly imbibes fluids, making it easy to mx with bone marrow aspirate or blood. Integra MOZAIK Strip guides the regeneration of bone across a critical defect site into which the strip 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 text describes the 510(k) summary for the Integra MOZAIK™ Osteoconductive Scaffold - Strip. This is a medical device application for a bone void filler, and the performance data presented is in the context of demonstrating substantial equivalence to a predicate device, not typically a standalone AI algorithm performance study.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
For this bone graft device, the "acceptance criteria" are implicitly demonstrated through substantial equivalence to a legally marketed predicate device (VITOSS® Scaffold Foam Bone Graft Matrix). The performance is characterized by attributes that are compared directly to the predicate.
| Feature / Acceptance Criteria (Implied by Predicate) | Integra MOZAIK™ Osteoconductive Scaffold - Strip Performance | VITOSS® Scaffold Foam Bone Graft Material (Predicate) |
|---|---|---|
| Indications for Use: |
- Bone void filler
- Skeletal system (extremities, spine, pelvis)
- Non-intrinsic stability defects
- Surgically treated/traumatic osseous defects
- Resorption & replacement by bone | Matches predicate's intended use, including specific applications in extremities, spine, and pelvis for non-intrinsic defects, and for surgically treated/traumatic defects, with subsequent resorption and replacement by bone. | Intended as a bone void filler for voids/gaps not intrinsic to stability, for surgically created/traumatic osseous defects, and for filling bony voids/gaps in the skeletal system (extremities, spine, and pelvis), with resorption and replacement by bone |
| Pore Structure (range) | 12 - 350 microns | 12 - 700 microns |
| Chemical Composition | Calcium salt with Type I bovine collagen | Calcium salt with Type I bovine collagen |
| Mineral Phase | β-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088 | β-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088 |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site |
| Biocompatibility | Biocompatible | Biocompatible |
| Resorption & Bone Growth | Demonstrated to support bone growth, ultimately resorbed and replaced by remodeled bone (based on animal study). | (Implied by osteoconductivity and intended use) |
2. Sample size used for the test set and the data provenance
The document states, "Integra MOZAIK Strip has been demonstrated to support bone growth in an animal study."
- Sample size for test set: Not specified beyond "an animal study."
- Data provenance: Prospective animal study. The country of origin is not specified but generally, such studies for FDA submission are conducted under GLP guidelines, often in the US or accredited international facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. Ground truth for an animal study proving bone growth would typically involve histological analysis by veterinary pathologists or bone histologists, but the specifics are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide this information.
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
No such study was done. This device is a bone void filler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study demonstrating bone growth, the ground truth would typically be established through pathology/histological analysis of the bone defects and surrounding tissue over time.
8. The sample size for the training set
This is not applicable as this is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical device, not an AI algorithm requiring a training set.
§ 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.