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510(k) Data Aggregation
(43 days)
Vitoss® Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
This submission describes a bone graft substitute (Vitoss Bioactive Foam), not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and performance data from in vitro studies.
Here's an attempt to address the relevant points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness substantially equivalent to predicates | "Vitoss Bioactive Foam is as safe and effective as its predicates." "The minor differences between Vitoss Bioactive Foam and its predicate devices raise no new issues of safety or effectiveness." "Performance data demonstrate that Vitoss Bioactive Foam is as safe and effective as its predicate devices." |
| Osteoconductivity | "Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone." |
| Osteostimulatory properties (in vitro) | "Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component." |
| Function as intended | "Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design requirements and performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended." |
| Resorption and replacement with bone | "Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process." (This is part of the Intended Use, implying it's an expected outcome, but direct performance data on the rate/extent of human resorption is not provided in this summary. It's likely inferred from the predicate devices and the material's properties.) |
| Suitable for intended use as a bone void filler | "Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure... for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis)." (This is the indication for use, supported by the other performance data and substantial equivalence argument.) |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) for an AI/ML device.
- The "performance testing" mentioned refers to in vitro studies. No specific sample sizes for these in vitro tests (e.g., number of strips, number of simulated body fluid trials) are provided in this summary.
- The data provenance is from in vitro studies, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A for an AI/ML device.
- Ground truth for material properties (e.g., calcium phosphate formation) would be established by standard laboratory analytical methods, not human expert consensus in the context of clinical images.
4. Adjudication method for the test set
- N/A for an AI/ML device.
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
- N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm.
7. The type of ground truth used
- The ground truth for the in vitro performance data (osteostimulatory properties) was based on laboratory measurements/observations of calcium phosphate formation in a simulated body fluid, as observed by standard analytical techniques.
8. The sample size for the training set
- N/A for an AI/ML device.
9. How the ground truth for the training set was established
- N/A for an AI/ML device.
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(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.
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(60 days)
Formagraft" Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine 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 by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.
Formagraft is a bone graft substitute consisting of resorbable purified fibrillar collagen and partially resorbable hydroxyapatite/tricalcium phosphate (HA / {}-TCP) ceramic. The bovine fibrillar collagen component is biocompatible and has low immunogenicity, making it a suitable material for providing a scaffold around which new bone can grow. Both hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) ceramic are radiopaque and highly biocompatible. HA is a polycrystalline substance with a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold. The porous B-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur. The porous HA / B-TCP ceramic has been shown to possess an osteoconductive property for filling bone defects and it can evoke a biologic response similar to that of bone.
The provided text describes Formagraft™ Collagen Bone Graft Matrix, a bone void filler, and its 510(k) clearance. However, it does not include information about specific acceptance criteria or performance studies with reported metrics in the format requested. The document focuses on regulatory classification, substantial equivalence to predicate devices, and intended use.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document states:
- Conformance with Performance Standards: "No performance standards have been established under Section 514."
- Voluntary Standards: It lists voluntary standards (ASTM F1185, ASTM F1088, ANSI/AAMI/ISO 11137, AAMI TIR 27) that the device complies with, relating to material composition and sterilization. These are not performance criteria in the sense of demonstrating clinical efficacy against specific numerical thresholds.
- Special Controls: It mentions the FDA CDRH guidance document Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry & FDA, June 2, 2003, as a special control. This guidance would outline the specific data and information required for clearance, but the document does not detail the specific acceptance criteria derived from this guidance or the results of studies against them.
- Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to pre-amendment or previously cleared predicate devices (Orquest, Inc. Healos Bone Graft Material; NeuColl, Inc. Collagraft Strip Bone Graft Matrix; Berkeley Advanced Biomaterials Inc. Bi-Ostetic; Orthovita Vitoss Scaffold Foam). This typically means showing similar intended use, design, and functional characteristics, rather than conducting new clinical trials with predefined performance metrics.
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