(185 days)
The INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ is indicated to 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 with bone during the healing process.
Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established.
Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1.2
Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.
This 510(k) summary for Inion BioRestore™ describes a medical device clearance based on substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with detailed performance metrics. Therefore, several requested categories of information directly related to performance studies with acceptance criteria, ground truth, and expert evaluation are not applicable or not provided in this document.
Here's a breakdown of the requested information based on the provided text:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not explicitly stated as numerical performance criteria. | The device is deemed "substantially equivalent" to predicate devices. | The 510(k) summary focuses on demonstrating that Inion BioRestore™ is as safe and effective as legally marketed predicate devices, not on meeting specific, pre-defined numerical performance targets. |
| Osteoconductivity | Demonstrated in vivo tests showing "more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite." | This is a comparative claim, not against an acceptance criterion. No specific numerical thresholds are provided. |
| Osteostimulation | Demonstrated in vitro cell culture tests with human adipose mesenchymal stem cells showing "an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity." | This is a qualitative claim based on in vitro testing. No specific numerical thresholds or comparative data against an acceptance criterion are provided. |
| Degradation | Based on pre-clinical testing, "most of the material degrades in vivo in six months." | This is an estimated timeframe based on pre-clinical data, not an explicit acceptance criterion against which performance is numerically measured. |
| Radiopacity | "The material is radiopaque." | This is a qualitative characteristic, not a performance metric against a specific criterion. |
Study Information
-
Sample size used for the test set and the data provenance:
- Test set and data provenance specific to a performance study: Not explicitly stated. The document refers to "in vivo tests" and "in vitro cell culture tests," but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests in the context of a "test set" for regulatory evaluation against acceptance criteria.
- The "performance data and specifications" mentioned in the substantial equivalence statement are used to compare the device to predicates, not against a standalone test set for specific acceptance criteria.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific "test set" requiring expert ground truth establishment for regulatory acceptance is detailed in this 510(k) summary. The evaluation relies on comparison to predicate devices and general pre-clinical testing results.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific "test set" with a need for expert adjudication is detailed.
-
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:
- Not applicable. This device is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical bone graft substitute, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "in vivo tests" demonstrating bone formation: The "ground truth" would likely be based on histological analysis, imaging (e.g., radiography, micro-CT) for assessing bone growth, and potentially gross examination by animal pathologists or histology experts. However, specific details are not provided.
- For the "in vitro cell culture tests": The "ground truth" for osteostimulation is evidenced by "alkaline phosphatase activity," which is a biochemical marker for osteoblast differentiation.
-
The sample size for the training set:
- Not applicable. This device is a physical bone graft substitute, not an AI model that requires a "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
In summary, this 510(k) clearance is based on demonstrating "substantial equivalence" to existing predicate devices, leveraging pre-clinical (in vivo and in vitro) data for general characterization rather than a specific performance study against defined acceptance criteria with a detailed clinical test set and expert evaluation. The document confirms that there are "no applicable mandatory performance standards" for this device.
§ 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.