(30 days)
These 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 a biodegradable bone graft substitute made of bioactive, biodegradable glass. 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 non-pyrogenic.
With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.
This document is a 510(k) premarket notification for the Inion BioRestore device. The information provided primarily focuses on the regulatory aspects, device description, and verification testing related to packaging modifications for an existing bone graft substitute. As such, the document does not contain the typical acceptance criteria and a study design for a software or AI-based medical device.
Therefore, many of the requested details, such as those related to AI algorithm performance, human reader studies, or training/test set ground truth establishment for an AI device, are not applicable to this submission.
However, I can extract the information that is present concerning the physical device's verification testing and acceptance criteria related to its packaging and shelf-life.
Here's the information based on the provided text, aligning with the closest relevant aspects of your request:
Acceptance Criteria and Device Performance for Inion BioRestore (Packaging Modification)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Biological Safety | Device must be biologically safe in new configuration. | Evaluation conducted; deemed safe. |
| Sterilization | Device must maintain sterility in new configuration. | Validation conducted; deemed sterile. |
| Shelf Life | Device must maintain properties for a specified shelf life (5 years). | Studies performed; 5-year shelf life confirmed and verified for new packaging. |
| Transportation and Handling | Packaging system must provide physical protection to the sterile barrier, prevent damage to products, and ensure functionality is not compromised during shipping/handling. | All acceptance criteria fulfilled. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each specific test (biological safety, sterilization, shelf life, transportation). The document mentions "evaluation was conducted," "validation was conducted," "studies were performed," and "a test was performed," implying a sample was used for each.
- Data Provenance: Not explicitly stated regarding country of origin or specific patient data as this relates to a physical device's integrity and sterility, not clinical data from patients. The testing appears to be laboratory-based and engineering-based (e.g., sterilization validation, physical handling tests). The submission itself originates from Tampere, Finland (Manufacturer: Inion Oy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable in the context of an AI device's ground truth. For this physical device's packaging verification, the "ground truth" would be established by validated scientific and engineering methods, adhering to relevant standards (e.g., ISO, ASTM for sterilization, shelf-life, and transportation testing). These tests are typically performed by qualified laboratory personnel and engineers, but specific numbers and qualifications are not provided in this regulatory summary.
4. Adjudication Method for the Test Set
- Not Applicable in the context of an AI device's ground truth adjudication. For physical device testing, results are adjudicated against pre-defined engineering and performance specifications, not through consensus of expert readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, not done. This type of study is relevant for AI-assisted diagnostic devices, not for the physical device (bone graft substitute) described here, nor its packaging modifications.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- No, not applicable. This refers to AI algorithm performance, which is not the subject of this 510(k) submission.
7. Type of Ground Truth Used
- For the physical device's performance related to packaging and shelf-life, the "ground truth" is based on:
- Validated laboratory measurements (e.g., sterility testing, material degradation analysis).
- Engineering specifications and standards (e.g., for packaging integrity, transport resilience).
- Biological safety assessments based on established toxicology and biocompatibility standards.
8. Sample Size for the Training Set
- Not Applicable. This refers to an AI training set, which is not relevant to this submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This refers to an AI training set's ground truth, which is not relevant to this submission.
Summary regarding the device (Inion BioRestore) as a whole (not just AI/Software):
The Inion BioRestore is described as a resorbable bone void filler device made of bioactive, biodegradable glass. The 510(k) submission (K191764) is specifically for a modification to the device, introducing "additional packaging sizes and packaging configurations" for existing morsels. The document emphasizes that "There are no changes to the implant, i.e. Inion BioRestore morsels are the same." Therefore, the submission primarily focuses on ensuring that the new packaging does not negatively impact the safety, sterility, or efficacy of the device, and that it maintains its shelf life and integrity during transport.
§ 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.