(185 days)
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected 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.
Norian SRS Bone Void Filler is an injectable, moldable and biocompatible bone void filler. The reactants pack contains sterile powder (calcium phosphate) and solution (dilute sodium phosphate) components. The reactants pack is designed to be placed in a reusable mixer where the two components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 - 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature (37°C). Norian SRS Bone Void Filler is slowly resorbed over a period of years. The 3cc, 5cc, and 10 cc reactants packs are provided sterile and are for single use only.
The provided text describes a 510(k) submission for the Norian SRS Bone Void Filler. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data (animal studies), rather than a clinical study evaluating the device's diagnostic performance or human-in-the-loop improvements. Therefore, many of the requested categories related to diagnostic device performance evaluations are not applicable or cannot be answered from this document.
Here's an analysis of the available information:
Acceptance Criteria and Study Details (Based on available information)
| Characteristic | Details from provided text |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is demonstratsubstantial equivalence to predicate devices (Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler and Pro Osteon® 500R Resorbable Bone Graft Substitute) in terms of safety and effectiveness. This is based on the ability of the material to support bone growth into a metaphyseal defect, resorb over time, and be replaced by bone. |
Reported Device Performance: Pre-clinical animal data demonstrated that Norian SRS Bone Void Filler supports bone growth into a metaphyseal defect. It was shown to resorb over a period of time, accompanied by bone ingrowth and bone remodeling. This performance was deemed "as safe and effective as the predicate devices." |
| 2. Sample size and data provenance (Test Set) | Not applicable for a diagnostic performance test set. The data provenance is "Pre-clinical animal data." The specific animal sample size is not mentioned. |
| 3. Number of experts and qualifications (Ground Truth - Test Set) | Not applicable for this type of non-clinical, animal-based study. The "ground truth" would be histopathological findings and imaging from the animal models, interpreted by veterinary pathologists or researchers. The number and qualifications of these experts are not detailed in this submission summary. |
| 4. Adjudication method (Test Set) | Not applicable for this type of non-clinical study. |
| 5. MRMC Comparative Effectiveness Study | No. This is not a diagnostic device, and thus, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is not applicable. |
| 6. Standalone Performance Study | Yes, in a way. The "Non-clinical performance data" section describes the device's performance in animal models in a standalone manner, demonstrating its ability to support bone growth and resorb. This is not "standalone algorithm performance" in the context of an AI/diagnostic device, but rather the device's intrinsic biological performance. |
| 7. Type of Ground Truth | The ground truth for the non-clinical study appears to be based on histopathology and imaging findings from animal models, demonstrating bone ingrowth, remodeling, and material resorption. |
| 8. Sample size for the training set | Not applicable. This is not an AI/machine learning device. The "training set" concept does not apply. |
| 9. How ground truth for training set was established | Not applicable. This is not an AI/machine learning 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.