(119 days)
Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.
The provided text describes the 510(k) summary for the Calcigen™ PSI Bone Graft Substitute. Based on the information provided, here's a breakdown of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate devices/literature review) | Reported Device Performance (Calcigen™ PSI) |
|---|---|
| Material composition (60% Hydroxyapatite, 40% Tri-calcium phosphate) | Composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). |
| Physical form (granules, cubes, cylinders) | Available as granules, cubes, or cylinders. |
| Porosity (multidirectional interconnected pores resembling cancellous bone) | Porous with multidirectional interconnected pores resembling that of cancellous bone. |
| Osteoconductive properties | Resorbable osteoconductive scaffold. |
| Resorption and replacement with bone during healing | Resorbs and is replaced with bone during the healing process. |
| Similar indications for use (bony voids/gaps in skeletal system, combination with autogenous bone marrow aspirate or blood) | Indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the bony structure. Can be combined with autogeneous bone marrow aspirate or autogenous blood. |
| Safe and effective as legally marketed predicate devices | "The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices." "Non-clinical laboratory testing and literature review determined the device will function as indicated." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This indicates that no clinical studies (and therefore no test set) were conducted with the Calcigen™ PSI device itself for this 510(k) submission. Substantial equivalence was claimed based on comparison to legally marketed predicate devices and non-clinical testing/literature review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical testing was performed for the Calcigen™ PSI device in this submission, there was no test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing and test set were used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or referenced for this 510(k) submission. The document states "Clinical Testing: None provided as a basis for substantial equivalence."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a bone graft substitute, not an algorithm, and its performance is not assessed in a standalone algorithmic manner.
7. Type of Ground Truth Used
For the Calcigen™ PSI device itself, no specific "ground truth" was established via clinical studies for this 510(k). Instead, the substantial equivalence relied on:
- Comparison of technological characteristics (materials, design, indications) to legally marketed predicate devices.
- Non-clinical laboratory testing and literature review, which would implicitly draw on established scientific understanding and historical data regarding bone graft substitutes.
8. Sample Size for the Training Set
Not applicable. This document pertains to a medical device (bone graft substitute), not an AI/algorithm-based device that would require a 'training set'.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.