(44 days)
Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surqically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling, and cellmediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 1 cc, 2.5 cc, 5 cc, and 10 cc syringe volumes.
OssDsign Catalyst is identical to the currently marketed product Osteo3 ZP Putty (K193075). The cleared Osteo3 ZP Putty was launched in the USA in October 2021 and marketed under the name OssDsign Catalyst.
Here's a breakdown of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary for the Catalyst Bone Void Filler.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed clinical study demonstrating the device's standalone performance against specific acceptance criteria. The performance testing summarized supports the claim of substantial equivalence. Therefore, the "acceptance criteria" here are inferred from the types of non-clinical testing performed and the comparison to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance Category |
|---|---|
| Chemical Composition Equivalence | Demonstrated (similar to predicate) |
| Physical Properties Equivalence | Demonstrated (similar to predicate) |
| Sterilization Effectiveness | Demonstrated (similar methods / predicate) |
| Material-mediated Pyrogenicity | Demonstrated (part of prior clearance) |
| Bacterial Endotoxin | Demonstrated (part of prior clearance) |
| Sterile Barrier Shelf Life | Demonstrated (part of prior clearance) |
| Product Shelf Life | Demonstrated (part of prior clearance) |
| Biocompatibility | Demonstrated (part of prior clearance) |
| Bone Ingrowth/Remodeling (Animal Model) | Demonstrated (mechanical performance in posterolateral spine fusion animal model for reference device K193075) |
| Mechanical Performance (In Vivo) | Demonstrated (mechanical performance in posterolateral spine fusion animal model via reference device K193075) |
| Intended Use Equivalence | Demonstrated (same intended use as predicate) |
| Indications for Use Equivalence | Demonstrated (nearly identical, differences do not raise new safety/efficacy issues) |
| Technological Characteristics Equivalence | Demonstrated (similar design principles, materials, manufacturing, physical form, sterilization) |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily relies on non-clinical testing and refers to data from the prior clearance (K193075) of an identical device.
- Sample Size: Specific sample sizes for each non-clinical test (e.g., sterilization, biocompatibility, mechanical testing) are not detailed in this summary. It states "non-clinical testing data were submitted" for K193075.
- Data Provenance: The data provenance is from non-clinical (laboratory and animal) studies conducted in support of the original device clearance (K193075). The specific countries where these tests were performed are not mentioned. The studies were retrospective in the context of this 510(k) submission, as they were conducted for a prior clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given that it's primarily non-clinical testing and comparison to predicates, the concept of "experts establishing ground truth for a test set" in the context of clinical reads (like a radiologist for imaging devices) doesn't directly apply in the same way. The "ground truth" for non-clinical tests is established by the methods, standards, and results of those tests.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1" typically apply to human interpretation of data (e.g., medical images) where discrepancies need resolution. The testing described here is primarily non-clinical compliance and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done as described in this 510(k) summary. This type of study would compare human performance with and without AI assistance, which is not relevant for a bone void filler device in this context. The document focuses on demonstrating substantial equivalence through non-clinical data and comparison of device characteristics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the Catalyst Bone Void Filler. This device is a bone void filler, not an algorithm or AI-powered diagnostic/therapeutic tool. Therefore, "standalone algorithm performance" is not a relevant concept here.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's characteristics and equivalence was established through:
- Non-clinical test results: Chemical composition analysis, physical properties testing, sterility testing, pyrogenicity, bacterial endotoxin, shelf life, biocompatibility studies.
- Animal testing: Specifically, mechanical performance in a posterolateral spine fusion animal model for the reference device (K193075).
- Comparison to predicate devices: The "ground truth" for substantial equivalence heavily relies on demonstrating that the Catalyst Bone Void Filler's characteristics and performance are comparable to (or identical to, in the case of K193075) legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical medical implant, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as #8.
§ 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.