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510(k) Data Aggregation
(65 days)
BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.
BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.
The provided text is a 510(k) Summary for the BonePlast® QS Calcium Sulfate Bone Void Filler. This document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than establishing novel acceptance criteria or conducting a study to prove meeting said criteria for a new device's performance.
Therefore, many of the requested categories related to performance studies, ground truth, and expert evaluation are not applicable in this context. The 510(k) process for this device relies on non-clinical testing and comparison to predicates, not on clinical performance studies.
Here's the breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (BonePlast® QS) |
|---|---|---|
| Material Composition | Similar/identical to predicate devices. | Identical in chemistry and formulation to the predicate device Calcigen™ S Bone Void Filler (K013790). |
| Design/Sizes | Similar/identical to predicate devices. | Similar to or identical to that of the predicate devices. |
| Indications for Use | Substantially equivalent to predicate devices. | "BonePlast® QS is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the stability of the bone structure (i.e., the extremities, spine, and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only." - This is deemed substantially equivalent to the predicate devices' indications. |
| Sterility | Sterile. | Supplied sterile. |
| Injectability | Injectable when mixed intra-operatively. | Becomes an injectable filling material when mixed with sterile setting solution intra-operatively. |
| Biodegradability | Biodegradable and resorbable. | Biodegradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies. |
| Functionality | Functional within its intended use. | Non-clinical laboratory testing performed to determine substantial equivalence indicated that the device was functional within its intended use. |
"Study that proves the device meets the acceptance criteria":
The "study" in this context is a non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices, specifically:
The overarching acceptance criterion for this 510(k) submission is that the BonePlast® QS Calcium Sulfate Bone Void Filler is substantially equivalent to these predicate devices in terms of technological characteristics (materials, design, sizes, and indications for use).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No human clinical "test set" in the traditional sense was used to evaluate performance against specific criteria, as this was a 510(k) submission based on substantial equivalence and non-clinical testing.
- Data Provenance: Not specified, but likely from internal laboratory testing given it's "non-clinical laboratory testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a "test set" was established by experts for performance evaluation; the assessment relied on technical specifications and comparison to predicates.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a clinical test set was employed.
5. 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 void filler and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is the established performance and safety of the legally marketed predicate devices. Substantial equivalence is demonstrated by showing the new device is as safe and effective as the predicates, primarily through material composition, design, and non-clinical functionality assessments. Biodegradability was based on animal studies.
8. The sample size for the training set
- Not applicable. No "training set" in the machine learning sense was used or described.
9. How the ground truth for the training set was established
- Not applicable. No "training set" or establishment of ground truth for such a set occurred.
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