(162 days)
Calcigen™-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.
Calcigen™-NaP Bone Void Filler is a synthetic, self-setting paste for use as a bone graft substitute. The product is provided in pre-measured quantities of powder and setting solution. The two components are mixed together intra-operatively to form a thick, moldable paste that is then applied to the bone void or defect. The paste can be shaped to completely fill the bone defect and hardens in-situ to prevent migration out the defect area. It is designed to be applied/delivered to the defect either using a spatula or equivalent instrument or injected thru a syringe into open defects. The material is resorbed and replaced by bone during the healing process.
The provided document is a 510(k) summary for a medical device called Calcigen™-NaP Bone Void Filler. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the information typically requested regarding acceptance criteria, specific device performance metrics, and detailed study parameters (like sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not present in this document.
Here's a breakdown of why and what information is available:
1. Table of acceptance criteria and reported device performance:
- Not Applicable. This document does not establish specific performance acceptance criteria for the Calcigen™-NaP Bone Void Filler as would be required for a novel device or a device seeking to demonstrate a specific clinical outcome. Instead, it claims substantial equivalence to predicate devices, meaning its safety and effectiveness are considered comparable to those already on the market.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data is presented. The submission relies on non-clinical testing and comparison to predicate devices.
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 establishment by experts for a test set is mentioned.
4. Adjudication method for the test set:
- Not Applicable. No test set or adjudication method is described.
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, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical bone void filler, not an algorithm or software.
7. The type of ground truth used:
- Not Applicable. No ground truth for device performance is explicitly used in the context of this 510(k) submission.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth for it exists for this type of device.
What the document does state regarding demonstration of safety and effectiveness:
- Non-Clinical Testing: "The information presented demonstrates that the Calcigen™-NaP Bone Void Filler is substantially equivalent to currently marketed predicate devices. The differences between Calcigen™-NaP Bone Void Filler and the predicates are not significant and have already been shown not to present additional safety or efficacy issues."
- Clinical Testing: "None is provided as the basis of substantial equivalence." (This explicitly states no clinical trials were done for this submission).
- Basis for Substantial Equivalence: "Calcigen™-NaP Bone Void Filler is shown by analysis of available information to be identical in intended use and equivalent in materials and form to currently marketed similar products. The product is identical in chemistry and formulation to 3i® Calcium Sodium Phosphate Bone Cement."
In essence, the "study" demonstrating the device meets "acceptance criteria" (which in this case is substantial equivalence) is a comparison to legally marketed predicate devices through non-clinical testing and analysis of materials, formulation, and intended use. The acceptance criteria are implicitly met by demonstrating that the device is "identical in intended use and equivalent in materials and form" to already cleared devices and that "differences... are not significant and have already been shown not to present additional safety or efficacy issues."
§ 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.