(35 days)
α-BSM Bone Substitute Material is indicated for filling bone voids or defects of the skeletal system (such as 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 traumatic injury to the bone. «-BSM Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.
α-BSM Bone Substitute Material is a synthetic, biocompatible calcium phosphate implantable paste that hardens at body temperature and converts to an apatitic calcium phosphate. It is provided in single use packages containing either 2.5, 5.0 or 10 grams (nominal) of a-BSM powder in a mixing bulb, sterile mixing solution, an appropriately sized syringe, and a 16 gauge needle.
α-BSM Bone Substitute Material is supplied sterile for single patient use. The product is packaged in a clear plastic sterilization pouch (with a second outer sterility barrier) containing: a unit does of sterile a-BSM Bone Substitute Material (dry, white powder) contained with an elastomeric (silicone) mixing bulb (available in 2.5, 5.0 or 10cc dose sizes) with a septum closure, a sterile syringe, a 16 gauge needle, and a vial of sterile saline. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. Once the liquid and powder are well mixed, the bulb is opened and the material, now in paste form, can be administered to the site via a syringe or by manual application. The material can be shaped into the desired form prior to application or shaped in situ in the defect. The setting process occurs in vivo at neutral pH and is non-exothermic and non-caustic.
α-BSM Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.
This 510(k) submission for the α-BSM Bone Substitute Material is a Special 510(k), which indicates that the device undergoes minor modifications compared to a previously cleared predicate device. Special 510(k)s typically focus on demonstrating that the changes do not significantly alter the device's safety or effectiveness, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required in the same way as for novel devices.
Based on the provided text, the submission relies on demonstrating substantial equivalence to the predicate device (α-BSM Bone Substitute Material cleared in K011048) rather than presenting new performance data against a specific set of acceptance criteria from a new study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
There is no explicit table of acceptance criteria or new reported device performance data presented in the provided document. The submission's core argument is substantial equivalence to a predicate device based on commonalities:
| Feature/Criterion | Predicate Device (K011048) | Subject Device (K072636) | Assessment/Comment |
|---|---|---|---|
| Indicated Use | Same | Same | Substantially Equivalent |
| Operating Principle | Same | Same | Substantially Equivalent |
| Materials | Same | Same | Substantially Equivalent |
| Shelf Life | Same | Same | Substantially Equivalent |
| Sterilization Processes | Same | Same | Substantially Equivalent |
| Manufacturer | Same | Same | Substantially Equivalent |
| Modifications | N/A | Minor modifications in labeling, IFU, and part numbers | Not significantly different from predicate |
2. Sample Size Used for the Test Set and Data Provenance
No new test set data is presented in this Special 510(k) submission to demonstrate performance against new acceptance criteria. The claim is based on the previously established performance of the predicate device. Therefore, no information on sample size for a new test set or its provenance is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no new test set data is presented for this specific submission, there is no mention of experts used to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no new test set data is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a bone substitute material, not an imaging or diagnostic device that would typically involve human readers for interpretation. Its effectiveness is assessed through its physiological performance (resorption and replacement with bone), which would be evaluated in studies (likely pre-clinical or clinical studies for the original predicate device) by clinical and histological outcomes, not human reader interpretation of images.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical bone substitute material, not an algorithm.
7. Type of Ground Truth Used
For the original predicate device (K011048) upon which this submission's substantial equivalence is based, the "ground truth" would have been established through clinical and/or pre-clinical studies demonstrating:
- Biocompatibility: Absence of adverse reactions.
- Resorption rates: How quickly the material breaks down.
- Bone ingrowth/replacement: Evidence of new bone formation.
- Mechanical integrity: Ability to fulfill its function.
This would involve histology (pathology) to observe cellular activity and bone formation, and potentially imaging (X-ray, CT) to assess filling of voids and radiographic bone density changes, and clinical outcomes data related to patient recovery and functional improvement.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary: This Special 510(k) relies on the prior clearance of a predicate device. The "acceptance criteria" are implicitly met by demonstrating that the modifications made to the device (labeling, IFU, part numbers) do not alter the fundamental characteristics or performance that allowed the predicate device to be cleared. No new studies or performance data are presented in this document for the K072636 submission itself.
§ 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.