(206 days)
Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Pro Osteon 500R Resorbable Bone Void Filler is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. Pro Osteon 500R has a trabecular structure which resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer laver will slowly resorb, delaving exposure of the underlying and faster resorbing calcium carbonate. Calcium carbonate resorption will normally occur within six months or less. When Pro Osteon 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.
Acceptance Criteria and Device Performance for Pro Osteon 500R Resorbable Bone Void Filler
The FDA 510(k) summary for Pro Osteon 500R Resorbable Bone Void Filler does not explicitly state quantitative acceptance criteria to be met by the device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Wright Medical Osteoset™ Bone Void Filler) across several key characteristics. The "reported device performance" is presented in relation to this substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as compared to predicate) |
|---|---|
| Bone Formation Rate | Substantially equivalent to the predicate device for the repair of tibial defects in rabbits. |
| Resorption Rate | Resorption of Pro Osteon 500R is substantially equivalent to the predicate device (6 months or less vs. 30-60 days for predicate). |
| Dissolution Rates | Similar to the predicate device when compared to essentially non-resorbable bone graft substitute materials. |
| Compressive Characteristics | Substantially equivalent to the predicate device and to trabecular bone. |
| Non-pyrogenic and Non-toxic | Testing indicates the product to be non-pyrogenic and non-toxic. |
| Osteoconductivity | Pro Osteon 500R provides an interconnected, porous scaffold which supports new bone ingrowth (similar to the predicate device's function, though mechanisms differ). |
| Material Composition | Both are calcium salts. Pro Osteon 500R is a composite of calcium carbonate and calcium phosphate; predicate is calcium sulfate and stearic acid. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document only mentions "animal testing" using "rabbits" for tibial defects. It does not specify the number of rabbits or the number of defects tested.
- Data Provenance: The study appears to be prospective animal testing conducted specifically for the 510(k) submission. The country of origin is not explicitly stated but is implicitly within the context of FDA submission, suggesting studies relevant to US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The animal study results would likely have been evaluated by veterinary pathologists or other researchers, but details on the number or qualifications of such experts are absent.
4. Adjudication method for the test set:
- This information is not provided. Given the nature of animal studies focusing on biological endpoints like bone formation and resorption, the "adjudication method" as typically described for clinical trials (e.g., 2+1, 3+1 for imaging reads) is unlikely to be applicable in the same way. Evaluation would have likely involved histopathological analysis and quantitative measurements.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a bone void filler (an implantable medical device), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers" and "AI assistance" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is an implantable medical device for bone repair, not an algorithm.
7. The type of ground truth used:
- For the animal studies, the ground truth would have been established through direct biological observation and measurement (e.g., histopathological assessment of bone ingrowth, direct measurement of resorption from tissue samples or imaging over time, and possibly macroscopic observation of defect repair).
8. The sample size for the training set:
- Not applicable. This summary describes testing for an implantable medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device submission.
§ 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.