(212 days)
Pro Osteon® 200R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 200R 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 graft substitute that resorbs and is replaced with bone during the healing process.
Pro Osteon 200R Resorbable Bone Graft Substitute is an osteoconductive porous calcium carbonate implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. Pro Osteon 200R Resorbable Bone Graft Substitute has a trabecular structure with multidirectional interconnected porosity with an approximate pore diameter of 190 - 230 microns. The product consists of an underlying calcium carbonate matrix covered by a very thin outer layer of calcium phosphate, approximately 2 to 10 microns in thickness. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate. When Pro Osteon 200R 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 calcium phosphate 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 calcium carbonate.
The provided document is a 510(k) summary for the Pro Osteon® 200R Resorbable Bone Graft Substitute. It does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics.
This document describes a medical device (a bone graft substitute), not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as:
- A table of acceptance criteria and reported device performance (in terms of AI metrics)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone performance
- Type of ground truth used (for AI)
- Sample size for the training set
- How ground truth for the training set was established
cannot be answered from the provided text.
The document does mention:
- Testing Summary: "Results of nonclinical testing, including bench testing and animal studies, support substantial equivalence of Pro Osteon 200R Resorbable Bone Graft Substitute to the predicate device, Pro Osteon 500R Resorbable Bone Graft Substitute." This indicates that traditional biomedical device testing (bench and animal) was performed to demonstrate substantial equivalence, but it does not detail specific acceptance criteria or results.
- Predicate Device: Pro Osteon 500R Resorbable Bone Graft Substitute (K980817) was used for comparison to establish substantial equivalence.
In summary, the provided text is for a conventional medical device and does not involve AI/ML components, thus the requested information regarding AI/ML acceptance criteria and studies is not present.
§ 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.