(24 days)
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Apaceram™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram™ is provided sterile for single patient use. Apaceram™ is composed of calcium salts, is osteoconductive, and provides an interconnected, highly porous scaffold environment for new bone ingrowth.
The provided text is a 510(k) summary for the Apaceram™ Bone Graft Substitute. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.
Here’s why it’s not possible to provide the requested information based on the given text:
- Type of Submission: This is a "Special 510(k)" primarily for a "change in ownership" from Pentax Corporation to HOYA Corporation. Special 510(k)s are typically used for well-understood, minor modifications to existing devices that do not affect the device's fundamental safety or effectiveness, often relying heavily on the equivalence to the predicate device.
- Focus on Equivalence: The core argument in this submission is that "The Apaceram™ Bone Graft Substitute is identical to the predicate device." It explicitly states, "The safety, performance and biocompatibility testing were submitted in the original Apaceram™ 510(k)." This means any detailed performance data, acceptance criteria, and specific studies would have been included in the original 510(k) submission (K071912), not in this update.
- Device Type: This is a bone graft substitute, a physical material. The questions you've asked (e.g., sample size for test set, experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set sample size) are highly specific to the validation of AI/ML-based diagnostic or prognostic devices. They are not applicable to the regulatory approval process for a bone graft material like Apaceram™.
Therefore, I cannot provide the requested table and study details because the provided document does not contain this type of information. It falls outside the scope of this specific 510(k) 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.