(112 days)
GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.
GenerOs (60 or 80) is a sterile osteoconductive bone void filler. This synthetic bone graft comes in the shape of granules or blocks. GenerOs (60 or 80) is supplied sterile for single patient use only. It is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.
The provided text is a 510(k) Summary Statement for a medical device called GenerOs Bone Void Filler. This document does not describe a study involving AI or software, nor does it provide acceptance criteria and detailed performance data in the way you're asking.
Instead, it's a regulatory submission to the FDA to demonstrate substantial equivalence to existing predicate devices. It focuses on the intended use, device description, and materials, asserting that these are substantially equivalent to devices already cleared for market.
Therefore, I cannot extract the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.
The document only states: "The safety and effectiveness of GenerOs are adequately supported by the substantial equivalence information provided within the Premarket Notification." This implies that the device's safety and effectiveness are established by its similarity to already approved devices, rather than through new, independent performance studies against specific acceptance criteria.
§ 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.