(125 days)
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.
The Resorbable Mesh Device is comprised of a resorbable mesh pouch containing demineralized human cortical bone in particulate form processed by FDA registered, AATB-accredited tissue banks. The resorbable mesh pouch is knitted from poly(lactic-co-glycolic) acid (PLGA) fibers which have a high glycolide content.
The Resorbable Mesh Device is offered in various sizes and provided in individually sterile packaged units and ready-to-use. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-6.
The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the "Resorbable Mesh Device." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than on proving performance against specific acceptance criteria for an AI/ML-driven device.
Therefore, the information required to populate the fields related to acceptance criteria, AI/ML study design, sample sizes, expert ground truth, and MRMC studies for an AI/ML device is not present in the provided text.
The document discusses non-clinical testing for the Resorbable Mesh Device, which includes: biocompatibility, sterilization, bacterial endotoxin, viral inactivation/clearance, osteoinductive potential, and in vivo (animal) safety and performance. However, these are standard tests for a physical medical device and do not relate to the performance of an AI/ML algorithm.
In summary, the provided FDA 510(k) document is for a physical medical device (Resorbable Mesh Device), not an AI/ML-driven device. Thus, the information requested in your prompt (especially points 1-9 regarding acceptance criteria, study design, and ground truth for AI/ML performance) is not applicable and not found in this document.
§ 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.