(58 days)
MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Easypack Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Ca3(PO4)2) and 25-35% Hydroxyapatite (HA - Caro(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The granules are covered with submicron-sized features and are premixed with a synthetic binder. New bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling.
MagnetOs Easypack Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Easypack Putty is gammasterilized, comes in several sizes in block form and is sterile packaged for single use only.
The provided document is a 510(k) summary for a medical device called "MagnetOs Easypack Putty." It details the device's characteristics, indications for use, and a demonstration of its substantial equivalence to predicate devices. However, the document does not contain information regarding software or AI components, nor does it specify detailed "acceptance criteria" in the typical sense of a pass/fail threshold for an AI model's performance metrics (e.g., AUC > 0.90, Sensitivity > 95%). Instead, it discusses the device's physical properties, biocompatibility, and clinical performance related to its function as a bone void filler.
Therefore, I cannot extract the specific information requested in questions 1-9 as they pertain to AI/software acceptance criteria and performance studies. The document describes a traditional medical device (a bone void filler) where "performance" relates to its ability to resorb and promote bone healing, not to the diagnostic accuracy of an AI algorithm.
The closest analogue to "acceptance criteria" in this document is demonstrating substantial equivalence to predicates through:
- Bench testing data: analytical characterization, chemical composition, physical properties.
- Biocompatibility testing: LAL test, pyrogenicity study, sterilization.
- Clinical/Animal performance data: fusion-based imaging assessment (for interbody fusion), animal performance data for other uses.
Since the request specifically asks about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device, and this document describes a physical medical device, I must state that the requested information is not available in the provided text.
§ 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.