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AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space and pelvis). These 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. AttraX Scaffold resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate. When used in intervertebral body fusion procedures, AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate and with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

AttraX Scaffold is an osteoconductive and resorbable bone void filler consisting of hydroxyapatite/tricalcium phosphate ceramic granules premixed with a highly purified type I bovine collagen that provides cohesion between the granules and acts as an absorbent matrix for fluids. The bone graft mimics the composition of natural bone and is biocompatible. AttraX Scaffold provides an osteoconductive environment for promoting new bone formation while resorbing at a rate consistent with bone healing. In situ, the collagen and ceramic components are resorbed and replaced by new bone, similar to the resorption and remodeling observed with autogenous bone.

The provided text is an FDA 510(k) clearance letter for a medical device called NuVasive AttraX Scaffold. This document does not describe a study proving the device meets acceptance criteria for an AI or software-related product. Instead, it details the substantial equivalence of a bone void filler to previously cleared predicate devices.

Therefore, I cannot extract the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided document.

The document discusses:

• Device Name: NuVasive AttraX Scaffold
• Device Type: Resorbable Calcium Salt Bone Void Filler Device (Class II)
• Indications for Use: Filling bony voids or gaps in the skeletal system (posterolateral spine, intervertebral disc space, pelvis), to be used in combination with autogenous bone or bone marrow aspirate, and with an intervertebral body fusion device when used in intervertebral body fusion procedures.
• Premarket Notification (510(k)): K240507
• Predicate Devices: NuVasive AttraX Scaffold (K172497) and NuVasive AttraX Putty (K203714).
• Performance Data (for prior clearance K172497): Non-clinical testing including chemical composition, physical properties, sterilization, bacterial endotoxin, packaging performance and shelf life, biocompatibility, and animal testing.
• MR Safety: Declared "MR Safe" based on scientific rationale per ASTM F2503 and FDA guidance, rather than testing, as it's composed of nonconductive, nonmetallic, nonmagnetic materials.
• Substantial Equivalence Argument: The subject device is identical to the primary predicate (K172497) in most aspects and substantially equivalent to the additional predicate (K203714) concerning intended use, indications, design principles, and performance. The key point of this submission (K240507) is to expand the indications of the AttraX Scaffold for use in the intervertebral disc space, which the document states is supported by previously provided animal testing from K172497.

In summary, the document addresses a conventional medical device (bone void filler) and its regulatory clearance based on substantial equivalence, not an AI or software device that would have the type of "acceptance criteria" and "study" details you are requesting related to algorithmic performance.

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