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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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AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. 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.

The subject AttraX Scaffold, is an osteoconductive and resorbable bone void filler designed for use in the skeletal system. AttraX Scaffold consists of ceramic granules premixed with purified type I bovine collagen. The ceramic granules are identical to those cleared as CuriOs (K090641; herein after referred to by the commercial name as AttraX Granules) and identical to the granules within AttraX Putty (K151584). The collagen binder used in AttraX Scaffold is manufactured from the same source material as that of the primary predicate Formagraft Collagen Bone Graft Matrix (K050789). AttraX Scaffold will be provided sterile in singleuse packages. Once hydrated with biological fluids or saline, AttraX Scaffold can be applied directly to bone defects or molded to fit the contours of complex bone defects.

This document is a 510(k) summary for the NuVasive® AttraX® Scaffold, a resorbable calcium salt bone void filler device. It establishes substantial equivalence to predicate devices, but it does not describe a study involving device performance against acceptance criteria in the context of an AI or diagnostic device. Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria from this document.

The document discusses:

• Device Name: NuVasive® AttraX® Scaffold
• Regulation Number/Name: 21 CFR 888.3045, Resorbable calcium salt bone void filler device
• Regulatory Class: Class II, Product Code MQV
• Predicate Devices: NuVasive Formagraft™ Collagen Bone Graft Matrix (K050789), NuVasive AttraX Putty (K151584), NuVasive AttraX Granules (K090641).
• Device Description: An osteoconductive and resorbable bone void filler made of ceramic granules (identical to AttraX Granules) premixed with purified type I bovine collagen (from the same source as Formagraft Collagen Bone Graft Matrix).
• Indications for Use: Fills bony voids or gaps of the skeletal system (posterolateral spine and pelvis), must be used with autogenous bone or bone marrow aspirate in the posterolateral spine. Resorbs and is replaced with bone.
• Performance Data: Mentions bench-top testing for physicochemical and crystallographic characteristics, in vivo animal data for intended use, ISO 10993 for biocompatibility, and bacterial endotoxin testing. These are conducted to support substantial equivalence, not to demonstrate performance against specific, quantifiable acceptance criteria for an AI or diagnostic device.

The questions you've asked (about sample sizes, experts, ground truth, MRMC studies, standalone performance) are highly relevant for the evaluation of AI/ML or diagnostic devices where performance metrics like sensitivity, specificity, AUC, etc., are established and compared against acceptance criteria. This document, however, pertains to a bone void filler and focuses on demonstrating substantial equivalence based on material composition, intended use, and existing predicate devices, rather than a diagnostic performance study.

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