(98 days)
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.
§ 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.