(265 days)
A- GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.
The A-GRIX TE Resorbable Bone Void Filler consists of 1 bottle of pre-measured surgical grade calcium salt mixture and 1 bottle of mixing solution. When mixed according to the direction, A-GRIX TE forms the biodegradable, biocompatible and radiopaque paste or putty for digitally applying directly or by dispensing into the defect site. Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. This product is supplied sterile for single patient use.
This document describes a 510(k) submission for the A-GRIX TE Resorbable Bone Void Filler, a medical device. The information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical performance targets and a detailed study proving those targets are met.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain a table with specific numerical acceptance criteria for device performance (e.g., tensile strength, porosity, resorption rate) nor does it report specific performance values for the A-GRIX TE product against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device by stating:
- "The A-GRIX TE Resorbable Bone Void Filler has the same intended use and technological characteristics as the A-GRIX Resorbable Bone Void Filler (K091688) marketed by AG DIGITAL Technology Corp."
- "Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" but does not provide details on the sample size used for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the full 510(k) submission, not in the provided summary.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and not provided in the document. The submission is for a material-based medical device (bone void filler), not an AI/software device that generates diagnostic outputs requiring expert ground truth for performance evaluation.
4. Adjudication Method for the Test Set
Not applicable, as ground truth is not established by expert consensus for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/software device.
7. Type of Ground Truth Used
The "ground truth" for this device would be established through bench testing against recognized standards, and potentially in vivo or in vitro studies to assess biocompatibility, resorption, and osteoconductivity. The document lists conformity to:
- ISO 10993 series: Biological evaluation of medical devices
- ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Radiation Sterilization
These standards define the methodologies and expected outcomes for performance ("ground truth") related to a bone void filler's properties, biocompatibility, and sterility.
8. Sample Size for the Training Set
Not applicable. This is not an AI/Machine Learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.