(102 days)
AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis) and may be used in combination with autogenous bone. These osseous defects may be surgically created of of traumatic injury to the bone and are not instrinsic to the stability of the bony structure. AttraX Putty resorbs and is replaced with bone during the healing process.
NuVasive AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules. Pressure applied by user manipulation allows the AttraX Putty to be molded into specific shapes, mixed with autograft, or contoured into a bone defect, as desired by the clinician. The subject device is identical to the primary predicate device Progentix AttraX Putty (K151584). No changes to the design, materials, or methods of manufacture have been made for this submission.
The NuVasive AttraX Putty is a resorbable calcium salt bone void filler device. The provided text outlines the 510(k) submission for this device, which aims to expand its indications for use as a bone graft replacement. The primary study presented to support this expansion is a clinical trial evaluating the device's performance in instrumented thoracolumbar posterolateral fusion.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the study's objective provides the implicit acceptance criterion: non-inferiority to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion.
| Acceptance Criteria (Stated Objective) | Reported Device Performance |
|---|---|
| Non-inferiority of AttraX Putty versus autologous bone graft in instrumented posterolateral fusion | "The Level I clinical evidence from this randomized controlled trial demonstrates the non-inferiority of AttraX Putty versus autologous bone graft in instrumented posterolateral spinal fusion." (The text states this conclusion directly, implying the acceptance criterion for non-inferiority was met. Specific metrics like fusion rates or patient outcomes are not detailed in this section.) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document states "a randomized controlled trial" and "a patient and observer blinded, multicenter, prospective, randomized controlled trial." However, the specific number of patients (sample size) enrolled in this clinical trial is not provided in the given text.
- Data Provenance: The study was a "multicenter, prospective, randomized controlled trial." The country of origin is not specified, but it's reasonable to assume it was conducted with data that would be relevant for FDA submission (likely in the US or with internationally recognized standards).
3. Number of Experts and Qualifications for Ground Truth
The text does not provide information regarding:
- The number of experts used to establish ground truth for the test set.
- The qualifications of those experts.
- How ground truth (e.g., successful fusion) was determined (e.g., by independent radiologists, surgeons assessing outcome).
4. Adjudication Method for the Test Set
The text does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set. It mentions the study was "patient and observer blinded," which relates to the methodology but not specifically to the adjudication of outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted/applicable in this context. This device is a bone void filler, and its effectiveness is determined by clinical outcomes (e.g., successful fusion, absence of complications) rather than the interpretation of medical images by multiple readers. The study was a direct comparison between the device and autologous bone graft for a clinical outcome.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not conducted/applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its clinical efficacy and safety in human subjects, not as an "algorithm only" system.
7. Type of Ground Truth Used
The ground truth used was clinical outcome data from human subjects, specifically focusing on the non-inferiority of the device compared to autologous bone graft in instrumented posterolateral spinal fusion. While not explicitly detailed, ground truth would likely involve assessments of fusion success (e.g., imaging like CT scans reviewed by radiologists, clinical stability assessments by surgeons, patient-reported outcomes). The text refers to "Level I clinical evidence," indicating robust clinical data.
8. Sample Size for the Training Set
This question is not applicable as the device is a medical implant, not an AI algorithm requiring a "training set" in the machine learning sense. The data used for evaluation comes from a clinical trial, which serves as the "test set" for regulatory clearance.
9. How Ground Truth for Training Set Was Established
This question is not applicable for the same reason as #8.
§ 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.