(278 days)
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. MagnetOs Putty may be used standalone or mixed with autograft. 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. MagnetOs Putty resorbs and is replaced with bone during the healing process.
MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Ca3(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The granules are covered with submicron-sized features and are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG.
The fast-resorbing polymeric binder in the subject device is improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules in both devices guide the three-dimensional regeneration of bone in the defect site into which it is implanted.
When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.
This 510(k) expands the device's indications for use in K181958 as an autograft extender only to also allow use of the device alone in posterolateral spine.
The furnished information primarily discusses the regulatory clearance (510(k)) of MagnetOs Putty and its substantial equivalence to predicate devices, rather than an AI/ML powered device. As such, it does not contain the specific details typically found in studies for AI/ML device performance and acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as the provided document pertains to a medical device for bone void filling.
However, I can extract the general acceptance criteria Met by the device for its regulatory clearance as a medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (MagnetOs Putty) |
|---|---|
| Biocompatibility | Met acceptance criteria (in accordance with ISO 10993-1). |
| Endotoxin Testing | Met acceptance criteria for Limulus amebocyte lysate (LAL) test (Ph.Eur. 2.6.14, USP ), and passed Materials-Mediated Pyrogenicity Rabbit study (USP 39-NF34). Marketed as "Non-Pyrogenic". |
| Sterilization | Complies with ISO 11137, achieving a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Shelf-Life | Product and sterile-barrier shelf-life studies conducted per ISO 11607. |
| Performance (Standalone Use in Posterolateral Spine) | Performance was "the same" compared to the primary predicate MagnetOs Granules in a posterolateral spinal fusion (PLF) animal model and confirmed with a small clinical data set. |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate devices (MagnetOs Granules K213111, MagnetOs Putty K181958, NuVasive AttraX Putty K191974) in intended use, indications for use, product classification, product code, technological characteristics, materials, and manufacturing process. |
This information does not relate to AI/ML software. Therefore, the following points are not applicable and cannot be answered from the provided text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.