(47 days)
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and 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. MagnetOs Putty may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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 - Cas(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 surface of the granules in MagnetOs Putty is covered with needle-shaped features that are submicron in size. The granules 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 designed to improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules 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.
MagnetOs Putty is MRI (Magnetic Resonance Imaging) Safe.
This document is a 510(k) summary for the MagnetOs Putty, a medical device intended to fill bony voids or gaps. The submission aims to expand its indications for use to include intervertebral disc space in conjunction with an intervertebral body fusion device.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes performance testing but does not explicitly list quantitative acceptance criteria for many of the tests, nor does it provide specific numerical results or performance metrics in a structured table. Instead, it states that the device "met the acceptance criteria" or "passed" certain tests.
| Test Type | Acceptance Criteria (as described) | Reported Device Performance (as described) |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1 | Performed and met standards. |
| Bacterial Endotoxins Test (BET) | Per Ph.Eur. 2.6.14 and USP . | MagnetOs Putty met the acceptance criteria for the Limulus amebocyte lysate (LAL) test. |
| Materials-Mediated Pyrogenicity | Per USP 39-NF34 (Rabbit study). | MagnetOs Putty passed the Materials-Mediated Pyrogenicity Rabbit study and is marketed as "Non-Pyrogenic". |
| Sterilization Validation | Per ISO 11137, ensuring a Sterility Assurance Level (SAL) of 10^-6. | Performed and complies with ISO 11137, ensuring a SAL of 10^-6. |
| Product and Sterile-Barrier Shelf-Life | Per ISO 11607. | Studies were conducted per ISO 11607. (No specific results given). |
| In-vitro study (Bone-like Apatite Layer) | N/A (implied positive outcome for intended mechanism). | Induced the growth of a bone-like apatite layer on the surface of the MagnetOs Granules component following exposure to simulated body fluid. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document refers to "non-clinical testing data, supplemented with clinical data" from a prior clearance (K230736). However, no specific sample sizes for test sets are mentioned for any of the individual tests (biocompatibility, endotoxins, pyrogenicity, sterilization, shelf-life, or in-vitro studies).
- Data Provenance: The document generally refers to "non-clinical testing data" and "animal functional studies," and "in-vitro studies." It also mentions "clinical data" but doesn't specify if this refers to human clinical trials or other types of clinical observations. No explicit mention of country of origin or whether the studies were retrospective or prospective is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in a way that directly answers the question. The document describes various scientific and engineering tests (e.g., LAL test, rabbit study, ISO standards) rather than expert-driven clinical ground truth for a test set. Establishing "ground truth" in this context would typically involve expert interpretation of medical images or patient outcomes, which is not detailed here for a specific test set.
4. Adjudication Method for the Test Set:
This is not applicable or mentioned in the provided text. The performance section describes laboratory and animal studies, not analyses requiring expert adjudication of a test set in the way one would for diagnostic imaging algorithms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a bone void filler, not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical and animal functional studies, the "ground truth" is established by direct observation of biological responses, chemical properties, and physical characteristics based on established scientific protocols and standards (e.g., bone-like apatite layer formation, successful sterilization, absence of pyrogenicity in rabbits).
For the "clinical data" mentioned as supplementary, the specific type of ground truth is not detailed in this summary. It might refer to surgical outcomes, imaging results, or patient follow-up, but the document does not elaborate.
8. The sample size for the training set:
This is not applicable. The MagnetOs Putty is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
§ 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.