(60 days)
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), and water for injection. Tactoset® Injectable Bone Substitute is provided sterile for single use in volumes ranging from 1cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.
This document is a 510(k) Premarket Notification for a medical device called Tactoset Injectable Bone Substitute. It aims to demonstrate that this new device is "substantially equivalent" to legally marketed predicate devices, meaning it is as safe and effective.
The provided document does not contain the detailed information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. This 510(k) is for a bone substitute material, not an AI or imaging device. The performance testing summary explicitly states:
- "Non-clinical verification testing data submitted to demonstrate substantial equivalence included bench performance testing as follows: Pull-out testing, Bone alignment testing"
- "Pyrogenicity and bacterial endotoxin testing were performed..."
- "No animal performance testing or clinical data are included in this submission."
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these are concepts primarily applicable to the validation of AI/ML or diagnostic imaging devices, not a bone void filler.
The document does not describe the following:
- A table of acceptance criteria and the reported device performance (in the context of an AI/ML study).
- Sample sizes used for a test set (related to AI/ML).
- Number of experts used to establish ground truth for a test set.
- Adjudication method for a test set.
- Multi reader multi case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- 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.