(170 days)
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible 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 surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, 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 in separate pre-loaded syringes) 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), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.
This document describes the FDA 510(k) premarket notification for the Tactoset® Injectable Bone Substitute. It is a medical device, specifically a resorbable calcium salt bone void filler. The information provided heavily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.
Therefore, many of the requested criteria regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this document, as it is about a different type of medical device (a bone substitute) and its premarket clearance process based on substantial equivalence.
However, I can extract information related to the performance testing and comparison for this specific device type, which serves a similar purpose of demonstrating safety and effectiveness.
Here's an analysis of the provided text based on your request, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense of numerical thresholds for a clinical study endpoint for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "performance" is shown by comparing the subject device's properties and animal study results to those of the predicates.
| Test/Property | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Tactoset with Iohexol vs. Predicate Tactoset) |
|---|---|---|
| Analytical Characterization | Similar to predicate | Conducted, results support substantial equivalence |
| Chemical Composition | Similar to predicate | Conducted, results support substantial equivalence |
| Physical Properties | Similar to predicate | Conducted, results support substantial equivalence |
| Mechanical Testing (Pull-Out, Compressive Strength, Bone Alignment) | Similar to predicate | Conducted, results support substantial equivalence |
| New Bone Formation (Rabbit Model, 26 weeks) | Similar to predicate | ~17% (Tactoset with Iohexol) vs. ~17% (Predicate Tactoset) |
| Implant Material Remaining (Rabbit Model, 26 weeks) | Similar to predicate | ~61% (Tactoset with Iohexol) vs. ~59% (Predicate Tactoset) |
| Empty Defect Bone (Rabbit Model, 12 weeks) | (Baseline for comparison) | ~6% |
| Physical Form | Injectable Paste/Putty | Injectable Paste/Putty |
| Device Volume (CC) | 4 | 4 |
| Mixing Time (Min) | 1 | 1 |
| Working Time (Minute) | 7-18 | 7-18 |
| Setting Time (Minute) | 10 | 10 |
| Sterility Method | Single Use, Sterile, SAL 10-6 | Single Use, Sterile, SAL 10-6 |
| Pyrogenicity | LAL |
§ 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.