(63 days)
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; MASTERGRAFT® Strip can also be used with autograft as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e.,the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is replaced with bone during the healing process.
MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% ß-tricalcium phosphate formulation. MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects.
MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. MASTERGRAFT® Putty is biocompatible. MASTERGRAFT® Putty readily absorbs bone marrow aspirate and has been shown to heal bone defects.
The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.
This document is a 510(k) summary for a medical device called MASTERGRAFT® (Strip and Putty). The purpose of this 510(k) is to add a new contraindication to the Instructions for Use (IFU).
Therefore, the submission demonstrates substantial equivalence by showing that the subject devices are identical to previously cleared predicate devices in several categories, rather than proving a new performance against acceptance criteria for a novel device. As such, many of the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
Here's the information that can be extracted based on the provided text, and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" and "reported device performance" are based on demonstrating substantial equivalence to predicate devices, focusing on the identity of technological characteristics.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|
| Indication for Use | Identical |
| Fundamental Scientific Technology (Operating Principle, Mechanism of Action) | Identical |
| Basic Design | Identical |
| Performance | Identical |
| Sterilization | Identical |
| Shelf-Life | Identical |
| Packaging | Identical |
| Use of rigid fixation | Identical |
| Safety and Effectiveness profile | Identical |
| Material Components | Identical |
| Biocompatibility | Identical |
2. Sample size used for the test set and the data provenance
- Not applicable. This 510(k) is a "Change Being Effected" for adding a new contraindication. No new clinical performance data from a "test set" was generated or reported for the purpose of demonstrating substantial equivalence for this specific submission. The established performance of the predicate device (which is deemed identical to the subject device) would have been based on prior studies. The document states: "No new non-clinical testing was performed or submitted in support of this 510(k)." The referenced animal studies for the original predicate devices are documented, but these are not "test sets" in the context of an AI/human performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new "ground truth" was established for a test set in this submission. This is not a study involving expert assessment of a new device's output.
4. Adjudication method for the test set
- Not applicable. There was no "test set" or adjudication process described as part of this 510(k) submission for demonstrating new performance.
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
- Not applicable. This device is a bone void filler, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone void filler, not an algorithm.
7. The type of ground truth used
- Not applicable. As established, this submission relies on demonstrating substantial equivalence to predicates, not on generating new performance data against a "ground truth" for a novel device or algorithm. The performance of the predicate devices would have been established through methods like animal models (as referenced in Table 4: Ovine Femoral Defect Model, Rabbit Lumbar Intertransverse Process Fusion Model, Ovine Cortico-cancellous Defect Model for "in-vivo performance comparison" and "fusion results").
8. The sample size for the training set
- Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.
§ 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.