(203 days)
MasterGraft® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix is to be combined with autogenous bone marrow and like MasterGraft® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices provide a bone void filler that resorbs and is replaced with bone during the healing process.
MasterGraft® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MasterGraft® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MasterGrati® Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is blocompatible.
MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGrafi™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, ostcoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
The purpose of this 510(k) application is to add the MasterGraft® Putty device to the previously cleared MasterGraft® product family.
This 510(k) premarket notification for Medtronic Sofamor Danek's MasterGraft® Putty and MasterGraft® Matrix provides information primarily focused on establishing substantial equivalence to previously cleared devices. It does not contain a study demonstrating the device's performance against specific acceptance criteria in the manner requested (e.g., clinical trial with quantitative performance metrics).
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, sample sizes, expert ground truth, adjudication, or MRMC studies because the provided document does not contain this type of information.
The document states:
- "Documentation was provided which demonstrated MasterGraft® Putty to be substantially equivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751)."
This indicates that the regulatory pathway chosen was a substantial equivalence determination, not a clinical study to prove performance against pre-defined acceptance criteria for a new, novel device. The FDA's letter (K051386/S2) confirms this in its approval, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent to legally marketed devices..."
However, I can extract the following relevant information based on the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | The device demonstrated substantial equivalence to predicate devices (MasterGraft® Matrix Resorbable Ceramic, Vitoss Scaffold Foam Flow, HEALOS® Bone Graft Material). The basis for this equivalence is not explicitly detailed in terms of performance metrics against specific criteria within this document, but rather implies similar intended use, technological characteristics, and safety/effectiveness profile as the predicate devices. |
2. Sample size used for the test set and the data provenance
- This document does not describe a "test set" or a study with a defined sample size for evaluating the device against acceptance criteria. The submission is based on demonstrating substantial equivalence to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
- This document does not describe a study involving adjudication of a test set.
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
- No MRMC study was conducted or reported in this document. The device is a bone void filler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device (bone void filler), not an algorithm or AI system.
7. The type of ground truth used
- Not applicable in the context of a performance study against acceptance criteria. The "ground truth" for this submission was the demonstration of substantial equivalence to legally marketed predicate devices based on a comparison of intended use, technological characteristics, and safety/effectiveness.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as there is no training set for this type of device.
§ 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.