(130 days)
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. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and 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 resorb 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. MASTERGRAFT® 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 biocompatible.
This is a 510(k) summary for a medical device (MASTERGRAFT® Putty), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation is not applicable.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, a regulatory pathway for medical devices that are similar to existing ones.
Here's a breakdown of what is provided in the document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not define acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML system. The "acceptance" here refers to the FDA's regulatory acceptance of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of an AI/ML evaluation. The device is a bone void filler, and its equivalence is based on material composition, intended use, and similar design to existing products, not on data analysis for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in the AI/ML sense (e.g., expert-labeled data) is not relevant here. The evaluation relies on comparing the device's characteristics and indications to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned or relevant.
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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this regulatory submission is essentially established by the FDA's existing regulations for medical devices and the characteristics of legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists.
Summary of what the document does provide regarding "acceptance criteria" and "study":
The "acceptance criteria" for this submission are the FDA's requirements for demonstrating substantial equivalence to legally marketed predicate devices. The "study" mentioned is the 510(k) premarket notification process itself, which involves providing documentation to the FDA to show this equivalence.
Key points from the document regarding substantial equivalence:
- Product Description: MASTERGRAFT® Putty is a combination of purified Type 1 bovine collagen, hydroxyapatite, and ß-tricalcium phosphate ceramic. It forms into a moldable putty when mixed with autogenous bone marrow, sterile water, and/or autograft. It is designed as an osteoconductive, porous implant that resorbs and is replaced by bone.
- Purpose of Application: To expand the indication for use with autograft as a bone graft extender.
- Indications for Use: Bone void filler for bony voids or gaps not intrinsic to bony structure stability, including use with autograft as a bone graft extender. Applied gently into skeletal system voids (e.g., posterolateral spine, pelvis, ileum, extremities), which can be surgically created or from traumatic injury. The device resorbs and is replaced by bone.
- Substantial Equivalence Documentation: The document states that "Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), 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)."
The "study" here is the regulatory review of this documentation by the FDA. The FDA's letter (pages 2-3) confirms they have reviewed the 510(k) and determined the device is substantially equivalent for the stated indications, allowing it to be marketed.
§ 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.