(105 days)
MASTERGRAFT® Contain 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 and can be used 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. When used in the pelvis, ilium, or extremities, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.
MASTERGRAFT® Contain is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Contain device, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß- tricalcium phosphate formulation. The device is supplied sterile in a premixed form for single patient use. The device 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. The device is designed with a cavity (ies) to contain and deliver autologous bone to the surgical site when used as a bone graft extender.
This document is a 510(k) premarket notification from the FDA, indicating that the device "MASTERGRAFT® Contain" is substantially equivalent to previously marketed predicate devices. This type of document does not contain acceptance criteria for device performance in the context of diagnostic or prognostic accuracy, nor does it describe a study to prove such criteria.
The acceptance criteria and study described in this document relate to the device meeting the requirements for substantial equivalence to predicate devices, focusing on material composition, intended use, manufacturing, and safety/biocompatibility.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative performance metrics in a table. Instead, it asserts substantial equivalence based on qualitative comparisons of characteristics. The criteria for acceptance are implicitly that the new device (MASTERGRAFT® Contain) is "Similar" or "Identical" across various features to the predicate devices (MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT).
| Acceptance Criteria Feature (Comparison to Predicate) | Reported Device Performance (MASTERGRAFT® Contain vs. Predicates) |
|---|---|
| Indication for Use | Similar |
| Fundamental Scientific Technology (Operating Principle, Mechanism of Action) | Identical |
| Sizes | Similar |
| Performance | Identical |
| Sterilization | Identical |
| Manufacturing principles | Identical |
| Shelf-Life | Identical |
| Packaging | Identical |
| Material Composition (Collagen, Granules) | Identical |
| Use of rigid fixation | Identical |
| Safety and Effectiveness profile | Identical |
| Geometry | Similar |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No new non-clinical testing was performed or submitted in support of this 510(k)." This means there was no specific "test set" of data generated for this particular submission. The data provenance would be tied to the previous submissions for the predicate devices (K082166 and K130335), which are not detailed here.
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. Since no new non-clinical testing was performed for this submission, there was no "test set" requiring ground truth establishment by experts in the context of device performance. The 510(k) review process involves FDA experts, but they are evaluating the submission rather than establishing ground truth for a test dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new testing or test set was described.
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/graft extender, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new testing or test set was described in this submission. The "ground truth" for the substantial equivalence claim relies on the previously established safety and effectiveness of the predicate devices based on their original testing, which would have adhered to various standards (e.g., biocompatibility standards listed) rather than a clinical ground truth like pathology for a diagnostic device.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, so there is no concept of 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.
Summary of the "Study" (or rather, "Evidence for Substantial Equivalence"):
The "study" that proves the device meets the acceptance criteria is actually the comparison study for substantial equivalence to previously cleared predicate devices (MASTERGRAFT® Strip K082166 and MASTERGRAFT® Matrix EXT K130335).
- Evidence: The submission leverages non-clinical testing performed for the predicate devices.
- Methodology: The sponsor asserted that MASTERGRAFT® Contain has "Identical" or "Similar" technological characteristics to the predicate devices across several categories, including material composition, intended use, mechanism of action, performance, sterilization, manufacturing, shelf-life, packaging, and safety/effectiveness profile. The key difference, the addition of a cavity, was deemed not to present a new worst-case scenario.
- Standards: The non-clinical testing for the predicate devices was performed in accordance with recognized consensus standards (e.g., ASTM, ISO standards for ceramic composition, animal tissues, and biocompatibility - ISO 10993 series). This serves as the basis for the "Performance" and "Safety and Effectiveness profile" claims of "Identical" to the predicates.
In essence, for this 510(k) submission, the "study" was a lack of new significant differences analysis, asserting that because the new device is fundamentally the same as already cleared devices, it meets the same safety and effectiveness standards, rather than proving a specific diagnostic accuracy or clinical outcome in a new trial.
§ 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.