(37 days)
GRAFTON® II eDBM is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON®II eDBM is resorbed/ remodeled and is replaced by host bone during the healing process.
GRAFTON®II eDBM is a human bone allograft product containing human demineralized bone matrix (DBM) and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. GRAFTON®II eDBM is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use.
GRAFTON®II eDBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been shown to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON®II eDBM finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. This bone forming activity exhibited by GRAFTON®II eDBM in the athymic rat surrogate assay should not be interpreted as a predictor of human clinical performance.
This document describes a 510(k) premarket notification for the GRAFTON®II eDBM device, a demineralized bone matrix allograft. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and expert involvement is not applicable in this context.
Here's an analysis based on the provided text, addressing the relevant sections and indicating where information is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a bone graft substitute, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to legally marketed predicate devices and confirming the osteoinductive properties through an athymic rat assay. There isn't a table of quantitative performance metrics in the way one would see for a diagnostic AI device.
| Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Demonstrated to be substantially equivalent to other 510(k) cleared DBM devices for similar indications. | GRAFTON®II eDBM is substantially equivalent to one or more predicate devices with respect to materials (human DBM and cortical bone chips). |
| Osteoinductivity (Qualitative): Confirmed consistent osteoinductivity in an athymic rat assay. | GRAFTON®II eDBM consistently produces DBM that is osteoinductive at 28 days using a five-point linear scale (0-4) to score bone formation. |
| Osteoconductivity (Qualitative): Stated as osteoconductive. | GRAFTON®II eDBM is stated to be osteoconductive. |
| Viral Inactivation: Proprietary processing steps validated to inactivate specific viruses. | Processing steps validated to inactivate HIV-1, hepatitis B virus, hepatitis C virus, CMV, and Polio virus. |
2. Sample size used for the test set and the data provenance
The primary performance data cited are from in vivo animal studies and an athymic rat assay.
- Athymic Rat Assay: Used for osteoinductivity testing. The sample size for this assay is not explicitly stated in the provided text, but it's referred to as "ongoing testing."
- In vivo Animal Studies: "The results of in vivo studies in animals showed that GRAFTON®II eDBM performs at least as well as, if not better than, predicate devices and/or autograft." The specific sample sizes for these animal studies are not provided.
- Data Provenance: The athymic rat assay is an in vivo animal model. The country of origin for the animal studies is not specified, but the submission is from a US company to the US FDA. The studies are prospective in the sense that they are conducted to demonstrate characteristics of the product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance evaluation relies on biological assays (athymic rat model) and in vivo animal studies, not on interpretations of data by human experts in the context of setting a "ground truth" for a diagnostic algorithm. The osteoinductivity scoring (0-4 scale) would likely be performed by trained lab personnel, but they are not referred to as "experts" in the context of establishing ground truth for an AI/software device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's biological properties is established through:
- Biological Activity (Osteoinductivity): Demonstrated via the athymic rat assay, which is a recognized in vivo model for assessing bone formation potential of DBM. The outcome is assessed by scoring bone formation.
- In Vivo Performance: Demonstrated through animal studies comparing the device to predicate devices and autograft.
8. The sample size for the training set
Not applicable. This is not an AI/software device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no 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.