(220 days)
GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities); surgically created defects or defects created by trauma. The voids or gaps may be large or small and may be unicortical or bicortical. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.
GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative use in filling bony voids or gaps of the skeletal system needing structural support. It is intended to be used in bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary process of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a five point linear scale to score bone formation at 28 days.
The provided text describes a 510(k) premarket notification for the GRAFTON® DBM device. This submission process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through a controlled clinical trial with acceptance criteria for device performance. Therefore, many of the requested categories for a study proving device acceptance criteria are not directly applicable or explicitly stated in this type of submission.
Here's an analysis of the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" as used in studies proving device performance (e.g., sensitivity, specificity, accuracy) is not explicitly detailed in a 510(k) summary for a demineralized bone matrix allograft. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance data" section in a 510(k) typically refers to evidence supporting the device's functional characteristics and safety compared to predicates, rather than quantifiable metrics against predefined targets.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductivity | GRAFTON® DBM is reported as osteoconductive. |
| Osteoinductivity (in athymic rat assay) | GRAFTON® DBM is reported as osteoinductive in an athymic rat assay, validated to consistently produce DBM with osteoinductivity. |
| – A "five point linear bone formation histological scoring system (0-5)" is used for assessment at 28 days. | |
| Viral Inactivation | The proprietary production process for DBM in GRAFTON® DBM has been validated to inactivate viruses (HIV-1, hepatitis B virus, hepatitis C virus, CMV, Polio). |
| Substantial Equivalence (overall) | GRAFTON® DBM is claimed to be substantially equivalent to predicate devices for similar indications for use, with respect to materials, readiness for use, and performance. |
Study Details (as inferable from the 510(k) summary)
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Sample size used for the test set and the data provenance:
- Osteoinductivity: An "athymic rat assay" was used. The sample size for this assay is not specified in the provided text.
- "Studies in animals and humans": The text mentions "The results of studies in animals and humans showed that GRAFTON® DBM performs as well as, if not better than, predicate devices and/or performs at least as well at load." However, no specific sample sizes or details of these studies are provided.
- Data Provenance: The athymic rat assay is an animal model. No specific country of origin or whether the animal/human studies were retrospective or prospective is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. For the athymic rat assay, the scoring system ("five point linear bone formation histological scoring system") is referenced, but the experts involved in applying this scoring or their qualifications are not detailed.
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Adjudication method for the test set:
- This information is not provided.
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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 or AI-assisted study was performed. GRAFTON® DBM is a bone graft product, not an AI-powered diagnostic or assistive device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm.
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The type of ground truth used:
- Osteoinductivity: Histological scoring (0-5 scale) of bone formation in an athymic rat model at 28 days. This is a surrogate biological measure.
- Viral Inactivation: Validation of the proprietary production process to inactivate specific viruses. This involves laboratory testing methods (e.g., spiking studies).
- Overall Performance: Comparison to "predicate devices and/or performs at least as well at load." The exact ground truth for these comparisons is not specified but would likely involve clinical outcomes or functional assessments used for the predicate devices.
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The sample size for the training set:
- Not applicable in the context of this 510(k) submission for a non-AI bone graft. The "proprietary production process" for DBM is mentioned as having been "validated to consistently produce DBM that is osteoinductive," implying a developmental and validation phase, but specific training set sizes are not relevant here.
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How the ground truth for the training set was established:
- Not applicable in the context of this 510(k) submission for a non-AI bone graft. The consistency and osteoinductivity of the product are "confirmed via ongoing testing... utilizing a validated athymic rat assay." The "validation" of the production process implies a ground truth was used to establish its effectiveness in achieving osteoinductivity, likely based on the histological scoring in the athymic rat model.
§ 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.