(210 days)
For orthopedic use, the OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone
OrthoBlast® II DBM Putty and Paste is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
The provided text describes a 510(k) premarket notification for a medical device (OrthoBlast® II DBM Putty and Paste), seeking expanded indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results for the device itself.
Therefore, many of the requested categories related to a performance study for AI devices (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract information related to the device's characteristics, its intended use, and the basis for its clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance / Basis of Acceptance |
|---|---|
| Material Composition | Derived from selected donated human bone tissue, processed into particles, demineralized using HCl. Combined with a reverse phase carrier and cancellous chips from the same donor. |
| Formulation | Formulated to a paste or putty-like consistency. |
| Osteoconductivity | OrthoBlast® II DBM Putty and Paste is stated to be osteoconductive. |
| Osteoinductivity | OrthoBlast® II DBM Putty and Paste is stated to be osteoinductive. |
| Sterility | Provided sterile. |
| Intended Use (as bone void filler) | For bony voids or gaps that are not intrinsic to the stability of the bony structure (extremities and pelvis). |
| Intended Use (as autograft extender) | For extremities, spine, and pelvis. |
| Substantial Equivalence (to Predicate Devices) | OrthoBlast® II is substantially equivalent to DynaGraft II (K040419) and OrthoBlast II Paste and Putty (K050642). Uses ground, human donor, demineralized cortical bone. Incorporates an inactive poloxamer reverse phase carrier (RPM). Identical indications for use. |
| Osteoinductive Potential (Demonstration Method) | Demonstrated in an athymic mouse model. |
| Safety and Effectiveness | Adequately supported by substantial equivalence information, materials data, and animal test results provided in the Premarket Notification. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document describes a 510(k) premarket notification for a medical device (bone graft material), not a study evaluating an AI device or a diagnostic test with a "test set" in the context of AI/diagnostics. The primary evidence presented is substantial equivalence to legally marketed predicate devices, material characterization, and an animal model for osteoinductivity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: See point 2.
4. Adjudication method for the test set
- Not Applicable: See point 2.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI device.
7. The type of ground truth used
- For the osteoinductivity claim, the "ground truth" was established through an athymic mouse model. For the overall device clearance, the "ground truth" for safety and effectiveness was largely based on demonstrating substantial equivalence to legally marketed predicate devices, supported by materials data and the results from the animal model.
8. The sample size for the training set
- Not Applicable: There is no "training set" in the context of this traditional medical device submission. The device is manufactured from human bone tissue; the "sample size" of donors or processed material is not detailed as a "training set."
9. How the ground truth for the training set was established
- Not Applicable: See point 8.
§ 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.