(48 days)
OrthoBlast® It DBM Paste and Putty are bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy ・
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor -
OrthoBlast® II DBM Paste and Putty 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 puttylike consistency.
OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
This document is a 510(k) summary for a medical device called OrthoBlast II DBM Paste and Putty, seeking clearance from the FDA. It is not a study report detailing acceptance criteria or device performance based on a study, but rather a regulatory submission for market clearance.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in the provided text.
Here's why and what information is available:
- Nature of the Document: This is a 510(k) "Premarket Notification." The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. It's not a clinical trial report that establishes new performance metrics through a study against predefined acceptance criteria.
- "Performance Data" Section (Section 7): This section states: "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."
- This indicates that "performance" in this context refers to demonstrating equivalence and safety through existing data, material characterization, and animal studies, not necessarily human clinical trials with statistical acceptance criteria.
- It also states "The osteoinductive potential is demonstrated in athymic mouse model." This is an animal study, not a human clinical study.
What can be extracted from the provided text is:
1. Device Name and Intended Use:
- Proprietary Name: OrthoBlast® II Demineralized Bone Matrix Paste and Putty
- Intended Use: Bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
2. Predicate Device:
- DynaGraft II Dental (Demineralized Bone Matrix) [K043573]
3. Basis for Equivalence (Instead of Acceptance Criteria):
The device is considered "substantially equivalent" based on:
- Utilizing ground, human donor cortical demineralized bone.
- Utilizing an inactive poloxamer reverse phase carrier (RPM).
- Having the same indications for use.
- Being provided sterile.
- Intended for single patient use.
Differences noted for context (though not acceptance criteria):
- Predicate device (DynaGraft II) contains more demineralized bone by weight and volume and less synthetic carrier.
- OrthoBlast II incorporates the same donor's cancellous tissue in particulate form, while DynaGraft II does not.
In summary, the provided text does not contain the information required to fill out the table and answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as it is a regulatory submission for substantial equivalence rather than a detailed study report.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.