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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

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.

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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.

Ask a specific question about this device