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BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.

BonAlive® granules is composed of osteostimulative calcium-phosphorous-sodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area. In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone. The BonAlive® granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the BonAlive® granules is radiodense thus enabling postoperative radiologic evaluation. Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use. BonAlive® granules is sterilized by irradiation and is available in different granule and unit sizes.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for the BonAlive® Granules device, a resorbable calcium salt bone void filler. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K071199 BonAlive Granules by Vivoxid Ltd.).

Therefore, the study design and associated information you're asking about (acceptance criteria, sample size, expert ground truth, MRMC studies, standalone performance, etc.) are not present in this document. This is because clinical performance data was not required to support the medical device's clearance.

The relevant section from the document is:

• {8} Section 12. Clinical Performance Data

  "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

Instead of clinical studies, the submission relied on demonstrating substantial equivalence through:

• Comparison of intended use, technological characteristics, and principles of operation to the predicate device (as detailed in {5} and {6}).
• Non-Clinical Performance Data (Apatite, Composition Heavy Metals, Crystallinity, Particle Size Distribution, Surface Area, Manufacturing & Specifications Validation, all listed in {7}).
• Biocompatibility testing (ISO 10993-1, including cytotoxicity, sensitization, systemic toxicity, and muscle implantation, detailed in {7}).
• Sterility and Shelf Life testing (EN ISO 11137 and ISO 11607, detailed in {8}).

In summary, BigCo, the document does not contain the information you requested regarding acceptance criteria, training/test set details, expert ground truth, or clinical study specifics because such studies were not required for this 510(k) clearance based on substantial equivalence.

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