Search Results

Bonalive® Orthopedics granules is an implant intended to fill bony voids or gaps of the skeletal system. (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process.

Bonalive® Orthopedics granules is composed of osteostimulative calcium-phosphoroussodium-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 P₂O₃. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its abilitate 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® Orthopedics granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the Bonalive® Orthopedics 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® Orthopedics granules is sterilized by irradiation and is available in different granule and unit sizes.

The provided document is a 510(k) summary for the Bonalive® Orthopedics granules. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria.

Instead, the document states that "No changes have been made to the subject device Bonalive® Orthopedics granules materials, manufacturing, or sterilization processes" compared to the predicate device (K191274 Bonalive® granules). Therefore, the non-clinical performance data, biocompatibility, sterility, and shelf-life testing performed on the predicate device are referenced as sufficient to support the substantial equivalence of the new device.

There is also a clear statement that "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This means no clinical study was conducted for the Bonalive® Orthopedics granules to demonstrate its performance against acceptance criteria.

Given the information provided, I cannot fulfill all parts of your request because the document explicitly states that no such study was performed for this specific device, and thus no performance data, sample sizes, expert ground truth, or MRMC studies are presented for it.

However, I can extract information regarding the type of non-clinical testing performed on the predicate device, which is considered applicable to the subject device.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance:

This table cannot be fully completed as no specific acceptance criteria for a new study on the Bonalive® Orthopedics granules are presented, nor is new device performance data reported from such a study. The document focuses on demonstrating that the subject device is identical to the predicate in key aspects.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No new test set or study was conducted for the subject device. The predicate device's testing is referenced. The document does not specify general sample sizes for the referenced non-clinical tests.
• Data Provenance: The document refers to testing performed on the predicate device, K191274 Bonalive® granules. No country of origin for the data is specified, and it relates to non-clinical laboratory testing rather than patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a bone void filler, and the described testing involves material and biological safety assessments, not diagnostic performance or expert-adjudicated clinical outcomes in a new study.

4. Adjudication method for the test set:

• Not applicable. No new test set requiring expert adjudication was conducted for the subject device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states "There was no clinical testing required to support the medical device." An MRMC study would be a type of clinical study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a medical device (granules for bone void filling), not an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests on the predicate device, the "ground truth" would be established by the scientific standards and reference methods defined by the relevant ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization, ISO 11607 for packaging), and the material specifications of the product (e.g., composition, particle size).

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

Ask a specific question about this device

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.

Ask a specific question about this device