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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)

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