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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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CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.

CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.

CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.

CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.

By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.

The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.

When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.

This document describes the regulatory submission for CERAMENT BONE VOID FILLER, a medical device, and its acceptance criteria as defined by the FDA. However, it does not describe acceptance criteria for an AI device's performance or a study proving an AI device meets those criteria.

Therefore, I cannot fulfill the request as it pertains to an AI device. The provided text is a 510(k) submission for a bone void filler and does not contain information about AI device performance testing, ground truth establishment, or clinical study methodologies for AI.

The closest relevant information is a statement about the device meeting "pre-determined acceptance criteria identified in the Design Control Activities Summary," but the document does not provide details about those specific acceptance criteria beyond general biocompatibility and mechanical properties for a bone void filler. It also mentions "Performance Testing" was previously provided, but again, the specifics of these tests and their results are not detailed in this submission.

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The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.

The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.

This document is a 510(k) summary for a medical device called GRAVITY™ Syndesmosis LP. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance metrics, sample sizes, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the provided text. The document states that "Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing" and "Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing," but it does not provide any details on the acceptance criteria or results of these tests. It also explicitly states "N/A" for clinical evidence.

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