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SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Synergy is a Xenograft of bovine origin. It contains macro and micro porous structures similar to Bio-Oss. Synergy is a purified osteoconductive mineral structure produced from bone in a multi-stage purification process. Synergy is chemically as well as structurally comparable to mineralized Bio Oss and Equimatrix. Synergy is used as an adjunctive therapy in restoring bony defects in the mouth. Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation. Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).

The provided text describes a 510(k) premarket notification for a dental bone grafting material called "Synergy" (K123876). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study designed to meet specific performance targets.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance or a study proving the device meets said criteria in the way a clinical trial or performance study report would.

The document primarily provides:

• Device description and intended use for Synergy, the predicate devices (Bio-Oss and Equimatrix™), and a comparison table.
• A statement of substantial equivalence to the predicate devices based on intended use, biocompatibility, sterility, physical and chemical testing, performance evaluation in an anatomically relevant animal model, and results of clinical cases (though the details of these cases or the animal study are not provided).
• Compliance with recognized standards (ISO 10993, ASTM F1088 - 04a, USP 31, ASTM F1185 - 03, ASTM F1581 - 08, Argentine Pharmacopeia) and FDA Special Controls Guidance Document for Dental Bone Grafting Material Devices.

Since the document does not present specific acceptance criteria or a detailed study to meet them, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, etc. Those details are typically found in a dedicated performance study report, which is not part of this 510(k) summary.

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This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading.

This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant supported restorations. Transitional supports for immediate replacement of missing teeth, For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant in various procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type implant with a specialized head, and accessories, designed to facilitate placing and using the implant in orthodontic procedures.. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are described in Quality System documentation.. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head has a 0.7 mm aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The JJG Evolution™ Orthodontic implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ Monoblock Implant system is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

The provided text is a 510(k) summary for the J.J.G. Evolution™ Mini-Implant System, Orthodontic Implant System, and Monoblock Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested sections about specific study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, ground truth type and establishment) cannot be extracted from the provided document as this type of information is generally not part of a 510(k) summary for devices demonstrating substantial equivalence based on material and design similarity.

The document states: "No performance standards are applicable, however we followed 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' issued May 12, 2004." This indicates that compliance is primarily based on meeting material specifications and functional similarity to predicates, rather than proving specific performance metrics through a clinical study.

Here's a summary of what can be extracted:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are primarily based on substantial equivalence to legally marketed predicate devices, as defined by the FDA's "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3." This means the devices must have the same intended use and similar technological characteristics (materials, design, manufacturing concepts) as their predicates.

The study presented is essentially a comparison to predicate devices rather than a performance study against numerical acceptance criteria.

Study Details

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

   • Not applicable/Not provided. The submission is based on a comparison of device characteristics and intended use to existing predicate devices, not a clinical trial or performance study with a test set of data.

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

   • Not applicable/Not provided. Ground truth in the context of a dataset is not relevant for this type of substantial equivalence submission.

3. Adjudication method for the test set:

   • Not applicable/Not provided.

4. 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/Not provided. This is not a study involving human readers or AI.

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

   • Not applicable/Not provided. This is not an algorithm-based device.

6. The type of ground truth used:

   • Not applicable/Not provided. The "ground truth" here is regulatory compliance and functional similarity to established predicate devices, rather than a clinical outcome or diagnostic truth.

7. The sample size for the training set:

   • Not applicable/Not provided. There is no training set mentioned, as this is not a machine learning or statistical model.

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

   • Not applicable/Not provided.

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