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S1 is intended for the following uses:
· Augmentation or reconstructive treatment of the alveolar ridge;

• · Filling of infrabony periodontal defects
• · Filling of defects after root resection, apicocectomy, and cystectomy
• · Filling of extraction sockets to enhance preservation of the alveolar ridge
• · Elevation of the maxillary sinus floor
  · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
  · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.

The provided text describes a 510(k) submission for a bone grafting material called "S1," manufactured by MedPark Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain any information about an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for such a device. The device "S1" is a physical bone grafting material, and the tests described are non-clinical (physical, chemical, biocompatibility, sterilization, packaging, and animal studies) typically performed for such medical implants.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are relevant to AI/ML device evaluations, not to the physical bone grafting material described in this document.

The document focuses on comparing the physical, chemical, and biological properties of S1 to predicate bone grafting materials (Geistlich Bio-Oss® and MBCP Gel™) to demonstrate substantial equivalence for regulatory clearance.

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