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The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, The system can be used in both adult and pediatric patients. Specific examples include:

Forefoot:

• · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• · Metatarsal or phalangeal fractures and osteotomies
• · Lesser metatarsal shortening osteotomies (e.g. Weil)
• · Fifth metatarsal fractures (e.g. Jones Fracture)

Mid/Hindfoot:

• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• · Calcaneo-Cuboid (CC) Fusion
• · Subtalar Fusion
• Medial Column Fusions
• · Cuneiform Fracture
• · Cuboid Fracture
• Navicular Fracture

Ankle:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures and Osteotomies
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures
• Tibiotalocalcaneal Joint Arthrodesis
• Tibiotalar Joint Arthrodesis
• Tibiocalcaneal Arthrodesis
• · Supramalleolar Osteotomy
• Fibular Osteotomy

First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• · Closing base wedge osteotomy
• Crescentic Osteotomy
• · Proximal Osteotomy (Chevron and Rotational Oblique)
• Distal Osteotomy (Chevron/Austin)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant

Flatfoot:

• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• · Calcaneal Slide Osteotomy

Charcot:

• · Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• · Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the device.

The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "min" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla®/Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

The provided text is a 510(k) summary for a medical device (Baby Gorilla®/Gorilla® Plating System) and does not contain information about the acceptance criteria and study proving an AI/ML powered device meets those criteria. The document describes a new version of an existing plating system and demonstrates its substantial equivalence to a predicate device through engineering analysis, rather than clinical study data for an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the given input. The categories requested, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are relevant to the evaluation of AI/ML medical devices, which this document does not describe.

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