(28 days)
The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra 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, hands, and wrists. 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 Fusion
- 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 document is a 510(k) premarket notification letter and summary for a medical device called the "Baby Gorilla®/Gorilla® Plating System." This document is primarily concerned with demonstrating "substantial equivalence" to a predicate device, as required by the FDA for certain medical devices.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets the acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device.
The performance data section states: "Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices."
This indicates that the performance data for this device relates to mechanical engineering analysis (e.g., strength, durability, material properties) to support its use in bone fixation, not to the performance of an AI/ML algorithm. The device itself is a physical bone plating system, not an AI diagnostic tool.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance for an AI/ML device based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical implant system.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.