(30 days)
The Baby Gorilla/Gorilla Bone Plates and Bone Screws of the Baby Gorilla/Gorilla Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, ioint 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 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 fixation, appropriate for the size of the device. The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include: Fractures and Osteotomies: Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc), Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture), Talar fractures, Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus, Metatarsal and phalangeal osteotomies, Weil osteotomy, Calcaneal osteotomy. Hallux Valgus Correction: Fixation of osteotomies (i.e. Akin, Scarf, Chevron), Interphalangeal (IP) arthrodesis, Proximal, midshaft, or distal osteotomy, Lapidus arthrodesis. Arthrodesis/Deformity Correction: 1st MTP arthrodesis, Metatarsal deformity correction, Tarsometatarsal joint arthrodesis, Naviculocuneiform joint arthrodesis, Talonavicular arthrodesis, Subtalar joint arthrodesis, Triple arthrodesis, Medial column arthrodesis, Subtalar joint distraction arthrodesis, Ankle arthrodesis, Lateralizing calcaneal osteotomy, Lateral column lengthening, Hammertoe. Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: Medial and lateral column, Subtalar, talonavicular, and calcaneocuboid.
Baby Gorilla/ Gorilla Plating System: The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. 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 “mini” 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 E138) and titanium alloy (per ASTM. Monster Screw System: The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available.
The provided text is a 510(k) summary for medical devices (Baby Gorilla/Gorilla Plating System and Monster Screw System), which are orthopedic implants. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance based on clinical studies or AI algorithm performance.
Therefore, the document does not contain any information about acceptance criteria for an AI device, nor does it describe a study involving AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies. The performance testing mentioned specifically refers to "Bacterial endotoxin testing, sterilization validation, and a cleaning Performance validation," which are standard tests for demonstrating the safety and effectiveness of the physical device itself (implants) and its sterility, not for evaluating an AI algorithm.
Since the request is to describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device, and the provided document is entirely about physical orthopedic implants and their substantial equivalence to predicates, I cannot fulfill the request using only the given input.
The document implicitly states that the acceptance criteria relate to demonstrating substantial equivalence for the new sterile-packed offerings of the screws, plates, and washers to the previously cleared non-sterile or differently-packaged versions of the same devices. The study proving this is the submission itself, which likely included documentation of the manufacturing process changes (sterilization, packing) and the performance testing mentioned (endotoxin, sterilization, cleaning validation) to show that these changes do not raise new issues of safety or effectiveness.
However, none of this relates to AI, machine learning, or image analysis, which the prompt heavily implies with terms like "AI vs without AI assistance," "standalone algorithm performance," "ground truth," and "expert concensus."
§ 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.