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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 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 size of 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 "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.

Here's an analysis of the provided text regarding the Baby Gorilla®/Gorilla® Plating System, focusing on the acceptance criteria and study information:

This document is a 510(k) Summary for a medical device (K190365), seeking clearance for substantial equivalence to previously marketed devices. In these types of submissions for orthopedic implants, the "acceptance criteria" are not clinical performance outcomes like sensitivity/specificity but rather engineering and material testing standards. The "study" refers to the engineering analyses and tests conducted to demonstrate that the modified device meets the performance characteristics of its predicates.

Based on the provided text, a table of acceptance criteria and reported device performance, and details about studies are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated as this is not a clinical study with patients. For engineering analysis, the "sample size" would refer to the number of physical samples tested or the scope of the computational models used. This information is typically detailed in the full test reports, which are not included in this summary.
• Data Provenance: The data comes from engineering analyses and testing conducted by the manufacturer, Paragon 28, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It is internal company data, likely from laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This type of information is not applicable to this submission. "Ground truth" established by experts (e.g., radiologists) is relevant for AI/imaging device clearances where clinical accuracy is being assessed. For a 510(k) for an orthopedic implant like the Baby Gorilla®/Gorilla® Plating System, the "ground truth" is based on established engineering principles, material science, and the functional performance of the device against recognized standards and predicate devices. No external expert panel is typically used for this type of "ground truth" establishment in engineering testing for substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations in clinical studies, particularly for diagnostic accuracy. Since this submission relies on engineering analysis and comparison to predicate devices rather than clinical interpretation of data, an adjudication method is not relevant.

5. 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

• No. An MRMC study is relevant for AI-powered diagnostic devices. This submission pertains to an orthopedic implant, which is a physical device used in surgery, not a diagnostic tool where human readers assess images. Therefore, no MRMC study was conducted, and the concept of "human readers improving with AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this 510(k) submission.

7. The Type of Ground Truth Used

• The "ground truth" for this medical device's claims of safety and effectiveness, for the purpose of a 510(k), is based on:
  • Engineering Standards: Compliance with recognized ASTM standards for materials (e.g., ASTM F67, F138, F136).
  • Mechanical Testing Results: Data from physical tests (e.g., fatigue, static strength, push-out/pull-out forces) that demonstrate the device's mechanical performance is equivalent to or better than predicate devices and suitable for its intended anatomical use.
  • Comparison to Predicate Devices: The foundational "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device must demonstrate it is "substantially equivalent" to these predicates in terms of intended use, technological characteristics, and performance.

8. The Sample Size for the Training Set

• Not applicable. A "training set" refers to data used to train machine learning models. This device is an orthopedic implant, not an AI/ML product. Therefore, no training set was involved.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As no training set was involved, this question is not relevant.

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