(29 days)
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).
This FDA 510(k) Premarket Notification document describes a medical device, the Baby Gorilla®/Gorilla® Plating System, which is a system for internal fixation of bones. The application is for substantial equivalence to a previously cleared device, not for a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC studies, effect size of AI assistance, specific ground truth methods for algorithm training, and detailed expert qualifications) are not applicable to this type of submission.
However, I can extract the relevant information regarding acceptance criteria and performance data as presented in the document for a medical device seeking substantial equivalence.
Acceptance Criteria and Reported Device Performance
The core of a 510(k) submission for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing that the new device has the same (or substantially similar) indications for use and technological characteristics, and that any differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Identical to the predicate device. | Identical to the predicate device (Baby Gorilla®/Gorilla® Plating System, K190365). |
| Technological Characteristics | - Performance |
- Basic Design
- Material
- Manufacturing
- Sizes (dimensions are comparable) | Same technological characteristics as the predicate:
- Performance
- Basic design
- Material (medical grade titanium, stainless steel, titanium alloy)
- Manufacturing
- Sizes (dimensions are comparable to those offered by predicate systems). |
| Safety and Effectiveness | Differences do not raise new questions of safety and effectiveness. | Differences between the subject and predicate devices were shown not to raise new questions of safety and effectiveness through engineering analysis. |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A) in the context of an AI/diagnostic device study. This submission is for a bone plating system, not a diagnostic algorithm. The "test set" here refers to the device itself and its components.
- Data Provenance: The performance data is derived from "engineering analysis." This typically involves laboratory testing of materials and designs, not clinical data from patients in a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information pertains to establishing ground truth for diagnostic or AI algorithm performance. For a bone plating system, the "ground truth" is adherence to established material properties, mechanical strength requirements, and manufacturing standards. This is evaluated by engineers and regulatory bodies against recognized standards, not by clinical experts establishing diagnostic ground truth.
4. Adjudication method for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies. This is not relevant for the engineering analysis of a bone plating system.
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:
- N/A. This is a device for internal fixation, not an AI or diagnostic tool. No human readers or AI assistance are involved in its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm. The device is a physical bone plating system.
7. The type of ground truth used:
- For this type of medical device (bone plating system), the "ground truth" is primarily based on engineering standards, material specifications (e.g., ASTM F67 for medical grade titanium, ASTM F136 for titanium alloy, ASTM F138 for stainless steel), and mechanical performance requirements. 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." This means the device's mechanical properties, biocompatibility, and intended function are assessed against established benchmarks and industry standards for similar devices. There is no "pathology" or "outcomes data" in the sense of a clinical trial used here to establish ground truth for a diagnostic context.
8. The sample size for the training set:
- N/A. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- N/A. As there is no training set for an AI algorithm, this question is not applicable.
§ 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.