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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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The R3ACT™ Stabilization System is intended as an adjunct in fracture repair and ligamentous injuries of small bones of the feet and ankles including the distal tibia, distal fibula, talus, and calcaneus, and as an adjunct in external and intramedullary fixation systems involving plates and rods. Specifically, the R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The R3ACT™ Stabilization System is a fixation device comprised of a titanium alloy screw, UHMWPE suture, and a polyurethane component. It is provided in various sizes to accommodate patient anatomy. The device maintains fixation prior to weight bearing and then allows motion after weight bearing. The implants can be used in conjunction with the Baby Gorilla®/Gorilla® Plating System (K203511).

This document describes the R3ACT™ Stabilization System, a medical device for fracture repair and ligamentous injuries of the feet and ankles. It is a 510(k) premarket notification to the FDA. The information provided is for a conventional medical device, not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered devices cannot be fully answered.

Here's the information extracted from the provided text regarding the device and its testing:

1. A table of acceptance criteria and the reported device performance

The provided text states: "All performance testing conducted for the R3ACTTM Stabilization System met the predetermined acceptance criteria or were otherwise considered acceptable." However, specific quantitative acceptance criteria and detailed performance results for each test are not provided in the document.

The document lists the following performance tests conducted:

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes (number of devices/components) used for each performance test. It also does not discuss data provenance in terms of country of origin or retrospective/prospective as these are typically relevant for clinical studies, which were not performed for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device underwent performance testing (mechanical and material tests) on the device itself, not a clinical study involving human or image data with ground truth established by experts.

4. Adjudication method for the test set

This question is not applicable for the same reason as point 3. Performance tests on a physical device do not involve adjudication by experts.

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

This question is not applicable. This is a conventional medical device, not an AI/ML powered device. No MRMC study was performed, and thus no effect size related to AI assistance is provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a conventional medical device, not an AI/ML powered device. No algorithm-only performance was evaluated.

7. The type of ground truth used

For the performance testing mentioned (e.g., torque to failure, static pullout), the "ground truth" would be the engineered specifications and expected physical behavior of the device components under various loads, as defined by engineering standards and design requirements. It's not "expert concensus, pathology, or outcomes data" in the context of clinical evaluation.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML powered device and therefore does not have a "training set" in the machine learning sense. The testing performed was for product performance validation.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this conventional medical device.

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