Search Results

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 size of the device.

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 F138), and titanium alloy (per ASTM F136).

The provided text is an FDA 510(k) clearance letter for the Baby Gorilla®/Gorilla® Plating System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested items regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of document and product (a metallic bone fixation system). This clearance is based on mechanical performance and material equivalence, not diagnostic accuracy or clinical outcomes as would be relevant for an AI/ML device.

Here's a breakdown of the relevant information from the provided document:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met if the modified design does not adversely affect the original testing performance and is "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not detailed in this clearance letter. Instead, the focus is on demonstrating that the revised device's characteristics are similar enough to an already approved device to not raise new safety or effectiveness concerns.
• Reported Device Performance:
  • Performance: Shown not to be adversely affected by modifications.
  • Basic Design: Similar to the predicate.
  • Material: Similar to the predicate (medical grade titanium per ASTM F67, stainless steel per ASTM F138, and titanium alloy per ASTM F136).
  • Manufacturing: Similar to the predicate.
  • Sizes (dimensions): Comparable to those offered by the predicate systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The clearance is based on engineering analysis and comparison to a predicate device, not a clinical study with a patient test set in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided. This is a hardware device (bone plating system), not an AI/ML diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable and not provided.

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 information is not applicable and not provided. This device is a bone plating system, not an AI-assisted diagnostic tool.

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

• This information is not applicable and not provided. This is a hardware device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's substantial equivalence is its physical and mechanical properties and performance, as determined through engineering analysis and comparison to a legally marketed predicate device (K203511). It's not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

• This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

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

• This information is not applicable and not provided.

Ask a specific question about this device

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.

Ask a specific question about this device