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 Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies, Hallux Valgus Correction, Arthrodesis/Deformity Correction, Fusion resulting from neuropathic osteoarthropathy (Charcot).

The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and 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, Mid/Hindfoot, Ankle, First metatarsal osteotomies for hallux valgus correction, Arthrodesis of the first metatarsophalangeal joint (MTP), Flatfoot, 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 Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or degenerative arthritis, Previously infected arthrosis, Revision of failed ankle arthrodesis, Revision of failed total ankle arthroplasty, Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis), Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid arthritis, Osteoarthritis, Nonunions or pseudarthrosis of hindfoot and distal tibia, Trauma (severe or malunited tibial pilon fracture), Charcot foot (neuroarthropathy), Severe end-stage degenerative arthritis, Instability and skeletal defects after tumor resection, Pantalar arthrodesis, Severe foot/ankle deformity.

HammerTube™M System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.

The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

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.

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 non0locking 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).

Phantom® Small Bone Intramedullarv Nail System: The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

Phantom® Hindfoot TTC/TC Nail System: The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

HammerTube™ System: The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile.

APEX 3D Total Ankle Replacement System: The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.

This FDA 510(k) summary (K231231) describes the MR Safety and Compatibility Testing and Labeling Updates for several Paragon 28 Orthopedic Fixation Devices. The document states that the purpose of this submission is to obtain clearance for Magnetic Resonance (MR) safety and compatibility testing and Magnetic Resonance Imaging (MRI) Safety Information updates to the labeling of previously cleared devices. It explicitly mentions that there are no other indications for use, design, material, processing, performance, or labeling modifications subject to the submission. This is crucial because it means the study described focuses solely on MR safety, not on clinical effectiveness of the orthopedic fixation devices themselves.

Therefore, the study focuses on ensuring the devices meet MR Conditional labeling requirements based on established standards, rather than evaluating their clinical performance in human patients.

Here's a breakdown of the requested information based on the provided text, with the caveat that the study is not a clinical effectiveness study of the orthopedic devices but rather a safety study for MRI compatibility:

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

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

The document does not explicitly state the specific "sample size" of devices tested for MR safety. The testing was performed on the described orthopedic fixation devices (Monster® Screw System, Baby Gorilla® / Gorilla® Plating System, Phantom® Small Bone Intramedullary Nail System, Phantom® Hindfoot TTC/TC Nail System, HammerTube™ System, APEX 3D™ Total Ankle Replacement System).

Data provenance is not directly about country of origin in this context; it's about the nature of the testing. The testing was prospective in relation to the submission, performed specifically to generate the data for the MR safety labeling update. The tests are in vitro (laboratory-based) rather than in vivo (on human subjects).

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 question is not applicable to the described study. The "ground truth" here is compliance with established engineering standards for MR safety, not a medical diagnosis or outcome requiring expert medical consensus. The testing involved standardized methods (ASTM standards) and engineering evaluations, not interpretation by medical experts for a test set of patient data.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers (e.g., radiologists) in a clinical diagnostic study. This study is an engineering safety performance study of medical devices, not a diagnostic study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is not about AI assistance or human reader performance. It is a safety study evaluating the compatibility of orthopedic implants with MRI environments.

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

No, this question is not applicable. This study involves the physical testing of orthopedic implants in an MRI environment to determine their safety and compatibility characteristics, not the performance of an algorithm.

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

The "ground truth" for this study is compliance with established, recognized engineering standards for MR safety as defined by ASTM (American Society for Testing and Materials) and the FDA's guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." These standards provide quantitative metrics and methodologies for evaluating magnetic force, torque, heating, and image artifact.

8. The sample size for the training set

This question is not applicable. The described study is not a machine learning or AI study, so there is no concept of a "training set."

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

This question is not applicable, as there is no training set in this type of device safety study.

Ask a specific question about this device

The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Device Name: TITAN 3-D® Wedge System

Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.

Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.

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

The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.

• Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
• Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.

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

Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.

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

Not applicable. This is an implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/software product that requires a training set.

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

Not applicable. See explanation for #8.

Ask a specific question about this device

The JAWS® Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis, and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.

Please note that the provided document is a 510(k) summary for a medical device (JAWS® Nitinol Staple System) seeking substantial equivalence to a predicate device, not an AI/ML-enabled imaging device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI device (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance) is not directly applicable or available in this document.

The document discusses performance testing in the context of demonstrating substantial equivalence for a physical medical implant, not an AI algorithm. The performance testing referred to here would typically involve mechanical, material, and functional tests of the staple itself, rather than diagnostic accuracy or effectiveness studies in the way you're asking for AI.

However, I can extract the information relevant to their definition of "acceptance criteria" and "study" as presented for this specific medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific numerical acceptance criteria for mechanical properties, MR compatibility, or corrosion are not detailed in this summary document. The "results...demonstrated the modified designs are substantially equivalent to the predicate devices" implies that the device met internal and regulatory standards for these tests. "All performance testing conducted...met the predetermined acceptance criteria or were otherwise considered acceptable."

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 applicable and thus not provided in the document as it pertains to a physical medical device (staple) and not a software/AI device. The "test set" here refers to physical samples of the staple and its components.

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):

• Not applicable as this is not an AI/diagnostic device. Ground truth, in the context of a physical device, would relate to manufacturing specifications, material properties, and mechanical performance standards, which are evaluated by engineers and technical experts.

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

• Not applicable as this is not an AI/diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials.

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:

• Not applicable. This device is a physical bone fixation staple, not an AI-assisted diagnostic tool.

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

• Not applicable. This document is for a physical medical device, not an algorithm.

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

• For this physical device, the "ground truth" would be objective engineering specifications, material standards (e.g., ASTM, ISO), and performance benchmarks for mechanical strength, fatigue, corrosion resistance, and MR compatibility. These are established through scientific principles and standardized testing methodologies rather than expert consensus on medical images or pathology.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device