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Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

• Fractures of the clavicle shaft
• Fractures of the lateral clavicle
• Malunions of the clavicle
• Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

• Split-type fractures of the lateral tibial plateau
• Lateral split fractures with associated depressions
• Pure central depression fractures
• Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

• Complex extra- and intra-articular olecranon fractures
• Non-unions of the proximal ulna
• Osteotomies
• Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.

However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.

Here's the breakdown based on the information available:

Acceptance Criteria and Study for Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.

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

• Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
• Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.

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

• Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.

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

• Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.

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

• Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.

7. The Type of Ground Truth Used

• Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.

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ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
  ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.

ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.

ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.

ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically bone plates and screws. It does not contain information about an AI/ML device, AI acceptance criteria, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or training/test set details from this document. The document describes the substantial equivalence of bone fixation appliances to existing predicate devices based on technological characteristics and mechanical performance data (e.g., static four-point bending, dynamic four-point bending, static torsion, static axial pullout).

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NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System consists of plates and screws in a variety of designs and sizes and made from Ti-6Al-4V alloy or stainless steel. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in, 3.5mm Cortex Self-tapping, 4.5 mm Cortex self-tapping and 2.7mm self-tapping cortex locking, 3.5mm selftapping Cortex Locking, 5.0 mm cortex Locking thread designs in various lengths. This system is not indicated for use in spine.

NET Brand of DHS/DCS Plating System made from Ti-6Al-4V alloy or stainless steel and consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw Self Tapping, The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel) and barrel angels varies in 130° to 150°. The DCS plate is having angle of 95°

The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7 mm and outer diameter of 12.5. The thread of DHS/DCS Screw has a buttress type.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 4.0 mm.

The provided document is a 510(k) Premarket Notification for the "NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria, as it is not a performance study in that sense.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is achieved by comparing the new device's technological characteristics, intended use, materials, and performance (via testing against established ASTM standards) to those of already approved predicate devices.

Here's an explanation based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not define specific "acceptance criteria" for clinical performance in terms of sensitivity, specificity, accuracy, or similar metrics for a new diagnostic or prognostic device. Instead, it demonstrates compliance with recognized engineering and material standards to show that the device performs equivalently to previously approved devices.

The "reported device performance" is essentially a confirmation of conformance to established ASTM standards for bone plates and screws.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a "sample size" in terms of patient cases or images, as it is a mechanical device submission. The testing involves mechanical specimens (e.g., plates and screws) tested according to the cited ASTM standards. The specific number of specimens tested for each standard is not detailed in this summary.
• Data Provenance: Not applicable as it's not a clinical or imaging study. The tests are mechanical and presumably conducted in a laboratory setting.

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

Not applicable. This is a submission for a bone fixation device, not a diagnostic device requiring expert interpretation for ground truth establishment. Mechanical testing relies on standardized methodologies, not expert consensus on clinical cases.

4. Adjudication method for the test set:

Not applicable for a mechanical device submission.

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 is a medical device for bone fixation, not an AI or diagnostic tool.

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

Not applicable. This is a medical device for bone fixation, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established performance benchmarks defined by recognized industry standards (ASTM F382, ASTM F384, ASTM F543 for performance, and ASTM F136, ASTM F138, ASTM F139 for materials). The device is deemed acceptable if it conforms to these standards, indicating mechanical properties are comparable to legally marketed devices.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this type of device submission. The "ground truth" for demonstrating substantial equivalence rests on adherence to material and performance standards, which are developed and accepted by the scientific and engineering community.

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