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The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System.

The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).

All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The provided document is a 510(k) summary for the LORRAINE 2.5/3.5mm Distal Humerus System. It describes the administrative information, device classification, predicate devices, indications for use, device description, and a summary of non-clinical tests.

However, this document does NOT contain information about any study involving Artificial Intelligence (AI) or machine learning, human readers, or image-based diagnostics. The device described is a metallic bone fixation appliance, specifically plates and screws, used for orthopedic applications (fractures, osteotomies, non-unions of the distal humerus).

Therefore, I cannot extract the information required by your prompt, such as:

• Acceptance criteria and reported device performance related to AI/ML.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods, as these relate to studies involving AI/ML performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data) in the context of AI/ML.

The "studies" described in the document are non-clinical tests related to the physical device itself:

• Sterilization validation: Ensuring the device can be properly sterilized.
• Packaging validation: Ensuring the sterile packaging integrity.
• Biocompatibility: Assessing the safety of the materials in a biological environment.
• Mechanical testing: Evaluating the strength and stiffness of the plates and screws, comparing them to predicate devices. This involves mechanical stresses, not data analysis or human-in-the-loop performance.
• MRI safety: Determining if the device is safe for patients undergoing MRI scans.

All these tests are standard for orthopedic implants and are designed to demonstrate the physical and material properties and safety of the device, not an AI or data-driven component.

Therefore, it is impossible to answer your request based on the provided text, as the text describes a physical medical device (orthopedic implant) and not an AI/ML powered device.

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The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.

The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.

The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.

The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.

The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.

The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.

The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.

The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.

The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.

The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides.

The plates and screws are manufactured from Stainless Steel and Titanium alloy.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates.

These all are mainly divided into:

• . Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates .

The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm.

The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm.

The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.

This document describes the 510(k) summary for the HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The information provided pertains to the substantial equivalence of a medical implant (bone plates and screws) to predicate devices, focusing on material, design, and mechanical performance rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from the given text.

The document discusses the following:

• Device Name: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
• Intended Use: Fixation of various bone fractures and osteotomies.
• Predicate Devices: A list of Synthes Locking Compression Plate Systems and Screws.
• Non-Clinical Testing:
  • Material Standards: ASTM F136, ASTM F138, ASTM F139 (for Stainless Steel and Titanium alloy).
  • Performance Standards: ASTM F382 (Metallic Bone Plates), ASTM F384 (Metallic Angled Orthopedic Fracture Fixation Devices), ASTM F543 (Metallic Medical Bone Screws), and FDA guidance documents for orthopedic screws and fracture fixation plates.
  • Performance Results: Conforms to Static Four Point Bend Test, Dynamic Four Point Bend Test (for plates), Torsional Properties, Driving Torque, and Pull-out Test (for screws).
• Clinical Evaluation: Not necessary to demonstrate substantial equivalence, as the device is similar in design, pattern, and intended use to predicate devices.

In summary, the provided text does not describe an AI/ML device or its performance evaluation. It details the regulatory clearance process for a traditional medical implant based on substantial equivalence.

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The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. 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 and Anteromedial 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,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula 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 fibula.

The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws. The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes.

This is a 510(k) premarket notification for a medical device, specifically the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral Distal Tibia Plates.

This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical safety and efficacy data. Therefore, the information you're requesting regarding acceptance criteria, study details, expert review, and ground truth establishment, which are typical for studies validating AI/ML diagnostic devices, are not present in this document. This submission focuses on engineering analysis and comparison to existing, already approved devices.

Here's why your specific questions cannot be answered from this document:

• This is not an AI/ML device. The device is a physical bone fixation system (plates and screws). Therefore, concepts like "device performance" in terms of classification metrics (sensitivity, specificity), "test sets," "training sets," "ground truth" (in the context of expert consensus or pathology for diagnostic accuracy), or "MRMC studies" are not applicable.
• 510(k) is about substantial equivalence. The primary way this device met its acceptance criteria was by demonstrating that it is "at least as strong as" and has similar indications, design, materials, and performance characteristics as previously cleared predicate devices.

However, I can extract information related to the device and its "proof" of meeting requirements based on the document provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, as explained, they are not applicable or not provided in this 510(k) submission for a physical implantable device:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through engineering analysis and fatigue testing, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a diagnostic assessment.
4. Adjudication method for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" equivalent here would be established engineering standards for strength and fatigue, against which the device was tested.
8. The sample size for the training set: Not applicable. No "training set" for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relied on demonstrating substantial equivalence through a comparison of indications, design, materials, and engineering performance (mechanical strength) to already approved predicate devices. It did not involve clinical studies or expert evaluations of diagnostic accuracy as would be the case for AI/ML diagnostic software.

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