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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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DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone.

DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus.

DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles.

DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system.

The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers:
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates
• 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate
• 3.5 mm VA Locking Attachment Plate

This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes the device, its intended use, and its comparison to predicate devices, along with non-clinical performance data. However, it does NOT describe an AI/ML powered device, nor does it contain any information about a study proving device meets acceptance criteria related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, or the establishment of ground truth by multiple experts.

Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of a physical orthopedic implant system to existing predicate devices, based on mechanical, MRI compatibility, sterilization, shelf-life, and biological safety testing. It does not mention any AI or machine learning components.

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The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.

The provided text is a 510(k) summary for the "Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins". This document is a premarket notification for a medical device seeking substantial equivalence to existing devices. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way one might for a novel AI device or a device requiring a PMA.

Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of regulatory submission. This submission primarily relies on non-clinical performance data and material characterization to demonstrate substantial equivalence to predicate devices, and explicitly states that "Clinical data was not needed to demonstrate the safety and effectiveness of the proposed devices."

Since this is a Class II device and a line extension, the focus is on mechanical and material testing to ensure it performs comparably to the predicate.

Here's an attempt to answer your questions based only on the information available in the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not provided. The document refers to "testing" and "evaluations" but does not specify the number of samples or specimens used in these mechanical or material tests.
• Data Provenance: Not specified, but generally refers to laboratory testing. Not applicable for retrospective/prospective human data.

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

• Not applicable. Ground truth as typically understood for AI/clinical studies (e.g., expert consensus on image interpretation) is not relevant for mechanical and material testing of an orthopedic implant. Performance is evaluated against engineering standards and specifications.

4. Adjudication method for the test set

• Not applicable. Performance is measured against predetermined test specifications and standards for mechanical and material properties. There is no "adjudication" in the clinical sense.

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 device or an imaging device requiring human-in-the-loop performance evaluation.

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

• Not applicable. This is not an algorithm or software device.

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

• The "ground truth" equivalent in this context would be the established engineering standards and material specifications (e.g., ASTM standards, specified endotoxin limits) that the device must meet, and the performance characteristics of the predicate device for comparison.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

Summary based on the document:

The device (Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins) demonstrates its performance and safety through non-clinical testing, material characterization, and comparison to a legally marketed predicate device (Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354)) to establish "substantial equivalence." The evaluations included various mechanical tests (Dynamic Fatigue, Connection Strength, Torque, Torsional Properties, Insertion/Removal Torque, Pull-out Strength) and material tests including endotoxin and corrosion assessments. All performed tests indicated that the device met the required specifications and demonstrated substantial equivalence to the predicate device. No clinical data or human reader studies were deemed necessary for this 510(k) submission.

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