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APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.

The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.

The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.

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

The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.

• Sample Size for Test Set: Not applicable, as no clinical test set was used.
• Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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 metallic bone fixation system, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm requiring a training set was used.

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

Not applicable, as no machine learning algorithm requiring a training set was used.

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The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.

The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.

The provided text is for a medical device (The OrthoPro Ankle Trauma System) that is a metallic bone fixation appliance. The acceptance criteria and the study performed for this type of device are primarily focused on non-clinical performance benchmarks, demonstrating substantial equivalence to predicate devices, rather than clinical performance measures or AI-driven diagnostic accuracy.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will largely pertain to biomechanical testing and comparison with legally marketed predicate devices, and not to a clinical study involving human readers, AI assistance, or diagnostic accuracy metrics typically seen in AI/ML medical devices.

Here's the breakdown based on the provided text, addressing the points where information is available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by demonstrating substantial equivalence in performance to predicate devices through standardized biomechanical testing. The performance is reported as meeting or exceeding the predicate.

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

The text explicitly mentions tests conducted on "the worse case plate" and "the screws" from the Ankle Trauma System. This implies a limited number of physical samples for mechanical testing, not a large test set of clinical data from patients. The provenance of these physical samples would be the manufacturing facility, representing the device itself.

• Sample Size: Not explicitly stated as a numerical count, but refers to "the worse case plate" and "the screws," indicating physical samples for destructive testing. Typically, biomechanical testing involves a statistically significant number of samples of the device and predicate to demonstrate equivalence; however, specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from in vitro biomechanical testing of the manufactured devices.

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

This question is not applicable to the non-clinical testing described. "Ground truth" in this context would refer to the established standards and methodologies of the ASTM documents (ASTM F382-99 and ASTM F543-07), which are developed by expert consensus within the field of biomaterials and medical devices. There are no "experts used to establish ground truth for the test set" in the sense of clinical reviewers or annotators, as this is a non-clinical, mechanical performance study.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for resolving discrepancies among multiple expert reviewers in clinical studies. No such adjudication was performed as this was non-clinical biomechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No. This type of study is performed for diagnostic imaging devices, often involving AI. This device is a metallic bone fixation appliance, and no such clinical or AI-related study was performed. The document explicitly states: "No clinical studies were performed."

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

No. This question is relevant for AI/ML medical devices. This device is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

• Standardized Biomechanical Testing Methods: ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Metallic Bone Screws).
• Performance of Predicate Devices: The measured mechanical performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable, as there is no training set for this device.

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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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The Synthes 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, 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 Variable Angle LCP Ankle Trauma System contains plates that are intended to treat fractures of the ankle, and includes multiple plate types to accommodate different fracture patterns and patient anatomy. Two new screw configurations are included in the Synthes Variable Angle LCP Ankle Trauma System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws. Specifically, the following plates and screws are included in the Synthes Variable Angle LCP Ankle Trauma System: • Medial and Anteromedial Distal Tibia Plates • Distal Tibia T Plates and Distal Tibia L Plates • Lateral Distal Fibula plate • 2.7mm Metaphyseal Screws • 3.5mm VA Locking Screws All of the plates will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. All of the plate configurations (with the exception of the Distal Tibia T plate, which is symmetrical), will be offered in left and right designs. The system accepts existing cortical and locking screws (i.e. K000684 and K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal Screws, and allows for both dynamic compression and locking through Combi holes.

The provided text describes Synthes Variable Angle LCP Ankle Trauma System. This is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML performance and study design are not applicable.

Here's an analysis based on the available information:

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

For a medical implant like the Synthes Variable Angle LCP Ankle Trauma System, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices in terms of mechanical properties and biocompatibility. The summary details these as:

• New screws shown to be substantially equivalent to existing screws. |
  | Biocompatibility/Materials | - Plates offered in stainless steel and titanium alloy (materials commonly used and accepted for bone fixation). |
  | Design Characteristics | - Similar design characteristics to predicate Synthes Systems. |
  | Indications for Use | - Similar indications for use to predicate Synthes Systems (fixation of ankle fractures, osteotomies, nonunions, malunions, and replantations in adults and adolescents with fused growth plates, particularly in osteopenic bone). |

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

The information provided does not detail specific "test sets" in the context of clinical studies with human subjects for performance evaluation as would be done for an AI/ML device. The testing mentioned ("engineering analysis, static strength, and fatigue strength testing") refers to mechanical testing of the device components. The sample size for such mechanical tests would be the number of physical samples tested, but this is not provided in the 510(k) summary. The provenance would be the laboratory where the testing was conducted, but this is also not specified.

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 is not applicable as there is no "ground truth" derived from human experts for this type of mechanical device submission. The substantial equivalence is based on engineering and material science principles.

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

Not applicable. There is no clinical adjudication mentioned.

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/ML device.

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

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

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

For this device, the "ground truth" for substantial equivalence is derived from:

• Established engineering principles (e.g., calculations of stress, strain).
• Material properties data for stainless steel and titanium alloys.
• Mechanical testing standards for orthopedic implants, which dictate how strength and fatigue are measured.
• Comparison to existing predicate devices and their known performance and safety profiles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

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

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