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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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