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The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.

Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm locking screws along with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.

This document is a 510(k) Summary for a medical device called "Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications." It's for an orthopedic implant, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their modified device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Here's the information extracted from the provided text that is relevant to the type of device:

Device Information:

• Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications
• Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
• Predicate Device: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes One Third Tubular LCP Plate
• Intended Use/Indications for Use: The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
• Material: Available in stainless steel and titanium.

Substantial Equivalence:
The document states that "Information presented supports substantial equivalence" to the predicate devices. This is the primary "acceptance criterion" for a 510(k) submission of this type. The specifics of how this equivalence was demonstrated (e.g., mechanical testing, material comparisons, design comparisons) are not detailed in this summary document but would have been part of the full 510(k) submission.

Regarding the specific questions about acceptance criteria and studies for an AI/ML device:

As this is a mechanical orthopedic implant, the following questions are not applicable:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.

Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft. 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm and 3.5 mm locking screws along with 2.4 mm, 2.7 mm and 3.5 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.

The provided text is a 510(k) Summary and FDA clearance letter for a medical device called "Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates." This document primarily describes the device, its intended use, and its substantial equivalence to a predicate device, leading to its clearance for market.

It does NOT contain information about acceptance criteria, specific device performance metrics, or details of a study that proves the device meets acceptance criteria in the context of clinical or diagnostic performance.

The 510(k) process for devices like bone plates typically focuses on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This often involves:

• Bench testing (mechanical properties, fatigue life, etc.) to ensure the new device performs equivalently to the predicate.
• Biocompatibility testing.
• Sterilization validation.
• No clinical trials or diagnostic performance studies are usually required unless the technological characteristics or intended use are significantly different from the predicate, or if it's a Class III device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it is not present in the provided document. The document confirms that the device was found "substantially equivalent" to a predicate device based on the information presented, which typically includes engineering and design comparisons, not clinical performance data in the sense of accuracy, sensitivity, or specificity.

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