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The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consists of metallic plates and screws that merge locking screw technology with conventional plating techniques. Locking screws provide the ability to create a fixed-angle construct while utilizing familiar AO plating techniques. A fixed-angle construct provides improved fixation in osteopenic bone or multifragment fractures where traditional screw purchase is compromised. The subject plates are available in various sizes in sterile configurations and are available in stainless steel and commercially pure titanium. The system also consists of implantable screws (K112583) that correspond to the subject device.

This is a 510(k) premarket notification for the DePuy Synthes 2.7mm LCP Plates (Modular Mini Fragment LCP System), a metallic bone fixation appliance. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a "test set" in the context of clinical data for the device's performance, as clinical testing was not necessary for the determination of substantial equivalence. The studies conducted were non-clinical (mechanical, MR compatibility, endotoxin, biocompatibility). Therefore, details like data provenance (country of origin), retrospective/prospective nature, and sample size for a test set (in a clinical sense) are not applicable or provided.

For the non-clinical studies:

• Mechanical Testing: The sample size for mechanical testing is not explicitly stated. The evaluation was a comparison to existing predicate plates.
• MR Compatibility: The sample size for MR testing is not explicitly stated.
• Endotoxin Testing: The sample size for endotoxin testing is not explicitly stated, but it involved testing the subject device(s).
• Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated.

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

Not applicable. As clinical testing was not required for substantial equivalence, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for non-clinical tests would be the established performance standards or test methods (e.g., ISO 10993-1 for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done, as clinical testing was not deemed necessary for this 510(k) submission.

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

Not applicable. This device is a bone fixation appliance, not an algorithm or AI-based diagnostic tool. The performance evaluated was physical and biological characteristics of the implant, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies was based on established engineering principles, international standards, and regulatory requirements:

• Mechanical Performance: Comparison to the known mechanical performance of the legally marketed predicate device.
• MR Compatibility: Established guidelines for MR Conditional parameters.
• Endotoxin Testing: The specified endotoxin limit (20 EU/device) and the LAL test method.
• Biocompatibility: ISO 10993-1 series of standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model, so there is no "training set" in the context of machine learning.

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

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

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The VariAx Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications include: compression fractures, intra-articular and extra-articular fractures, displaced fractures. Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: Internal fracture fixation; Osteotomies; Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below: T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: Compression fractures; Intra-articular and extra-articular fractures; Displaced fractures; Reconstruction procedures; T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: Intra-articular and extra-articular fractures of the Distal Radius, Displaced and compression fractures of the Distal Radius; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Reconstruction procedures in the Foot & Ankle and Distal Radius; T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; Single, segmental and comminuted fractures; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Normal bone density or osteopenic bone.

This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.

Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.

The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.

This document is a 510(k) summary for a medical device submission, specifically for the VariAx Distal Radius Plate System and VariAx 2 System.

The FDA 510(k) clearance process is for demonstrating substantial equivalence to a predicate device, not for proving a device "meets acceptance criteria" in the way one might prove performance of a new diagnostic algorithm. This specific document states that no clinical or non-clinical testing beyond LAL testing was required for this submission because the changes are primarily related to packaging configuration and no new components have been added. The products themselves remain identical to previously cleared predicate devices (K141430 and K140769).

Therefore, the information you've requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details do not apply to this specific 510(k) submission. This document explicitly states:

• "No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system." (Page 8)
• "Clinical testing was not required for this submission because there are no new components being added to the system." (Page 8)

The "acceptance criteria" for this submission are simply that the new packaging configuration does not alter the fundamental safety or effectiveness of the previously cleared components.

Given the nature of this 510(k), I cannot generate the requested table or answer the specific questions about performance studies, as such studies were not part of this particular submission. The device's "performance" was established by the original predicates it references, not by new studies for this packaging change.

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