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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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The VariAx Distal Radius Locking 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.

This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.

The provided document describes a 510(k) submission for a line extension to a bone plating system, specifically the VariAx Distal Radius Plating System. This type of submission is for medical devices that are "substantially equivalent" to predicate devices already on the market. Therefore, the "acceptance criteria" and "study" are focused on demonstrating this substantial equivalence through non-clinical testing, rather than a clinical study establishing efficacy or diagnostic performance as would be expected for an AI/ML device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "worst case subject plates" were tested. It does not specify the exact number of plates or samples tested, but implies that representative samples deemed "worst case" were selected for mechanical testing.
• Data Provenance: The testing was "non-clinical laboratory testing." The document does not specify the country of origin of the data beyond implying it was conducted to ASTM standards, which are international standards. The testing was retrospective in the sense that it evaluates the manufactured product against established standards and a predicate device, not in the context of a prospective patient study.

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

This type of information is not applicable to this submission. The "ground truth" for this device's acceptance is based on engineering standards (ASTM F382-99:2008) and comparison to a legally marketed predicate device, not on expert medical consensus on diagnostic outcomes or interpretations.

4. Adjudication Method for the Test Set

This is not applicable. There was no expert-based ground truth to adjudicate for this type of submission. The performance was assessed against engineering standards.

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

This is not applicable. This submission is for a physical medical device (bone plating system), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.

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

This is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is:

• Engineering Standards: Compliance with "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
• Predicate Device Performance: Demonstrating substantial equivalence to the mechanical, intended use, and operational principles of the TriMed Wrist Plates (K060041).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Manufacturing processes are validated, but this isn't referred to as a "training set" in the context of AI/ML.

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

This is not applicable for the same reason as point 8. There is no training set mentioned in the context of an AI/ML algorithm.

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The VariAx Distal Radius Locking 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.

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market a line extension to the VariAx Distal Radius Plating System, which was cleared in K040022, as the Universal Distal Radius System. The VariAx Distal Radius Plating System Line Extension consists of multiple internal fixation plates in varying lengths and widths. The portfolio of plates is being extended to include new plate width (intermediate) and new plate length (extrashort). The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, and K132502. The subject components will be available sterile and non-sterile.

The provided text is for a 510(k) submission for a medical device (VariAx Distal Radius Plating System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or safety through clinical trials in the same way a new drug or novel medical device might.

Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. This is because these are more typical requirements for AI/ML-driven devices or those requiring extensive clinical evidence.

The relevant sections are "Non-Clinical Test" and "Clinical Testing".

Here's a breakdown of what is available:

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

• Acceptance Criteria: The implicit acceptance criterion is "substantial equivalence" to the predicate devices (VariAx Distal Radius Plating System (K040022) and the VariAx Distal Radius Line Extension of XXL Plates (K100271)) in terms of intended use, design, materials, and operational principles. Specifically for mechanical performance, the standard "ASTM F382 - 99: 2008" serves as the benchmark.
• Reported Device Performance: "Testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the currently marketed predicate devices."

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

• Sample Size for Test Set: This device is a mechanical implant. The "test set" refers to physical samples of the device undergoing non-clinical mechanical testing. The document states "worst case subject plates" were tested but does not specify the exact number of plates or samples.
• Data Provenance: The testing was "Non-clinical laboratory testing," implying in-vitro or bench testing, not human patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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)

• Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this type of mechanical device submission. The "ground truth" here is compliance with an engineering standard (ASTM F382).

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

• Not Applicable. This pertains to expert review of medical images or data. For mechanical testing, the "adjudication" is the pass/fail result according to the specified ASTM standard.

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

• No. This is not an AI/ML device. MRMC studies are not applicable.

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

• No. This is a mechanical implant, not an algorithm.

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

• The "ground truth" for this device's performance is adherence to established engineering and material standards for metallic bone plates (ASTM F382 - 99: 2008). The comparison is against predicate devices that also met these standards.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML system. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

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