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The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:

• Open reduction and internal fixation of fractures, mal-unions, and non-unions
• Following excision of benign bone tumors
• Replantations and reconstructions
• Arthrodeses of joints involving small bones
• Osteotomies, including deformity correction such as rotation, lengthening, shortening
• Pathological fractures, including impending pathologic fractures

The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.

The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).

However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.

Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:

Acceptance Criteria and Study to Prove Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.

6. Standalone Performance

The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.

7. Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by:

• Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
• Engineering principles and material properties: Used in Finite Element Analysis.
• Physical measurements under controlled laboratory conditions.

This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical device.

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The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.

The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction.

The provided document is a 510(k) summary for the Synthes 2.4mm Variable Angle LCP Volar Rim Distal Radius System. This type of submission is for medical devices that are substantially equivalent to a predicate device and, as such, does not contain acceptance criteria and studies demonstrating device performance in the same way a de novo or PMA submission would.

Instead, the documentation focuses on demonstrating substantial equivalence through:

1. Comparison of intended use and design features to predicate devices.
2. Mechanical testing to show comparable performance in terms of mechanical strength and fatigue to predicate devices.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not typically included or required for a 510(k) submission based on substantial equivalence to existing devices. Such detailed studies are usually reserved for novel devices or those with higher risk classifications where clinical efficacy and safety need to be established independently.

However, I can extract the information related to the device description and the type of testing performed to support substantial equivalence.

Here's a breakdown of what can be extracted from the provided text, addressing the closest relevant points:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The general implied acceptance criterion is "comparable mechanical strength and fatigue" to predicate devices.
• Reported Device Performance: The document states that "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in regards to mechanical strength" and "Testing conducted to support the substantial equivalence for the 2.4mm VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue strength of the subject device." It also mentions "Functional & mechanical testing demonstrates the comparable mechanical and functional properties of the 2.4mm Variable Angle LCP Volar Rim Radius System to the predicate devices."

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified. Mechanical testing typically involves a set number of specimens, but this detail is not provided in a 510(k) summary.
• Data Provenance: The testing was conducted by Synthes (USA), the sponsor of the device. The data would be internal to the company, performing the tests to demonstrate equivalence. It is not patient data, but rather mechanical test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth/Experts: This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards and test methods, not by expert consensus on clinical data. No human experts are involved in establishing a "ground truth" for mechanical properties in this context.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined engineering parameters, not subjective interpretations requiring adjudication.

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

• MRMC Study: No. This is a medical implant (bone plate) used for fixation of fractures, not an image-based diagnostic or AI-powered device. Therefore, MRMC studies are irrelevant.

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

• Standalone Performance: No. This is not an algorithmic device. The performance is physical and mechanical.

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

• Ground Truth: For this type of device and study, the "ground truth" refers to established engineering standards for mechanical properties (e.g., strength, fatigue limits) and the mechanical properties of the predicate devices. It is based on objective physical measurements and engineering analysis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no "training set" as this is not a machine learning/AI device. Finite element analysis (FEA) was used, which involves computational models, not a data training set.

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

• Ground Truth for Training Set: Not applicable for the same reason as above. FEA relies on material properties and geometric models, not a "ground truth" for a training set. The FEA was used to "determine the worst case construct" for further dynamic loading testing.

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