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The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:

• Post-traumatic arthritis of the joints of the wrist .
• Rheumatoid wrist deformities requiring restoration ●
• Complex carpal instability ●
• Post-septic arthritis of the wrist ●
• Severe unremitting wrist pain related to motion
• Brachial plexus nerve palsies
• o Tumor resection
• Spastic deformities

VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527 (VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).

This document describes a 510(k) premarket notification for the Stryker VariAx 2 Wrist Fusion System, a metallic bone fixation appliance. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your requested information:

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device. The goal is to demonstrate that the new device is as safe and effective as the predicate.

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

The document states: "Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence."

• Sample Size: The exact sample size for the mechanical testing is not specified in this document. It refers to "worst case subject plates," implying a representative selection, but the number is not given.
• Data Provenance: The testing was "non-clinical laboratory testing." The country of origin of the data is not specified, but the sponsor is Stryker Trauma AG, located in Switzerland, and the contact person is in Germany. The testing itself would likely have occurred in a laboratory setting associated with the manufacturer or a contracted testing facility. It is prospective in nature, as it's testing performed specifically for this submission.

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 device is a mechanical implant, not an AI/diagnostic device. As such, "ground truth" in the context of expert consensus for diagnostic interpretation is not applicable. The "ground truth" for the non-clinical testing is established by the ASTM F382-14 standard for metallic bone plates, which defines the acceptable mechanical properties. The "experts" in this context would be the engineers and technicians performing and interpreting the mechanical tests according to the standard. Their qualifications are not specified but would be in mechanical engineering or materials science.

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

Adjudication methods like 2+1 or 3+1 are typically for clinical studies involving human interpretation or subjective endpoints. For non-clinical mechanical testing, there is no adjudication method mentioned or typically required in the same sense. The results are quantitative measurements against an established standard (ASTM F382-14). Discrepancies would be handled through repeat testing or calibration, not expert consensus.

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 MRMC study was done. This is a hardware implant device, not an AI or diagnostic software.

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

Not applicable. This section is for AI/software devices. The device is a physical bone fixation system.

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

For the non-clinical mechanical testing, the "ground truth" for evaluating the device's performance is:

• Compliance with the ASTM F382-14 'Standard specification and test method for metallic bone plates'. This standard defines the acceptable mechanical properties, such as fatigue strength.

8. The sample size for the training set

Not applicable. This device is a hardware implant and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. See point 8.

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The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
• intra-articular or extraarticular fractures of the distal humerus
• osteotomies
• nonunions
The olecranon plates are indicated for:
• intra-articular or extraarticular fractures of the proximal ulna
• osteotomies
• nonunions

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 Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.

This submission is for a medical device, the VariAx Elbow Plating System, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's a breakdown of the provided information, focusing on the relevant sections for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as this is a non-clinical, mechanical testing study. The document refers to testing "worst case subject plates," implying a representative sample of each new plate type was tested.
• Data Provenance: The testing was "Non-clinical laboratory testing" performed by Stryker Trauma AG. The country of origin of the data is not specified but is presumably where Stryker Trauma AG conducts its R&D and testing. It is prospective testing designed to evaluate the new plates.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to a non-clinical mechanical performance study. Ground truth is established by the ASTM F382-99 standard and the mechanical properties of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This was mechanical testing against a standard and predicate device performance.

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

Not applicable. This is a medical device for fracture fixation, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. There is no algorithm for this device. The "standalone" performance here refers to the mechanical performance of the device itself. The study confirms that the device's mechanical properties (strength, fatigue, etc.) meet the specified standard and are equivalent to predicate devices.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates": This standard defines the acceptable mechanical properties for bone plates.
• Performance of Legally Marketed Predicate Devices: Specifically, the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) were used as benchmarks for substantial equivalence comparison.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and does not involve a "training set" in that context. The "training" in this case refers to the engineering design and manufacturing processes that result in the device.

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

Not applicable. There is no "training set" ground truth in the context of an AI/ML device. The design and manufacturing of the device are based on established engineering principles, biomechanical understanding of bone fixation, and compliance with materials standards (e.g., ASTM F136 and ASTM F67 for titanium alloys).

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Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a line extension to the VariAx Clavicle System, which was previously cleared in VariAx Clavicle System (K113760 & K130116). The VariAx Clavicle System consists of anatomically contoured. Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The subject plates are fixed to the clavicle using 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056 and K132502. This 510(k) submission is intended to introduce Hook Plates to the currently marketed VariAx Clavicle System. The plates are manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes).

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Non-clinical laboratory testing" and "fatigue testing" which would involve a certain number of test samples (e.g., plates) but the exact quantity is not specified.
• Data Provenance: The testing was "Non-clinical laboratory testing" conducted by the sponsor (Stryker Trauma AG). This indicates it was likely conducted in a controlled lab environment. No information on country of origin of data beyond the sponsor's location (Mahwah, NJ) is provided. It is considered prospective in the sense that the tests were designed and executed to evaluate this specific device prior to its marketing.

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

Not applicable. This was a non-clinical, mechanical and material testing study, not a clinical study requiring expert assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable, as it was a non-clinical, mechanical and material testing study. The "adjudication" was based on comparing the mechanical performance data (e.g., fatigue curves, stress analysis from FEA) of the subject device against the established performance of the predicate device.

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

No. This document explicitly states: "Clinical testing was not required for this submission." Therefore, no MRMC study was conducted.

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

No. This is a medical device (bone fixation plate), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established performance characteristics (e.g., fatigue limits, material properties, structural integrity) of the predicate devices. The subject device's performance was compared against these established standards as determined through engineering and material science testing (e.g., fatigue testing, Finite Element Analysis).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the traditional sense 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 medical device.

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The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.

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, midand 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.

The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.

The VariAx 2 System is a medical device designed for internal bone fixation. Its acceptance was determined through non-clinical laboratory testing, demonstrating substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific numerical values for the acceptance criteria or reported performance. The "acceptance criteria" and "reported device performance" are inferred from the statement "Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing."

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not specify the sample size used for each non-clinical test.
• Data Provenance: Not applicable as the testing was non-clinical laboratory testing. The country of origin for the sponsor, Stryker Trauma AG, is Switzerland.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable. The regulatory pathway for this device (510(k)) focuses on substantial equivalence through non-clinical testing for fracture fixation systems, not on human expert assessment for image interpretation or diagnosis. Therefore, no experts were used to establish ground truth in the context of image interpretation.

4. Adjudication Method for Test Set:

Not applicable. This was a non-clinical device testing study, not a clinical study involving human judgment or interpretation requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states, "Clinical testing was not required for this submission."

6. Standalone Performance Study:

Yes, in a way. The non-clinical laboratory tests assess the performance of the device components (screws and plate-screw constructs) in isolation, under controlled laboratory conditions, to determine their mechanical properties and functional equivalence to predicate devices. This represents an "algorithm only without human-in-the-loop performance" in the context of a physical device's mechanical integrity.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria was based on engineering and mechanical performance benchmarks established by predicate devices and recognized industry standards for bone fixation appliances. These benchmarks are inherently quantitative and objective, derived from physical testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical bone fixation system, not an AI/ML algorithm. Therefore, 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 medical device submission.

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The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.

The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws.

This FDA 510(k) summary describes a medical device, the Variax Clavicle System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-driven device.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided document is a 510(k) summary for a traditional medical device (a bone fixation system) and explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

This device is not an AI/ML device, and its approval relies on demonstrating substantial equivalence to existing predicate devices through non-clinical testing (fatigue strength and pull-off testing) and comparison of technological characteristics.

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Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension.

The VariAx™ Elbow System is intended for fracture fixation of long bones. The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.

This 510(k) summary describes a modification to the indications for use of the VariAx Elbow System, which is a bone plate and screw system. The submission does not involve a medical device that uses AI or machine learning, and therefore the concepts of acceptance criteria, device performance, ground truth, training sets, or expert adjudication as typically applied to AI/ML devices are not relevant here.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K073557) rather than providing performance data against specific acceptance criteria for a new or significantly modified device.

Here's a breakdown of why the requested information cannot be provided based on the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. This submission is for changing the indications for use of an existing device type, not for a device with a performance metric that would be assessed against specific acceptance criteria in the context of an AI/ML study. The device itself (bone plates and screws) is a mechanical fixation device, not a diagnostic or prognostic system with performance metrics like accuracy, sensitivity, or specificity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm or a study designed to evaluate performance metrics. The substantial equivalence argument relies on the inherent properties of the device materials and design, not on clinical data.

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. There is no "ground truth" to establish for this type of submission, as it's not evaluating the output of an algorithm against a known correct answer.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or related adjudication process is described or relevant.

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 a physical medical device, not an AI-assisted diagnostic tool. No human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established or used for this type of submission.

8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable. No ground truth for a training set.

Summary of the Study (Substantial Equivalence Justification):

The "study" in this context is a substantive equivalence justification, a regulatory pathway for medical devices that are similar to legally marketed predicate devices.

• Acceptance Criteria (for regulatory clearance): The acceptance criterion for this submission is demonstrating that the modified VariAx Elbow System is substantially equivalent to its predicate device (K073527) for the new indications for use. This involves showing that the modifications do not raise new questions of safety and effectiveness.

• Reported Device Performance (as presented):

  • Intended Use: The revised intended use is for fracture fixation of long bones, specifically for "Distal Humerus Plates for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions" and "Olecranon Plates for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions."
  • Basis for Equivalence:
    • No design changes: "No mechanical testing was needed to demonstrate substantial equivalence of the subject components since no design changes were made to the system."
    • Identical manufacturing methods, packaging, and sterilization.
    • Identical materials: Both predicate and subject devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.
    • Identical mechanical & functional properties: "The mechanical & functional properties of the subject VariAx Elbow System are identical to the predicate device VariAx Elbow System K073527."

In essence, the "study" proving the device meets the "acceptance criteria" (of substantial equivalence) is the assertion and demonstration that the physical device itself is unchanged from a previously cleared device, only its stated indications for use are being clarified and expanded. Therefore, the performance characteristics are assumed to be identical to the predicate device.

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The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.

This document describes a Special 510(k) submission for the VariAx Elbow System Plate Line Extension. This is not a study focused on diagnostic accuracy or AI performance in the traditional sense. Instead, it is a submission for a medical device (bone plates and screws) and primarily discusses its substantial equivalence to a previously cleared predicate device.

Therefore, many of the typical acceptance criteria and study design elements requested in a clinical or AI performance study are not applicable to this type of submission. The focus here is on mechanical and functional equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the way one might for a diagnostic AI study (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this device modification is substantial equivalence to the predicate device in terms of mechanical strength and functional properties.

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

• Not Applicable in the context of clinical or AI performance data. This submission relies on mechanical and functional testing of the device itself, not patient data or a "test set" of cases. The "sample" here refers to the number of physical devices tested to demonstrate mechanical properties. The document does not specify the exact number of plates/screws tested, only that mechanical and functional testing was performed.
• Data Provenance: The testing would have been conducted by the manufacturer (Howmedica Osteonics Corp.) in a laboratory setting. There is no "country of origin of the data" in the sense of patient demographics for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. For a medical device like bone plates, "ground truth" is established through engineering and material science principles, manufacturing specifications, and international standards for mechanical testing. It's not typically established by clinical experts reviewing cases.

4. Adjudication Method for the Test Set:

• Not Applicable. This concept is relevant for studies involving human reviewers or AI output that needs to be assessed for accuracy against a reference standard. For mechanical testing, the results are objective measurements (e.g., load at failure, fatigue cycles).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance. The VariAx Elbow System Plate Line Extension is a physical device for fracture fixation, not a diagnostic tool.

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

• No. There is no algorithm or AI component to this device. It is a physical bone plate system.

7. The Type of Ground Truth Used:

• For this submission, the "ground truth" for demonstrating device performance would be based on:
  • Mechanical Test Standards: Established international and national standards for testing the strength, fatigue life, and other mechanical properties of bone plates and screws (e.g., ASTM standards).
  • Predicate Device Performance Data: The established and cleared performance metrics of the previously approved VariAx Elbow System (K073527) serve as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning product where a "training set" of data is used. The device is designed and manufactured based on engineering principles and material science.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

In summary: The provided document is for a "Special 510(k)" for a medical device line extension. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical efficacy studies involving patient data or AI performance metrics. Therefore, many of the typical questions for AI study design are not relevant in this context.

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