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The Stryker Anchorage 2 CP System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients.

Indications include:

• Replantation
• Joint fusions
• Corrective osteotomies
• Osteopenic bone

This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new Anchorage 2 CP System. The Anchorage 2 CP System is an internal fixation device that consists of various plates used with compatible screws to treat different types of corrective osteotomies and fractures in the foot and ankle. The subject plates comprise of a new countersunk screw interface that is only compatible with the new inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The subject components will be available sterile and non sterile. The plates will be available in sizes ranging from 23-49mm in length. The Anchorage 2 CP System is introducing Ø3.6mm and Ø4.1mm inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The Anchorage 2 CP Ø3.6mm CP lag screws will be available in sizes ranging from 20-44mm in length and the Anchorage 2 CP Ø4.1mm CP lag screws will be available in sizes ranging from 20-70mm. The Anchorage 2 CP System includes holes that are only compatible with the existing VariAx 2 System screws that were previously cleared in the VariAx 2 System (K132502).

Apart from the CP Lag screws, the associated accessories include:

• CP Reamer
• CP Drill Guide for T8 Ø3.6mm CP lag screws
• CP Drill Guide for T10 Ø4.1mm CP lag screws
• CP Templates

This document describes the Anchorage 2 CP System, a medical device for internal fixation in foot and ankle. The information provided outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to predicate devices, rather than a study proving it meets specific acceptance criteria in the typical sense of AI/diagnostic device performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of device and submission. This is a 510(k) premarket notification for a bone fixation system, relying on non-clinical performance testing and comparison to legally marketed predicate devices to establish substantial equivalence. Clinical studies, AI algorithm development, and human reader performance are not relevant to this submission.

Here's a breakdown of the available information based on your request, with an emphasis on what is and isn't provided or applicable:

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" conducted for the Anchorage 2 CP System was a series of non-clinical performance tests designed to demonstrate that the device is as safe and effective as its predicate devices.

• Type of Study: Non-clinical (benchtop) biomechanical testing and biocompatibility testing. No human or animal clinical studies were required or performed.
• Biomechanical Testing Performed:
  • Construct Fatigue Strength Testing as per ASTM F382-14 (Plates and CP Screws)
  • Insertion Torque Testing as per ASTM F543-13 (CP Screws)
  • Shear-off Testing as per ASTM F543-13 (CP Screws)
  • Pull-out Testing as per ASTM F543-13 (CP Screws)
• Biocompatibility Testing Performed:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993-1," which is recognized by FDA.
• Ground Truth for Testing: Adherence to the specified ASTM standards for mechanical performance and ISO 10993-1 for biocompatibility.
• Conclusion: "Testing demonstrated that the Anchorage 2 CP System is substantially equivalent to the predicate devices currently cleared for marketing." The non-clinical data supported the safety of the system and demonstrated that it should perform as intended, thereby meeting the requirement for substantial equivalence.

In essence, for this Class II bone fixation device, "acceptance criteria" are met by demonstrating through standardized non-clinical testing that the device functions comparably to already approved predicate devices and is biocompatible. The nature of the device (a physical implant) means that many of the typical AI/diagnostic study metrics are not relevant.

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The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:

· Replantation

• · Joint fusions
• · Corrective osteotomies
• · Osteopenic bone

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 Ø2.4mm, T10/T8 Ø2.7mm, and T10 Ø3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.

This document is a 510(k) premarket notification for the Stryker VariAx 2 System, a device for internal fixation, reconstruction, and treatment of foot and ankle fractures. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with detailed acceptance criteria and performance data in the typical sense of a diagnostic or AI-driven device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This document describes a modification to an existing device rather than a new device that requires extensive clinical performance studies as an AI/diagnostic device would.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for this type of request:

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

Since this is a submission for a bone fixation system and not a diagnostic or AI device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to its ability to meet established safety and effectiveness standards, often through comparison with a predicate device. The document states that the evaluations demonstrated the device "met the performance requirements" and is "as safe and effective as the predicate device." Specific numerical criteria for mechanical performance (e.g., tensile strength, fatigue life) are not provided in this summary.

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

The document mentions "Non-Clinical Testing" which likely refers to bench testing (mechanical testing, materials characterization).

• Sample Size for Test Set: Not specified. This would typically be a number of physical device units tested, not a patient sample size.
• Data Provenance: Not explicitly stated as retrospective or prospective, but given it's non-clinical testing, it would be laboratory-generated data from newly manufactured devices. The country of origin for the sponsor is Switzerland (Stryker Trauma AG, Selzach, Switzerland).

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

This concept is not applicable here. Ground truth, in the context of device performance, typically refers to expert consensus for diagnostic accuracy or pathology for disease presence. For a mechanical device, performance is established through engineering and biomechanical testing, often against recognized standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this type of device submission.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical trials. This is a mechanical device submission.

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 not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For this type of device, "ground truth" would be defined by engineering specifications and established test standards (e.g., ISO, ASTM standards for bone fixation implants). The device's performance is measured against these objective criteria in a laboratory setting. Pathology or outcomes data are not used as "ground truth" for demonstrating substantial equivalence of a modified mechanical implant in a 510(k).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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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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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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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 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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