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The LORRAINE 2.5/3.5mm Distal Humerus System is 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.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System.

The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).

All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The provided document is a 510(k) summary for the LORRAINE 2.5/3.5mm Distal Humerus System. It describes the administrative information, device classification, predicate devices, indications for use, device description, and a summary of non-clinical tests.

However, this document does NOT contain information about any study involving Artificial Intelligence (AI) or machine learning, human readers, or image-based diagnostics. The device described is a metallic bone fixation appliance, specifically plates and screws, used for orthopedic applications (fractures, osteotomies, non-unions of the distal humerus).

Therefore, I cannot extract the information required by your prompt, such as:

• Acceptance criteria and reported device performance related to AI/ML.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods, as these relate to studies involving AI/ML performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data) in the context of AI/ML.

The "studies" described in the document are non-clinical tests related to the physical device itself:

• Sterilization validation: Ensuring the device can be properly sterilized.
• Packaging validation: Ensuring the sterile packaging integrity.
• Biocompatibility: Assessing the safety of the materials in a biological environment.
• Mechanical testing: Evaluating the strength and stiffness of the plates and screws, comparing them to predicate devices. This involves mechanical stresses, not data analysis or human-in-the-loop performance.
• MRI safety: Determining if the device is safe for patients undergoing MRI scans.

All these tests are standard for orthopedic implants and are designed to demonstrate the physical and material properties and safety of the device, not an AI or data-driven component.

Therefore, it is impossible to answer your request based on the provided text, as the text describes a physical medical device (orthopedic implant) and not an AI/ML powered device.

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The VariAx Foot system is intended for use in internal fixation or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to:

• · Replantation
• · Lag screw techniques
• · Joint fusions
• · Corrective osteotomies
• Treatment of fractures

VariAx Foot is a system used for internal fixation applications. VariAx Foot consists of self-fapping locking and non-locking screws, as well as corresponding washers and compatible bone plates. Since its original submission (K063875), the screws of the system have been modified. The modification includes the addition of a cutting flute to the 2.7mm and 3.5mm locking and nonlocking screws and a change in the Tox head of the 2.7mm screws. The lengths of the 2.7mm diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.

This document is a 510(k) premarket notification for the VariAx Foot system, a metallic bone fixation appliance. It is a submission to demonstrate substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert review, adjudication methods, and MRMC studies is not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

• No Acceptance Criteria or Device Performance Study (in the sense of AI/ML or diagnostic accuracy): This 510(k) submission is for a physical medical device (bone fixation system). The "acceptance criteria" here are related to demonstrating substantial equivalence for regulatory approval, primarily through non-clinical testing focused on mechanical properties and biocompatibility. It's not about the accuracy or performance of an algorithm or diagnostic tool.
• No Sample Sizes for Test/Training Sets, Ground Truth, Experts, or Adjudication: These concepts are relevant to studies evaluating diagnostic accuracy, often in AI/ML contexts. This submission discusses mechanical testing, not diagnostic performance.
• No MRMC or Standalone Studies: Again, these are specific to evaluations of diagnostic or AI-assisted tools, which the VariAx Foot system is not.

While the requested table and categories are not directly applicable, I can provide a summary based on the information that is present in the document.

Summary of Device and Regulatory Submission:

The VariAx Foot system is a metallic bone fixation appliance used for internal fixation or arthrodesis of small bones in the foot and ankle, and treatment of fractures, among other procedures.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This document describes a 510(k) submission for a physical medical device, not a study involving a "test set" in the context of diagnostic accuracy or AI/ML. The "testing" referred to is non-clinical mechanical and biocompatibility testing. The data provenance would be from internal lab testing by Stryker GmbH.

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

• Not Applicable: No "ground truth" or "experts" for diagnostic assessment are mentioned or relevant to this type of submission.

4. Adjudication method for the test set

• Not Applicable: No adjudication method for a "test set" is mentioned 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 bone fixation device, 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 a physical bone fixation device, not an algorithm.

7. The type of ground truth used

• Not Applicable: No "ground truth" (in the sense of diagnostic accuracy) is mentioned. The "truth" in this context is the physical and biological performance of the device as assessed through non-clinical methods.

8. The sample size for the training set

• Not Applicable: No "training set" is relevant to this device or submission.

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

• Not Applicable: No "training set" or "ground truth" for it is relevant to this device or submission.

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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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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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