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The VariAx 2 Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• Intra- and extra-articular fractures
• · Compression fracture
• Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• Osteotomy

The VariAx 2 Mini Fragment System is used for internal fixations and is composed of sterile and nonsterile plates. Additionally, the plates are provided in locking and non-locking options, as well as various lengths, thicknesses, and configurations.

The VariAx 2 System is used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of commercially pure titanium and titanium alloy with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

The provided document is a 510(k) premarket notification for the Stryker VariAx 2 System and VariAx 2 Mini Fragment System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as might be seen for novel devices.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them in the way this request envisions for a software or AI-based medical device.

However, I can extract the information provided about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) submission.

Here's the breakdown of what is available based on the provided text:

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

The document does not specify quantitative acceptance criteria. Instead, it states that "The aforementioned testing demonstrated that the VariAx 2 Mini Fragment System and the VariAx 2 System are substantially equivalent to the predicate devices." This implies that the performance of the new devices in these tests was comparable to or better than the predicate devices, satisfying the FDA's requirement for substantial equivalence for mechanical properties.

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 does not specify the sample sizes (e.g., number of screws, plates tested) for the non-clinical mechanical tests. It also does not provide information on data provenance as these are physical device tests, not data-driven studies.

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. This was a non-clinical, mechanical testing study of physical medical devices, not a study involving expert interpretation of data.

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

Not applicable. This was a non-clinical, mechanical testing study.

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 was a non-clinical, mechanical testing study, not a human reader study involving AI.

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

Not applicable. This was a non-clinical, mechanical testing study.

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

For the mechanical tests, the "ground truth" or reference for comparison was the performance of the identified predicate devices (Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886) and Synthes (USA) Modular Mini Fragment LCP System (K063049) for the Mini Fragment System, and VariAx 2 System (K180500) for the VariAx 2 System). The tests measured physical properties and compared them against known standards or the predicate's performance. For MRI safety, the ground truth would be established by industry standards or FDA guidance for MR compatibility.

8. The sample size for the training set

Not applicable. This was a non-clinical, mechanical testing study, not an AI or machine learning study requiring a training set.

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

Not applicable. This was a non-clinical, mechanical testing study.

Summary of the Study:

The study referenced in the 510(k) submission is a non-clinical mechanical testing study. Its purpose was to demonstrate substantial equivalence of the VariAx 2 Mini Fragment System and the VariAx 2 System to their respective predicate devices.

Tests Performed:

• Torsion
• Insertion Torque
• Pull-out
• Four-point bending
• MRI assessments (magnetically-induced displacement force, magnetically-induced torque, RF-induced heating, and image artifacts)

Conclusion of the Study:

The non-clinical testing "demonstrated that the VariAx 2 Mini Fragment System and the VariAx 2 System are substantially equivalent to the predicate devices." Additionally, the devices were found to be MR conditional. Clinical testing was not required for this submission.

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The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• · Intra- and extra-articular fractures
• · Compression fracture
• · Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• · Osteotomy

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, as well as no mention of sample sizes, data provenance, expert panels, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification summary for the VariAx 2 System, which is a medical device for internal fixation. It discusses the device's substantial equivalence to predicate devices based on non-clinical mechanical testing.

Therefore, I cannot provide the requested information.

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The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• · Intra- and extra-articular fractures
• · Compression fracture
• · Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• · Osteotomy

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation plating systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

This submission builds on K140769 by simplifying and clarifying the indications statement, and by expanding the treatment population to include pediatric patients.

I am sorry, but the provided text from the FDA 510(k) K173135 for the "VariAx 2 System" does not contain any information about acceptance criteria, device performance data (from a study), or details about a study design (like sample size, ground truth establishment, expert qualifications, etc.) for an AI/algorithm-based medical device.

This FDA submission is for a bone fixation system (screws, plates, washers), which is a physical medical device, not a software or AI-based device. The document explicitly states:

• "No new devices were introduced with this submission. No mechanical testing was presented."
• "Clinical testing was not a requirement of this submission."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a hardware medical device and does not detail performance studies in the way you are asking about (which are typical for AI/ML or diagnostic devices).

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The VariAx Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications include: compression fractures, intra-articular and extra-articular fractures, displaced fractures. Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: Internal fracture fixation; Osteotomies; Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below: T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: Compression fractures; Intra-articular and extra-articular fractures; Displaced fractures; Reconstruction procedures; T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: Intra-articular and extra-articular fractures of the Distal Radius, Displaced and compression fractures of the Distal Radius; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Reconstruction procedures in the Foot & Ankle and Distal Radius; T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; Single, segmental and comminuted fractures; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Normal bone density or osteopenic bone.

This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.

Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.

The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.

This document is a 510(k) summary for a medical device submission, specifically for the VariAx Distal Radius Plate System and VariAx 2 System.

The FDA 510(k) clearance process is for demonstrating substantial equivalence to a predicate device, not for proving a device "meets acceptance criteria" in the way one might prove performance of a new diagnostic algorithm. This specific document states that no clinical or non-clinical testing beyond LAL testing was required for this submission because the changes are primarily related to packaging configuration and no new components have been added. The products themselves remain identical to previously cleared predicate devices (K141430 and K140769).

Therefore, the information you've requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details do not apply to this specific 510(k) submission. This document explicitly states:

• "No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system." (Page 8)
• "Clinical testing was not required for this submission because there are no new components being added to the system." (Page 8)

The "acceptance criteria" for this submission are simply that the new packaging configuration does not alter the fundamental safety or effectiveness of the previously cleared components.

Given the nature of this 510(k), I cannot generate the requested table or answer the specific questions about performance studies, as such studies were not part of this particular submission. The device's "performance" was established by the original predicates it references, not by new studies for this packaging change.

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The 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 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:
  • o Compression fractures;
  • Intra-articular and extra-articular fractures; O
  • Displaced fractures: o
  • Reconstruction procedures; o
• · 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, o
  • Displaced and compression fractures of the Distal Radius: o
  • Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; O
  • Reconstruction procedures in the Foot & Ankle and Distal Radius; o
• 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; o
  • Single, segmental and comminuted fractures; ਼
  • Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
  • Normal bone density or osteopenic bone. O

This Special 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. 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, ankle, distal tibia 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 provided text describes a medical device, the VariAx 2 System, which consists of bone screws and instrumentation for internal fixation. This is a 510(k) submission seeking authorization to market the device. The core of the submission is to demonstrate that the VariAx 2 System is substantially equivalent to a previously cleared predicate device (K132502).

Here's the analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• Materials
• Operational Principles
• Design for use in internal bone fixation in adult patients | The subject device components are "substantially equivalent to the previously cleared VariAx 2 System (K132502) in regards to intended use, materials, and operational principles and similar with regard to design for use in for internal bone fixation in adult patients." |
  | Performance Requirements (Safety & Effectiveness) as demonstrated through risk analysis and verification/validation. | "The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate device (K132502). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices." |
  | Compliance with ISO 14971: "Medical Devices – Application of risk management of medical devices." | A risk analysis was performed according to the requirements of ISO 14971. |

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

The document does not provide details on specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The evaluation focuses on comparative analysis of the subject components against the predicate device rather than a new clinical study with human subjects or a defined "test set" in the context of AI testing. The "test set" implicitly refers to the physical components of the device undergoing non-clinical testing.

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

This information is not applicable in the context of this 510(k) submission for a bone fixation system. Ground truth and expert consensus are typically relevant for AI/medical imaging device evaluations where diagnostic accuracy is assessed against expert interpretations or pathological findings. Here, the assessment is based on engineering principles, materials science, and prior regulatory approvals.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods are used in studies involving subjective interpretation, often by human readers, to establish a definitive ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This type of study is specifically designed for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The VariAx 2 System is a physical bone fixation device, not an AI-powered diagnostic tool.

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

A standalone algorithm performance test is not applicable. The device is a physical medical implant, not a software algorithm.

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

The "ground truth" in this context refers to the established safety and effectiveness of the predicate device (K132502) and compliance with relevant engineering and quality standards. The non-clinical tests (material properties, mechanical performance, risk analysis) conducted on the subject device components serve to demonstrate that they meet these established benchmarks for a bone fixation system. There is no mention of expert consensus, pathology, or outcomes data to establish ground truth in the way it's used for AI or diagnostic devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device submission, which does not involve machine learning or AI.

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

This is not applicable for the same reason as point 8.

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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 Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 System. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the foot and ankle. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 14-70mm in length.

The provided text does NOT describe acceptance criteria or a study that proves the device meets acceptance criteria related to clinical performance or diagnostic accuracy.

Instead, the document details a 510(k) premarket notification for a bone plate system (VariAx 2 System). This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through non-clinical testing for mechanical performance, rather than clinical efficacy studies.

Here's a breakdown based on the information provided and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (Non-clinical): The document states "Construct Fatigue Strength Testing" was performed. However, it does not specify the sample size of the constructs tested (e.g., number of plates/screws).
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It only states "Non-clinical laboratory testing was performed on the VariAx 2 System components".
• Retrospective/Prospective: Non-clinical testing of this nature is neither retrospective nor prospective in the same sense as patient studies; it's laboratory-based.

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

• Not Applicable: This information is not relevant as no clinical test set or ground truth based on expert review was established or used for this submission. The "ground truth" for the non-clinical testing would be the physical properties and performance measured in the lab.

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

• Not Applicable: No clinical test set requiring expert adjudication was used.

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 device is a bone plate system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant to this submission.

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

• Not Applicable: This device is a physical medical implant, not an algorithm.

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

• Non-clinical: The "ground truth" for the non-clinical testing would be the physical and mechanical properties of the device constructs (e.g., load to failure, cycles to failure) measured according to established engineering standards (though the specific standards are not detailed in this summary).
• Clinical: No clinical ground truth was established as no clinical testing was required.

8. The sample size for the training set:

• Not Applicable: As this is a medical implant and not a machine learning model, there is no "training set" in the context of AI.

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

• Not Applicable: See point 8.

In summary: The provided document is a regulatory submission for a physical medical device (bone plates) that relies on demonstrating substantial equivalence through non-clinical mechanical testing. It explicitly states "Clinical testing was not required for this submission." Therefore, most of the requested information pertaining to clinical studies, human readers, AI, or clinical ground truth is not present and not relevant to this specific regulatory pathway.

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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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