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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 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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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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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 Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Homedica Osteonics is extending the Variax Distal Radius Plates of the Variax Distal Radius Plating System to include XXL sized plates as well as to modify the indications for use for the XXL Volar Distal Radius Plates to include Osteotomies, non-unions and mal-unions.

Each plate will accept a locking screw, bone screws, locking pegs, and partially threaded screws. The XXL plates are precontoured performed for palmer, fixation. Screws are selftapping and have either cross-pin or torx heads.

Plates are offerered in 5,8,11,and 15 hole options with a 2mm distal profile height and 3mm profile shaft height. All plates are straight and pre-contoured to fit the radial bow beyond the shaft. Gliding holes all for allignment of the plate and allow for additional bone reduction if required.

This K100271 document is a 510(k) Summary of Safety and Effectiveness for the VariAx Distal Radius Line Extension of XXL Plates. It describes a medical device (bone plates and screws) and seeks to demonstrate its substantial equivalence to existing devices.

The document does not contain information about software, AI, or diagnostic performance studies. Instead, it focuses on the mechanical and design equivalence of bone plates and screws. Therefore, it does not provide the specific details requested for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies that would be relevant for a diagnostic or AI-based device.

Based on the provided text, here's what can be extracted and a clear statement of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not describe acceptance criteria or reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) or human reader improvement for an AI system. Instead, the "performance" discussed is related to the mechanical properties and design of the bone plates to establish substantial equivalence.

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

Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.

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

Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.

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 document describes bone plates and screws, not an AI-assisted diagnostic system.

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

No. This document describes bone plates and screws, not an AI algorithm.

7. The type of ground truth used

Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm. The "ground truth" for mechanical testing would implicitly be the established mechanical engineering standards and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This document describes bone plates and screws, not an AI algorithm.

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

Not applicable. This document describes bone plates and screws, not an AI algorithm.

In summary, the provided document K100271 pertains to the regulatory submission for a physical medical device (bone plates and screws) and primarily establishes substantial equivalence based on mechanical testing and design attributes. It does not involve any AI, software, or diagnostic performance claims that would necessitate the types of studies and criteria outlined in the input request.

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