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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no "ground truth" to establish for this type of submission, as it's not evaluating the output of an algorithm against a known correct answer.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No human reader studies are mentioned.

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

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

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

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

Summary of the Study (Substantial Equivalence Justification):

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

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

• Reported Device Performance (as presented):

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

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

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

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

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

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

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

• Not Applicable. See point 8.

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

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

The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially equivalent in K073527. This Special 510(k) submission is intended to address the addition of the 7mm washer to the predicate VariAx Elbow System.

This 510(k) summary describes a line extension for the VariAx Elbow System, adding a 7mm washer. As such, the study primarily focuses on demonstrating the substantial equivalence of the new component to existing predicate devices, rather than establishing new performance criteria for a novel device.

Here's an analysis of the provided information, framed by your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a line extension for an existing bone fixation system, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence for the added component. The primary acceptance criteria for this type of device extension would be:

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

The document states "Functional and mechanical testing" was performed. However, it does not specify the sample size for these tests for the new 7mm washer.

The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate equivalence. The country of origin of the data is not specified, but it can be inferred to be from the manufacturer (Howmedica Osteonics Corp.) in the USA.

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

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert consensus. There are no clinical images or diagnostic interpretations requiring expert radiologists or other medical professionals for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements and do not require adjudication by human experts.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images. The VariAx Elbow System Line Extension is a mechanical implant, not an AI or diagnostic device.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI or software-only device.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by validated engineering principles and standards for bone fixation devices. This might include standards for fatigue strength, torsional strength, bending strength, etc., depending on the specific mechanical tests performed. The document implies that the "comparable mechanical & functional properties" were assessed against the predicate device, which would have itself been evaluated against such standards.

8. The Sample Size for the Training Set

There is no training set mentioned or implied because this is a mechanical device undergoing physical testing, not a machine learning model.

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

This is not applicable as there is no training set.

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The VariAx™ Elbow System is intended for fracture fixation of long bones. Indications include:

• Distal Humerus
• Proximal Ulna

This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Elbow System are intended to add different types of plates and screws to the Stryker® Plating System portfolio.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the VariAxTM Elbow System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and its substantial equivalence to other Stryker plating systems.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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