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The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.

The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.

Indications include the following:

• . osteotomies, and non-unions
• . fixation of fractures
• normal bone density and osteopenic bone .

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for a device modification of VariAx 2 One-Third Tubular Plates previously cleared in K141204 (VariAx 2 One-Third Tubular Plating System). Modification includes a change of plate thickness and addition of grooves to the waist part of the plate to improve mechanical behavior.

The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 23-191mm in length.

The request asks for specific information regarding acceptance criteria and a study proving device performance, based on the provided document. However, the document is a 510(k) summary for a medical device (VariAx 2 One-Third Tubular Plating System) seeking clearance for a modification to a previously cleared device. It explicitly states that clinical testing was not required for this submission and focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.

Therefore, many of the requested items, which relate to clinical studies, ground truth establishment, and expert involvement, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: The document mentions that a risk analysis was performed according to DIN EN ISO 14971 and "the subject device met the performance requirements." However, the specific numerical acceptance criteria (e.g., a specific tensile strength, fatigue life, or accuracy metric) are not explicitly stated in this summary. The "performance requirements" are only broadly referenced.
• Reported Device Performance: The document states that the "evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject device in comparison to the previously cleared predicate device (K141204)." It concludes that the device "is as safe and effective as the predicate device" based on non-clinical tests. Again, specific quantitative performance results are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided. The document explicitly states "Clinical testing was not required for this submission" and focuses on non-clinical tests and comparison to a predicate device. Thus, there is no "test set" in the context of clinical data, no sample size, and no data provenance from clinical 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)

• This information is not provided. As explained above, no clinical test set requiring expert-established ground truth was performed for this submission.

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

• This information is not provided. No clinical test set requiring adjudication was performed for this 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

• This information is not provided. This device is a bone fixation system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this device type, and no such study was performed or mentioned.

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

• This information is not provided. This device is a mechanical implant, not an algorithm.

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

• This information is not provided. Given that no clinical studies were performed for this submission, there's no mention of ground truth types for a clinical test set. For non-clinical tests, "ground truth" would refer to measured physical properties, which are not detailed.

8. The sample size for the training set

• This information is not provided. No training set is mentioned as this is a non-clinical device modification submission.

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

• This information is not provided. No training set is mentioned in the document.

In summary: The provided document is a 510(k) summary for a device modification focusing on non-clinical testing and substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. Therefore, most questions related to clinical studies, test sets, ground truth establishment, and AI performance are not applicable or answerable from this document.

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The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients. The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. Indications include the following: osteotomies and non-unions, fixation of fractures, normal bone density and osteopenic bone.

The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.

The provided text describes a 510(k) submission for a medical device called the "VariAx 2 One-Third Tubular Plating 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 defined acceptance criteria and extensive performance studies.

Therefore, the requested information regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test and training sets, expert involvement, and adjudication methods is not applicable in this case.

Here's why and what information is available:

• Acceptance Criteria and Device Performance: Not applicable. For 510(k) submissions, the device's "performance" is assessed relative to predicate devices through non-clinical testing to demonstrate that it performs at least as safely and effectively. There are no pre-defined numerical performance metrics or acceptance criteria in the typical sense of a clinical study for a novel device.
• Study Proving Acceptance Criteria: Not applicable.
• Sample size for test set and data provenance: Not applicable. No clinical test set.
• Number of experts and qualifications: Not applicable. No ground truth established by experts.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable. No training set as there is no AI algorithm.
• How the ground truth for the training set was established: Not applicable.

What was done (Non-Clinical Testing):

The submission states:

• Non-Clinical Testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence.
• Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.
• The following testing was performed:
  • 4-Point Bending Out of Plane Testing
  • 4-Point Bending Construct Out of Plane Testing

This non-clinical testing would have involved mechanical tests to compare the strength and performance of the new device to the predicate devices under simulated physiological conditions. The "acceptance criteria" here implicitly would be that the new device's performance in these mechanical tests is equivalent to or better than the predicate devices, thereby supporting the claim of substantial equivalence. However, specific numerical thresholds are not provided in this document.

Summary Table (with N/A where information is not applicable to a 510(k) for a physical device):

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