(84 days)
The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.
The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.
The Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments
The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex Button device links the cable and bone screw together. The button is position
hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.
Here's an analysis of the provided text regarding the Hex Button Device's acceptance criteria and study, structured to answer your questions:
The provided 510(k) summary for the Hex Button device (K992617) does not contain information about clinical studies with human readers or AI assistance. The performance data section describes engineering tests to demonstrate the device's mechanical integrity. Therefore, some of your requested information, particularly regarding AI performance, human reader studies, and ground truth for training/testing sets, cannot be extracted from this document as it pertains to a physical medical device, not an AI/Software as a Medical Device (SaMD).
However, I will extract the relevant information that is available:
Acceptance Criteria and Device Performance (Engineering Tests)
| Acceptance Criteria Category | Specific Test/Performance | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Static Yield | Cerclage cable was the failure mode. Hex Button showed little to no wear. In no test cases did the Hex Button fail. |
| Corrosion Resistance | Crevice Corrosion Fatigue | Cerclage cable was the failure mode. Hex Button showed little to no wear. In no test cases did the Hex Button fail. |
Study Details (Based on Available Information)
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Sample Size used for the test set and the data provenance:
- The document describes engineering tests, not studies with a "test set" in the context of diagnostic performance (e.g., images for AI).
- The sample size for these mechanical tests is not explicitly stated (e.g., "N=X Hex Buttons were tested").
- Data provenance is not applicable since these are laboratory mechanical tests of the physical device components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the outcome of mechanical stress and corrosion tests, evaluated by engineering standards rather than expert clinical consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. These were engineering tests with predefined failure criteria for mechanical properties, not diagnostic performance with subjective interpretation.
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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 a physical medical device (a surgical hardware component), not an AI/SaMD. MRMC studies are not relevant for this type of device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device, not an algorithm. Standalone performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the "ground truth" was the mechanical failure point observed during static yield and corrosion fatigue tests, as well as the absence of wear/failure on the Hex Button itself. This is determined by material science and engineering principles and measurements.
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The sample size for the training set:
- Not applicable. The device is a physical component, not an AI model, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
Summary regarding the nature of the study:
The Hex Button device is a surgical implant component. The "study" described in the 510(k) summary (Performance Data section) consists of benchtop engineering tests for static yield and crevice corrosion fatigue. These tests aimed to demonstrate the physical and mechanical integrity of the Hex Button itself when used in conjunction with a cerclage cable, specifically showing that the Hex Button did not fail and exhibited minimal wear, while the cerclage cable (the component connecting through the button) was the intended failure point under stress.
The submission relies on substantial equivalence to an existing predicate device (Cerclage Cable with Hex Button Device, K974016), leveraging the prior testing and clearance of that predicate. The "Performance Data" is provided to confirm that the Hex Button material and design in this new submission behave identically or acceptably to the previously cleared device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.