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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)

Study Details (Based on Available Information)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Cerclage Cable with Hex Button device is indicated for use where wire, cable, or band cerclage is used in combination with plates. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

The Cerclage with Hex Button is a cerclage cable and a button device that links the cable and bone screw together . The button is positioned in the hex of a bone screw. The cerclage cable is passed through the button and around the bone. The cerclage is crimped to lock the cable in place.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cerclage Cable with Hex Button.

Important Note: The provided text is a 510(k) summary for a medical device. These summaries often focus on demonstrating equivalence to existing devices rather than exhaustive performance studies on novel devices. Therefore, some of the requested information (like detailed AI-specific studies, multi-reader multi-case studies, or specific training set details) is unlikely to be present as this is a mechanical medical device, not an AI/software device.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on static yield loading values. The core acceptance criterion is that the new device's performance in this metric is equivalent to or better than the predicate devices.

Study Details

Given the nature of the device (a mechanical cerclage system) and the regulatory submission type (510(k)), the "study" described is a comparative performance test against predicate devices, specifically focusing on mechanical properties.

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

   • Sample size: Not explicitly stated. The summary mentions "static yield loading values" which implies a series of mechanical tests were conducted on prototypes of the new device and the predicate devices. However, the exact number of units tested is not provided.
   • Data provenance: Not explicitly stated, but it would be laboratory testing conducted by Pioneer Laboratories (retrospective in the sense that the testing was completed before the submission). There is no indication of country of origin for data as it's a mechanical test, not patient data.

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

   • This is not applicable as the "ground truth" for a mechanical device's performance is established by engineering specifications and mechanical testing standards, not expert consensus. Performance is measured against physical properties like yield strength.

3. Adjudication method for the test set:

   • Not applicable. Mechanical tests involve objective measurements, not subjective interpretation requiring adjudication among experts.

4. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The Cerclage Cable with Hex Button is a mechanical implant, not an AI system.

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

   • No, this is not applicable. This device is a physical medical implant, not an algorithm or software. Its performance is inherent to its mechanical design and materials, not an algorithm's output.

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

   • The "ground truth" for this type of device's performance is based on engineering standards and mechanical test results (e.g., force applied, deformation measured, point of yield). The predicate devices' established performance in these tests serves as the benchmark for equivalence.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable. There is no training set for this mechanical device.

Summary of Device Equivalence Claim

The 510(k) summary clearly states that equivalence is predicated on the similar intended use and technological characteristics (cables, crimps, bone plates, tensioning mechanisms) to the predicate devices. The key performance data provided to affirm this equivalence is the static yield loading values, which were found to be comparable between the new device and the predicate devices. This demonstrates that under relevant mechanical stress, the new device performs similarly to devices already on the market.

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