(58 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static yield loading values equivalent to predicate devices | The Cerclage Cable with Hex Button device's static yield |
| loading values were found to be equivalent to the values of the three 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.
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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.
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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.
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Adjudication method for the test set:
- Not applicable. Mechanical tests involve objective measurements, not subjective interpretation requiring adjudication among experts.
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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, 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.
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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.
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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.
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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.
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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.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.