(87 days)
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
The devices covered by this submission include cables, beaded cables, cable sleeves, trochanteric grips, trochanteric grip plates, and mini cleat. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Dall-Miles Cable System components are manufactured from stainless steel or cobalt chromium alloy (Vitallium®) materials.
The purpose of this submission is to modify the labeling of the Dall-Miles Cable System to add MR Conditional labeling.
This document is a 510(k) premarket notification for the Dall-Miles® Cable System, focusing on adding MR Conditional labeling. It does not describe an AI/ML-driven medical device requiring human performance studies for its acceptance criteria. Therefore, most of the requested information (sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this submission.
However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet them, specifically for its MR Conditional labeling.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them for its MR Conditional labeling:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MR Conditional Labeling, based on FDA Guidance and ASTM Standards) | Reported Device Performance (Summary of Testing) |
|---|---|
| Magnetically Induced Displacement Force: Must be acceptable for patient safety in the MR environment. | Testing performed per ASTM F2052-15. (Implied acceptable performance to support MR Conditional labeling) |
| Magnetically Induced Torque: Must be acceptable for patient safety in the MR environment. | Testing performed per ASTM F2213-17. (Implied acceptable performance to support MR Conditional labeling) |
| Image Artifact: Must not produce excessive artifacts that compromise diagnostic image quality within the MR environment. | Testing performed per ASTM F2119-07 (Reapproved 2013). (Implied acceptable performance to support MR Conditional labeling) |
| Radiofrequency (RF) Induced Heating: Must not cause clinically significant heating of the implant or surrounding tissue during MR imaging within specified parameters. | Testing performed per ASTM F2182-19. (Implied acceptable performance to support MR Conditional labeling. The labeling will provide safe scanning parameters.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical 'sample size' of patients or data points in the clinical sense. Instead, the "test set" pertains to the physical Dall-Miles Cable System components themselves, tested in a laboratory setting. The typical approach for device material testing like this involves testing a sufficient number of representative samples of each device configuration to ensure robust and reproducible results according to the specified ASTM standards. The document doesn't specify the exact number of physical samples tested.
- Data Provenance: This was non-clinical laboratory testing conducted to characterize the compatibility of the device in the MR environment. The document does not specify a country of origin for the data; it would be generated in a lab setting where the physical tests are performed. It is analogous to "prospective" testing as it's specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for MR compatibility is established by adherence to recognized engineering standards (ASTM) and FDA guidance documents. These standards define the methodologies and acceptable limits for MR environments.
- Qualifications of Experts: The work is implicitly performed by engineers, physicists, and technicians with expertise in medical device testing, MR physics, and relevant ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a human reader study requiring adjudication of interpretations. The tests are objective measurements against defined standards.
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:
- MRMC Study: No. This submission does not involve an AI/ML-driven device or a human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for MR Compatibility in this context is defined by scientific principles, relevant engineering standards (ASTM), and FDA guidance documents that specify the acceptable parameters and methodologies for evaluating device behavior in an MR environment. It's essentially "physical laws and established engineering standards."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. There is no AI/ML model or training set involved.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. There is no training set involved.
§ 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.