(71 days)
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty.
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place. The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable.
The provided text describes a medical device called the "Dall-Miles Trochanter Cable SuperGrip," a bone fixation cerclage. It appears to be a 510(k) summary filed in 1996 for a modification of an existing device.
Based on the content of the provided 510(k) summary, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or algorithm performance is present.
The document focuses on demonstrating substantial equivalence to previously cleared devices (K 872224, K 900926, and Biomet Medical Products' BMP Cable System) based on:
- Intended use
- Materials
- Design
- Operational principles
- Indications and contraindications
The modification described is specifically about reducing the angle at which the cable exits the Grip to relieve potential stress concentrations in the cable.
Therefore, I cannot provide the requested table or detailed study information because the provided text does not contain any data related to:
- Acceptance criteria or reported device performance in a measurable sense (e.g., sensitivity, specificity, accuracy, mechanical test thresholds). The document only states the modification "relieves potential stress concentrations."
- Sample sizes for test sets or training sets.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement data. This device is a physical implant, not an AI diagnostic tool.
- Standalone (algorithm-only) performance. This is not an algorithm.
- Type of ground truth (pathology, outcomes data, etc.).
- How ground truth for a training set was established.
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510 (k) Summary
Proprietary Name: Dall-Miles Trochanter Cable SuperGrip
Common Name: Bone Fixation Cerclage
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Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010
Proposed Regulatory Class: Class II Device Product Code: OR(87) JDQ
For information contact: Frank Maas
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 6/3/96
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.
The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable.
The substantial equivalence of the Dall-Miles Trochanter Cable Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's original Dall-Miles Cable Grip System (K 872224 and K 900926) and Biomet Medical Products' BMP Cable System.
§ 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.