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K Number
K962162
Device Name
DALL-MILES TROCHANTER CABLE SUPERGRIP
Manufacturer
HOWMEDICA CORP.
Date Cleared
1996-08-14

(71 days)

Product Code
JDQ
Regulation Number
888.3010
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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:

  1. 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."
  2. Sample sizes for test sets or training sets.
  3. Data provenance (country, retrospective/prospective).
  4. Number or qualifications of experts for ground truth.
  5. Adjudication method.
  6. Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement data. This device is a physical implant, not an AI diagnostic tool.
  7. Standalone (algorithm-only) performance. This is not an algorithm.
  8. Type of ground truth (pathology, outcomes data, etc.).
  9. How ground truth for a training set was established.

§ 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.