(304 days)
The DPR Cable is intended for:
- Spinal applications include sublaminar and intraspinous process wiring for trauma applications.
- Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
The device is intended for single patient use only.
The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.
The provided text is a 510(k) Premarket Notification for a medical device called the "DPR Cable." This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details regarding acceptance criteria, study design for proving device performance (especially for an AI/algorithm), ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies do not apply to this type of regulatory submission for this medical device.
The document discusses biomechanical testing to show equivalence in performance characteristics to predicate devices, but this is not an AI/algorithm study.
Here's an attempt to extract relevant information, highlighting where the requested details are not applicable based on the provided text's context as a 510(k) for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating equivalence to predicate devices through biomechanical testing, rather than explicit criteria for an AI's accuracy or clinical performance. The table in the document (Page 5) compares the technological characteristics and certain performance metrics with the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (DPR Cable K143716) | Predicate Device Performance (Titanium Alloy Songer Cable System/Atlas™ Cable System K920201) |
|---|---|---|---|
| Indications for Use | Similar to predicate | See "Indications for Use Statement" | See table |
| Materials of Composition | Biocompatible, suitable for intended use | Dyneema Purity® UHMWPE and Bi2O3 | Titanium Steel and Titanium Alloy |
| Device Characteristics | Functional, strong | Flexible, high strength | High strength |
| Radiopaque | Yes | Yes | Yes |
| Fixation | Secure/effective | Knot | Integral Crimp |
| Dimensions | Suitable for application | 4 mm | 1 mm diameter |
| Tensile Strength of fixated loop | Equivalent to or better than predicate | 2289+/-35 | 1005+/-49 |
| Fatigue Strength | Equivalent to or better than predicate | 1559N |
§ 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.