(17 days)
a) General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.
b) Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below.
- Primary total hip arthroplasty.
- Revision total hip arthroplasty.
- Any procedure using anterolateral or lateral approaches.
The Smith & Nephew Orthopaedic Cabling System consists of: a cable with or without clamps or swages; trochanteric grips with or without clamp plates.
The provided document is a 510(k) Premarket Notification for a medical device (Smith & Nephew Orthopaedic Cabling System) seeking substantial equivalence to legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found in an AI/algorithm-based device submission.
Instead, this document focuses on demonstrating substantial equivalence for a physical orthopedic cable system, which involves comparing its intended use, materials, design, and operational principles to existing devices. Therefore, the questions related to AI/algorithm performance, sample sizes for test/training sets, experts, and adjudication methods are not applicable to this type of submission.
Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
For a physical device like an orthopedic cable system, "acceptance criteria" and "reported device performance" are typically related to mechanical properties, biocompatibility, and manufacturing quality, rather than statistical performance metrics (e.g., accuracy, sensitivity) for an AI. These specific criteria and performance values are not detailed within this 510(k) summary. The summary focuses on establishing equivalence in:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use Equivalence | Intended uses are identical or very similar to predicate devices: general orthopaedic repair procedures and trochanteric reattachment. |
| Materials Equivalence | Uses materials similar to predicate devices (cables, clamps/swages, trochanteric grips). |
| Design Equivalence | Design is similar to predicate devices (features cables, clamps/swages, trochanteric grips). |
| Operational Principles Equivalence | Uses similar technology to achieve proper bone fracture fixation as predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical orthopedic implant, not an AI/algorithm. There is no "test set" in the context of evaluating an algorithm's performance on data. The evaluation is against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no 'ground truth' establishment in the context of an AI/algorithm test set for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/algorithm. For a physical device, the "ground truth" would implicitly be established through engineering specifications, biomechanical testing, and clinical experience with equivalent predicate devices to ensure safety and effectiveness. These specific studies are not detailed in this 510(k) summary but would be part of the full submission.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm device.
Summary of the study conducted (as implied by a 510(k) for a physical device):
The "study" or evaluation for this device is a demonstration of substantial equivalence to legally marketed predicate devices. This involves a comprehensive comparison of:
- Intended Use: The indications for use for the Smith & Nephew Orthopaedic Cabling System (general orthopaedic repair procedures, including specific fracture types and trochanteric reattachment) are presented and compared to those of existing, legally marketed predicate devices.
- Technological Characteristics: The device's design (cable with or without clamps/swages, trochanteric grips) and operational principles (similar technology for tension, compression, and locking) are described and asserted to be similar to predicate devices.
- Materials: While not explicitly detailed, it's implied that the materials used are common for such devices and comparable to those in predicate devices.
Predicate Devices Used:
The Smith & Nephew Orthopaedic Cabling System claims substantial equivalence to:
- Smith & Nephew's Orthopaedic Cable Systems (K842977, K875156, K924141)
- Biomet's BMP Cable System (K982545)
- Howmedica's Dall-Miles Cable System (K971741)
- Pioneer's Cerclage Cable with Hex Button (K974016)
- Zimmer's Cable-Ready Cable Grip System
The 510(k) process for a Class II device like this relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than requiring new clinical trials to prove efficacy from scratch.
§ 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.