(30 days)
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
PERI-LOC Ankle Fusion Bone Plates and the VLP Extra Large Percutaneous Calcaneus Plate are for single use only.
The subject devices are comprised of implantable, locking bone plates and a device specific instrument. All described implants are manufactured from implant grade stainless steel material. The subject implant devices are available in the following sizes:
| Device Type | Available Length |
|---|---|
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary, | |
| LH/RH with Compression Slot, 3H | 67mm |
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary, | |
| LH/RH with Compression Slot, 5H | 92mm |
| PERI-LOC 3.5mm Hindfoot Ankle Fusion Utility Plates, | |
| LH/RH with Compression Slot, 5H | 104mm |
| VLP 2.7mm Percutaneous Calcaneus Plates, Extra Large, LH/RH | 68mm |
A new device specific instrument is also described in this Special 510(k) premarket notification in select sections and exhibits.
The provided text [K120667](https://510k.innolitics.com/search/K120667) is a 510(k) summary for medical device clearance, specifically for orthopedic implants (bone plates). It does not contain information typically associated with the acceptance criteria and study results for AI/ML-based diagnostic or prognostic devices.
The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are characteristic of studies evaluating the performance of AI algorithms.
The provided document refers to:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a performance study in the AI/ML sense.
- Pre-clinical evaluation: A pre-clinical evaluation was conducted, but the document only states "Results were compared against previously cleared PERI-LOC Ankle Fusion Plate predicate devices" without detailing the acceptance criteria, specific measures, or results. This is likely mechanical testing or similar engineering validation, not a clinical study to establish diagnostic performance.
- Intended Use: describes the medical purpose and patient population.
- Technological Characteristics: compares the device to predicates.
Therefore, I cannot extract the requested information as it is not present in the provided 510(k) summary.
Conclusion:
The provided document describes a medical device (bone plates) that is not an AI/ML-based diagnostic or prognostic device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., sensitivity, specificity, AUC, human reader improvement, ground truth methodology) are not applicable or detailed in this submission. The "study" mentioned is a "pre-clinical evaluation" to support substantial equivalence, likely involving mechanical or material testing, not the evaluation of an algorithm's diagnostic accuracy.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.