(35 days)
The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint
The Bone Fusion Plate System consists of plates, and screws. The design features of the components included in the Bone Fusion Plate System are summarized below:
Bone Fusions Plate
- · Left and Right configurations
- · Available in 2 options
2.7mm Cruciform Screws
- · Non-locking
- · Lengths available: 8, 10, 12, 14, 16, 18, 20, 22, 24mm
3.2mm Cruciform Screws
- · Non-locking
- · Lengths available: 14, 16, 18, 20, 22, 24mm
The provided text describes a 510(k) submission for the "Bone Fusion Plate System," which is a metallic bone fixation appliance. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving specific performance criteria through a study with acceptance criteria in the way a new, novel device might.
Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an algorithm or AI model.
The information requested in your prompt (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML-based medical devices, which aim to perform diagnostic or predictive tasks. The Bone Fusion Plate System is a physical medical device (implants for bone fixation) and its evaluation for substantial equivalence relies on comparison to a legally marketed predicate device, material information, and analysis data, rather than the types of clinical performance studies you've outlined for AI/ML devices.
Summary of why the requested information cannot be provided from the input:
- Acceptance Criteria & Device Performance Table: Not applicable. The submission is for substantial equivalence to a predicate device, not for meeting specific performance metrics of an AI/ML algorithm.
- Sample size for test set & data provenance: Not applicable. There is no AI/ML algorithm being tested on a dataset.
- Number of experts & qualifications for ground truth: Not applicable. Ground truth for an AI/ML model is not relevant to this device type.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This device is a physical implant, not an AI assistance tool for human readers.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable. There is no AI/ML model to train.
- How ground truth for training set was established: Not applicable.
The 510(k) summary focuses on:
- Intended Uses/Indications: To help increase bone union rate and maintain toe position during fusion for various foot conditions.
- Device Description: Plates and screws (non-locking cruciform screws of different sizes).
- Substantial Equivalence: Claimed equivalence to the "HALLU® Plate System." This is the primary "proof" in this type of submission. The safety and effectiveness are supported by comparative information, material data, and analysis.
To clarify, the provided document relates to a traditional medical device's regulatory approval pathway, not an AI/ML device, which would require different types of performance evaluation and data.
§ 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.