(30 days)
The K2 Hemi Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful MTP joint.
The KMI Great Toe Implant System consists of 4 (four) sizes of toe implants. The implants will now be plasma coated. It is constructed of materials that have a lona clinical history of proven acceptance and performance. This system is intended for press fit use only and will be promoted as such in the Surgical Protocol 81-0065.
The provided text is a 510(k) premarket notification for a medical device called the "K2 Hemi Great Toe Implant System." This document is focused on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not include information about acceptance criteria or a study proving device performance in the context of AI/ML or software validation.
The document discusses:
- Device Name: K2 Hemi Great Toe Implant System
- Intended Use: Treatment of patients with inflammatory arthritis in the first metatarsal joint with good bone stock and integrity of the first metatarsal head, along with clinical conditions like Hallux valgus, hallux rigidus, and unstable/painful MTP joint.
- System Description: Consists of 4 sizes of toe implants, now plasma coated, made of materials with a long clinical history. Intended for press-fit use.
- Equivalence to Marketed Product: States identical design (except for spike feature elimination), identical operating principle/surgical protocol, and identical packaging/sterilization. The primary difference is the addition of a titanium plasma coating.
- Predicate Devices: Harmos Orthopedic, Inc. Great Toe Implant System (K014164) and Futura Biomedical Hemi Toe implant (K971047).
Since the request asks for information related to acceptance criteria and studies that prove device performance, specifically in the context of AI/ML validation metrics, and the provided text is for a physical orthopedic implant seeking 510(k) clearance based on substantial equivalence, the requested information (points 1-9) cannot be extracted from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but this is a regulatory standard, not a performance metric for AI/ML as implied by the questions.
Therefore, I must state that the provided information does not contain the details necessary to answer the questions about acceptance criteria, study design, sample sizes, expert involvement, or AI/ML performance metrics.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.