(271 days)
The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone with the following clinical conditions: hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) ioint. The device is a single use implant intended to be used with bone cement.
The Life Spine Metatarsal Hemi Implant is an implant that has a tapered stem and a rounded head. The tapered stem allows for the implant to be fixated into the 1st metatarsal. The rounded head resurfaces the metatarsal head in the metatarso-phalangeal joint.
I apologize, but the provided text is a 510(k) premarket notification for a medical device (Life Spine Metatarsal Hemi Implant) and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested for aspects like sample size, ground truth, or expert qualifications for performance evaluation.
The document states that Finite Element Analysis, bench testing (static and dynamic), and engineering rationale were presented to demonstrate substantial equivalence to predicate devices, but it does not detail the specific acceptance criteria for these tests, nor does it present the results of these tests in a tabular format as performance data.
Therefore, I cannot provide the information requested in your numbered list based on the input text. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on a detailed clinical performance study with defined acceptance criteria and study parameters.
§ 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.