(192 days)
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemi-arthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:
- Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsal/phalangeal (MTP) joint
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The components are anatomically designed, monolithic devices designed for resurfacing of the head of the 1st metatarsal or the phalangeal (MTP) joint. The devices are made from cobalt chromium alloy with a commercially pure titanium plasma spray. These devices are intended as hemi-arthroplasties at either surface and are press-fit.
Each device is boxed individually and delivered sterile for single use.
This 510(k) summary for the "Ascension® Metal Great Toe System" does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a submission to the FDA for premarket notification, seeking substantial equivalence to already legally marketed predicate devices. The basis of substantial equivalence is stated as: "There are no significant differences between the Ascension Metal Great Toe System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."
This type of submission typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than providing a detailed study with acceptance criteria for device performance. Performance data, if any, for demonstrating equivalence would usually be comparative to the predicate devices and might not be presented in the format of "acceptance criteria" and "reported device performance" against those criteria in the summary.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory approval through substantial equivalence, not on specific performance studies with acceptance criteria.
Information not available in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.