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510(k) Data Aggregation
(105 days)
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- Hallux rigidus stage 3 and 4 ◆
- Hallux valgus and hallux rigidus .
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.
The provided text describes the Ascension® MOVEMENT™ Great Toe System, a total arthroplasty device. The submission focuses on establishing substantial equivalence to predicate devices based on testing and geometrical comparison, rather than clinical performance or AI/software system evaluation. Therefore, many of the requested categories are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Interconnection strength testing (axial, shear, bending strength) | Performed to substantiate equivalence. (Specific results not detailed in provided text) |
| Geometrical comparisons between subject and predicate devices | Completed. (Specific measurements not detailed in provided text) |
2. Sample size used for the test set and the data provenance
Not applicable. The submission is for a medical device (great toe implant) and relies on mechanical testing and geometrical comparison, not a test set of data typically used for AI or diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant for this type of device submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used
Not applicable in the context of clinical "ground truth" as typically defined for diagnostic or AI devices. The "ground truth" for this device's acceptance would be established by validated engineering and biomechanical testing standards for orthopedic implants.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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