(269 days)
The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint. 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 Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece prosthesis that replaces the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.
The prosthesis consists of an anatomically shaped and polished metatarsal implant, made of CoCrMo, which glides on a polyethylene inlay that is preassembled on a conically shaped phalangeal component made of titanium alloy Ti-6AI-4V.
Metatarsal and Phalangeal implant are intended for cemented use only.
The provided text describes a medical device, the Merete ToeMobile™ Anatomical Great Toe Resurfacing System, and its regulatory clearance process, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
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Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document focuses on demonstrating substantial equivalence based on similar design, materials, and intended use to previously cleared predicate devices.
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Study Details (Sample Size, Ground Truth, etc.): No specific study is described in terms of sample size, data provenance, ground truth establishment, or expert involvement. The 510(k) pathway for this type of device often relies on non-clinical performance data (material testing, mechanical testing) and clinical history of predicate devices rather than a new clinical study with acceptance criteria for a novel device performance.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, as no clinical study with human readers is described.
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Standalone Performance Study: Not mentioned, as no clinical study with the algorithm (device) alone is described.
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Type of Ground Truth Used: Not applicable, as no study with a defined ground truth is described.
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Training Set Sample Size and Ground Truth for Training Set: Not applicable, as no machine learning algorithm or AI is mentioned, and thus no training set is relevant.
In summary, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The document is a regulatory submission for substantial equivalence based on material and design similarity to existing devices, not a performance study report.
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