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The Ortho/Pro Hemi Toe is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adiacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, majntain range of motion and reduce pain without altering the joint biomechanics. The Hemi Tor requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (OrthoPro Hemi Toe) and primarily focuses on establishing substantial equivalence to predicate devices, not on performance criteria or clinical study results.

The key statement regarding testing is: "The Ortho/Pro Hemi Toe does not incorporate any new technological characteristics as compared to the predicate devices. The Ortho/Pro Hemi Toe and the predicate devices are made ofinial the same material." This indicates that the regulatory approval was likely based on equivalence in design, materials, and intended use, rather than a specific performance study with acceptance criteria.

Therefore, I cannot provide the requested table or details about a study, as that information is not present in the provided text.

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