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Hemi-arthroplasty 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 stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.

The provided text is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving the device meets specific acceptance criteria through a study with the features requested in the prompt.

Therefore, the information requested in your prompt (specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not present in the provided document.

Here's why and what the document does provide:

1. Acceptance Criteria and Reported Device Performance: This document states the new device (Contoured Articular Prosthetic (CAP) ™ 7.0mm MTP Resurfacing Hemi-arthroplasty) is "substantially equivalent" to a previously cleared device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.). It explicitly states: "The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the sponsor's previously cleared and commercially marketed device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.)." and "The fundamental scientific technology of the proposed device has not changed relative to the predicate device."

   • Implication: For a 510(k), the "acceptance criteria" isn't a set of performance metrics for a clinical study comparing the new device to a standard. Instead, the acceptance criterion is that the new device is as safe and effective as the predicate device. The "reported device performance" is the assertion of substantial equivalence due to the similarity in design, materials, and intended use.

2. Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: None of these details are provided because a 510(k) submission primarily relies on comparing the new device's characteristics to a predicate device, not on new clinical studies or AI algorithm performance tests. The device described is a physical implant, not an AI/ML-driven diagnostic tool.

In summary, the provided document does not contain the information you requested about acceptance criteria and a study proving their fulfillment because it's a 510(k) premarket notification for a medical implant, which demonstrates substantial equivalence to an existing device rather than presenting new quantitative performance data in the manner you've outlined for an AI/ML diagnostic.

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