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• A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
• Degenerative arthritis
• Rheumetoid arthritis
• Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
• A titanium version is available for use only in patients susceptible to nickel-chromium allergies.
  The BioPro Hemi-Edge Toe System is not intended for spinal use.

The BioPro Hemi-Edge Toe System will be available in two material options: it can be manufactured from either Cobalt Chrome (ASTM F1537) or Titanium 6-4 (ASTM F1472). The system will be available in 5 sizes in both porous and non-porous coated versions as a press fit design. The basic implant design is unchanged to the original design which consists of a contoured articulating surface to simulate the normal concave articulation of the proximal phalanx in the toe. The current implant is a modification to the original implant design which includes a partial surrounding lip or rim adjacent the outer perimeter of the articulating surface. The purpose of the lip/rim is to prevent osteophyte bone on-growth to the articular surface that could inhibit function of the device. Two(2) small windows in opposite comers of the lip/rim allow either visual or needle verification in seating of the prosthesis on resected bone. The current implant design still includes the diamond shaped stem which provides a press-fit intra-medullary fixation. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The provided text describes the BioPro Hemi-Edge Toe System, a medical device for toe joint replacement. However, it does not contain any information about a study that establishes acceptance criteria or reports on device performance based on a study.

Instead, the document is a 510(k) Summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). In this case, the manufacturer is claiming substantial equivalence to existing predicate devices based on material, geometry, design/markings, and indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided text.

Here's why each of your requested points cannot be addressed from the given document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "No nonclinical testing was used in the determination of substantial equivalence." This means no specific performance metrics or acceptance criteria derived from a study are presented.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned because no study was conducted to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
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 device is a physical implant, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established as no performance study is described.
8. The sample size for the training set: Not applicable. This device is a physical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document relies on demonstrating substantial equivalence to predicate devices rather than presenting data from a new performance study with specific acceptance criteria.

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