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Accuframe™ is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

Accuframe is a machined custom titanium framework for fabrication of multi-unit screwretained, cement-retained or combination of screw and cement-retained restorations with attachment at the abutment level. It is compatible with implants and abutments manufactured by Straumann, Nobel Biocare, Astra Tech, 3i and Zimmer.

The provided 510(k) summary for the Cagenix, Inc. Accuframe™ device (K081157) does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that for 510(k) submissions, manufacturers typically show that their new device is as safe and effective as a legally marketed device that FDA has already cleared. This process usually does not involve setting new, quantifiable acceptance criteria and conducting a standalone study to prove performance against those criteria in the same way a PMA (Premarket Approval) submission might.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies from the provided text.

Based on the content of the 510(k) summary:

• Acceptance Criteria and Reported Device Performance: Not specified. The submission relies on substantial equivalence to predicate devices.
• Sample size used for the test set and the data provenance: Not applicable. No test set or associated study details are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
• Adjudication method for the test set: Not applicable.
• 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: No MRMC study is mentioned. The device is a physical framework, not an AI or imaging diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical framework, not an algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The submission primarily focuses on the device's intended use, device description, and equivalence to marketed devices. The "study" in this context is the company's demonstration that the Accuframe™ is "substantially equivalent in indications and design principles to predicate devices." This substantial equivalence is the basis for FDA clearance in this case, rather than detailed performance against pre-defined acceptance criteria from a specific clinical study within the 510(k) summary itself.

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