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CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant to create the final device.

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device.

CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

The provided text describes the "CloudPoint FastDesign Chairside," a dental abutment design software. However, it does not contain the detailed acceptance criteria for device performance, nor the specifics of a study proving the device meets those criteria, as typically requested in your prompt.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abutment Design K200100) based on intended use, indications for use, and technological characteristics. It mentions "Software verification and validation" and "Cybersecurity Analysis" as non-clinical data submitted, but does not provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document states that software verification and validation were conducted to "verify that the software development output met the input requirements, and to validate that the software specifications confirm to user needs and its intended uses," but it does not list these specific requirements or their direct performance outcomes.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method: Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted. The document states "No clinical data is included in this submission."
6. Standalone (algorithm only) performance study: Not explicitly detailed with performance metrics. The software verification and validation focused on confirming design limitations and specifications.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable as this is a design software, not an AI/ML diagnostic algorithm that typically relies on a training set in the same way. The document highlights "software design verification and validation."
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance data is:

• Non-clinical data submitted:
  • Software verification and validation, according to the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.
  • Cybersecurity Analysis, according to the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on October 02, 2014.
• No clinical data is included in this submission.
• Software Verification and Validation details:
  • Conducted by Prismatik Dentalcraft, Inc. to verify that software development output met input requirements and validate that software specifications conform to user needs and intended uses.
  • Used to address questions related to substantial equivalence based on technical feature differences.
  • Provided for the compatible abutment design library to demonstrate use with the software suite.
  • Conducted to demonstrate that "restrictions prevent design of the patient-matched component of the two-piece hybrid dental abutment outside of the allowable design limitations, including screenshots under user verification testing."
  • Established that "the design limitations and specifications are locked and cannot be modified within the abutment design library."
• Cybersecurity Analysis details:
  • Risk assessment (hazard analysis, mitigation, design considerations for intentional and unintentional cybersecurity risks) was performed.
  • Concluded that benefits outweigh residual risk after mitigation, and all risks were mitigated as far as possible.

In summary, the provided text confirms the device underwent software verification and validation and cybersecurity analysis as non-clinical testing to support its substantial equivalence, but it does not offer the specific device performance acceptance criteria or detailed study results you've requested.

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