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The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.

The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as a software for simulating / evaluating dental implant placement and surgical treatment options.

This appears to be a 510(k) clearance letter from the FDA for the SimPlant System, and it describes the device, its indications for use, and its substantial equivalence to previously cleared devices. However, this document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

The nature of a 510(k) submission, especially an older one like this (2004), often relies on demonstrating substantial equivalence to a predicate device rather than presenting new, extensive performance studies with detailed acceptance criteria as one might see for a PMA or more modern 510(k)s.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Here's what I can extract based on the information provided, and where information is missing:

1. Table of acceptance criteria and the reported device performance

• Information Missing: This document does not specify any quantitative acceptance criteria or report device performance against such criteria. The clearance is based on substantial equivalence.

2. Sample size used for the test set and the data provenance

• Information Missing: The document does not describe a "test set" or any performance study data as part of this 510(k) submission that would require a sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Information Missing: This information is not present as no test set or ground truth establishment process is described.

4. Adjudication method for the test set

• Information Missing: No 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

• Information Missing: No MRMC study or any study involving human readers or AI assistance is mentioned. The device is described as "image processing system" and "preoperative software," not an AI diagnostic tool in the modern sense.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Information Missing: No standalone performance study is described. The device's clearance is predicated on substantial equivalence, implying its performance is comparable to its predicates, not independently verified via a specific study detailed here.

7. The type of ground truth used

• Information Missing: No ground truth is described as no performance study is detailed.

8. The sample size for the training set

• Information Missing: No training set is mentioned. This is a software device cleared via 510(k) through substantial equivalence, not a machine learning model developed with a training set.

9. How the ground truth for the training set was established

• Information Missing: No training set or ground truth for it is mentioned.

Summary of what the document does provide context for:

• Device Name: SimPlant System
• Intended Use: Software interface and image segmentation system for transfer of imaging information from medical scanners (CT, MR) and for simulating/evaluating dental implant placement and surgical treatment options.
• Regulatory Clearance: 510(k) clearance based on substantial equivalence to predicate devices (SIM/Plant product K924810 and CT-Modeller K970617).
• Date of Clearance: May 25, 2004.

To obtain the detailed performance study information you are looking for, one would typically need to review the full 510(k) submission, which is not fully provided here, or look for published clinical studies related to the device, especially if it were a newer, AI-driven device. For older devices cleared via substantial equivalence, detailed performance studies as described in your request were often not a prerequisite for clearance in the way they might be today.

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