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The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.

The MS System is a dental implant made of Ti-6Al-4V metal. The MS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is R.B.M (Resorbable Blasting Media).

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested.

The document is a 510(k) Summary for a dental implant system (MS System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and a study to meet them.

Here's a breakdown of what is and is not in the provided text:

What is present:

• Device Name: MS System Dental Implant
• Intended Use: The text describes the intended use for two versions: MS System (Denture) and MS System (Narrow Ridge).
• Material: Ti-6Al-4V metal.
• Surface Treatment: R.B.M (Resorbable Blasting Media).
• Biocompatibility: Mentions biocompatibility tests were performed.
• Predicate Devices: K072959 (MS System (Denture)), K080594 (MS System (Narrow Ridge)), and K080129 (Secure Implant System).

What is NOT present in the provided text:

• A table of acceptance criteria and reported device performance: This document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations" and that the "MS System has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific quantitative acceptance criteria or the actual performance results against those criteria.
• Sample size used for the test set and data provenance: No information about a specific test set, its size, or where the data came from (country, retrospective/prospective).
• Number of experts and qualifications for ground truth: No mention of experts or their role in establishing ground truth for any test.
• Adjudication method for the test set: Not applicable as no test set with expert ground truth is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study would compare human reader performance with and without AI. Since the device is a dental implant, not an AI diagnostic tool, an MRMC study is not relevant and not mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
• Type of ground truth used: Not applicable as no specific performance study with ground truth is described.
• Sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The document concludes that the MS System is "safe and effective and substantially equivalent to the predicate device." This substantial equivalence is based on similar material, indication for use, design, and technological characteristics, as well as general safety and biocompatibility tests, but not a detailed performance study against specific acceptance criteria as you would typically see for a new diagnostic device or AI algorithm.

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