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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower iaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple abutments are provided for each diameter implant for both cement-retained and screwretained prostheses.

Here's an analysis of the provided text regarding the Neodent Implant System's acceptance criteria and studies:

Based on the provided K101945 510(k) summary for the Neodent Implant System, the information is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device. Therefore, many of the requested categories (2-6, 8-9) that pertain to traditional clinical studies or AI model development are not explicitly addressed in this type of submission.

The "testing" mentioned is a bench performance test, not a clinical study involving human subjects or AI algorithms.

Acceptance Criteria and Reported Device Performance

Study Details (Applicable to Bench Testing)

• 1. Table of Acceptance Criteria and Reported Device Performance: (Addressed above)

• 2. Sample Size for Test Set and Data Provenance:

  • Sample Size: Not explicitly stated in the summary, but ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to establish a statistically significant fatigue limit or to demonstrate survival at specific load levels.
  • Data Provenance: The study was a bench test, not a clinical study with patient data. Its provenance is the manufacturer's testing facility (JJGC Indústria e Comércio de Materiais Dentários SA).

• 3. Number of Experts Used to Establish Ground Truth and Qualifications:

  • Not applicable. This was a physical bench test to measure mechanical properties, not an assessment requiring expert interpretation of images or clinical outcomes.

• 4. Adjudication Method for the Test Set:

  • Not applicable. This was a physical bench test, not an assessment requiring consensus among observers. The "ground truth" was the physical behavior of the materials under stress according to the ISO standard.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No. This was a bench test for mechanical strength. MRMC studies are typically for evaluating diagnostic imaging devices or AI tools that assist human readers.

• 6. Standalone Performance Study (Algorithm Only):

  • No. This device is a physical dental implant system, not a software algorithm.

• 7. Type of Ground Truth Used:

  • For the dynamic fatigue test, the "ground truth" is defined by the physical and mechanical properties of the materials and the assembly, as measured and interpreted according to the ISO 14801 standard. This standard specifies how to conduct the tests and determine failure or endurance limits.

• 8. Sample Size for the Training Set:

  • Not applicable. This was not a machine learning model, so there is no training set.

• 9. How Ground Truth for Training Set was Established:

  • Not applicable. As above, no training set for an AI model.

Overall Conclusion from Document

The 510(k) summary for the Neodent Implant System focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. The primary "study" mentioned is a bench performance test that confirmed the mechanical strength of the implants and abutments according to the ISO 14801 standard. This type of submission relies heavily on proving that the new device shares the same intended use, technological characteristics, materials, and operating principles as established predicate devices, and that any differences do not raise new questions of safety or effectiveness. It is not an AI/software device submission and thus does not include details regarding clinical trials, expert adjudication, or AI model development specific to those types of products.

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