(198 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from ISO 14801) | Reported Device Performance (From Summary) |
|---|---|---|
| Mechanical Strength (Fatigue) | Implants and abutments must withstand dynamic fatigue forces appropriate for intended use in the oral cavity. (Referencing ISO 14801: Dentistry - Implants - Dynamic fatigue tests for endosseous dental implants) | "Results confirmed the strength of the system." (Specifically for Titamax CM Implants with CM Abutments) |
Study Details (Applicable to Bench Testing)
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1. Table of Acceptance Criteria and Reported Device Performance: (Addressed above)
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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).
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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.
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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.
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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.
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6. Standalone Performance Study (Algorithm Only):
- No. This device is a physical dental implant system, not a software algorithm.
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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.
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8. Sample Size for the Training Set:
- Not applicable. This was not a machine learning model, so there is no training set.
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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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.