(112 days)
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
This 510(k) submission (K053478) for the NSI Hexed and Non-Hexed Endosseous Implant System did not include a study or defined acceptance criteria related to device performance in an AI/software context. This submission is for an endosseous dental implant system, which is a physical medical device, not an AI or software-based device.
The "acceptance criteria" and "device performance" in this context refer to the physical and manufacturing properties of the dental implants, as well as their sterilization and packaging. There are no performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices.
Here's a breakdown of the information provided in the context of a physical device submission:
1. A table of acceptance criteria and the reported device performance
The submission details specific standards that the device and its manufacturing processes meet, rather than specific numerical performance metrics in the way one would describe AI.
| Acceptance Criteria (Standards Met) | Reported Device Performance / Compliance |
|---|---|
| Material Standards: | |
| ASTM F67-95 Grade III or Grade IV Titanium | Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. |
| Sterilization Standards & Method: | Sterilization of these implants is achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10⁻⁴. Validation of sterilization is done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). |
| ISO 11137 | Compliance with "Sterilization of Health Care Products – Requirements for validation and routine control – Radiation sterilization." |
| ISO 11737-2 | Compliance with "Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterility performed in the validation of a sterilization process." |
| ISO 13409 | Compliance with "Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGy as a sterilization dose for small or infrequent production batches." |
| Packaging Validation Standards: | Packaging validation protocols followed the listed standards. |
| ASTM D 4169-04 | Compliance with "Standard Practice for Performance Testing of Shipping Containers and Systems." |
| ASTM F 88-00 | Compliance with "Standard Test Method for Seal strength of Flexible Barrier Materials." |
| ASTM F 1929-98 | Compliance with "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration." |
| ISO 11607 | Compliance with "Packaging for terminally sterilized medical devices." |
| Technological Characteristics & Design Comparability | The physical properties and designs of the additional implants and accessories were comparable to legally marketed predicate devices. "Any differences in the technological characteristics did not raise new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no "test set" in the context of clinical performance data or AI evaluation. The "data" refers to the results of testing against the physical/manufacturing standards mentioned in point 1. These tests are typically performed in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no clinical studies or AI evaluations were conducted, there was no need for experts to establish ground truth in this context. The "ground truth" for the physical device relates to its adherence to material, manufacturing, sterilization, and packaging standards, which are verified through established engineering and quality control procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical studies or AI evaluations were performed.
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
- Not Applicable. This is a physical dental implant, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/clinical sense). The "ground truth" for this device's acceptance is its compliance with established engineering, material, sterilization, and packaging standards (e.g., ASTM, ISO standards) and its substantial equivalence to predicate devices. This is verified through laboratory testing and documentation, not clinical outcomes or expert consensus on interpretations of data.
8. The sample size for the training set
- Not Applicable. No AI or machine learning model was developed or trained for this device.
9. How the ground truth for the training set was established
- Not Applicable. As no AI training occurred, no ground truth for a training set was established.
Summary:
This 510(k) submission is for a physical medical device (dental implants). The "acceptance criteria" and "study" described in the document relate to the manufacturing process, materials, sterilization, and packaging of the implants, rather than clinical performance studies or AI/software validation. The claim for substantial equivalence is based on the device's similar technological characteristics and intended use to legally marketed predicate devices, and its compliance with relevant voluntary industry standards for materials, sterilization validation, and packaging. No clinical studies were conducted or deemed necessary for this particular submission.
§ 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.