(216 days)
Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).
The provided document is a 510(k) Summary for the Point implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories about acceptance criteria, efficacy studies, and ground truth are not directly addressed in this type of submission.
However, I can extract information related to non-clinical testing and general acceptance of performance based on standards.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Met criteria of ISO 10993 series for medical devices. |
| Fatigue (ISO 14801:2016) | Result is "strong enough to achieve their intended use." |
| Non-pyrogenic (USP Bacteria Endotoxins Test) | Meet established pyrogen limit. |
| Usability Evaluation (ISO 11607-1:2019 & FDA Guidance) | Aseptic presentation evaluated. |
| Packaging Integrity (Low and high magnification images) | Evaluation of broken tip and damage after removal from packaging and disconnection of fixture jig. |
| Quality System (QS) Plan | Method and frequency of acceptance activities ensure conformity with product specifications. |
| Gamma Sterilization (ISO 11137-1, -2) | Achieved a Sterility Assurance Level (SAL) of 10^-6. Demonstrated a shelf life of 5 years for fixture, 8 years for healing abutment. |
| Steam Sterilization (ANSI/AAMI ST79, ST8, ISO 17665-1, -2) | Achieved a Sterility Assurance Level (SAL) of 10^-6. Validated for abutments with the same material/process. |
| MRI Safety (FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | MRI review performed to evaluate metallic devices for magnetically induced displacement force and torque. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified. The manufacturer is PointNix Co., Ltd. from REPUBLIC OF KOREA.
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)
- This information is not applicable and not provided in a 510(k) summary for a dental implant system. The document focuses on physical, chemical, and biological performance testing against established standards, not on diagnostic accuracy requiring expert consensus as ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The tests mentioned are non-clinical, objective tests against engineering and biological standards, not requiring human adjudication of results in the way a clinical imaging study might.
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 dental implant system, not an AI-powered diagnostic device. No MRMC studies were mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental implant system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference for acceptance is primarily the criteria defined by international and national standards (e.g., ISO 10993, ISO 14801, ISO 11137, ANSI/AAMI, USP), as well as FDA guidance documents. These standards define methodologies and acceptable limits for properties like biocompatibility, fatigue strength, sterility, and packaging integrity.
8. The sample size for the training set
- Not applicable. This is a medical device (dental implant), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8).
Summary of Study Type:
The "studies" described are a series of non-clinical performance tests conducted to demonstrate that the physical, chemical, and biological properties of the Point implant system meet established international standards and FDA guidance for dental implants. These are largely laboratory-based tests comparing the device's performance against predefined thresholds and methodologies specified in the standards. No clinical studies (human trials) were included in this 510(k) 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.