(266 days)
This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function.
This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Intended for delayed loading.
- (1) This Product is designed to be used in dental surgery in mandible or maxilla-arch, where has missing teeth, to have dental crown, fixation-bridge, over-denture installed afterwards, and to support and restore patient's chewing function.
- (2) This implant (Ti-one 101 TS dental implants (Fixture)) is made of grade 4 pure titanium, featuring sandblasting + acid etching surface treatment (SLAffinity).
- (3) Healing screw is one-piece abutment made of grade 4 titanium.
- (4) Abutment is two-piece abutment made of grade 4 titanium. Its surface was anodized.
- (5) Label attached to the surface of outer packaging indicates specification and model number.
The range of diameter for implant (fixture) is provided as below:
Ø Diameter: 3.5, 4.0, 4.5, 5.0 mm
Length: 7.0, 8.0, 9.5, 11.0, 12.5, 14.0 mm
All diameters are available in all lengths, other than the 3.5mm diameter which is not available in the 7.0mm length.
The range of diameters and angulations for each screw model and abutment model are provided as below:
Healing Screw: Ø 4.3 mm, G/H 1.0, 3.0, 4.0 mm, Height (H) 3.5, 5.0, 7.0 mm
Angled Abutment: Ø 4.5, 5.5 mm, G/H 3.5 mm, V/H 11.0 mm, Length (L) 14.13, 14.15, 14.20 mm, Angulation range 12.5°, 20.0°, 27.5°
The provided document is a 510(k) summary for the "Ti-one 101 TS Dental Implant System." It does not describe an AI or software as a medical device (SaMD). Instead, it details a traditional medical device (dental implant system) and its non-clinical testing for substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI/SaMD studies are not applicable.
Here's an analysis of the provided information, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Sterilization | Compliance with ISO11737-1:2006, ISO11737-2:2009, ISO 11137-2:2013 | Proposed device complies with all listed ISO standards. |
| Shelf Life | Compliance with ASTM F1980:2016, ASTM F1929:2012, ISO 11607-1:2006, ASTM F-88 / F88M:2015, ISO 11737-2:2009 | Proposed device complies with all listed ASTM and ISO standards. |
| Biocompatibility | Compliance with ISO 10993 series (various parts), USP, and OECD guidelines for predicate device; USP and AAMI for non-pyrogenic test. | Predicate Device (K110425): Complies with all listed ISO, USP, and OECD requirements for cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, pyrogenicity, in vitro mutation/aberration tests, and 14-day/90-day toxicity tests. |
| Proposed Device (Non-pyrogenic): Complies with USP 40:2017 , USP 40:2017 , AAMI ST72:2011. | ||
| Performance Testing | Compliance with ISO 14801:2007 and ASTM F543-13:2013 | Reported as meeting "pre-defined acceptance criteria." (Specific details of torque, fatigue, or SEM/EDS results are not provided beyond this statement). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the document. The document refers to "test reports" for each test category but does not include the number of units tested.
- Data Provenance: The biocompatibility tests for the predicate device (K110425) are leveraged from the same manufacturer, Hung Chun Bio-S Co., Ltd. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though performance and biocompatibility testing of medical devices are typically prospective bench or in-vitro tests conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical dental implant, not an AI or SaMD requiring expert interpretation for ground truth establishment. Its performance is evaluated through standardized mechanical, biological, and sterilization tests.
4. Adjudication method for the test set
- Not Applicable. As above, the device is evaluated through objective, standardized tests, not through expert adjudication of data.
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 study is for a physical medical device (dental implant system), not an AI or SaMD. No human readers or AI assistance are involved in its evaluation as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or SaMD.
7. The type of ground truth used
- For the non-clinical tests (sterilization, shelf life, biocompatibility, performance), the "ground truth" is defined by the specific requirements and passing criteria of the referenced international/national standards (e.g., ISO, ASTM, USP, AAMI, OECD guidelines). The device's performance is measured against these objective criteria.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/SaMD. There is no concept of a "training set" in the context of this 510(k) summary.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no training set for this device.
§ 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.