(393 days)
The OT-F2 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 OT-F3 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 is suitable for insertion in completely healed jaw bone (late implantation).
The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136.
The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) premarket notification summary for dental implants, not a clinical study report for an AI device. Therefore, many standard AI study criteria will not be applicable.
The document discusses two distinct dental implant systems: the OT-F2 and the OT-F3, each with its own predicate device comparison. I will treat them separately for clarity, as the provided text presents them as essentially two separate 510(k) submissions consolidated under the same K-number.
OT-F2 Dental Implant System (K113113 - Part 1)
1. Table of Acceptance Criteria and Reported Device Performance
For the OT-F2 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate device (Pitt-Easy Dental Implant System, K053242). The reported device performance is presented as a comparison of technological characteristics.
| Acceptance Criteria (Based on Predicate) | OT-F2 Reported Performance |
|---|---|
| Material: Titanium Grade 4 acc. to ASTM-F67 | Titanium Grade 4 acc. to ASTM-F67 |
| Exterior geometry: cylindrical, threaded | cylindrical, threaded |
| Maximum diameter [mm]: 3.8/4.1/4.9 | 3.8/4.1/5.0 (Slight variation, likely deemed equivalent) |
| Implant lengths [mm]: 8/10/12/14/16 | 8/10/12/14/16 |
| Surface treatment: acid etched or Titanium Plasma Spray | acid etched |
| Pretreatment: non (without sand blasting) | non (without sand blasting) |
| Sterilization: gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 | gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 |
| Packaging: blister packaging in double - sterile condition | blister packaging in double - sterile condition |
| Abutments: Titanium (0°), Ball Head (0°), Temporary (0°), Bar (0°) | NaturalLine (0°), TecLine (0°), CreativeLine (0°), ProfiLine (0°) (Comparable types and angles) |
| Accessories for implants: cover screws | cover screws for each implant, anodised |
| Accessories for abutments: abutment screw | abutment screw for each abutment |
| Indications for Use: Support for fixed or removable dental prostheses | Same broad indication, including immediate loading with good primary stability |
| Fatigue Test (ISO 14801:2003): Stable screw joint | Stable screw joint at the highest forces tested |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
- Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2") and external lab reports (e.g., MDS, Duddeck, IGMHS). The tests listed are for material properties, sterilization validation, aging, and fatigue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI device.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI device.
7. Type of Ground Truth Used
The ground truth for the OT-F2 system is established through:
- Comparison of technological characteristics to a legally marketed predicate device (510(k) pathway).
- Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
- Results from non-clinical tests on material properties, sterilization efficacy, and aging.
8. Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device.
OT-F3 Dental Implant System (K113113 - Part 2)
1. Table of Acceptance Criteria and Reported Device Performance
For the OT-F3 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate devices (K926354, K971196, K032140 Endopore Dental Implant System). The reported device performance is presented as a comparison of technological characteristics.
| Acceptance Criteria (Based on Predicate) | OT-F3 Reported Performance |
|---|---|
| Material: Titanium Grade 5 acc. to ASTM-F136 | Titanium Grade 5 acc. to ASTM-F136 |
| Exterior geometry: conical | conical |
| Angulation of corpus: 10° | 12° (Slight variation, likely deemed equivalent) |
| Implant lengths [mm]: 5/7/9 | 5/7/9 |
| Maximum diameter [mm]: 4.1 / 5.0 | 4.1 / 5.0 |
| Uncoated area [mm]: 1 or 2 | 1.2 (Within range or comparable) |
| Surface treatment: sintered surface | sintered surface |
| Pretreatment: non (without sand blasting) | non (without sand blasting) |
| Material for surface treatment: Titanium powder Grade 4, grain size 50-150μm | Titanium powder Grade 4, grain size 50-150μm |
| Sintering process: high vacuum at 1250° | high vacuum at 1250° |
| Sterilization: gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 | gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 |
| Packaging: pouches in double - sterile condition | blister packaging in double - sterile condition (Difference noted, but acceptable for equivalence) |
| Accessories for implants: cover screws | cover screws for each implant |
| Indications for Use: Support for fixed or removable dental prostheses | Same broad indication, suitable for completely healed jaw bone (late implantation) |
| Fatigue Test (ISO 14801:2003): Stable screw joint | Stable screw joint at the highest forces tested |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
- Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2", "IfW Report 4451 Metallographie") and external lab reports (e.g., MDS, Duddeck, Endolab, IMA Test Report). The tests listed are for material properties, sterilization validation, aging, and fatigue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI device.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI device.
7. Type of Ground Truth Used
The ground truth for the OT-F3 system is established through:
- Comparison of technological characteristics to legally marketed predicate devices (510(k) pathway).
- Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
- Results from non-clinical tests on material properties, sterilization efficacy, aging, surface analysis, shear bonding strength, tension testing, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device.
Overall Note: The provided text is a 510(k) Premarket Notification Summary for dental implants, which are physical medical devices, not AI-powered software or diagnostic tools. As such, the typical "acceptance criteria" and "study types" for AI devices (like sample size for test sets, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) are not relevant to this document. The "study" here refers to non-clinical engineering and materials testing, and the "acceptance criteria" are demonstrating substantial equivalence to predicate physical devices.
§ 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.