(268 days)
Intended use for Touareg NP CloseFit™ Dental Implant System:
- To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
- For single-stage or two-stage procedures.
- For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
- The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
- The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.
Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.
Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).
The provided text is a US FDA 510(k) premarket notification for a dental implant system. It describes the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. However, it does not contain a typical study report structure with specific acceptance criteria and detailed performance results that would be expected for a device proving its own acceptance criteria in the way a clinical trial or a performance study would.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary requirement for a 510(k) submission. This means the device is shown to be as safe and effective as a predicate device, rather than meeting novel acceptance criteria derived from a primary clinical study.
Therefore, many of the requested points (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set size, training set ground truth) are not directly applicable or available in this type of regulatory document. The "study" described here is a bench performance test (fatigue testing) used to compare the new device to its predicates.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a specific "acceptance criteria" table in the format typically seen for novel device performance claims. Instead, it states that the device was subjected to fatigue testing in accordance with FDA guidance and ISO 14801:2007. The acceptance criterion for this type of test is typically that the device must withstand a specified number of cycles at a certain load without failure, demonstrating performance equivalent to or better than the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Durability / Fatigue resistance (as per ISO 14801:2007) | "Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device. The testing represent that the implants and abutments are substantially equivalent to the identified predicates." (Page 9) |
| Sterility Assurance Level (SAL) of 10^-6 for radiation sterilization | "Sterilization is validated by the bioburden method. The sterility assurance level (SAL) that Adin Dental Implant Systems Ltd. intends to meet for the Touareg NP CloseFit™ Dental Implants is 10^-6." (Page 8) (Implied acceptance: SAL achieved) |
| Sterility Assurance Level (SAL) of 10^-6 for moist heat sterilization | "NP CloseFit™ Dental abutments also underwent extensive validation activities for moist heat sterilization for achieving a Sterility Assurance Level of 10^-6 (according to the FDA consensus standards) by using the parameters: Moist-Heat Sterilization at gravity fed autoclave 132 C° For 15 minutes exposure time, 20 minutes drying time, using the Overkill method. The sterlization was made in accordance with applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 17665-1:2006... and ISO 17665-2:2009..." (Page 9) (Implied acceptance: SAL achieved) |
| Cleaning, packaging, shelf-life validation | "NP CloseFit™ Dental Implant System also underwent extensive validation activities for cleaning, packaging, shelf-life and sterilization in accordance with Guidance... and all applicable recognized FDA consensus standards..." (Page 9) (Implied acceptance: validations successful) |
| Risk analysis conclusions | "Results of risk analysis, case studies, sterilization validation, and packaging testing have demonstrated that Touareg NP CloseFit™ Dental Implant System equivalent to the predicate device implants tested." (Page 9) (Implied acceptance: risks are comparable or acceptable) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "worst-case test samples" were identified and subjected to fatigue testing. It does not provide the specific number of samples (N) used for this testing.
- Data Provenance: The tests are non-clinical, bench-top tests conducted to ISO standards. The company is Adin Dental Implant Systems Ltd. from Israel. The testing itself would likely have been done in a laboratory, potentially in Israel or by a certified testing facility elsewhere. This is not
retrospective or prospective clinical data.
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 is not applicable as the "test set" here refers to physical dental implant samples for bench testing, not a dataset requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for physical bench testing. The evaluation is based on objective measurements and observations of mechanical failure or integrity according to the ISO standard.
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
This is not applicable. This submission is for a physical medical device (dental implant), not a diagnostic AI device requiring human reader interaction or multi-reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fatigue testing, the "ground truth" is the physical performance of the device samples against engineering and material science standards (e.g., ISO 14801:2007), where failure is an objective event. For sterilization, the "ground truth" is the demonstration of microbial lethality to achieve the specified Sterility Assurance Level.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.