(147 days)
Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.
The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm. Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant. The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating. Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.
This document describes a 510(k) premarket notification for the Straumann® Mini Implants. The information provided heavily focuses on the comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance against specific quantitative acceptance criteria in a human population.
Therefore, many of the requested details regarding acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert involvement for ground truth, and MRMC studies will not be present in this type of regulatory submission. The performance testing outlined here is primarily bench testing to demonstrate mechanical and material equivalence.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The document does not specify quantitative clinical performance acceptance criteria (e.g., success rates, complication rates) and corresponding reported device performance from a clinical trial. Instead, the "acceptance criteria" discussed are related to bench testing for demonstrating equivalence to predicate devices.
Table 1: Acceptance Criteria (Bench Testing) and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (Summary from Bench Testing) |
|---|---|---|
| Insertion Torque | Reach a suitable implant insertion torque, comparable to predicate/reference devices. | Average value of insertion torque measurements for each bone plate density and each implant length are "within the defined acceptance criteria." |
| Wear Testing (Optiloc® attachment retention) | Retention force loss of the Optiloc® blue ring within acceptable limits. | The retention force loss of the Optiloc® blue ring on Straumann Mini Implants "passed the acceptance criteria." |
| Biocompatibility | No new issues raised compared to previously cleared materials. | Roxolid material and TiN coating previously cleared (K083550, K190040). |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10^-6. | Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, achieving SAL of 10^-6. |
| Shelf Life | Maintain integrity and sterility for 5 years. | Determined through real-time and accelerated aging (ASTM F 1980) to be 5 years. |
| Pyrogenicity | Meet pyrogen limit specifications. | Testing limit of 20 EU/device met via LAL Endotoxin Analysis. |
| Dynamic Fatigue | Mechanical performance comparable to predicate devices under dynamic loading. | Demonstrated equivalence to primary predicate devices in tests conducted according to ISO 14801 and FDA Guidance. |
Study Details (Based on Provided Document)
Given that this is a 510(k) submission primarily relying on substantial equivalence through bench testing, a traditional clinical study with a "test set" in the context of AI/diagnostic device evaluation (as implied by the detailed questions) was not conducted or reported here. The performance testing discussed pertains to physical and mechanical characteristics of the dental implants.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the samples of the physical device used for bench testing (e.g., number of implants for insertion torque, wear, and fatigue tests). Specific quantities are not provided, but these are typically small, controlled laboratory samples.
- Data Provenance: Not applicable in terms of patient data. The data provenance is from laboratory bench testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader studies or data labeling, not bench testing of a physical implant.
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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:
- No. This is irrelevant to the evaluation of a dental implant's mechanical and material properties. The device is a physical implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This also refers to AI/software performance, not a dental implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on engineering standards and specifications (e.g., ISO 14801, ISO 11137), and the properties of the previously cleared predicate devices. For example, a successful fatigue test to a certain threshold is "ground truth" for mechanical durability.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As noted above, there is no training set for this type of device.
Summary of what the document primarily reports:
The document, a 510(k) summary, demonstrates the substantial equivalence of the Straumann® Mini Implants to legally marketed predicate devices. This is achieved by:
- Comparing Indications for Use: Showing the new device's indications are equivalent to a predicate (K031106), with one difference (not indicated for inter-radicular transitional applications) that does not raise new safety or effectiveness questions.
- Comparing Technological Characteristics: Detailing similarities and differences in material, dimensions, coating, surface treatment, etc., with predicates and reference devices (Table 1).
- Performance Testing (Bench Testing): Conducting various engineering tests (insertion torque, wear, biocompatibility, sterilization, shelf life, pyrogenicity, dynamic fatigue) and demonstrating that the device meets internal "acceptance criteria" for these tests, which are implicitly set to show equivalence to or non-inferiority against the predicate devices' known performance. The tests adhere to relevant FDA guidance and ISO standards.
This type of submission is common for Class II medical devices where clinical trials are not explicitly required if substantial equivalence can be demonstrated through non-clinical means.
§ 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.