(152 days)
AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with AIDT Dental implant Systembents intended to be surgically placed in the Sorews) are enabose lower jaw arches to provide support for prosthetic bone of the upper of artificial tooth, in order to restore patient esthetics deviocs, suon ao an arming abutments indicated for both screw and chewing function. Straigrations are included. The implants are indicated for single or multiple unit restorations and can be used in indicator for oingle applications. The device is intended for Splinted and non opinious appress and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.
AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM).
The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.
The provided document is a 510(k) summary for the AIDI Dental Implant System (K101755). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel technologies.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, etc.) you would expect for a diagnostic AI device. Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness.
The key performance attribute evaluated and reported is torque strength.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance (AIDI Dental Implant System) |
|---|---|
| High torque strength, comparable to predicate devices. | "high torque strength for AIDI Dental Implants." "resembled the same torque strength" as predicate devices. |
Study Information:
Given this is a 510(k) for a dental implant, the type of "studies" and "ground truth" are very different from what you would typically find for an AI medical device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The "test set" in this context refers to the AIDI Dental Implant System components used in the nonclinical torque strength tests.
- Data Provenance: The study was a "nonclinical test data... Torque Test Report." No country of origin is specified, and it's inherently a prospective lab test, not retrospective patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for torque strength testing in medical devices like implants is established through standardized engineering tests, not expert consensus.
- Qualifications of Experts: N/A for this type of test.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This is a physical, mechanical test, not a subjective interpretation requiring adjudication.
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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:
- MRMC Study: No, this type of study was not done. This is a physical dental implant, not a diagnostic AI device that assists human readers.
- Effect Size: N/A.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a physical dental implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for the "torque strength" was established by mechanical testing (Torque Test Report) following presumably an established standard for dental implants.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. There is no "training set" in the context of this 510(k) submission, as it describes a physical device, not a machine learning model.
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How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set mentioned or implied for this device.
Overall Conclusion from the Provided Text:
The K101755 submission for the AIDI Dental Implant System is a predicate-based 510(k). The primary "study" supporting its safety and effectiveness is a nonclinical torque strength test. The "acceptance criteria" are met by demonstrating that the AIDI system exhibits a "high torque strength" that "resembles the same torque strength" as its legally marketed predicate devices (IDI™ Implant System (K081860) and NobelActive™ Internal Connection Implant (K071370)). No clinical studies or AI/software performance studies were submitted or required for this type of device. The ground truth for the single reported performance metric (torque strength) was established through objective mechanical testing.
§ 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.