(357 days)
The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.
The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it. The One Plus Implant System is available in the following sizes. Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5
The provided document is a 510(k) premarket notification for the "One Plus Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria and results as typically seen for novel medical device approvals or AI/algorithm-based devices.
Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics. It is a regulatory submission for a physical device, and the "testing" mentioned is primarily related to manufacturing, sterility, and material properties to ensure safety and performance equivalence, not a clinical performance study as would be conducted for a diagnostic AI.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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A table of acceptance criteria and the reported device performance: Not applicable. The document assesses "substantial equivalence" based on design, materials, intended use, and manufacturing processes, not on a set of clinical performance metrics with pre-defined acceptance criteria. The non-clinical testing mentioned (sterilization, shelf life, chemical/SEM analysis) is to ensure the product itself is safe and functions as intended, not to measure a clinical performance against a threshold.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of clinical performance data in this submission. The non-clinical testing refers to lab tests on the device itself.
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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): Not applicable. There is no ground truth established by experts for clinical performance in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is a physical dental implant, not an AI-powered diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here would be established procedures for manufacturing and testing of medical devices (e.g., sterility standards, material composition verification).
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The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
What the document does provide regarding "testing" and "performance":
The document states under "8. Non-Clinical Testing":
- Sterilization validating testing: Performed in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. This demonstrates that the device can be effectively sterilized.
- Accelerated shelf life testing: Performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2. This demonstrates the stability of the device over its intended shelf life.
- Chemical and SEM image analyses: Performed to verify no residual material after RBM treatment on the fixture. This ensures the surface treatment is properly applied and safe.
The "acceptance criteria" for these tests would be the specific standards and thresholds defined within the cited ISO and ASTM documents. The "reported device performance" would be that the device met these standards, allowing the conclusion of substantial equivalence for these aspects. However, these are not clinical performance metrics.
§ 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.