(107 days)
US System and SSII mini are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. US System is for two stage surgical procedures. It is not for one stage surgery or immediate load. The SSII mini is for one and two stage surgical procedures. It is not for immediate load.
The US system is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The provided text is a 510(k) summary for a dental implant system (US System) and does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the way requested.
Here's why and what information can be extracted:
- Nature of the Document: This is a premarket notification (510(k)) submission. In the US, for Class II devices, a 510(k) demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and reported performance metrics against those criteria.
- Focus of the Document: The document focuses on comparing the "US System" to a predicate device (AVANA Dental Implant System) based on materials, intended use, design, and technological characteristics. The goal is to show they are similar enough that the new device is as safe and effective as the predicate.
- Missing Information: The document does not describe:
- Specific quantitative acceptance criteria (e.g., success rates, torque values, fatigue life thresholds).
- A study specifically designed to prove performance against such acceptance criteria.
- Sample sizes for test sets in the context of clinical or performance studies.
- Ground truth establishment, expert qualifications, or adjudication methods, as these are typically part of clinical or diagnostic performance studies, not typically central to a substantial equivalence claim for a mechanical device like a dental implant in this context.
- Any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, as this is relevant for diagnostic imaging devices, not mechanical implants.
- Standalone algorithm performance, as there's no algorithm involved.
- Details of a training set or how ground truth for a training set was established.
Information that can be extracted or inferred:
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Acceptance Criteria and Reported Device Performance: This is not explicitly stated in a table format. The "acceptance criteria" here is primarily demonstrating substantial equivalence to the predicate device. The "reported device performance" is essentially that it has similar material, indication for use, design, and technological characteristics to the predicate and has undergone "safety, performance, and product validations prior to release" to ensure compliance with regulations. Specific quantitative performance metrics are not given.
Acceptance Criteria (Inferred from 510(k) process) Reported Device Performance (Inferred from 510(k) text) Substantial Equivalence to Predicate Device "similar material, indication for use, design and technological characteristics as the predicate device." Compliance with applicable International and US regulations "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." Safety and Effectiveness "Osstem concludes that the US System is safe and effective..." -
Sample Size and Data Provenance for Test Set: Not applicable or not detailed in this type of submission. The "test set" in this context would likely refer to engineering or biocompatibility tests, not a clinical study on patients with a defined sample size as would be found in a diagnostic AI study.
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Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth as typically understood in AI/diagnostic studies is not established for this type of device comparison.
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Adjudication Method: Not applicable.
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MRMC Comparative Effectiveness Study: No. This is not a diagnostic AI device.
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Standalone Performance: The "US System" is a physical dental implant. Its performance is inherent to its design and material properties, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
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Type of Ground Truth Used: Not applicable in the context of a diagnostic or AI device. For a physical implant, "ground truth" might refer to known material properties or successful integration rates from historical data, but this is not detailed.
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Sample Size for Training Set: Not applicable. There is no algorithm or training set.
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How Ground Truth for Training Set was Established: 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.