(314 days)
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
The provided text describes a 510(k) submission for the "Chaorum Implant System," which is an endosseous dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested categories about acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document. This submission pertains to a physical medical device (dental implants), not a software or AI/ML-driven device.
However, I can extract information regarding the non-clinical testing performed to validate the safety and substantial equivalence of the physical device.
Here's the relevant information that can be extracted, acknowledging that it does not fit the typical format for AI/ML algorithm evaluation:
1. A table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it report specific performance values against those criteria. Instead, it lists the types of non-clinical tests conducted to validate the device's safety and substantial equivalence. The conclusion states that "Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device." This implies that the device met the unstated acceptance criteria for each test to support the substantial equivalence claim.
Therefore, for AI/ML-specific criteria, this section is N/A as this is not an AI/ML device.
For the physical device, a table summarizing the types of non-clinical tests performed is provided in the document:
| No | Test Title | Test Standard | Implied Acceptance |
|---|---|---|---|
| 1 | Physical tests (visual, packaging, packaging seal efficacy, dimension, sterility - direct transfer method) | Not explicitly listed for each, but general quality control and sterility standards apply. | The device's physical attributes, packaging integrity, and sterility were confirmed to meet established standards. For sterility, the direct transfer method was used, implying successful sterilization according to protocol. Dimensions and visual inspection would have ensured conformance to design specifications. |
| 2 | RBM/SLA Surface treatment tests (roughness average, developed surface area ratio, surface characteristics (SEM), surface composition analysis (EDX)) | Not explicitly listed for each, but general material and surface characterization standards apply. | The RBM and SLA surface treatments were characterized and confirmed to be consistent with the intended design and expected properties for dental implants, ensuring appropriate surface characteristics for osseointegration. |
| 3 | TiN coating tests (surface roughness and abrasion testing) | Not explicitly listed, but material and coating standards apply. | The TiN coating was evaluated for its roughness and abrasion resistance, confirming its suitability for the device's function and durability. |
| 4 | Mechanical properties test (adaptation accuracy (Implant to abutment compatibility), 35° compressive loads, torsional breaking force, removal torque force, fatigue test) | Not explicitly listed, but industry standards for dental implant mechanical testing apply. | The mechanical integrity and performance of the implant system (fixtures, abutments, screws) were confirmed through various tests, demonstrating appropriate strength, compatibility, and durability under simulated physiological loads to ensure device functionality and patient safety. This would include ensuring the device can withstand chewing forces without failure and maintain a stable connection between components. |
| 5 | Sterilization validation and shelf-life tests | Not explicitly listed, but ISO 11137 series and ISO 11607 series are common standards. | Sterilization processes (gamma irradiation) were validated to ensure the device is sterile at the point of use, and shelf-life testing confirmed that the sterility and integrity of the device are maintained over its intended storage period. |
| 6 | Biocompatibility tests (Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity, Pyrogen Test, Local Lymph Node Assay (LLNA), Bone Implantation Test) | ISO10993 series (specific parts listed in the document) | The device materials and design were proven to be biocompatible, meaning they do not cause adverse biological reactions (e.g., cell toxicity, irritation, sensitization, systemic toxicity, fever, or undesirable tissue reactions) when in contact with human tissue or implanted in bone. The bone implantation test would demonstrate appropriate osteointegration or tissue response in a living model. |
2. Sample size used for the test set and the data provenance:
N/A. This does not refer to an AI/ML algorithm's test set. The non-clinical tests described involve physical devices and material samples. The document does not specify the number of units or samples used for each physical or biocompatibility test, nor the provenance in the context of "data" (e.g., country of origin, retrospective/prospective). These are laboratory tests on manufactured articles.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. This is not an AI/ML device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would be the accepted standards and specifications for material science, mechanical engineering, and biocompatibility, as evaluated by engineers and scientists in accredited labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or interpretive task (often in AI/ML performance evaluation). This is not relevant to the non-clinical physical and biological testing of a dental implant.
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:
N/A. MRMC studies are used to evaluate diagnostic systems, often with AI components assisting human readers. This document describes a physical medical device, not a diagnostic system with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
N/A. This is not an AI/ML algorithm; it is a physical dental implant system.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by:
- Engineering specifications and design requirements: For dimensional accuracy, mechanical properties, and compatibility.
- Material standards: ASTM F136, ASTM F67 for titanium alloys.
- International standards: ISO10993 series for biocompatibility.
- Sterilization validation protocols: For sterility and shelf-life.
There is no "expert consensus" or "pathology" in the sense of clinical diagnostic ground truth for these types of tests, other than expert evaluation within the relevant engineering and scientific fields to ensure compliance with standards.
8. The sample size for the training set:
N/A. This is not an AI/ML algorithm. There is no concept of a "training set" for the physical device.
9. How the ground truth for the training set was established:
N/A. As above, no training set is involved.
§ 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.