(364 days)
SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.
SDS2.2 dental implants are a two-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS2.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs (standard shoulder and oval shoulder). The implants are provided sterile in sterile packaging and are intended for single use. The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days. SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured. After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations. SDS2.2 standard implant posts are available in different designs. The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided non-sterile.
The document is a 510(k) premarket notification for the SDS2.2 dental implant system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes physical and mechanical properties, material composition, manufacturing processes, and sterilization validation rather than AI/ML algorithm performance.
Therefore, many of the requested bullet points for describing AI/ML device acceptance criteria and study details cannot be directly answered from this document. The document describes a traditional medical device (dental implant) and its non-clinical testing for safety and effectiveness.
Here's an analysis based on the provided document, addressing what can be inferred and stating what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in a formal table with values for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses the device meeting "existing requirements and acceptance criteria" based on various regulatory standards and non-clinical tests.
| Acceptance Criteria Category/Standard | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Components subjected to biological evaluation per ISO 10993-1, including cytotoxicity (ISO 10993-5). Demonstrated biocompatibility through tests regarding Cytotoxicity, Bioburden, and Endotoxins. Methods for manufacturing, cleaning, and sterilization are established and validated. |
| Performance Testing | Risk analysis per ISO 14971 guided performance tests. Successful fatigue testing (ISO 14801), surface investigation (scanning electron microscope), and laboratory testing for extractable cytotoxic substances, pyrogenicity, and total organic carbon. Meets existing requirements and acceptance criteria like predicate devices. |
| Sterilization Validation & Shelf Life | Sterilization validated per ISO 11137-2. Proved minimal sterilization dose of 25 Gy leading to SAL of ≤ 10^-6. Packaging system validated per ISO 11607-2 for performance during sterilization and storage up to 5 years (accelerated aging). Non-sterile products' end-user sterilization validated per ISO 17665-1. |
| Compliance with Applicable Standards | Meets all requirements of listed standards (e.g., ISO 14801, ISO 7405, ISO 13356, ISO 10993 series, ISO 14971, ISO 15223-1, ISO 11607 series, ISO 11137 series). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This document describes testing for a physical medical device (dental implant), not an AI/ML algorithm. The "test set" in this context refers to physical implants subjected to various lab tests (e.g., fatigue testing, material analysis). The sample sizes for these specific physical tests are not provided in this summary document.
- Data Provenance: Not applicable for AI/ML dataset. The "data" refers to the results of bench testing and physical-chemical characterization of the implant. There is no mention of country of origin or retrospective/prospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used to train and evaluate an algorithm. For a dental implant, "ground truth" is established through engineering and material science standards and confirmed by accredited lab testing, not by expert physicians interpreting images or data for AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers to resolve discrepancies in annotations or diagnoses for AI/ML ground truth. This is not relevant to the physical 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:
No. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes a physical medical device and its non-clinical performance, not an AI/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This concept is specific to AI/ML algorithm testing. The device is a physical implant; its "performance" is inherently "standalone" in mechanical terms, but it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for evaluating this device's performance is based on established engineering and material standards for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and the successful outcome of physical bench tests and material analyses. It's not based on clinical imaging, pathology, or outcomes data in the sense used for AI/ML.
8. The sample size for the training set:
Not applicable. There is no AI/ML training set discussed in this document.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set discussed in this document.
§ 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.