(175 days)
The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The T.A.G.'s Dental Implant System is composed of three sub-families:
(1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm.
(2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2
(3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm.
The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
Provided are accessories which are used in dental implantation procedures. They are: Superstructures which are Healing Caps & Abutments made from Titanium Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are single patient use to be supplied non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the T.A.G. Dental Implant System.
It's important to note that the provided document is a 510(k) summary for a dental implant system, which is a medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "training set," "ground truth experts," "adjudication," and "MRMC studies" are typically not applicable in the context of hardware medical devices like dental implants. The "performance" here refers to mechanical and material performance, not diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic device with metrics like sensitivity, specificity, or AUC. Instead, it refers to compliance with established standards for mechanical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments | Met the requirements of the standards (ISO14801). |
| Compliance with ISO 14801: Static and Cycling Loading Test of Dental Implants | Met the requirements of the standards (ISO14801). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For ISO 14801, standard practice involves testing multiple samples per device configuration (e.g., different lengths, diameters) to establish statistical significance. The document states "testing, which was submitted."
- Data Provenance: The testing was "performed at an accredited independent laboratory." The country of origin of the data is not explicitly stated, but the manufacturer (T.A.G. Medical Products) is located in Kibbutz Gaaton, Israel. The testing would, therefore, likely originate from a lab commissioned by the manufacturer, possibly in Israel or an international lab accredited to perform such tests. The study is prospective in the sense that the implants were manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This concept is not applicable to this type of device and study. "Ground truth" for mechanical testing is established by the physical testing results themselves and their compliance with engineering specifications, not by expert consensus or interpretation of images. An independent accredited laboratory performing the tests serves as the "expert" in terms of confirming the test methodology and results.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device and study. Adjudication typically refers to resolving discrepancies in human interpretation, which is not relevant for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of a device (often AI-assisted) on human performance. Since the T.A.G. Dental Implant System is a physical implant, such a study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable. The device is a physical dental implant, not an algorithm. The performance testing described (mechanical loading) is inherently "standalone" in the sense that it assesses the device's physical properties directly, without human interpretation of results needing to be factored into the device's intrinsic function.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the dental implant system is the physical measurement and observation of the implant's behavior under controlled mechanical stress, as defined by the ISO 14801 standard. This standard specifies how dental implants should be subjected to static and dynamic (cycling) loading to evaluate their fatigue strength and resistance to fracture. The "truth" is whether the implant withstands the specified forces and cycles without failure, thus meeting the criteria of the standard.
8. The Sample Size for the Training Set
This concept is not applicable. Dental implants are hardware devices. There is no "training set" in the machine learning sense. The design and manufacturing process are informed by engineering principles, material science, and previous experience, but not through an iterative learning process with a "training set" of data like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for a hardware medical device. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material specifications (e.g., Ti-6Al-4V-ELI), regulatory requirements (e.g., FDA guidance, ISO standards), and clinical experience with similar devices.
§ 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.