(279 days)
Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.
Implantium Prosthetics is a device made of titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Combi Abutment, Screw Abutment, Dual Abutment, Angled Abutment, Ball Abutment, Temporary Abutment and Cover screw. Material is of Pure Titanium Grade 4 of ASTM F 67-00 or of Titanium alloy 6A1-4V of ASTM F 136-98. Its surface is partially TiN coated. It is supplied non-sterile.
The provided text is a 510(k) summary for the Implantium Prosthetics device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness criteria. Therefore, the document does not contain the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria, study details, and ground truth establishment.
Here's why the information is not present in the provided text:
- 510(k) Submissions vs. Clinical Studies: A 510(k) is a premarket notification that demonstrates a device is substantially equivalent to a legally marketed predicate device. This typically involves comparing device design, materials, indications for use, and performance data (often bench testing) to the predicate. It generally does not require new clinical studies with human subjects to establish performance metrics like sensitivity, specificity, accuracy, or to conduct multi-reader multi-case studies, as would be expected for novel devices or those seeking a higher regulatory clearance.
- Device Type: The device, "Implantium Prosthetics," is an endosseous dental implant abutment, which is a Class II device. For such devices, direct human performance studies (like those implied by your questions, such as AI-assisted reading or expert consensus for ground truth) are typically not part of the substantial equivalence pathway unless specifically requested by the FDA for complex new features. The "extensive safety, performance, and product validations" mentioned are most likely bench testing and material compatibility evaluations, not clinical performance studies on patient data.
Based on the provided text, I cannot complete the table or answer most of your detailed questions. The document explicitly states:
- "Implantium Prosthetics has the same device characteristics as the predicate device. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide."
- "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
- "Dentium Co., Ltd. concludes that Implantium Prosthetics is safe and effective and substantially equivalent to predicate devices..."
This all points to a comparison with existing devices and compliance with standards, not a new study establishing performance metrics against a defined acceptance criterion with human readers or AI.
If this were a document describing a clinical study to establish acceptance criteria for a novel diagnostic AI device, the following information would be expected:
(Unable to provide the requested table and answers based on the provided text)
However, I can extract the general conclusion and device information from the provided text:
- Device Name: Implantium Prosthetics
- Intended Use: "as an aid in prosthetic rehabilitation."
- Regulatory Clearance: 510(k) clearance, demonstrating substantial equivalence to predicate devices (Implantium, Dentium Co., Ltd. K041368 and Astra Tech Implants, Astra Tech Inc., K931767).
- Material: Pure Titanium Grade 4 (ASTM F 67-00) or Titanium alloy 6A1-4V (ASTM F 136-98). Partially TiN coated.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)