(300 days)
Implantium Prosthetic is intended for use as an aid in prosthetic rehabilitation.
Implantium Prosthetics is a device made of pure titanium or titanium alloy intended for use as an aid in prosthetic rehabilitation. It consists of Healing Abutment, Dual Milling Abutment, Dual Abutment, Multipurpose Abutment, Solid Abutment, Direct Casting Abutment, Cover Screw and screw. Its surfaces are partially TiN coated or uncoated. It is supplied non-sterile and sterilized by the recommended sterilization method in the instructions for use.
The provided 510(k) summary for the "Implantium Prosthetics" device does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this document is a premarket notification (510(k)) seeking substantial equivalence to a predicate device. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
Here's why the requested information isn't present in this document and what it implies for your questions:
- Acceptance Criteria & Device Performance: This document states: "Implantium Prosthetic has the same material, design, use and device characteristics as the predicate device." It concludes "that Implantium Prosthetic is safe and effective and substantially equivalent to the predicate device as described herein." This means the acceptance criterion is substantial equivalence to the predicate device (K052957), not a set of specific performance metrics measured by a new study. The performance of the new device is assumed to be equivalent to the predicate because of the shared characteristics.
Therefore, I cannot populate the table or answer the specific questions about a study demonstrating performance criteria directly from this 510(k) summary. The document does not describe such a study.
To answer your questions based on the provided text, I must state that the information is not available in the given document.
Here's a breakdown of why each point cannot be addressed:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implicit acceptance criterion is "substantial equivalence" to the predicate device (Implantium Prosthetic, Dentium Co., Ltd., K052957). Specific numerical performance criteria are not stated.
- Reported Device Performance: No specific performance metrics or results of a performance study for the device are reported. The document relies on the equivalence to the predicate device.
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Sample sized used for the test set and the data provenance: Not applicable. No test set for device performance is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.
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Adjudication method for the test set: Not applicable. No test set is mentioned.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This document does not describe an MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental implant prosthetic, not an algorithm or AI.
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The type of ground truth used: Not applicable. No performance study requiring ground truth is mentioned.
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The sample size for the training set: Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is a physical product, not an AI/ML algorithm.
§ 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.)