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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:

1. 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.

2. Sample sized used for the test set and the data provenance: Not applicable. No test set for device performance is mentioned.

3. 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.

4. Adjudication method for the test set: Not applicable. No test set is mentioned.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This document does not describe an MRMC study.

6. 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.

7. The type of ground truth used: Not applicable. No performance study requiring ground truth is mentioned.

8. The sample size for the training set: Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This device is a physical product, not an AI/ML algorithm.

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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.

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