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The HC-Bios Dental Implant System 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, and to restore the patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Device Description

The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy 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, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the HC-Bios Dental Implant System, focusing on acceptance criteria and the study proving adherence:

The provided document describes a traditional 510(k) submission for a dental implant system. As such, the "study" proving the device meets acceptance criteria is primarily non-clinical testing demonstrating substantial equivalence to a predicate device. This is typical for Class II devices like dental implants. There is no mention of clinical studies involving human patients, AI components, or complex ground truth establishment for diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Adherence to recognized standards for biological evaluation of medical devices (ISO 10993 series).	"A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed... The tests were conducted in accordance with ISO 10993-10, ISO 10993-10, ISO 10993-11, ISO 10993-12." (Note: ISO 10993-10 is listed twice, likely a typo.) These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria." The material is pure titanium and titanium alloy, which are well-established biocompatible materials for dental implants. The predicate uses titanium metal and titanium alloy; the proposed device uses Grade 4 titanium and AISI 316L Stainless Steel.
Physical/Mechanical	Adherence to recognized standards for mechanical testing of dental implants (ISO 14801, ASTM F 543, ASTM F 1980). Demonstrated performance comparable to the predicate device.	"A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed... The tests were conducted in accordance with ISO 14801, ASTM F 543, and ASTM F 1980." These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria." The document states, "The result of bench testing indicates that the new device is substantially equivalent to the predicate device."
Sterilization	Adherence to recognized standards for sterilization of medical devices (ISO 11137-1).	"The tests were conducted in accordance with... ISO 11137-1." These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria."
Substantial	Similar intended use, design, technology/principles of operation, materials, and performance to the predicate device, with no new issues of safety or effectiveness raised by any differences.	The document explicitly states the "HC-Bios Dental Implant System is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the Dentium Co., Ltd Implantium which is the subject of K041368." Bench testing results support substantial equivalence. The predicate and proposed devices share identical intended use, classification, and regulatory code. While materials differ (Grade 4 Ti & AISI 316L SS vs. Ti & Ti alloy), these are all standard biocompatible materials for implants, and this difference is implicitly covered by the biocompatibility and mechanical testing. Dimensions have slightly larger ranges for the proposed device, but this is also addressed by testing.
Initial Stability	Achieve > 40 Ncm upon insertion for single surgical procedures (for Type I, II, or III bone).	This is an explicit indication for use criterion. While no specific test result is provided for this exact metric, the overall bench testing, particularly mechanical tests (ISO 14801, ASTM F 543), supports the device's ability to achieve appropriate initial stability, as it is deemed substantially equivalent for its intended use.

Note: For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is generally demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented here is to support that claim of equivalence, often by showing the proposed device meets relevant performance standards and has similar characteristics to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a number of devices or cases. The "test set" refers to the samples of the HC-Bios Dental Implant System that underwent non-clinical (in vitro and in vivo preclinical) testing. These are typically representative samples of the manufactured device. The common practice for such testing involves a sufficient number of samples to achieve statistical significance or meet the requirements of the specific test standard (e.g., a certain number of fatigue test samples).
Data Provenance: The tests were "in vitro and in vivo preclinical" and "bench testing." This refers to laboratory and possibly animal testing. The location of the testing laboratories is not specified, but the manufacturer is based in Taiwan. The data is entirely retrospective relative to the 510(k) submission, meaning the tests were completed before the submission. There is no indication of human patient data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission.

No Human Experts for Ground Truth: Since this is non-clinical testing of a physical medical device (dental implant), there is no 'ground truth' established by a panel of human experts in the way one would for an AI diagnostic algorithm. The "truth" or "correctness" of the device's performance is determined by its adherence to established engineering, material, and biocompatibility standards (e.g., ISO, ASTM).
Qualifications: The tests would have been performed by engineers, materials scientists, and toxicologists familiar with the respective ISO/ASTM standards and Good Laboratory Practices (GLP), but they are not acting as "experts establishing ground truth" in a diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical device testing described in this 510(k). Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers when establishing ground truth, typically in imaging or clinical diagnostic studies. For physical device testing, the results are objectively measured against predefined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable.

No AI Component: The HC-Bios Dental Implant System is a physical dental implant. There is no mention of any AI component, software, or diagnostic capabilities that would involve human readers or AI assistance.
No MRMC Study: Consequently, an MRMC comparative effectiveness study, which is typically performed for AI-powered diagnostic devices, was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, there is no AI algorithm or software product in this submission. This is a physical medical device.

7. The Type of Ground Truth Used

For this device and submission type, the "ground truth" is defined by:

Established Industry Standards: ISO 10993 (biocompatibility), ISO 14801 (mechanical testing for dental implants), ASTM F 543, ASTM F 1980, and ISO 11137-1 (sterilization).
Predicate Device Performance: The performance characteristics and safety profile of the legally marketed Dentium Co., Ltd Implantium (K041368). The "ground truth" for substantial equivalence is that the proposed device performs comparably to this predicate given its intended use.
Material Properties: The established safety and performance characteristics of Grade 4 titanium and AISI 316L Stainless Steel in medical applications.

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning or AI component to this device, and therefore no "training set." The device is a physical implant, not a data-driven model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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