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510(k) Data Aggregation
(111 days)
BHDENTAL IMPLANT SYSTEM
The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.
The provided text describes the BHdental Implant System, which is a dental implant device. For medical devices like this, "acceptance criteria" and "device performance" are typically demonstrated through compliance with recognized standards and specific performance testing, rather than through studies involving human test sets, expert ground truth, or AI comparative effectiveness as would be common for diagnostic AI software.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| FDA Guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments | "The device complies with the following standards" - Implies compliance. |
| ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants" | "A series of safety and performance testing were performed to demonstrate that the BHdental Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue..." - Implies compliance through testing. |
| ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy | "The device complies with the following standards" - Implies compliance. |
| ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications | "The device complies with the following standards" - Implies compliance. |
| ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments | "The device complies with the following standards" - Implies compliance. |
| ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry | "A series of safety and performance testing were performed... These tests include: ...biocompatibility." - Implies compliance through testing. |
| ASTM F746-04 (Reapproved 2009) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials | "A series of safety and performance testing were performed... These tests include: ..., corrosion resistance..." - Implies compliance through testing. |
| ISO 10993 -1:2003 Biological evaluation of medical devices -Part 1: Evaluation and testing | "The device complies with the following standards" - Implies compliance. |
| Specific Safety/Efficacy Areas: Fatigue, Corrosion Resistance, Biocompatibility | "A series of safety and performance testing were performed to demonstrate that the BHdental Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance... and biocompatibility." - Indicates device was tested and found compliant. |
| Specific Manufacturing Process: Sand Blasting Process | "A series of safety and performance testing were performed... These tests include: ..., sand blasting process..." - Indicates process was evaluated for safety/efficacy aspects. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this device and the provided documentation. The performance testing described is primarily mechanical, material, and biocompatibility testing, not clinical studies with human "test sets" in the diagnostic AI sense.
- Data Provenance: Not applicable. The data comes from laboratory and material testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for dental implant material and mechanical properties is established by the specifications in the standards (e.g., ISO, ASTM) and the results of laboratory tests performed by qualified technicians/engineers.
4. Adjudication method for the test set:
- Not applicable. The "test set" consists of physical devices or materials undergoing engineered tests, not clinical cases requiring adjudication.
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 relevant for diagnostic imaging interpretation or other scenarios where human readers interact with AI, which is not the case for this dental implant device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering standards and material specifications (e.g., the strength required by ISO 14801 for fatigue, the chemical composition specified in ASTM F136, the biological response deemed safe by ISO 10993). Test results are compared against these predetermined specifications.
8. The sample size for the training set:
- Not applicable. This device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no AI training set.
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