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510(k) Data Aggregation
(118 days)
Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.
The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506.
The dimension ranges of the subject device are below:
| No. | Device Name | Dimension |
|---|---|---|
| 1 | Angled Abutment | Ø 4.5, 5.5 (D) x 8 mm (Post Height) x 17° |
| 2 | Abutment Screw (Cleared in K213506) | Ø 2.35 (D) x 8.4 mm (L) |
Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.
The Angled Abutment is compatible with the following implant systems.
| Manufacturer | 510(k) No. | Implant system compatibility | Dimension |
|---|---|---|---|
| ARUM DENTISTRY Co., Ltd. | K213506 | NB 1 SA Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| ARUM DENTISTRY Co., Ltd. | K230725 | NB Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
The provided text is an FDA 510(k) summary for a dental device called an "Angled Abutment." It does not contain any information about an AI/ML powered device, a study involving human readers, or any other data that would allow for the detailed description requested in the prompt regarding acceptance criteria and a study to prove performance for an AI/ML product.
The document primarily focuses on demonstrating the substantial equivalence of the "Angled Abutment" to previously cleared predicate devices based on its materials, design, intended use, and mechanical performance testing (specifically static and fatigue testing according to ISO 14801).
Therefore, I cannot fulfill your request for information related to:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for training set or how its ground truth was established for an AI/ML device.
The document is solely about a physical dental implant component and its mechanical and material properties. The 'Performance Data' section only mentions biocompatibility, sterilization validation, mechanical performance testing (ISO 14801), and MR environment condition assessment – none of which involve AI/ML.
Ask a specific question about this device
(91 days)
The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.
The ITI angled abutment is placed into the dental implant to provide support for the prosthetic restoration. The subject device of this 510(k) is a modification of the 171 Angled Abutment, previously cleared by FDA under K941393 for angulation correction in the saggital plane of the anterior maxilla. The intended use of the modified angled abutment is for angulation correction in all areas of the oral cavily.
The modified angled abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.
The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the 171 implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is also composed of Grade 4 titanium. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.
The document provided is a 510(k) summary for a dental abutment, not a study reporting on the performance of an AI/ML powered device. As such, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML system.
The document describes the ITI Angled Abutment and compares its features to other legally marketed predicate devices. It clearly outlines the intended use, design, and composition of the device. However, it does not mention any acceptance criteria in the context of device performance metrics or any study that would typically be conducted for an AI/ML powered medical device (e.g., a standalone performance study, MRMC study, or details about training and test sets).
Therefore, I cannot provide the requested table and information as it is not present in the provided text.
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