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ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.

Customized Abutments are compatible with the implant systems listed in the Compatibility Table:

All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).

Patient-Specific Abutment is compatible with following Implant Systems:

Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.

Patient-specific abutment design parameters:

The provided text describes the 510(k) submission for ARUM DENTISTRY Co., Ltd.'s "Customized Abutment." This is a Class II medical device (dental implant abutment). The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for FDA clearance.

Here's a breakdown of the requested information, based on the provided text. It's important to note that many of the typical "acceptance criteria" and "study proves that the device meets the acceptance criteria" details for AI/ML devices, such as those related to accuracy, sensitivity, specificity, or reader studies, are not applicable to this type of device. This is a physical, custom-fabricated medical device (dental abutment), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the "acceptance criteria" here refer to performance testing (mechanical, biocompatibility, sterilization) to ensure the device is safe and effective and substantially equivalent to a predicate. The study that proves it meets criteria is the testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of abutments tested for mechanical performance. It refers to "worst-case constructs" for each compatible implant line. This is typical for mechanical testing where a representative "worst-case" configuration is tested to demonstrate the device's limits.
• Data Provenance: The testing data is derived from non-clinical performance tests (mechanical testing, sterilization validation, biocompatibility) of the device and its predicate. The origin of the raw data (e.g., specific lab, country) is not detailed, but it is implied to be internal or from a contract testing lab as part of the manufacturer's quality system. It is prospective for the specific tests performed to support this submission.

3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable to this type of medical device submission. Ground truth (in the AI/ML sense) is not established by human experts for mechanical/biocompatibility testing. The "ground truth" for proving the device meets acceptance criteria relies on the results of standardized engineering and biological tests conducted according to recognized standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

• Not applicable. There is no human adjudication process involved in interpreting the results of mechanical, biocompatibility, or sterilization tests for this device. The results are compared directly to pre-defined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This is a physical, custom-fabricated dental device, so such a study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is not an algorithm. Performance evaluation for this device is based on physical and material properties, not algorithmic output.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective, standardized test methods (e.g., stress-strain measurements for mechanical testing, biological assays for biocompatibility, sterility indicator results for sterilization). It is based on engineering and scientific standards rather than expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML or software device that undergoes "training." Its design and manufacturing are based on established engineering principles for dental abutments.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" for this type of device. The "ground truth" for its development and validation relies on adherence to design specifications, material standards, and validated manufacturing processes.

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