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The Ball Abutment Systems are used for implant retained mucosa-supported restorations, such as overdentures where the patient is fully edentulous in the arch to be restored. There are two types of Ball Abutment system, internal and external type, and the ball abutment technique is used on Ball Abutment System implants in the maxilla or mandible.

The abutments with the following diameters are available in sizes of 2.85mm, 3.10mm, 5.00mm, and 6.00mm. The male part for each diameter is available in gingival heights of 2.0mm, 4.0mm, and 6.0mm, and the ball head diameter is 2.25mm. There are a total of 15 different size ball abutment systems being offered by Megagen.

External type: The lower part of the Ball Abutment is composed of internal circle so that the external hex of fixture can be inserted. It can combine with screw to be fixed. The top part of the abutment is ball type, and the ball head diameter is 2.25mm, and it is designed to be able to connect with Dalbo Plus which is fixed on overdenture.

Internal type: This type of abutment is inserted and combined with fixture in order to support the overdenture. The sides of lower part of the abutment have been constructed with an 11° so that they can contact with upper part of the inner fixture. The top part of the abutment is designed as a ball type, and the ball head diameter is 2.25mm. This type of design enables to be connected with Dalbo Plus, overdenture.

The provided text describes a 510(k) premarket notification for a dental device, the "Ball Abutment System," and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and related performance metrics for the device itself.

Instead, the submission for the Ball Abutment System relies on an argument of substantial equivalence. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is a common pathway for medical device clearance in the US, particularly for Class II devices.

Therefore, many of the requested categories (acceptance criteria, sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of submission as the core of the submission is a comparison to established devices, not de novo performance testing against specific clinical endpoints.

Here's a breakdown of the information available based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The submission does not define specific performance acceptance criteria for its own device. Instead, it asserts that the device is "substantially equivalent" to predicate devices, meaning it meets the safety and effectiveness profile of those existing, cleared devices.

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

• Not Applicable. There is no "test set" in the context of a performance study described in this submission. The submission is a comparison of the new device's design, materials, and intended use to existing predicate devices.

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

• Not Applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or corresponding adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a dental implant component, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this submission.

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 a software algorithm.

7. The Type of Ground Truth Used:

• Not Applicable. The "ground truth" implicitly referred to is the established safety and effectiveness of the predicate devices through their prior clearances and market use. No new ground truth for a novel performance claim is present.

8. The Sample Size for the Training Set:

• Not Applicable. No training set for an algorithm is described.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. No training set or corresponding ground truth establishment is described.

Summary of what IS provided regarding "proof" and "acceptance":

The "study" or "proof" for this device revolves around demonstrating substantial equivalence to predicate devices already on the market.

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the Ball Abutment System must have:
  • The same intended use as the predicate devices.
  • The same technological characteristics, or if different, those differences do not raise new questions of safety or effectiveness.
  • Be as safe and effective as the predicate devices.
• Study/Proof that the device meets criteria:
  • Basis: The submission is a "510(k) premarket notification" which is explicitly to demonstrate substantial equivalence.
  • Methodology: The manufacturer states they performed "Testing and other comparisons" to establish substantial equivalence. They claim the device is "substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance" to the predicate devices (Osstem Implant Co., Ltd, Altatec GmbH - K063861, K051636).
  • Materials: The device is manufactured from Ti-6Al-4V ELI and stainless steel, stated to meet ASTM and ISO standards, which would be consistent with materials used in predicate devices.
  • Device Characteristics: The submission notes that the Ball Abutment "has the same device characteristics as the predicate device. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide."
  • Safety/Performance Validation: The document states, "The Ball Abutment has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." (However, specific data from these "validations" or "safety tests" is not included in this summary excerpt).
  • Conclusion: The manufacturer concludes that the differences between their device and the predicates "do not raise any questions regarding its safety and effectiveness" and that the device "is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent."

In essence, for this 510(k) submission, the "acceptance criteria" are the legal and regulatory thresholds for demonstrating substantial equivalence, and the "study" is the comparison and testing (referenced but not detailed) that supports this claim of equivalence.

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