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Anker II Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker II Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter (≥03.3mm) and short (length ≤ 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the maxillary lateral incisor or the mandibular central incisors.

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This document does not contain the information requested for acceptance criteria and the study proving a device meets those criteria.

The provided text is a 510(k) Premarket Notification from the FDA for a dental implant system (Anker II Dental Implant System). It states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

This type of FDA letter focuses on:

• Substantial Equivalence determination: This means the FDA believes the new device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) application.
• Regulatory information: It outlines the relevant regulations (e.g., general controls, manufacturing practices, labeling) that the device manufacturer must comply with.
• Indications for Use: It explicitly states what the device is intended for.

What is missing from this document for your request:

• Acceptance Criteria Table: There is no table defining specific performance metrics (e.g., accuracy, precision, strength, biocompatibility thresholds) that the device must meet.
• Reported Device Performance: No actual performance data from a study (e.g., tensile strength, fatigue testing results, clinical outcome data) is provided. The letter only refers to the device being "substantially equivalent."
• Study Design Information: There is no mention of:
  • Sample sizes for test sets or training sets.
  • Data provenance (country, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC studies, effect sizes, or even if an AI component is involved (this is a traditional dental implant, not an AI device).
  • Standalone performance.
  • Type of ground truth used or how it was established.

In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report or study describing performance against specific acceptance criteria.

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Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter (Ø 3.3mm) and short (length

Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.

Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.

Anker Dental Implant System ST and AT series consist of fixture, abutments (healing cap, solid abutment, cementable abutment, angled abutment, temporary restoration screw, screw retained abutment, locator abutment) and closure screw.

Fixtures are made of pure titanium (grade IV) and there surface was treated by SLA (Sand-blasted, Large grit. Acid-etched) process. Diameters of fixtures are including 3.3 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Cover screw, closure screw and most abutments are made of titanium alloy. Temporary abutment and convertible temporary cylinder (SB-III series) are made of SUS316L stainless steel instead of titanium alloy. All products are sterilized as finished products.

The provided text is a 510(k) summary for the Anker Dental Implant System, a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a novel AI/software medical device might.

Therefore, the information requested in your prompt (especially points 1-7, and 9 for a training set) is not directly applicable to this document. This submission does not describe an AI/software device with performance metrics like sensitivity, specificity, or reader improvement. It describes a physical dental implant system and relies on non-clinical testing to demonstrate that it meets established safety and performance standards by being similar to already approved devices.

Here's a breakdown of what can be extracted and why other parts cannot, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the AI/software sense. This document does not define quantitative performance metrics like accuracy, sensitivity, or specificity with specific acceptance thresholds for the dental implant system as a whole in the way an AI diagnostic tool would.
• Instead, acceptance is demonstrated by meeting harmonized standards for mechanical and biocompatibility testing. The "reported device performance" is that it passed these tests. The table on page 8 lists the testing items and standards referenced, implying that meeting these standards is the "acceptance criteria" for those specific aspects.
  • Compressive forces and fatigue tests: ISO14801 (Likely relates to mechanical strength and durability under chewing forces)
  • Compatibility test of dental implant/abutment interface: N/A (Indicates no specific standard, but testing was performed)
  • Corrosion test: ASTM G3-89
  • Residual of Acidic Substances Test: ISO10993-12 (Biocompatibility, specifically related to the SLA surface treatment)
  • Biocompatibility tests: ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10, ISO10993-11, Pharmacopeia US, OECD guideline #473, OECD guideline #474 (Cover various aspects like genotoxicity, cytotoxicity, irritation, sensitization, systemic toxicity)
  • Sterilization validation of GAMMA irradiation: ISO11137-1
  • Shelf life Validation: ASTM F88/F88M-09, ASTM F1140-07, ASTM F1929-98, ISO11737-2 (Relates to package integrity and sterility maintenance over time)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable in the AI/software sense. There isn't a "test set" of patient data in the context of an AI algorithm. The testing involves physical samples of the dental implants. The document does not specify the number of individual implant units tested for each non-clinical test (e.g., how many implants were subjected to fatigue testing).
• Data provenance: The tests are likely performed by the manufacturer or accredited labs compliant with the referenced standards. The manufacturer is Alliance Global Technology Co., Ltd. from Taiwan.

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

• Not applicable. There is no "ground truth" establishment by experts in this context as would be done for an AI diagnostic algorithm. The "ground truth" for these physical tests is adherence to the scientific principles and methodologies outlined in the referenced ISO and ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This concept relates to expert review of medical images or data for AI algorithm validation. For physical device testing, adherence to a standard's protocol and acceptance criteria is the assessment method.

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 physical dental implant, not an AI software. No human reader study with or without AI assistance was performed.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the typical AI sense. For this device, the "ground truth" is defined by the technical specifications and performance requirements derived from harmonized standards (e.g., ISO for mechanical properties, ASTM for corrosion, ISO 10993 for biocompatibility). Passing these tests constitutes meeting the "ground truth" of safety and performance for a dental implant.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" as it's not an AI/machine learning model.

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

• Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device (dental implants), not an AI/software medical device. Therefore, the questions related to AI/software performance metrics, ground truth establishment by experts, and training/test set methodologies are not relevant and cannot be answered from this text. The "study" that proves the device meets "acceptance criteria" here refers to the non-clinical testing performed according to recognized international standards, demonstrating equivalence to predicate devices.

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