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The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

The UNIdental Symphony Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. Symphony 1 Fixture is Bone level, and Symphony 2 Fixture is Tissue level.

Symphony 1 Fixture is a taper shape that gradually decreases the outer diameter of the lower part from the upper part.

And It is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. It is a structure that can perform a tapping function at the same time without a separate tap. It couples up with the abutment and its hexagon shape.

Symphony 2 Fixture is a structure with a round shape at the end. It couples up with the abutment and its octagon shape. The area that touches the patient's gums is pure titanium surface.

The upper structure of the abutments support prosthetics such as artificial teeth to restore patient's total mouth function.

The provided text details the 510(k) summary for the UNIdental Symphony Implant System, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and performance data in the traditional sense of a clinical study for an AI/CADe device.

This document describes a dental implant system, which is a physical medical device, not a software or AI-driven diagnostic device. Therefore, the questions related to "AI vs without AI assistance," "standalone algorithm performance," "number of experts for ground truth," "adjudication methods," and "training/test set size and provenance" are not applicable to this type of medical device submission.

The "acceptance criteria" for a dental implant system of this nature typically revolve around meeting established engineering standards and demonstrating comparable performance (e.g., mechanical strength, biocompatibility, sterilization efficacy) to already cleared predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.

Here's an interpretation of the provided information based on the typical requirements for a physical medical device:

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

The document doesn't explicitly list "acceptance criteria" in a numerical table format for each performance metric, as one might see for an AI device's sensitivity/specificity. Instead, the acceptance is implicitly demonstrated by showing substantial equivalence to existing predicate devices through various non-clinical tests and material comparisons. The "performance" is implicitly deemed acceptable if it meets the established standards that the predicates have also met.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI model. For the non-clinical physical testing (fatigue, biocompatibility, sterilization, etc.), the sample sizes would be determined by the specific ISO/ASTM standards referenced. These standards usually specify the number of samples required for robust statistical analysis to demonstrate compliance. This is not a "data provenance" like for AI models, but rather the laboratory conditions under which the physical tests were conducted. The document doesn't specify the country of origin for the non-clinical testing data, but the submitter is UNIdental Co., Ltd. in Korea. This is inherently a prospective testing process for the device being submitted.

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

• Not Applicable. This is a physical dental implant, not a diagnostic AI device requiring expert consensus for ground truth.

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

• Not Applicable. See point 3.

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-assisted diagnostic device.

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

• Not Applicable. This is a physical dental implant, not an algorithm.

7. The type of ground truth used:

• For physical devices, "ground truth" is established through adherence to recognized national and international consensus standards (e.g., ISO, ASTM) for material properties testing, mechanical performance, biocompatibility, and sterilization. For example, the "ground truth" for fatigue resistance is meeting the load cycles and fracture limits defined by ISO 14801. Biocompatibility "ground truth" is meeting the criteria of ISO 10993 series.

8. The sample size for the training set:

• Not Applicable. This is a physical device submission; there is no "training set" in the context of an AI model.

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

• Not Applicable. See point 8.

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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.

Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.

The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.

The provided document is a 510(k) premarket notification for "Healing Abutments and Cover Screws." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of rigorous, large-scale studies typically associated with AI/ML-based medical devices or novel technologies.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission. This document describes a change in the sterilization method for existing devices, not a new device with performance metrics that require extensive clinical validation studies beyond sterilization and biocompatibility.

Here's an analysis based on the information available in the document:

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

For a 510(k) submission concerning a change in sterilization method for mechanical components like healing abutments and cover screws, the "acceptance criteria" revolve around demonstrating that the new sterilization method achieves the required sterility assurance level and does not adversely affect the device's material properties or function, maintaining its substantial equivalence to the predicate.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance data typical for AI/ML devices. The "tests" here are primarily engineering and laboratory validations:
  • Sterilization Validation: ISO 11137 standards define the number of units and replicates required for sterility testing (e.g., bioburden determination, dose mapping, sterility testing), which are often small, specific lots. This is standard laboratory validation, not a patient-based test set.
  • Aging Studies: ASTM F1980 dictates sample sizes for accelerated aging, again, laboratory testing of physical samples.
  • Biocompatibility: Relies on a prior submission (K041368) which presumably included its own biocompatibility testing. No new "sample size" for a clinical test set is mentioned for biocompatibility here.
• Data Provenance: The studies are laboratory-based ("Non-clinical testing data"). The manufacturer is located in the Republic of Korea (Dentium Co., Ltd.). The data would be derived from their internal validation processes. It is neither retrospective nor prospective in the sense of patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This submission does not involve image interpretation or clinical diagnosis where expert ground truth would be established. The "ground truth" for sterilization is a defined SAL, verified by microbiological and physical testing per ISO standards. The "ground truth" for material properties is based on ASTM standards and prior biocompatibility data.

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

• Not Applicable. As there is no clinical "test set" based on human interpretation or an AI algorithm's output requiring adjudication, this concept does not apply.

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 traditional medical device (dental implants and accessories), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission is based on:
  • Standardized Sterility Assurance: Achieving a defined SAL of 10^-6, verified through validated sterilization processes and testing compliant with ISO 11137-1 and ISO 11137-2.
  • Material Standards: Biocompatibility established against Ti-6Al-4V ELI (ASTM F136) as per regulations and previous submissions.
  • Engineering Performance: Shelf-life demonstrated through accelerated and real-time aging studies per ASTM F1980.
  • Substantial Equivalence: Demonstrated by comparing engineering specifications and intended use against legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This involved physical device manufacturing and validation, not machine learning model training.

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

• Not Applicable. (See point 8)

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