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· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

· Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading

Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

This appears to be a 510(k) summary for a dental implant, "Bone Chamber Implant," seeking substantial equivalence to existing predicate devices. Consequently, the document describes non-clinical bench testing to demonstrate equivalence, rather than clinical trials with human subjects. Therefore, many of the requested items related to clinical study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) will not be applicable and the acceptance criteria will be based on engineering performance standards.

Here's an analysis based on the provided text:

Key Takeaway: The device's acceptance criteria and proven performance are primarily based on demonstrating mechanical equivalence to predicate devices through bench testing, specifically fatigue testing, following ISO and FDA guidance. No clinical studies were performed.

Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are the ability of the device to meet the specified performance standards in the referenced guidance documents and ISO standards, and to perform comparably to the predicate devices. The "reported device performance" is that the device met these criteria.

Study Details (Non-Clinical Bench Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical count for each test (e.g., number of implants tested for fatigue). The document states "the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'." For regulatory submissions like 510(k), compliance with the standards' requirements for sample size is assumed.
   • Data Provenance: The studies were non-clinical bench tests, not involving human data. The company is MegaGen Implant Co., Ltd., located in Daegu, South Korea. The testing was conducted internally or by a contracted lab to meet international and FDA standards.

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

   • Not Applicable. This was non-clinical bench testing of physical properties, not an assessment requiring expert clinical judgment or ground truth determination (like image interpretation). The "ground truth" here is the physical measurement against a standard.

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

   • Not Applicable. This refers to clinical adjudication, which is not relevant for bench testing.

4. 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:

   • No. No MRMC study was done, as this is a physical dental implant, not an AI software or imaging device that human readers would interpret.

5. 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.

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

   • Engineering Standards and Specifications. The "ground truth" for non-clinical testing refers to the established requirements and thresholds defined by international standards (e.g., ISO 14801) and FDA guidance documents for medical device performance (e.g., fatigue strength, biocompatibility, sterilization efficacy). The device's performance is compared against these quantitative and qualitative criteria.

7. The sample size for the training set:

   • Not Applicable. This refers to the training of an algorithm or AI model. This device is a physical product.

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

   • Not Applicable. As above, this refers to algorithm training.

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