(321 days)
MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant. The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment. The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.
The provided text is a 510(k) Summary for the MegaGen Implant Co., Ltd.'s Healing Abutment and Cover Screw. This document is a regulatory submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not a study reporting on specific acceptance criteria and performance data in the traditional sense of a clinical trial or performance study against pre-defined metrics.
Therefore, the information required for topics like acceptance criteria, reported device performance (with quantifiable metrics), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not explicitly present or applicable in the provided regulatory summary.
Here's an analysis of what can be extracted and what is explicitly not available based on your request:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new device is as safe and effective as a device already on the market. It does not typically present a table of quantitative acceptance criteria and then report the device's performance against those specific criteria with numerical results.
Instead, the document details physical and material similarities to predicate devices and states that non-clinical testing data "support demonstrating substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated with numerical values. For the "Precision Fit Test," it mentions that "the test was conducted by selecting randomly among the subject devices in each Implant System." It does not specify the number of devices tested.
- Data provenance: Not specified. The non-clinical tests mention adherence to international standards (ISO, ASTM, USP) but do not detail the origin of the test data (e.g., country where testing was conducted, whether it was retrospective or prospective).
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)
This information is not applicable/not provided. The document is about physical dental devices (healing abutments and cover screws) and their material/mechanical properties, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The non-clinical tests relate to biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, and precision fit, which are typically assessed through laboratory tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reasons as #3. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.
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
This information is not applicable/not provided. This document pertains to physical dental devices, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This document pertains to physical dental devices, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of the device's non-clinical testing. The "ground truth" for non-clinical tests (like biocompatibility, sterility, material properties) is typically defined by reference standards (e.g., ISO, ASTM specifications, USP limits for endotoxin) rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as #8.
In summary, the provided document is a regulatory submission (510(k) Summary) demonstrating substantial equivalence for physical dental devices. It focuses on comparing the new device to existing predicate devices based on design, materials, manufacturing processes, and non-clinical performance (biocompatibility, sterility, etc.), rather than reporting on a clinical or performance study with detailed acceptance criteria, quantitative performance metrics, and specific study designs typical for AI or diagnostic devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)