Search Results

The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Denture) is a dental implant made of Ti-6Al-4V metal intended to be surgically placed in the bone of the upper or lower jaw arches,
The MS System (Denture) is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is of R.B.M (Resorbable Blasting Media).

This section describes the acceptance criteria and the study conducted to prove the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided 510(k) summary, the device is an Endosseous Dental Implant. The information supplied focuses on establishing substantial equivalence to predicate devices rather than specific quantitative performance metrics and acceptance criteria for a new type of device. Therefore, the "acceptance criteria" here are fundamentally based on demonstrating design, function, and material equivalence to the predicate devices.

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

The provided 510(k) summary does not describe a "test set" in the context of a clinical trial or a performance study involving a specific data sample size for evaluation against ground truth. Instead, the assessment for substantial equivalence relies on:

• Engineering analyses and design comparisons: Comparing the device's design, materials, and manufacturing processes to those of legally marketed predicate devices.
• Bench testing: Safety tests (including biocompatibility) and performance/product validations were mentioned. The specific sample sizes for these bench tests are not provided in this summary but would typically involve a sufficient number of units to ensure statistical confidence in the results for the tested parameters (e.g., mechanical strength, fatigue leading, biocompatibility panels).
• Data Provenance: The document explicitly states the "Company and Correspondent making the submission" is OSSTEM Implant Co., Ltd. located in #507-8 Geoje3-Dong Yeonje-Gu, Busan, 611-804, Republic of Korea. Therefore, the data provenance for the development and testing would originate from this company or its contracted testing facilities, likely in Korea. The submission is retrospective in the sense that the testing and validation were completed prior to the 510(k) filing.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective data interpretation (e.g., radiological reads, pathological assessments). For this medical device, an endosseous dental implant, the "ground truth" for demonstrating substantial equivalence is established through objective engineering principles, material science standards (e.g., ISO, ASTM), and regulatory compliance.

There is no mention of "experts" establishing a ground truth for a test set in the conventional sense of a diagnostic or prognostic study. The FDA's review process itself involves experts (e.g., engineers, scientists, clinicians within the FDA) who evaluate the submitted data against regulatory requirements and established scientific principles.

4. Adjudication Method for the Test Set

As there is no described test set involving subjective interpretation or expert reads, an adjudication method (like 2+1, 3+1) is not applicable or specified in the summary. The "adjudication" for substantial equivalence is the FDA's regulatory decision based on the submitted evidence.

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

An MRMC comparative effectiveness study is not relevant to this device, as it is a physical medical device (dental implant) and not an AI-powered diagnostic or prognostic tool intended for human readers. Therefore, no such study was conducted, and no effect size regarding AI assistance is applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is also not applicable to the MS System (Denture), as it is a physical device and not an algorithm or software. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established based on:

• International and US regulations and standards: Ensuring the device complies with established safety and performance benchmarks for dental implants (e.g., biocompatibility standards, mechanical testing standards).
• Material specifications: Verifying that the Ti-6Al-4V material meets medical-grade standards.
• Predicate device characteristics: The design, materials, and intended use of legally marketed predicate devices serve as an established "ground truth" for what constitutes a safe and effective dental implant.
• Bench test results: Objective data from mechanical, fatigue, and other performance tests.

8. The Sample Size for the Training Set

This device is a physical medical implant, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI model development. The design, development, and testing of the implant are based on engineering principles and existing scientific knowledge regarding dental implant function and biocompatibility.

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

As explained above, there is no "training set" used in the development and approval of this physical medical device. Therefore, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for manufacturing and quality control in general for such a device is established through adherence to Good Manufacturing Practices (GMP) and product specifications.

Ask a specific question about this device