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 (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.

The MS System is a dental implant made of Ti-6Al-4V metal. The MS System 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 R.B.M (Resorbable Blasting Media).

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested.

The document is a 510(k) Summary for a dental implant system (MS System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and a study to meet them.

Here's a breakdown of what is and is not in the provided text:

What is present:

• Device Name: MS System Dental Implant
• Intended Use: The text describes the intended use for two versions: MS System (Denture) and MS System (Narrow Ridge).
• Material: Ti-6Al-4V metal.
• Surface Treatment: R.B.M (Resorbable Blasting Media).
• Biocompatibility: Mentions biocompatibility tests were performed.
• Predicate Devices: K072959 (MS System (Denture)), K080594 (MS System (Narrow Ridge)), and K080129 (Secure Implant System).

What is NOT present in the provided text:

• A table of acceptance criteria and reported device performance: This document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations" and that the "MS System has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific quantitative acceptance criteria or the actual performance results against those criteria.
• Sample size used for the test set and data provenance: No information about a specific test set, its size, or where the data came from (country, retrospective/prospective).
• Number of experts and qualifications for ground truth: No mention of experts or their role in establishing ground truth for any test.
• Adjudication method for the test set: Not applicable as no test set with expert ground truth is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study would compare human reader performance with and without AI. Since the device is a dental implant, not an AI diagnostic tool, an MRMC study is not relevant and not mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
• Type of ground truth used: Not applicable as no specific performance study with ground truth is described.
• Sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The document concludes that the MS System is "safe and effective and substantially equivalent to the predicate device." This substantial equivalence is based on similar material, indication for use, design, and technological characteristics, as well as general safety and biocompatibility tests, but not a detailed performance study against specific acceptance criteria as you would typically see for a new diagnostic device or AI algorithm.

Ask a specific question about this device

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) are intended for single use only and not for immediate loading.

The MS System (Narrow Ridge) is a dental implant made of Ti-6Al-4V metal. The MS System (Narrow Ridge) 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 (Narrow Ridge) is of R.B.M (Resorbable Blasting Media).

The provided document, K080594, is a 510(k) summary for the OSSTEM Implant Co., Ltd. MS System (Narrow Ridge) dental implant. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive validation studies as typically seen for novel medical devices.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes for test and training sets, expert qualifications, and adjudication methods are not available in this summary. The document focuses on regulatory compliance and equivalence to existing devices.

However, based on the information provided, here's what can be inferred or explicitly stated:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this revolve around demonstrating substantial equivalence to predicate devices in terms of intended use, technology, claims, material composition, and performance characteristics. The primary performance characteristic alluded to is the safety and effectiveness for its intended use.

Study Details:

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

   • Not explicitly stated. The document mentions "safety, performance, and product validations prior to release" and "biocompatibility tests," but does not provide details on sample sizes for these tests, nor whether they involved human subjects or specific implant models in a "test set" context for performance evaluation against a ground truth. Given it's a 510(k) for a device with predicate, the focus would be on bench testing and material characterization rather than large-scale clinical trials.
   • Data Provenance: The company is OSSTEM Implant Co., Ltd. from Busan, Republic of Korea. The testing would likely have been conducted in facilities in the Republic of Korea or by contracted labs. The document does not specify if any clinical data (retrospective or prospective) was used for performance claims, rather it emphasizes bench testing and material data.

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

   • Not applicable/Not explicitly stated. For this type of 510(k) submission, "ground truth" as it relates to expert consensus on clinical findings (e.g., in an AI diagnostic study) is not relevant. The "ground truth" for a dental implant would be the material specifications, mechanical properties, biocompatibility standards, and successful long-term osseointegration and function (which is typically demonstrated through predicate devices and general clinical experience rather than a specific "ground truth" panel for a single submission).

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

   • Not applicable/Not explicitly stated. This concept is typically relevant for studies where human expert disagreement on interpretation or diagnosis needs resolution (e.g., in image-based diagnostic AI). It does not apply to the type of safety and performance testing described for a dental implant in a 510(k) submission.

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. This is a hardware medical device (dental implant), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

   • No. This question is specific to AI algorithms and does not apply to a dental implant device.

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

   • The "ground truth" for this device would be based on material science standards, mechanical testing standards, biocompatibility standards (e.g., ISO/ASTM), and established clinical performance of predicate devices. The document refers to "safety tests including biocompatibility" and "performance, and product validations," which align with these types of objective, measurable ground truths, rather than subjective expert consensus or diagnostic outcomes directly from patients in the context of this submission. Outcomes data from clinical studies are generally not required for 510(k) applications demonstrating substantial equivalence.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. "Training set" refers to data used to train machine learning models. As this is a hardware device submission, no AI training set would be relevant.

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

   • Not applicable. As no training set is relevant, this question is not applicable.

Ask a specific question about this device

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

The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

The MS system (Provisional) is a dental implant system made of titanium metal intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to seve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. It has a screw-formed one piece of fixture and abutment made of Titanium Alloy Ti-6AL-4V (ASTM F 136) ELI with diameter 1.8, 2.5mm and length 10, 13, 15mm It has machined surface, and is supplied sterile.

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) summary for a dental implant system (MS system Provisional) and primarily focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, contra-indications, and confirms that safety and performance validations were conducted.

However, it does not include:

• Specific acceptance criteria: There is no table or explicit listing of performance metrics and their target values.
• Reported device performance: While it states "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations," it does not provide the results of these tests or any quantitative performance data.
• Details about the study that proves the device meets acceptance criteria: There is no description of a clinical or technical study, its methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance: These are not applicable as the device is a physical dental implant, not an AI or imaging diagnostic tool.
• Sample sizes for test or training sets, or how ground truth was established for these datasets.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about the study, sample sizes, experts, adjudication, or ground truth. The document confirms that "extensive safety, performance, and product validations" were done and "appropriate safeguards have been incorporated," but it does not elaborate on the specifics of these validations or present data.

Ask a specific question about this device