(108 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | The MS System (Denture) is made of Ti-6Al-4V metal, which is the same material commonly used in predicate dental implants. |
| Intended Use | The MS System (Denture) is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices (denture stabilization), restoring the patient's chewing function. This aligns with the intended use of predicate devices. |
| Technological Characteristics | The surface treatment of the MS System is R.B.M (Resorbable Blasting Media). This is considered similar to other commercially available products and aligns with established technologies for dental implants. |
| Design and Function | The MS System (Denture) is substantially equivalent in design and function to the predicate devices: The Maximus™ OS Implant (K041938) and Intermezzo™ PLUS (K053354). |
| Safety - Biocompatibility | Safety tests, including biocompatibility, were performed to ensure compliance with applicable International and US regulations. (Specific results not detailed in this summary, but determined to be compliant). |
| Performance - Validation | Performance and product validations were conducted prior to release. (Specific results not detailed in this summary, but determined to be compliant). |
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.
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Image /page/0/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized circular design with the word "osstem" below it. The contact information includes the address: #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, as well as the telephone number: +82 51 850-2500, fax number: +82 51 850-4341, and website: www.osstem.com.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: October 8 , 2007
- Company and Correspondent making the submission:
| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | #507-8 Geoje3-Dong Yeonje-GuBusan, 611-804, Republic of Korea |
| - Contact : | Mr. JongHyuk Seo |
| - Device : | |
| Trade or (Proprietary) Name : | MS System (Denture) |
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant21CFR872.3640Class IIDZE |
| FEB - 4 2006 |
4. Description :
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).
The MS System (Denture) is substantially equivalent in design, function and intended use to the The Maximus TM OS Implant of BioHorizons Implant Systems, Inc. K041938 and Intermezzo TM PLUS of Mega'Gen Co., Ltd. K053354.
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Image /page/1/Picture/0 description: The image shows a logo with the word "osstem" written in lowercase letters. Above the word is a circular symbol that appears to be two overlapping or intertwined circles. The logo is simple and modern, with a focus on the circular symbol and the clean typography of the word "osstem".
5. Indication for use :
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.
6. Review :
The MS System (Denture) has similar material, indication for use, design and technological characteristics as the predicate device.
The MS System (Denture) has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
7. Conclusion :
Based on the information provided in this premarket notification, Osstem concludes that the MS System (Denture) is safe and effective and substantially equivalent to the predicate device as described herein
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Public Health Service
Image /page/2/Picture/3 description: The image shows the text "FEB - 4 2008". The text indicates a date in February of 2008. The day of the month is the 4th.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osstem Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K072959
Trade/Device Name: MS System (Denture) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 22, 2008 Received: January 22, 2008
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Kim
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clues
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized image of three circles intertwined. The text provides the company's address as #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, along with their phone number (+82 51 850-2500), fax number (+82 51 850-4341), and website (www.osstem.com).
510(k) Number K 070950
Device Name: MS System (Denture)
Indication for use : 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.
Prescription Use X (Per 21CFR801 Subpart D)
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suse Rumar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC72159
QS-QI-505-2(Rev.0)
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.