(184 days)
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.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| 1. Substantial Equivalence to Predicate Devices: Device must demonstrate similar material, indication for use, design, and technological characteristics to legally marketed predicate devices. | The MS System (Narrow Ridge) is described as "substantially equivalent in design, function and intended use" to the Zimmer One-Piece Implants (K071235), NobelDirect® 3.0 (K070857), and MS System (Denture) (K072959). It has "similar material, indication for use, design and technological characteristics as the predicate device." The material is Ti-6Al-4V metal, and the surface treatment is R.B.M (Resorbable Blasting Media), which is implied to be similar or equivalent to the predicate devices. |
| 2. Safety and Effectiveness: The device must be safe and effective for its indicated use. | "The MS System (Narrow Ridge) 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." The conclusion states, "Osstem concludes that the MS System (Narrow Ridge) is safe and effective and substantially equivalent to the predicate device as described herein." |
| 3. Compliance with Applicable Regulations: Device must comply with relevant international and US regulations. | "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." |
| 4. Indication for Use: The device performs as intended for its specified indication. | Intended to be used "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." The performance is implied to meet this indication through equivalence to predicates. |
Study Details:
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable. As no training set is relevant, this question is not applicable.
§ 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.