(194 days)
The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.
The JNE Implant System is an endosseous dental implant made of Ti-6Al-4V ELI alloy and consists of several components. Geometrically, the fixture is screw-type. An abutment is connected to the fixture through a tapered-joint. Fixtures are treated with sandblast and acid etching using scanning electron microscopy (SEM).
The provided document is a 510(k) summary for the "GC JNE Implant System," a medical device cleared by the FDA. It declares substantial equivalence to previously cleared predicate devices. Unfortunately, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets those criteria with quantitative performance metrics. The language used is general and refers to comparative performance.
Therefore, I cannot fulfill all the requirements of your request as the information is not present in the provided text. However, I will answer what I can based on the available information, noting where data is absent.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The document states: "Several tests were performed on the device. All tests demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices."
This is a general statement rather than specific, quantitative acceptance criteria and reported device performance. For medical devices, acceptance criteria are typically measurable thresholds for performance metrics (e.g., specific fatigue life in cycles, fracture strength in Newtons, precise biocompatibility test results, etc.). The document does not provide these details.
| Acceptance Criteria (Not Explicitly Stated / Inferred from "Substantially Equivalent") | Reported Device Performance (Not Explicitly Stated / Inferred) |
|---|---|
| Mechanical Performance: |
- Comparable fatigue life to predicate devices.
- Comparable fracture strength to predicate devices.
- Comparable screw loosening/loosening torque.
- Comparable biological performance (biocompatibility). | Mechanical Performance:
- Device "performs comparably to and is substantially equivalent to the predicate devices" in terms of mechanical properties and function.
- Passes "several tests" demonstrating safety and effectiveness. |
| Material Composition: - Ti-6Al-4V ELI alloy. | - Made of Ti-6Al-4V ELI alloy, same as specified. |
| Surface Treatment: - Sandblast and acid etching (using SEM for verification). | - Fixtures are treated with sandblast and acid etching, with SEM verification. |
| Intended Use: - Functionally equivalent for supporting prosthetic devices to restore chewing function. | - Intended use is consistent with predicate devices for supporting prosthetic devices to restore chewing function. |
Study Details
Given the context of a 510(k) submission, the "study" referred to is a series of tests to demonstrate substantial equivalence to predicate devices, not an effectiveness study in the clinical trial sense. The document does not detail specific study methodologies, sample sizes, or ground truth establishment.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. "Several tests were performed" does not provide quantitative sample size.
- Data Provenance: Not specified. The manufacturer is "GC CORPORATION, TOKYO 174 - 8585 JAPAN," and the sterilization facility is in Japan. This suggests testing might have been done in Japan, but it is not explicitly stated. The document doesn't indicate if the data is retrospective or prospective.
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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 provided. For this type of device (dental implant), "ground truth" typically refers to objective engineering measurements (e.g., fatigue cycles, material composition analysis, surface morphology) rather than expert interpretation of images or clinical outcomes. The document does not mention any expert panels or their qualifications for establishing ground truth for these engineering performance tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. Adjudication methods like 2+1 are relevant for studies involving human interpretation or clinical endpoints where there might be disagreement. This document describes engineering performance testing, which is objectively measured.
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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 not an AI-assisted device, nor is it a diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm or AI. Standalone performance for an algorithm is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Measurements/Industry Standards: The "ground truth" would be established by objective measurements against recognized engineering standards for dental implants (e.g., ISO standards for dental implants, ASTM standards for materials testing) and comparison to the performance of the predicate devices. This might include:
- Mechanical testing results (fatigue, fracture resistance, torque out).
- Material characterization (chemical composition, surface roughness, morphology).
- Biocompatibility assays.
- The document does not specify the exact standards or specific measurement criteria used.
- Engineering Measurements/Industry Standards: The "ground truth" would be established by objective measurements against recognized engineering standards for dental implants (e.g., ISO standards for dental implants, ASTM standards for materials testing) and comparison to the performance of the predicate devices. This might include:
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The sample size for the training set:
- Not applicable. This phrase typically refers to the data used to train a machine learning algorithm. This device is a physical dental implant, not an AI/ML product.
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How the ground truth for the training set was established:
- Not applicable. As above, this concept refers to AI/ML development, which is not relevant to this device.
In summary, the provided document is a regulatory filing for substantial equivalence. It confirms that the device was tested and found to perform comparably to predicate devices, thus demonstrating safety and effectiveness for its intended use. However, it does not offer the granular detail of specific acceptance criteria, quantitative performance metrics from a defined study, or the methodologies for establishing ground truth as one might expect from a full clinical trial report or a detailed engineering validation protocol.
§ 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.