(118 days)
This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.
The Neodent Graft Screw (Graft Screw) is an implantable device used for fixation of bone blocks in dental surgery. The design of the Graft Screw includes a tapered, self-drilling tip and a cruciform head. The Graft Screw is available in various lengths, thread diameters and head diameters.
Here's an analysis of the provided 510(k) summary regarding the Neodent Graft Screw, focusing on acceptance criteria and study details:
This submission (K103084) is for a dental device (Neodent Graft Screw) that is a Class II device and received a Substantial Equivalence (SE) determination from the FDA. For such devices, the primary "acceptance criteria" and "study" are typically demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. Clinical studies are often not required for this type of device unless there are novel features or concerns that cannot be addressed by non-clinical means.
Based on the provided document, the "acceptance criteria" and "study" revolve around demonstrating the device's technological characteristics are substantially equivalent to predicate devices.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Evidence from Study |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and commonly used for implantable devices. | The device is made of "biocompatible alloys commonly used for implantable devices." (Implicitly, these meet established biocompatibility standards, likely through material specification and engineering review.) |
| Physical Dimensions | Device encompasses a similar range of physical dimensions (length, thread diameter, head diameter) to predicates. | "The subject and predicate devices encompass the same range of physical dimensions, including thread form, thread pitch, diameters and lengths." (Confirmed through engineering design review.) |
| Functional Characteristics | Device exhibits similar functional characteristics (e.g., self-drilling, self-tapping). | "Each is described as self-drilling, self-tapping and/or self-cutting." (Confirmed through engineering design review, implying the Neodent Graft Screw possesses these characteristics similar to predicates.) |
| Intended Use | Device shares the same intended use as predicate devices. | "This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only." This matches the implicitly acceptable intended use of the predicate devices for achieving substantial equivalence. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This submission relies on non-clinical testing which consisted of "material specification and engineering design review." There was no "test set" in the sense of patient data or a specific cohort of devices being critically evaluated against a ground truth from a study. Instead, the device's specifications and design were compared against established standards, regulatory requirements, and the characteristics of predicate devices.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from the manufacturer's own engineering and material specifications, and comparison data for predicate devices.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As noted above, there was no "test set" requiring expert-established ground truth in a clinical or imaging context. The evaluation was based on engineering and material specifications review, implying the expertise of the manufacturer's R&D team and the FDA's reviewers.
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Adjudication Method for the Test Set:
- Not applicable. There was no clinical imagery or patient data requiring an adjudication method.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING: Not applicable to this device."
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- No. This device is a physical implantable medical device, not an AI/algorithm-driven one.
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The Type of Ground Truth Used:
- The "ground truth" for this type of 510(k) submission, focused on substantial equivalence through non-clinical testing, is primarily:
- Material specifications: Conforming to recognized material standards for biocompatibility and mechanical properties.
- Engineering design parameters: Adherence to established design principles for dental implants/screws.
- Performance characteristics of predicate devices: The "truth" of what constitutes an acceptable dental graft screw is established by the legally marketed predicate devices.
- The "ground truth" for this type of 510(k) submission, focused on substantial equivalence through non-clinical testing, is primarily:
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Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of an AI/machine learning model.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. There was no "training set."
Summary of the FDA's Review for K103084:
The FDA determined that the Neodent Graft Screw is substantially equivalent to its predicate devices based on the information provided. This determination was made because the "design, materials and functional characteristics of the Neodent Graft Screw are substantially the same as those in the predicate devices." The non-clinical testing consisted of "material specification and engineering design review," which was deemed sufficient to establish substantial equivalence without the need for clinical testing.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.