(111 days)
The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.
The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm. The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a. The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies.
It is important to note that the provided document is a 510(k) premarket notification for a medical device (MEDICON IMF-Orion Screws). For such devices, particularly those claiming substantial equivalence, the focus is often on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, rather than establishing new acceptance criteria through novel clinical studies with specific performance metrics akin to diagnostic AI.
The document primarily relies on comparisons to predicate devices and literature references rather than reporting specific performance metrics from a dedicated study against pre-defined acceptance criteria.
Acceptance Criteria and Study Details for MEDICON IMF-Orion Screws
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" are implied by the substantial equivalence criteria to predicate devices and the favorable safety and effectiveness profile reported in the cited literature. The device performance is primarily described in terms of its characteristics and consistency with known safe and effective practices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Serve as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures. | Yes. The MEDICON IMF-Orion Screws have the same intended use as predicate devices. (Page 2, 2.7 & Page 3, 2.13) |
| Material Composition: Manufactured from biocompatible and strong material suitable for bone implantation. | Ti6Al4V according to ASTM F 136-02a. This is identical to several predicate devices, with one predicate using 316-L, though the document emphasizes the primary material. (Page 1, 2.6 & Page 3, 2.13) |
| Design Characteristics: Functional screw design (e.g., self-tapping/self-drilling, appropriate thread lengths, head shape for gripping). | Various lengths (10, 12, 14, 16 mm). Diameter of shafts: 2.0 mm. Head diameter: 4.0 mm, grooved for wires/rubber bands, tapered inner hexagonal. Self-retaining fit to the blade. Self-tapping & self-drilling function. These characteristics are described as very similar to SE (Substantially Equivalent) devices, with slight differences in size and specific thread functions not adversely affecting safety/effectiveness. (Page 1, 2.6 & Page 2, 2.9 & Page 3, 2.13) |
| Sterilization Method: Effective sterilization validated to appropriate standards. | Steam Sterilization to SAL of 10^-6. Specific cycle: 3 times pre-vacuum, 132° C, holding time 4 minutes (full cycle), drying time 10 minutes. Validated according to ISO 14937:2000. This is consistent with predicate devices. (Page 3, 2.13) |
| Safety and Effectiveness: Demonstrate comparable safety and effectiveness to predicate devices. | Clinical results of the MEDICON IMF-Orion Screws made out of Titanium Alloy (Ti6Al4V) and manufactured after ASTM F136-02a have shown their safety and effectiveness. This is supported by three cited literary references. "The results of design validation and clinical testing raise no new issues of safety and effectiveness." (Page 2, 2.10 & 2.12) The differences in design and size do not adversely affect safety and effectiveness. (Page 2, 2.12) |
| Compliance with Industry Standards: Adherence to relevant manufacturing, packaging, and sterilization standards. | Certifies compliance with required ISO/EN/ASTM and other device-related standards. (Page 2, 2.11) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a prospective clinical trial with a defined number of subjects. The document refers to "clinical results of the MEDICON IMF-Orion Screws" but does not quantify the number of patients or cases.
- Data Provenance: The device is German (Medicon eG, Tuttlingen, GERMANY D-78532). The clinical evidence cited is from "German Literature" (OP-Journal 2003, Die FAMI-Schraube...) and "Literature Addenbrooke's NHS" (UK). This suggests data originating from Germany and the UK. The studies appear to be retrospective literature reviews rather than new prospective trials for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document relies on published clinical literature.
- Qualifications of Experts: The literature cited would have been authored by medical professionals (surgeons, oral and maxillofacial surgeons, etc.) based on their clinical experience and observations. However, their specific qualifications (e.g., years of experience, subspecialty) are not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned, as this is not a study involving expert consensus on cases. The evidence is derived from existing clinical literature, where the "ground truth" would be established by the standard clinical diagnostic and outcome assessment practices described within those publications.
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
- No, an MRMC comparative effectiveness study was not done. This device is a surgical implant, not an AI-powered diagnostic tool. Therefore, a study of "human readers improving with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance study (algorithm only) was not done. This device is a physical surgical screw, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" is based on clinical outcomes reported in medical literature concerning the safety and effectiveness of similar IMF screws, specifically those made of Ti6Al4V according to ASTM F136-02a. This implies successful temporary fixation, bone stabilization, and absence of adverse events as assessed by clinical professionals in real-world settings over time.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve an AI algorithm with a distinct "training set." The assessment is based on existing predicate device performance and published clinical experience with similar materials and designs.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, there is no ground truth established for one.
§ 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.