(112 days)
The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.
Speedy Orthodontic Screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is composed of screw and head; screw is implanted in the maxilla and/or mandible, and head is used for the connection of wire. It is from 5.35-10.5mm in total length and is made of Titanium 6Al-4V alloy. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
This submission is a 510(k) summary for a medical device called the "Speedy Orthodontic Screw." It's a premarket notification to the FDA, demonstrating that the new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission relies on showing similarities in design, materials, and intended use, rather than conducting new clinical trials for acceptance criteria specific to AI performance. Therefore, many of the requested fields are not applicable to this type of device submission.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided text as separate acceptance criteria with corresponding performance metrics for an AI device. The submission is not for an AI device, but a physical medical device. The "review" section mentions "safety, performance, and product validations" and a "review of literature pertaining to the safety and biocompatibility." These are general statements of evaluation rather than specific, quantifiable acceptance criteria or performance numbers.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical, non-AI medical device submission. No "test set" of data in the context of AI performance analysis is mentioned. The submission relies on demonstrating substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment in the context of image interpretation or diagnostic accuracy for an AI device is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" for interpreting data is mentioned for this physical device submission.
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
Not applicable. This is not an AI device, and therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no mention of "ground truth" in the context of an AI device's performance. The safety and effectiveness of the device are assessed by demonstrating similarity to the predicate device and inherent material/design properties.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is relevant to this device submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The document describes a submission based on substantial equivalence to a predicate device, not on specific clinical studies demonstrating new performance metrics against predefined acceptance criteria for an AI or novel physical device.
The "study" or justification for safety and effectiveness is presented as:
- Comparison to a Predicate Device: The Speedy Orthodontic Screw is compared to the "Dual Top Anchor System Screws, Jeil Medical Corporation, K033767." The submission states that the new device has "the same device characteristics as the predicate device. Material, design and use concept is similar."
- Safety and Performance Validations: The document claims the device "has been subjected to extensive safety, performance, and product validations prior to release." While "extensive" is stated, no specific details, methodologies, or results of these validations are provided in this summary.
- Literature Review: "An extensive review of literature pertaining to the safety and biocompatibility of Speedy Orthodontic Screw has been conducted." Again, no specific literature or findings are detailed.
- Incorporated Safeguards: The submission states that "Appropriate safeguards have been incorporated in the design of Speedy Orthodontic Screw."
In essence, the "proof" is the argument of substantial equivalence to an already legally marketed, safe, and effective device, reinforced by general statements about safety testing and literature review, rather than a detailed report of novel performance data against specific, quantifiable acceptance criteria.
§ 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.