(87 days)
The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodonic movement of teeth.
The Ortho Organizers Temporary Orthodontic Anchor is a device that is temporarily implanted in the alveolar ridge to provide a fixed anchorage point for various orthodontic tooth movements. It is a single-piece design that features a threaded shaft and a low profile proximal head. The head incorporates a button and undercut that serves as an attachment point. The tapered conical section below the button incorporates a transverse circular opening which also serves as an attachment point. Vertical flats below the conical section enable use of tools to turn the device into its fully implanted position. The head terminates in a collar that separates the attachment points from the threaded portion of the device. The device is available with a short collar or a long collar to accommodate variations in soft tissue thickness. The device is made of titanium alloy conforming to the requirements of ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The device will be sold non-sterile and is intended to be sterilized prior to use.
The provided text is a 510(k) summary for a medical device called the "Ortho Organizers Temporary Orthodontic Anchor." This document describes the device, its intended use, and its equivalence to already marketed predicate devices.
However, it does not contain any information regarding specific acceptance criteria, performance data from a study, or details about a study design (such as sample size, data provenance, ground truth establishment, or expert involvement).
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through comparing design, materials, and intended use, rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.
Here's a breakdown of what can be inferred from the text and why most questions cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define any specific acceptance criteria (e.g., success rates, failure rates, accuracy metrics) or present data from a study demonstrating specific device performance against such criteria. The submission focuses on substantial equivalence based on design and material similarities to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical or performance study details are mentioned.
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)
- Cannot be provided. No ground truth establishment is described, as there is no performance study data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described.
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
- Cannot be provided. This device is a physical orthodontic anchor, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth is established as no performance study is detailed. The "ground truth" for this type of submission is typically the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Cannot be provided. No training set is relevant or mentioned for this physical device.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or associated ground truth is relevant or mentioned.
Information that IS present in the document:
- Device Name: Ortho Organizers Temporary Orthodontic Anchor
- Intended Use: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
- Material: Titanium alloy conforming to ASTM F 136 Standard Specification (Ti-6A1-4V titanium alloy).
- Sterilization: Sold non-sterile, intended to be sterilized prior to use.
- Classification: Class II (21 CFR 872.3640), Product Code DZE.
- Predicate Devices: The submission states that equivalence was demonstrated to "legally marketed predicate devices." While specific predicate device names are not given in the provided text, the basis of the 510(k) is the substantial equivalence to these devices in terms of "intended use, design, materials and functional characteristics."
In summary, the provided text is a regulatory submission for a physical medical device (an orthodontic anchor) based on substantial equivalence, not a clinical study report with performance data and 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.