(297 days)
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.
The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver. The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136). It is single-use only and may not be reused. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use.
The provided text is a 510(k) summary for the ATOZ Mini-Screw, an orthodontic anchor screw. It describes the device, its indications for use, and a comparison to predicate devices, along with non-clinical testing results. However, it explicitly states that clinical data was not required for this submission.
Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to clinical studies and performance evaluation against a defined ground truth, which were not part of this 510(k) submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed, there are no "acceptance criteria" related to diagnostic or evaluative performance against a medical condition, nor is there "reported device performance" in that context. The document refers to "bench test" results to demonstrate substantial equivalence to a predicate device, focusing on mechanical strength and biocompatibility.
Table of Bench Test Criteria and Performance (from "Summary of Non-Clinical Data")
| Acceptance Criteria Category | Specific Test | Standard Applied | Reported Performance (Implied by Substantial Equivalence Claim) |
|---|---|---|---|
| Mechanical Strength | Torque strength | ISO 19023, ASTM F543 | Meets or exceeds predicate device performance |
| Torsional strength | ISO 19023, ASTM F543 | Meets or exceeds predicate device performance | |
| Pullout strength | ISO 19023, ASTM F543 | Meets or exceeds predicate device performance | |
| Biocompatibility | In vitro Cytotoxicity | ISO 10993-5:2009 | Biocompatible for intended use |
| Skin Sensitization | ISO 10993-10:2010 | Non-sensitizing for intended use | |
| Oral mucosa irritation | ISO 10993-10:2010 | Non-irritating for intended use | |
| Acute systemic toxicity study | ISO 1093-11:2017 | Non-acutely toxic for intended use | |
| Chemical analysis test | ISO 10993-18:2020 | Meets material specifications | |
| Sterilization | Sterility Assurance Level (SAL) of 1E-6 (after user steam sterilization) | ISO 17665-1:2006, etc. | Achieves SAL of 1E-6 |
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. The non-clinical tests would have their own sample sizes for material testing, but this is not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
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. The ATOZ Mini-Screw is a physical medical device (orthodontic anchor screw), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The ATOZ Mini-Screw is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established by adherence to recognized international standards (ISO, ASTM) for mechanical properties, biocompatibility, and sterilization, along with material specifications for the Titanium Alloy (ASTM F136).
8. The sample size for the training set: Not applicable as no machine learning training set was used.
9. How the ground truth for the training set was established: Not applicable as no machine learning training set was used.
In summary, the provided document is a 510(k) premarket notification that relied on non-clinical (bench) testing and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical studies involving patient data or expert evaluations of diagnostic performance.
§ 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.