(391 days)
The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.
The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment is complete. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single use only.
Screws are essentially C-type screw head design and size. Screw diameters and lengths are offered in the following range: thread diameter (1.75 mm) and overall length (11.10 – 15.10 mm). The screw tip has a self-drilling feature for insertion and removal. It is manufactured from a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). These devices are supplied sterilized by gamma irradiation. This device is individually packaged in a polyethylene bag.
The provided document is a 510(k) premarket notification for the ACR Screw System, an orthodontic anchorage screw. It describes the device, its indications for use, and its substantial equivalence to predicate devices, primarily through non-clinical testing. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI-driven devices.
The document focuses on demonstrating physical and material equivalence, as well as safety and basic functionality. Therefore, I cannot fully answer your request for acceptance criteria and a study proving device performance in the way you've outlined for AI/diagnostic devices.
Here's an attempt to extract relevant information given the limitations of the provided text:
1. A table of acceptance criteria and the reported device performance
The document details performance testing related to mechanical properties, biocompatibility, sterilization, bacterial endotoxin, and shelf-life. However, explicit quantitative acceptance criteria and detailed reported performance values for each are not presented in a comparative table within the document. Instead, it states that tests "met predetermined acceptance criteria" or "all test requirements were met."
| Test Category | Acceptance Criteria (Stated broadly) | Reported Device Performance (Stated broadly) |
|---|---|---|
| Mechanical Properties | In accordance with ISO 19023:2018 and ASTM F543-17 objectives for pull-out, torsion, and torque. | Performance "determined" and implied to be acceptable for substantial equivalence. No specific values provided. |
| Biocompatibility | In accordance with ISO 10993-1, ISO 10993-5, ISO 10993-12. | Deemed biocompatible due to use of same materials and manufacturing process as previously cleared predicate device (K063495). |
| Sterilization | Achievement of a Sterility Assurance Level (SAL) of $10^{-6}$ and meeting all test requirements per ISO11137-1, -2, -3. | SAL of $10^{-6}$ was achieved, and all test requirements were met. |
| Bacterial Endotoxin | Test limit of 0.06 EU/mL per ANSI/AAMI ST72:2011. | Testing met predetermined acceptance criteria. |
| Shelf-Life | Confirm stability and effectiveness of packaging for 3 years (sterility, peel strength, dye penetration, burst) per ISO 11607-1, ISO 11607-2, ASTM F1980-21. | Device met the acceptance criteria for each test (sterility, peel strength, dye penetration, burst) for a 3-year shelf life. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for mechanical, sterilization, bacterial endotoxin, or shelf-life testing. The data provenance is implied to be from internal testing by BioMaterials Korea, Inc. or their contracted labs, primarily from South Korea, as indicated by the manufacturer's and consultant's addresses. All tests are non-clinical (laboratory/bench).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to the non-clinical testing described. Ground truth for these types of tests is established by standardized testing protocols and measurement instruments, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for non-clinical testing.
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 device is a physical orthodontic screw, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical tests (mechanical properties, biocompatibility, sterilization, etc.) is established by adherence to international standards and validated laboratory test methods (e.g., ISO and ASTM standards for material properties, sterility, and packaging integrity).
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.