(90 days)
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.
Steri-Oss Single Stage Surgical Placement dental implants are designed to serve as supports for prosthetic devices intended to restore a patient's chewing function. Dental implants are intended to mimic the root portion of this structure to aid in restoration of chewing function in patients who have lost natural dentition through disease, trauma or other cause. Implants integrate into the jaw bone. By providing a stable foundation analogous to the root portion of a natural tooth, and in combination with an abutment structure (i.e., a foundation for an artificial crown), dental implants provide a platform upon which the dentist can build an artificial crown or bridge, thereby restoring the patient's ability to chew. The Steri-Oss Single Stage Surgical Placement implants are slightly tapered and vary in diameter from 3.25 millimeters to 5.0 millimeters (neck dimension) depending upon the specific implant design, and vary from 8 millimeters to 18 millimeters in length. They may have no coating or a coating consisting of titanium alloy or hydroxyapatite. Titanium or hydroxyapatite coatings are applied as a plasma spray. The implants are available in cylindrical or threaded configurations and have either a flat top or a hex lock configuration at the apical surface.
The provided text is a 510(k) summary for a medical device (dental implants). It is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to a predicate device.
This document describes a medical device, not an AI/ML powered device. Many of the requested categories are therefore not applicable. This document does not describe acceptance criteria for an algorithm's performance, nor does it conduct a study to prove an algorithm meets them. Instead, it describes the physical characteristics and intended use of a dental implant and compares it to a previously cleared predicate device to argue for substantial equivalence.
Here's an analysis of the provided text in the context of your request, highlighting where information is not applicable:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The provided 510(k) summary (K963227) for "Steri-Oss Implants For Single Stage Placement" describes a medical device (endosseous dental implants) and asserts its substantial equivalence to a predicate device. The concept of "acceptance criteria" and "study proving device meets acceptance criteria" as typically applied to AI/ML performance is not applicable to this document. Instead, the submission focuses on demonstrating that the new device has the same technological characteristics, intended use, and performs in a substantially equivalent manner to an already cleared predicate device. The "acceptance criteria" here implicitly revolve around demonstrating this substantial equivalence based on physical and functional comparisons.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Characteristics (Submission Device) |
|---|---|
| Material: Same body material as predicate. | Titanium alloy |
| Coating Materials: Same as predicate. | None, HA, or TPS |
| Design: Same configurations as predicate. | Threaded or cylindrical |
| Superior Surface: Same options as predicate. | Flat or Hex Lock |
| Length (mm): Same range as predicate. | 8, 10, 12, 14, 16, 18 mm |
| Diameter (mm): Same range as predicate. | 3.25, 3.8, 4.1/4.5, 5.0/4.5 mm |
| Packaging: Same as predicate. | Double vial |
| Sterility: Same as predicate. | Sterile |
| Intended Use: Same as predicate. | Support for prosthetic devices to restore patient chewing function; surgically placed using the single stage surgical placement method. |
| Performance: Substantially equivalent function. | "identical in all aspects" to corresponding implants cleared for marketing for two-stage surgical placement, including materials, fabrication, physical dimensions, geometry, sterilization, packaging. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document is a regulatory submission for a physical medical device. It does not describe a "test set" of data for algorithmic performance. The comparison and equivalence are based on the manufacturing specifications, materials, and design of the implant itself.
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. There is no "ground truth" establishment in the context of an AI/ML algorithm's performance within this document. The "truth" here is the physical and functional identity of the new implants to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set for algorithmic performance 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
- Not applicable. This document is not about AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" in this context is the established characteristics and performance of the predicate device, to which the new device is compared for substantial equivalence in its physical form and function. There is no data-driven ground truth in the typical AI/ML sense.
8. The sample size for the training set
- Not applicable. There is no training set for an algorithm described.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an algorithm described.
§ 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.