(113 days)
The Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).
The provided text describes a Surgical Drill system (Implant Integration Systems Surgical Drills) intended for use with a specific dental implant (Dual Integrator Dental Implant), and states that it is similar to other predicate devices.
However, this document is a 510(k) Summary of Safety and Effectiveness from 1996. It focuses on demonstrating substantial equivalence to pre-existing devices, which is the regulatory pathway for many medical devices in the US.
Therefore, the document does not contain any of the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related data. The concept of "acceptance criteria" and "device performance" in the context of advanced AI algorithms, multi-reader multi-case studies, and ground truth establishment as described in your request did not generally apply to the regulatory submission for a surgical drill system in 1996.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily identifies predicate devices for substantial equivalence.
- Sample size used for the test set and the data provenance: This information is not present in the document. No test set or data studies are described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: This information is not present in the document.
- 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: This information is not present in the document. AI was not a factor in medical device regulation or development in this context in 1996.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document. This device is a surgical drill, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the document.
- The sample size for the training set: This information is not present in the document.
- How the ground truth for the training set was established: This information is not present in the document.
In summary, the provided document is a regulatory submission for a physical surgical tool from 1996, and the type of detailed performance criteria and study information you are asking for (which are common for AI-driven medical devices) are completely absent and not applicable to this kind of product or its regulatory pathway at that time.
§ 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.