(83 days)
A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.
The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.
The provided text describes a 510(k) premarket notification for a medical device, specifically the "Spline Dental Implant System - Temporary Abutment." This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study designs for AI/software-based devices is not present in this document.
However, I can extract the relevant information that is available about the "performance data" and comparison to a predicate device, interpreting the request in the context of this specific regulatory submission.
Explanation of Device and Regulatory Context:
The device is a "Temporary Prosthetic Component" for dental implants. It's designed to be used for a limited duration (maximum of six weeks) to support temporary restorations. The submission focuses on demonstrating that this "Temporary Abutment" is substantially equivalent to an already legally marketed "Spline Dental Implant System - Fixed Abutment" (the predicate device).
Substantial equivalence is demonstrated by showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
Here's how I can address your prompt based on the provided text:
Acceptance Criteria and Device Performance for Spline Dental Implant System - Temporary Abutment (K982305)
Regulatory Context: This submission is a 510(k) premarket notification, which establishes "substantial equivalence" to a predicate device, not necessarily standalone safety and efficacy through clinical outcomes. Acceptance criteria here refer to the demonstration of identical or highly similar technological characteristics and equivalent performance in bench testing to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (Temporary Abutment) |
|---|---|---|
| Intended Use | Same as predicate, with specific duration limitation. | "To be used for a maximum of six weeks as an abutment for cemented provisional prostheses." (Identical to predicate's use for permanent abutments, but with time limit) |
| Available Diameters | Identical to predicate device. | 3.25mm, 4.0mm & 5.0mm |
| Material | Identical to predicate device. | Titanium alloy |
| Manufacturing Site | Identical to predicate device. | Sulzer Calcitek, Carlsbad, CA. |
| Packaging | Identical to predicate device. | tray with tyvek lid |
| Sterility | Identical to predicate device. | Non-sterile |
| Overall Design | Identical to predicate device. | "identical" to predicate device |
| Technological Characteristics | Same as predicate device. | "The Temporary Abutments have the same technological characteristics as the predicate device." |
| Bench Top Testing | Demonstrated substantial equivalence to predicate device. | "Bench top testing demonstrate the substantial equivalence of the Temporary Abutment to the predicate device." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The submission mentions "bench top testing," which refers to laboratory-based mechanical or physical tests, not human subject data. The number of units tested is not provided.
- Data Provenance: Not specified, but generally, bench testing data for such submissions would be generated by the manufacturer (Sulzer Calcitek Inc.) in a controlled laboratory environment. It is not retrospective or prospective clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable here. "Ground truth" from experts is relevant for diagnostic devices (e.g., radiologists interpreting images). For a mechanical device like a dental abutment, "ground truth" is established through engineering specifications, material properties, and mechanical performance standards via bench testing, not expert consensus on clinical findings.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations (e.g., imaging studies). For bench testing, results are typically objective measurements against predefined engineering standards.
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 is not an AI/software device, and no MRMC study or human reader performance assessment was conducted or required for this type of medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for demonstrating substantial equivalence for this device would be the engineering specifications, material properties, and established mechanical performance characteristics of the predicate device. The Temporary Abutment's performance in bench testing was compared against these established characteristics to show it performs equivalently.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning/AI device, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set.
§ 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.