(87 days)
Endosseous implants and abutments are indicated for surgical placement into the upper and Lower jar arches as permanent support for prosthetic appliances, to restore a patient's masticatory fower jur arches as permaint oupport resally coating applied to implants/abutments improves the overall esthetics of the completed restoration.
3i proposes to apply a TiN coating to abutment cylinder surfaces with exception of the implant mating surface interface area. On implants, the coating will be applied to coronal. transgingival collar area. Implant/abutment interface surfaces will not be coated. Current dimensional characteristics and specifications for implants and abutments to be TiN coated do not change. Cleaning, packaging and sterilization operations will be accomplished by the same means and under the same controls as non-TiN coated implants and abutments.
The provided text is a 510(k) summary for a medical device (TiN Coated Implants and Abutments). It details the device, its intended use, and evaluations for substantial equivalence, but it does not contain a study that proves the device meets specific acceptance criteria in the format of a clinical trial or performance study with defined metrics, sample sizes, and ground truth.
Instead, the document focuses on:
- Biocompatibility: Stating that Titanium Nitride (TiN) is a proven biocompatible material based on existing literature and its widespread use.
- Physical Performance Evaluation: Describing a limited set of physical tests to assess adhesion and performance with cement-retained prosthetics.
- Substantial Equivalence Argument: Asserting that the TiN-coated devices are substantially equivalent to existing 3i implants/abutments and competitive systems already using TiN coatings, primarily differing only in the TiN coating itself.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, experts, and ground truth cannot be extracted directly from this document in the manner typically associated with studies proving device performance against specific, quantifiable acceptance criteria.
However, I can extract the available information regarding the "device performance evaluation" and present it as acceptance criteria for those specific tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "DEVICE/DESIGN PERFORMANCE EVALUATION") | Reported Device Performance | Comments |
|---|---|---|
| Scratch Adhesion (TiN to CP titanium): (Value to demonstrate strong adhesion and prevent delamination under mechanical stress) | 2.5 - 2.75 kg | This indicates the force required to cause delamination. A higher value generally means better adhesion. No specific "pass/fail" threshold is explicitly stated, but the values are provided as a measure of performance. |
| Adhesion of cement retained prosthetic to TiN: (Visual observation criterion for no delamination or loss of coating after removal of cemented copings) | Visual observation of TiN abutments after removal of cemented copings revealed no de-lamination or loss of coating. | This is a qualitative assessment. The acceptance criterion is "no delamination or loss of coating." |
| Removal force of cemented copings from TiN vs. non-coated abutments: (To ensure the TiN coating does not negatively impact prosthetic retention, ideally equal to or greater than non-coated, and with reduced variability) | Removal of cemented copings from TiN coated abutments was equal to or greater than copings from non-coated abutments with a significantly smaller standard deviation. | This suggests improved and more consistent retention with the TiN coating, which would be a positive performance aspect. |
| Resistance to scraping with a steel dental curette: (To ensure coating integrity during handling and clinical use) | TiN coating was not removed from substrate, when scraped with a steel dental curette. | This is a qualitative assessment. The acceptance criterion is "coating not removed." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document uses phrases like "TiN abutments" and "copings" without providing the number of units tested for any of the physical performance evaluations.
- Data Provenance: Not specified, but generally, such tests would be conducted by the manufacturer in a laboratory setting. It is not explicitly stated whether the data were retrospective or prospective, but performance evaluations are typically prospective for new device features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The "ground truth" for the physical performance tests (scratch adhesion, visual observation of delamination, removal force) would be the direct measurements or observations from the tests themselves, not expert consensus on clinical outcomes. For qualitative assessments like "no de-lamination" or "not removed," it would be the judgment of the test operator, whose qualifications are not mentioned.
4. Adjudication method for the test set
- Not applicable/Not specified. For the physical performance tests, the results are objective measurements or direct observations. There's no mention of a panel or group needing to adjudicate conflicting interpretations of test results.
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
- No. This document does not mention an MRMC study. The device is a physical dental implant coating, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document does not describe an algorithm or AI component.
7. The type of ground truth used
- For the physical performance evaluation:
- Scratch Adhesion: Direct measurement of force in kilograms.
- Adhesion of cemented prosthetics (visual observation): Direct visual observation of the coating integrity.
- Removal force of cemented prosthetics: Direct measurement of force.
- Resistance to scraping: Direct visual observation of coating integrity after scraping.
- For the overall device: The "ground truth" for its safety and effectiveness is largely based on its substantial equivalence to legally marketed predicate devices and the established biocompatibility of TiN.
8. The sample size for the training set
- Not applicable. There is no AI/algorithm being trained, so no training set is mentioned or relevant.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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.