(248 days)
The INNO SLA Mini Plus® Implant System is divided into two types:
-
Cemented Type
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors to serve as temporary support prosthetic devices during stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients. -
Ball Type
The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exeed one hundred and eighty (180) days.
The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.
The provided text is a 510(k) summary for the INNO SLA Mini Plus® Implant System, which establishes substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study for performance. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.
However, I can extract the non-clinical performance data and related information as presented.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of acceptance criteria with corresponding device performance metrics from a formal study. Instead, it describes various non-clinical tests conducted or leveraged to demonstrate substantial equivalence to predicate devices. These tests primarily focus on material properties, manufacturing processes, and safety aspects.
| Acceptance Criteria (Implied) | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | Leveraged K201323; Biocompatibility tests performed and results support substantial equivalence. |
| Shelf Life | Leveraged K132242. |
| Sterilization Validation | Leveraged K201323. Sterilization validation test conducted for POM caps & Nylon caps per ISO 17665-1 and ISO 17665-2. |
| Endotoxin Limit | Endotoxin testing to be conducted on random batch every two months using Limulus amebocyte lysate (LAL) test (gel-clot technique). |
| Fatigue Testing | Not required as no angled abutments in the submission. |
| MRI Safety | Non-clinical worst-case MRI review conducted. Scientific literature (Kim et al., Woods et al.) and ASTM standards (F2052, F2213, F2182, F2119) referenced to confirm stability of CP Ti Gr.4 in MRI environment and address FDA guidance. |
| Material (CP Ti Gr.4) | Confirmed stability in MRI environment. |
| Material (POM caps, Nylon caps) | Sterilization validation achieved. |
| Manufacturing (SLA surface treatment) | Leveraged K132242. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes non-clinical tests, and for those, the "sample size" would refer to the number of units tested. This detail is not present. Data provenance (country of origin, retrospective/prospective) is also not applicable or not disclosed for these non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. This document focuses on demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of characteristics, not through a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple readers or assessors, which is not described here.
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
This information is not provided. The device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental implant system, not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Biocompatibility/Chemical Analysis: The ground truth would be established by industry standards and regulatory requirements for safe material interaction with biological systems.
- Sterilization Validation: Ground truth is established by meeting the sterility assurance level (SAL) defined by ISO standards.
- Shelf Life: Ground truth is established by assessing material degradation over time under specific conditions.
- Endotoxin Testing: Ground truth is established by meeting specified pyrogen limits.
- MRI Safety: Ground truth is established by referenced scientific literature and adherence to ASTM standards and FDA guidance for MR safety, which define acceptable parameters for magnetic field interaction, heating, and artifact generation.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would have involved a sample size of the physical device components, but these details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 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.