(238 days)
STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.
STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function.
STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.
The provided document is a 510(k) summary for the STERI-OSS Implant System, which is a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets pre-defined acceptance criteria for performance in a clinical setting. For medical devices undergoing 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific novel performance acceptance criteria through clinical studies.
Therefore, the requested information elements such as "acceptance criteria and the reported device performance," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are typically not applicable in the context of a 510(k) substantial equivalence submission for a device like a dental implant. These elements are more commonly associated with clinical trials or performance studies for novel devices or software with AI/ML components requiring new clinical evidence.
The document describes non-clinical testing to demonstrate that the differences between the subject device and predicate devices do not affect substantial equivalence.
Here's a breakdown of the available and non-applicable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not applicable in the format typically used for performance studies with defined acceptance criteria for clinical outcomes. The document instead presents a comparison of technological characteristics with predicate devices and reports on non-clinical engineering and materials testing to support substantial equivalence.
| Item | Acceptance Criteria (Not explicitly defined for clinical performance) | Reported Device Performance (as per non-clinical testing) |
|---|---|---|
| Fixture | - Material: Pure Titanium Grade 4 (ASTM F67) | Matches predicate/reference devices |
| - Connection type: Internal Hex | Matches predicate/reference devices | |
| - Surface Treatment: SLA | Matches predicate/reference devices | |
| - Sterilization: Gamma Sterilization | Matches predicate/reference devices | |
| - Dimensions: Within similar dimensional range of predicates | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Straight Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Solid Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Angled Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range, supported by mechanical bench testing for differences | |
| Screw | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices; difference with cp-Ti predicate deemed minor |
| (Abutment Screw) | - Principle of operation: Connect abutment to fixture | Matches reference devices |
| - Surface Treatment: None | Matches reference devices | |
| - Dimensions: Within reference device dimensions | Demonstrated to be within range | |
| Screw | - Material: Ti6Al4V ELI (ASTM F136) | Matches some reference devices; difference with cp-Ti predicate deemed minor |
| (Cover Screw) | - Principle of operation: Protect internal portion of implant | Matches reference devices |
| - Surface Treatment: None | Matches some reference devices; difference with anodized predicate deemed minor | |
| - Dimensions: Within range of reference device dimensions | Demonstrated to be within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches some reference devices; difference with cp-Ti predicate deemed minor |
| (Healing Abutment) | - Principle of operation: Help soft tissue of gum naturally formed | Matches reference devices |
| - Surface Treatment: None | Matches some reference devices; difference with anodized predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| General Non-Clinical | - ISO 14801:2016 (Fatigue) | Successfully tested for worst-case scenario |
| - ISO 11137-1/2 (Gamma Sterilization) | Validated | |
| - ANSI/AAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1/3 (End User Sterilization) | Validated | |
| - ASTM F88, F1140, F1929, F2096 (Shelf Life) | Tested (5 years) | |
| - ISO 10993-1/5/12 (Biocompatibility) | Evaluated and tested | |
| - USP (Pyrogen and Endotoxin) | Endotoxin testing conducted per batch (limit |
§ 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.