(296 days)
The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:
Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)
This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|---|
| Indications for Use | Identical or equivalent to predicate devices. | The subject device's indications for use are "substantially equivalent" to predicate devices, addressing prosthetic support for dental restorations in partially or fully edentulous individuals. Minor wording differences are considered acceptable and not affecting substantial equivalence. |
| Technical Characteristics | Similar design, material, sizing, connection interface, sterilization method, and principle of operation to predicate devices, or minor differences not affecting safety and effectiveness. | Multi-unit Abutment: Largely identical to predicate and reference devices in most characteristics, with minor differences in total length and gingival height falling within combined ranges or being considered negligible. Surface treatment (Anodizing vs. Machined) changed for some, but shown not to affect substantial equivalence. |
| Multi-unit Angled Abutment: Similar to predicate and reference devices. Minor differences in diameter, length, post height, gingival height, and angulation are within combined ranges or considered negligible. Connection interface differences (Hex/Octa vs. Octa only) covered by reference devices. Surface treatment (Anodizing vs. Machined) addressed by other predicate/reference devices. | ||
| Multi-unit Abutment Screw, Abutment Screw, Multi Post Screw, Healing Cap, Temporary Cylinder, CCM Cylinder, Cylinder Screw: Similar in most characteristics to predicate/reference devices, with minor dimensional differences (diameter, length, post height, gingival height) falling within combined ranges or being deemed minor and not affecting substantial equivalence. | ||
| Biocompatibility | Meets ISO 10993-1 requirements. | Evaluation performed according to ISO 10993-1. No additional testing required as material composition, manufacturing process, and patient-contacting parts are identical to cleared predicate devices (AnyOne Internal Implant System K123988 and AnyRidge Octa 1 Implant System K182448). |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6 post-user sterilization. | Non-sterile device supplied to user. Sterilization validation testing for steam sterilization performed according to ISO 11137 and ISO 17665-1, 2 to verify SAL of 10^-6. |
| Performance (Physical Properties) | Meets performance criteria defined by ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment." | Bench tests performed, and results "met the pre-set criteria." The Multi-unit Angled Abutment (worst-case) was specifically tested for fatigue. Fatigue testing not considered for straight abutments as per guidance. |
| Modified Surface Treatment | Evaluation performed in accordance with "Section 11 of Class II Special Controls Guidance Document". | Multi-unit Abutment, Multi-unit Angled Abutment described as having same surface treatment (Anodizing) and manufacturing process as K123988 and K182448. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)