(92 days)
The BioClean Implant Restorative System is designed to support fixed/detachable partial or full arch restorations on endosseous dental implants in the maxilla for the purpose of restoring masticatory function. It is used in fixed/detachable restorations that can be attached with a friction-based engagement system.
All digitally designed copings for use with the BioClean Implant Restorative System are to BioClean Dental or a validated milling center for manufacture.
The BioClean Implant Restorative System is compatible with the following:
| BioClean Implant Restorative System Compatibility | |
|---|---|
| Implant Components | Configurations |
| Bone Level Straumann® Multi-Unit | |
| Abutments NC/RC | |
| Straumann Multi-Unit Abutment Occlusal | |
| Screw | 4.6mm Platform Diameter, All Gingival |
| Heights |
The BioClean Implant Restorative System provides rigid connection of partial and full arch restorations to endosseous dental implants in the mandible or maxilla.
The BioClean Implant Restorative System consists of copings, denture housings, and retention inserts that are intended to allow for a fixed/detachable prosthesis to be connected to OEM multiunit abutments for stable attachment of the prosthesis to endosseous dental implants. All BioClean copings are made of titanium alloy and have the same coronal ridge retention design that attaches to the prosthesis component by a friction-based engagement system. The subject device coping connects to the OEM multi-unit abutment and is specific to each compatible abutment system and diameter.
The subject device copings are offered with angulation from 0° to 9° in 0.5° increments and also in a patient specific version in which the dental laboratory technician designs the coping in CAD software and then sends the design to BioClean Dental or a validated milling center for fabrication from a coping blank. By use of a combination of pre-manufactured and patientspecific versions of the copings, a multi-unit prosthesis can be created in which the copings are parallel.
The provided text is a 510(k) Summary for a dental device, the BioClean Implant Restorative System. It details the device's indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, the specific study design (e.g., sample sizes for training/test sets, data provenance), expert involvement, or statistical analysis of device performance against defined criteria, which would typically be found in a clinical study report or a more detailed performance evaluation.
The document states that "Non-clinical testing data submitted to demonstrate substantial equivalence included:" and then lists several types of tests:
- Sterilization validation
- Biocompatibility testing
- Mechanical testing (ISO 14801 for dynamic loading of dental implants)
- Reverse engineering to verify OEM compatibility
- Retention testing
- Non-clinical worst-case MRI review
While "Retention testing was conducted to ensure that retention is maintained throughout the expected use of the product. Retention strength of the subject devices was tested and compared to the retention strength of reference device K033699," this is the only mention of a quantitative comparison to a reference device's performance, but it does not provide acceptance criteria or the actual performance values.
Therefore, I cannot fully answer your request based on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of fundamental device characteristics and indications for use, rather than presenting a performance study against explicit acceptance criteria with detailed statistical results.
Here's what can be extracted and what is missing based on your prompts:
1. A table of acceptance criteria and the reported device performance
Cannot be fully provided from the text. The document states that "Retention testing was conducted to ensure that retention is maintained throughout the expected use of the product. Retention strength of the subject devices was tested and compared to the retention strength of reference device K033699." However, it does not explicitly define acceptance criteria (e.g., "retention strength must be X N or within Y% of predicate") nor does it report the specific measured retention strength values for either the subject device or the reference device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated for quantifiable metrics like retention strength) | (Specific values not reported for quantifiable metrics like retention strength) |
| Retention is maintained throughout expected use. | Retention strength tested and compared to reference device K033699. (Specific results not given). |
| OEM compatibility verified. | Key dimensions measured from OEM implants, abutments and screws; dimensions and tolerances established for corresponding BioClean copings to ensure compatibility. |
| Biocompatibility compliant. | Testing according to ISO 10993-5 and ISO 10993-12. (Implicitly met, no specific data presented). |
| Sterilization validated. | Validation according to ISO 17665-1 and ISO 17665-2. (Implicitly met, no specific data presented). |
| Mechanical testing compliant with standards. | Testing according to ISO 14801. (Implicitly met, no specific data presented). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the text. The document describes non-clinical laboratory testing, but does not specify the sample size for any of the tests (e.g., number of devices tested for retention, number of samples for biocompatibility). Data provenance (country of origin, retrospective/prospective) is also not mentioned, but given it's non-clinical lab testing, it's typically done in a controlled environment and not tied to patient data provenance in the same way clinical studies are.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not available. This document describes non-clinical engineering and biological performance testing of a physical medical device (dental implant components). Ground truth as established by experts (e.g., radiologists interpreting images) is not relevant to the types of tests described here (mechanical, biocompatibility, sterilization validation).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth from multiple readers. This is not relevant to the non-clinical lab testing described.
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 device is a physical dental implant restorative system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
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 (expert concensus, pathology, outcomes data, etc)
Not applicable/Implicit in testing standards. For mechanical testing (ISO 14801), the "ground truth" is defined by the physical properties and performance metrics specified in the standard. For biocompatibility (ISO 10993), the "ground truth" for safety is determined by the absence of cytotoxic effects or other adverse biological responses as per the standardized test protocols. For sterilization, it's documented sterility assurance levels. This is not "ground truth" in the sense of clinical diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is hardware, not a machine learning algorithm that requires a training set. The term "training set" would apply if this were an AI or software device.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is involved for this hardware device.
§ 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.)