Search Results

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:

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.

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.

Ask a specific question about this device

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.

The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization.

The provided text describes a 510(k) premarket notification for dental implant abutments, focusing on the substantial equivalence of the new device to existing predicate devices. However, it does not contain information about a study that proves a device meets specific acceptance criteria related to a machine learning or AI-driven medical device, nor does it include details about ground truth establishment, expert adjudication, or MRMC studies, which are characteristic of AI/ML device evaluations.

The document is purely a regulatory submission for a physical medical device (dental abutments) and focuses on engineering and biocompatibility testing for substantial equivalence, not performance criteria for diagnostic or algorithmic accuracy.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document refers to "Performance Testing" for the dental abutments, but this is in the context of mechanical, sterilization, and biocompatibility testing, not AI/ML performance.

To answer your request, I would need a document describing the evaluation of an AI/ML medical device.

Ask a specific question about this device