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The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.

TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.

Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.

Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).

However, I can extract the information that is available and explain why other requested details are missing.

Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):

This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.

Missing Information and Explanations:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/None. No clinical test set to adjudicate.

4. 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 (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. As above, this is a physical medical device, not an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.

7. The sample size for the training set:

   • Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.

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Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.

The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.

The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.

Therefore, the input document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone algorithm performance study.
• The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.

The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.

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The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.

The provided text describes the 510(k) summary for the PrimeLOC Attachment System, a dental device. It outlines the device's administrative information, classification, predicate devices, indications for use, description, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does not contain information about "acceptance criteria" and how the device's performance measured against those criteria in a structured, quantitative table, as would be typical for an AI/ML medical device submission. The performance data section describes non-clinical testing for areas like sterilization, biocompatibility, mechanical testing (dynamic loading, removal force), and MRI compatibility. It does not mention any clinical study involving a test dataset, ground truth established by experts, or metrics like accuracy, sensitivity, or specificity that would be relevant for an AI/ML device in the context of an "acceptance criteria" table.

Therefore, I cannot fulfill parts 1-9 of your request as the information is not present in the provided document. The document describes a traditional medical device (dental attachment system) clearance, not an AI/ML device that would typically involve the type of study design and data points you're asking about.

To answer your request based on the provided document, the following points are addressable:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. The document describes non-clinical performance characteristics (sterilization, biocompatibility, mechanical properties) and demonstrates substantial equivalence to a predicate device. It does not present quantitative acceptance criteria for clinical performance in the manner of an AI/ML device (e.g., accuracy, sensitivity, specificity) against a test set. The "Performance Data" section discusses:
  • Sterilization validation (ISO 17665-1, ISO 17665-2)
  • Biocompatibility testing (ISO 10993-5, ISO 10993-12)
  • Mechanical testing (ISO 14801 for dynamic loading; testing removal force of retention insert)
  • Non-clinical worst-case MRI review (using scientific rationale and published literature)

Regarding the study that proves the device meets "acceptance criteria" (interpreting "acceptance criteria" in the context of this traditional device as demonstrating substantial equivalence through non-clinical testing):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable/Not Provided. The performance data mentioned are non-clinical tests (e.g., sterilization, biocompatibility, mechanical testing). These are laboratory/benchtop tests, not a clinical "test set" in the context of patient data for an AI/ML algorithm. The document does not specify typical sample sizes for these tests (e.g., how many abutments were tested for removal force), nor data provenance (as it's not patient-derived data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. This is not an AI/ML device where expert radiologists or similar professionals would establish ground truth for a test set. The "ground truth" for the non-clinical tests would be the established standards for sterilization, biocompatibility, and mechanical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Not a clinical study requiring adjudication of expert readings.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not Applicable / Pre-defined standards. For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1 and 17665-2.
  • Biocompatibility: Ground truth is defined by the requirements of ISO 10993-5 and 10993-12.
  • Mechanical Testing: Ground truth is defined by the requirements of ISO 14801 for dynamic loading, and internal company specifications for retention force (compared to the predicate).
  • MRI Review: Ground truth is based on scientific rationale and published literature for material properties in an MR environment.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not Applicable. There is no "training set."

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional Class II dental device (an attachment system for dental implants), not an AI/ML medical device. Therefore, the questions related to AI/ML specific study design elements (test sets, ground truth by experts, MRMC studies, training sets) are not applicable to the content of this document.

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The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.

TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.

The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (TSV™ BellaTek® Encode® Healing Abutments) demonstrating substantial equivalence to a predicate device.

The document explicitly states: "No clinical data were included in this submission." and relies on non-clinical testing data and equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

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