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The Tapered Screw-Vent® X Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.

The Tapered Screw-Vent®X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

The provided text describes a dental implant device, the Tapered Screw-Vent® X Implant, and outlines its characteristics, comparison to predicate devices, and testing performed. However, it does not contain information regarding acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML algorithm or software.

The document is a 510(k) summary for a medical device (endosseous dental implant) and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing (mechanical performance) and some clinical data on safety and basic performance.

Therefore, for the requested information related to acceptance criteria and an AI/ML study, the answer is: Not applicable / Not provided in the document.

Here’s a breakdown based on the document's content, highlighting why the requested information for AI/ML performance is not available:

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

• Not applicable for AI/ML performance. The document does not mention any AI/ML components or software.
• The "Non-clinical Testing" section states: "Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use." This general statement refers to mechanical and material performance, not AI/ML metrics.

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 for AI/ML test sets. The document refers to clinical studies for human subjects, not a dataset for software testing.
• Clinical Study Sample Size (for device performance): Not explicitly stated in terms of number of patients for the studies, only that a "controlled population" and "normal patients and subjects with elevated risk factors" were included.
• Data Provenance (for clinical studies): Not specified (e.g., country of origin).
• Study Type: "A prospective clinical study" and "A second, longitudinal data collection study" were conducted.

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 for AI/ML ground truth. The document describes clinical studies evaluating implant performance in patients, where "ground truth" would likely be clinical outcomes observed by treating clinicians, not expert consensus on an image or data set for an AI algorithm. No information is provided about expert panels or their qualifications for establishing ground truth as requested for AI/ML evaluation.

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

• Not applicable. No adjudication method for an AI/ML test set is mentioned.

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. No MRMC study is mentioned, as this device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. No AI algorithm is part of this submission.

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

• Not applicable in the AI/ML context. For the clinical studies mentioned, the "ground truth" would be related to clinical outcomes such as implant loading success, osseointegration, absence of adverse events, etc. The document states: "No device related adverse events were reported in either study to date." This implies observed clinical outcomes.

8. The sample size for the training set:

• Not applicable. No AI training set is mentioned.

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

• Not applicable. No AI training set is mentioned.

In summary: The provided document is for a physical medical device (dental implant) and does not contain any information related to AI/ML algorithms, their acceptance criteria, performance studies, or associated ground truth establishment.

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Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw type endosseous dental implant design for bone level placement and can be used in a single or two stage protocol. Refer to Figure 1, product renderings. The implant will have a straight body with an external single lead thread design. The new device implant body, fabricated from 6Al-4V titanium alloy, features single lead threads that begin 0.75mm apical of the base of the implant Spline tines and continue to the apex of the implant. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake andle to the osteotomy in a manner similar to a spiral flute thread tap. It has a Spline interface that consists of six tines. These tines interdigitate with like tines on abutments used in the system to create an anti-rotation interface. The new device will feature hydroxylapatite (HA) coating , hydroxylapatite coating with additional Zimmer Dental MP-1® processing equivalent to existing Zimmer Dental implants (K953101, K011028, K013227, K061410, K072589),

The provided text describes a 510(k) premarket notification for a dental implant and focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new device.

Therefore, the requested information cannot be fully extracted from the provided document as it does not contain details about a study that proves the device meets specific acceptance criteria in the format requested. Specifically:

• Acceptance Criteria and Device Performance Table: The document does not provide a table of acceptance criteria and reported device performance metrics in the context of a performance study. It discusses similarity to predicate devices.
• Sample size for test set and data provenance: No test set is described.
• Number of experts and their qualifications: Not applicable, as no ground truth establishment for a test set is mentioned.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned. The document is about establishing substantial equivalence, not conducting a comparative effectiveness study.
• Standalone (algorithm only) performance: Not applicable as this is a physical dental implant, not an algorithm.
• Type of ground truth used: Not applicable, as there's no diagnostic or screening study described.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document is a regulatory submission for a dental implant (3.25mm Spline® Twist™ Implant, HA Coated), asserting its substantial equivalence to existing predicate devices (Integral VI Biointegrated Dental Implant System, Small Diameter Spline Twist Implant, and Calcitek HA-Coated Endosseous Dental Implants). This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device.

The "study" in this context is the comparison made for substantial equivalence, which primarily focuses on design, materials, indications for use, and a comparison of their characteristics to demonstrate that the new device does not raise new questions of safety or effectiveness.

Key information from the document related to comparison/equivalence:

• Device Description: The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw-type endosseous dental implant for bone level placement. It features a straight body, external single lead thread design, helical cuts (flutes) for self-tapping, a Spline interface with six tines for anti-rotation, and a hydroxylapatite (HA) coating.
• Comparison Statement: "The new device is substantially equivalent to the predicate devices. The device's, general structure, and function in the endosseous implant system remains the same as the predicate devices." (Page A5-3)
• Specific Similarities Highlighted:
  • Design: Similar to the previously cleared Small Diameter Spline Twist Implant, including the Spline interface and its tines.
  • Body Dimensions: Body is "identical" to the Small Diameter Spline Twist Implant, with a .1240" (3.15mm) major diameter for single lead threads.
  • Material: Fabricated from the same 6AL-4V titanium alloy as the Small Diameter Spline Twist Implant and the Integral VI Biointegrated Dental Implant System, specified to ASTM B328 and ISO 5832-3.
  • HA Coating: Features the same HA coating as the predicate Integral VI Biointegrated Dental Implant System, applied via plasma spray and processed with hydro-thermal treatment (MP-1) similar to Calcitek HA-Coated Endosseous Dental Implants.
  • Prosthetics: Uses the same prosthetics (engaging and non-engaging abutments, copings) as the predicates, made from titanium alloy, gold alloy, and plastic.
  • Surgical Instruments: Will use similar surgical instruments, with an added 2.7 mm intermediate drill and utilizing existing taps and driving tools.
  • Indications for Use: The stated Indications for Use on page A5-2 are consistent with general dental implant applications (edentulous mandibles/maxillae for denture prostheses, bridgework, single tooth replacement, immediate or conventional loading under appropriate conditions).

In summary, the document serves as evidence for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study against predefined acceptance criteria for a novel device.

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The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.

The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.

The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional coping is not to exceed 28 days.

The new abutments have a prepared margin and cone shape. A prepared margin and cone shape top portion and an apex with a hex configuration with 1 degree tapered flats. . The taper on the cone of the abutment is 3 degrees. The cone of the abutment has a flat section for anti-rotation.

The Healing Cap is made to precisely fit the abutment for placement on the Abutment at the time of placement to protect the soft tissue during the healing process.

The provisional coping is made to precisely fit the abutments to allow for the placement of a provision crown on the abutment.

This document is a 510(k) Pre-Market Notification for a medical device (Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The 510(k) summary (pages 0-1) describes:

• Submitter's Information: Zimmer Dental Inc.
• Device Name: Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping
• Device Classification Name: Endosseous Dental Implant Abutment
• Predicate Device(s): Zimmer® Dental 3.5mm Hex-Lock Abutment (HLA3/3), Zimmer® Contour Healing Cap, Zimmer Contour Provisional Coping.
• Device Description: The new abutments have a prepared margin and cone shape, a hex configuration with 1-degree tapered flats, and a 3-degree cone taper with a flat section for anti-rotation. The healing cap and provisional coping are designed to precisely fit the abutments.
• Intended Use: (page 1)
  • Hex-Lock Short Abutment: Terminal or intermediate abutment for a cemented prosthesis (single or multiple-unit restoration).
  • Short Healing Cap: Used with the Short Hex-Lock Abutment to prevent soft tissue irritation and material lodging during healing.
  • Short Provisional Coping: Used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment, not to exceed 28 days of use.
• Device Comparison: (page 1) The new devices are described as "equivalent in design with Predicates" and "dimensional modifications" (shorter in overall height) to previously cleared devices. Materials, general structure, and function remain the same.

The FDA letter (pages 2-3) confirms the clearance of the device based on substantial equivalence to predicate devices, subject to general controls and applicable specific controls.

The "Indications for Use" form (page 4) reiterates the intended uses as described above.

Therefore, based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. This type of information (specific performance data, acceptance criteria, details of a clinical or non-clinical study) is typically found in the full 510(k) submission, not necessarily in the publicly available 510(k) summary or determination letter. The document explicitly states this is a "Special 510(k): Device Modification" and relies on substantial equivalence to predicate devices, implying that extensive new performance studies with acceptance criteria might not have been required beyond demonstrating that the modifications do not raise new questions of safety or effectiveness.

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