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The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.

LOCATOR® RTx Attachment System is compatible with the following implant systems.

LOCATOR® RTx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR® as a resilient attachment for endosseous implants. All LOCATOR RTx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.

This document describes the regulatory approval for a medical device called "LOCATOR® RTx". It is a Premarket Notification (510(k)) submission to the FDA. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than proving performance against specific acceptance criteria for a novel device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, performance data from a study, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for AI/ML device performance is not directly applicable or available in this type of regulatory submission for a dental implant abutment system.

Here's a breakdown of why the requested information isn't present and what is provided:

• Acceptance Criteria and Reported Device Performance (Table 1): This document does not list quantitative acceptance criteria or corresponding performance scores for the device's clinical efficacy or accuracy in the way an AI/ML device would. Instead, it demonstrates equivalence through design, materials, intended use, and compatibility with existing implant systems. The "performance data" refers to non-clinical testing.

  • What is provided: A comparison table (page 6) outlines design parameters (Abutment Diameter, Abutment Angle, Abutment/Implant Interface, Divergence Allowance, Prosthesis Attachment Type, Material) between the subject device (LOCATOR® RTx) and its primary and additional predicate devices. The "performance" is implicitly considered equivalent if these parameters are similar and non-clinical tests (sterilization, biocompatibility, coating characterization) pass.

• Sample sizes for test set and data provenance: Not applicable. This wasn't a clinical performance study with a test set of patient data. The "performance data" was non-clinical testing.

  • What is provided: Mention of non-clinical testing: "sterilization testing, biocompatibility testing of the TiCN coating, and characterization testing of the TiCN coating." No sample sizes for these tests are explicitly stated in this summary.

• Number of experts and qualifications for ground truth: Not applicable. Ground truth typically refers to objective labels for a dataset used to evaluate diagnostic or prognostic performance (e.g., confirmed disease status for an AI model). This is not that type of study.

• Adjudication method for the test set: Not applicable.

• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device or a device where human interpretation of medical images is involved.

• Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.

• Type of ground truth used: Not applicable in the context of an AI/ML device. For this device, "ground truth" might be considered to be established engineering specifications and material standards that the device must meet during manufacturing and testing.

• Sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."

• How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Acceptance (as presented in a 510(k) context):

The "acceptance criteria" for the LOCATOR® RTx are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through the following:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

2. Sample Sized used for the test set and the data provenance:
* As explained, this was a 510(k) for substantial equivalence based on design, materials, and non-clinical performance testing (sterilization, biocompatibility, coating characterization). There isn't a "test set" in the context of clinical data for performance evaluation. Data provenance would be from internal lab testing for the specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth in this context is based on established engineering and material science standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.

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 a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for demonstrating substantial equivalence and safety/effectiveness in a 510(k) for this type of device relies on:
* Compliance with recognized standards: ISO 17665 (sterilization) and ISO 10993 (biocompatibility).
* Comparison to predicate devices: The established safety and effectiveness of the primary and reference predicate devices serve as the benchmark.
* Engineering and materials specifications: Ensuring the device meets its design specifications and material properties.

8. The sample size for the training set:
* Not applicable. No "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:
* Not applicable.

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The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

Not Found

The provided document is an FDA 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed clinical study report addressing performance metrics.

Therefore, I cannot provide the requested information based on the given text.

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The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla.

The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.

Not Found

I apologize, but the provided text from the FDA 510(k) summary for the "X-2 Implant Bar and Distal Extension" does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The document is a letter from the FDA granting substantial equivalence for a dental implant abutment system, allowing it to be marketed. It includes:

• Trade/Device Name: X-2 Implant Bar and Distal Extension
• Regulation Number and Name: 872.3630, Endosseous Dental Implant Abutment
• Regulatory Class: II
• Product Code: NHA
• Indications for Use: Details for the X-2 Implant Attachment, X-2 Bar Attachment System, and X-2 Distal Extension Attachment System.

The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance outcomes for new devices. The letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

Therefore, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, MRMC study, or standalone performance) from the provided text as it focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The Locator Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for a dental device, specifically "Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-to Female." It states that the device is substantially equivalent to legally marketed predicate devices.

The information requested in the prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not contained within this FDA letter.

This letter is a regulatory approval document confirming substantial equivalence based on information submitted by the manufacturer. It does not typically detail the specific performance testing, acceptance criteria, or study methodologies that led to that determination. These details would be found in the 510(k) submission itself, which is a separate document and not provided here.

Therefore, I cannot provide the requested table and study details based on the input document.

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The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The Locator Implant Anchor is an abutment for endosseous implants.

Here's an analysis of the provided text regarding the Locator Implant Anchor, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Removal Retention Force: The sample size is not explicitly stated. It mentions "Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor," implying that multiple measurements were taken for each device, but the number of devices or measurements is not provided.
• Fatigue Strength: The sample size for fatigue testing is not explicitly stated. It refers to "the Angle Correction Base," indicating a specific component was tested.
• Data Provenance: Not specified. The document does not indicate the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable to this submission. The device is a physical medical device (implant abutment), and the testing described involves objective physical measurements (retention force, fatigue strength) rather than subjective expert assessment of data like images or patient outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable. As a physical device with objective measurements, there is no need for expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This information is not applicable. The device is an implant abutment, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable. The device is a physical implant abutment and does not involve an algorithm.

7. The Type of Ground Truth Used

• The ground truth for the performance testing is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.
  • For removal retention force, the ground truth is the direct measurement of force required to remove the anchor.
  • For fatigue strength, the ground truth is the direct measurement of the force sustained after a specified number of cycles.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The comparison is made against a predicate device.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no training set for this device.

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