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Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.

The provided document is a 510(k) Summary for Intra-Lock® Dental Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set, ground truth, or expert review.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set ground truth cannot be extracted from this document.

The key phrases that indicate the nature of this submission are:

• "No new performance testing was conducted." This explicitly states that no new studies (clinical or non-clinical) were performed to establish performance metrics against acceptance criteria for this specific submission.
• "Mechanical bench testing of two previously identified Intra-Lock Dental Implant System worst-case scenario (i.e. smallest diameter implant / angled abutments), which remains applicable for the implants contained in this submission and was previously reviewed in K103194, April 21, 2011 and/or K111199, August 8, 2011." This indicates that any relevant performance testing was conducted for previous submissions (K103194, K111199) and is being referenced, not newly presented or detailed here.
• "Conclusion: Based on the data within this submission, the Intra-Lock dental implants are substantially equivalent to the predicate dental implants identified. The minor differences between proposed devices and the predicate devices raise no new issues of safety, risk to health or effectiveness." This reinforces that the goal is to demonstrate substantial equivalence, not to meet specific quantitative performance criteria through a new study.

In essence, this 510(k) submission relies on the established safety and effectiveness of its predicate devices and argues that the new device's differences do not introduce new risks, rather than providing new performance data against acceptance criteria.

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Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

The provided text describes the 510(k) summary for the Intra-Lock® 15° Angled Abutment, a dental device, and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.

The document focuses on:

• Device Identification: Name, common name, classification, and predicate devices.
• Intended Use/Indications: To support prosthetic devices with Intra-Lock® dental implants in partially or fully edentulous patients.
• Technological Characteristics: Narrow prosthetic interface (SQ Platform), magenta anodization.
• Mechanical Testing: Static and dynamic fatigue testing in accordance with ISO 14801:2007.
• Substantial Equivalence: Claim that the device is substantially equivalent to predicate devices based on design, materials, intended use, and operational principles, raising no new safety or effectiveness issues.

There is no mention of acceptance criteria related to algorithms, performance metrics like accuracy, sensitivity, specificity, or any studies involving AI/ML models, human readers, or ground truth establishment for such models.

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The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Intra-Lock Dental Implant System with Blossom." It describes a dental implant system and presents information to demonstrate its substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device itself is a dental implant, not an AI/ML powered device, therefore no information regarding AI/ML powered device acceptance criteria, study design or performance is available.

The relevant "Testing" section states: "Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device."

Therefore, the only acceptance criteria and study data provided relate to the physical properties of the dental implant, specifically its fatigue properties.

Here's the breakdown of the information that can be extracted, and where AI/ML related information is explicitly not present:

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for the fatigue testing. (e.g., how many implants were tested, how many cycles).
• Data Provenance: The standard used for testing is ISO 14801, an international standard. No information regarding country of origin of the data or whether it was retrospective or prospective is given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as the "ground truth" for a mechanical fatigue test is determined by the physical failure of the device, not expert opinion.

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

• This question is not applicable as there is no human adjudication involved in a mechanical fatigue test.

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

• This question is not applicable as the device is a physical dental implant, not an AI/ML powered device that would involve human readers or AI assistance.

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

• This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.

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

• The ground truth for the fatigue test is the physical failure or successful endurance of the dental implant under specific cyclic loading conditions, as defined by the ISO 14801 standard. This is a mechanical performance ground truth.

8. The sample size for the training set

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set."

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

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set" ground truth.

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