Search Results

S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.

The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).

Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:

• Indications for Use: The subject device's indications align with those of multiple predicate devices.
• Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
• Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.

Reported Device Performance (in terms of substantial equivalence):

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
• Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.

3. Number of Experts for Ground Truth and Their Qualifications

• Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.

4. Adjudication Method

• Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.

6. Standalone (Algorithm Only) Performance Study

• No. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

• Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.

8. Sample Size for the Training Set

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

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

• Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.

Ask a specific question about this device

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.

Ask a specific question about this device

The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.

The Essential Cone implants are fitted with an internal octagonal conical connection.

The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.

Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.

8mm Implants are not indicated for use as unitary implants and for immediate load.

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.

Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.

The relevant sections of the document are primarily focused on:

• Device Identification: Name, manufacturer, contact.
• Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
• Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
• Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
• Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.

Ask a specific question about this device