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The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.

The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.

Here's a breakdown of the acceptance criteria and the study information for the ORA Implant Abutment System, based on the provided text:

ORA Implant Abutment System

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., specific thresholds for force, displacement, or reliability percentages). Instead, the acceptance criterion for the ORA Implant Abutment System is substantial equivalence to its predicate devices in terms of design, materials, intended use, operating principles, and manufacturing.

The reported device performance is that it meets this criterion through application and functional testing.

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

The document mentions "non-clinical test data" and "application and functional testing" to evaluate performance characteristics.

• Sample Size for Test Set: Not explicitly stated as a number of devices tested. The testing involved "tolerance analysis of platforms to identify worst case test samples." This suggests a selection of representative samples based on design variations, rather than a large statistical sample size of identical units.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal (conducted by or for Sterngold Dental, LLC) and is retrospective in the sense that it's comparing a new device to existing predicate devices' performance characteristics, rather than collecting new clinical data.

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

This section is not applicable as the study described is non-clinical performance testing for substantial equivalence, not a study involving human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the described study is non-clinical performance testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary." The comparison is for substantial equivalence to predicate devices based on technical characteristics and non-clinical performance.

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

This question is not applicable as the ORA Implant Abutment System is a physical medical device (implant abutment), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is demonstration of equivalent performance characteristics to legally marketed predicate devices through non-clinical testing. The predicate devices themselves represent established safe and effective designs in the market.

8. The Sample Size for the Training Set

This section is not applicable as the ORA Implant Abutment System is a physical device and no machine learning algorithm was described that would require a "training set."

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

This section is not applicable for the same reasons as point 8.

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The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.

The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.

There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.

The devices are supplied non-sterile, therefore there is no shelf life.

The provided document is a 510(k) Premarket Notification for the SFI Bar® Implant Abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested categories for device performance, ground truth, and comprehensive study details are not applicable or available in this type of regulatory submission. The document primarily describes non-clinical testing to support the claim of equivalence.

Here's a breakdown based on the available information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated as numerical counts of products tested. The document mentions "tolerance analysis of platforms -to-identify-worst-case-test-samples" which implies selected samples were tested, but the exact number isn't provided.
• Data Provenance: Not specified. Given it's a US-based company submitting to the FDA, it's highly probable the testing was conducted in the US, but this is not explicitly stated. The testing is described as non-clinical, likely laboratory-based.
• Retrospective or Prospective: Not applicable, as this refers to clinical studies, and only non-clinical testing was performed.

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)

• Number of Experts & Qualifications: Not applicable. Non-clinical testing for equivalence does not typically involve expert consensus to establish a "ground truth" in the way clinical studies do. The "ground truth" for material specifications and performance would be established by engineering standards and internal company specifications.

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

• Adjudication Method: Not applicable. This concept is relevant to clinical studies involving human interpretation or subjective assessments. Performance testing of abutments involves objective measurements against engineering specifications.

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

• MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is a dental implant abutment, not an AI-powered diagnostic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. The device is a mechanical component (dental abutment), not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be engineering specifications, material standards (like ASTM F136), and validated test methodologies to assess physical properties and fit. There is no biological "ground truth" in the context of this 510(k) submission.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The device is a manufactured medical device, not an AI/ML model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment. The implant abutments fit Nobel Biocare Brånemark System®. Nobel Biocare (Steri-Oss®), Keystone (Lifecore), 3i Implant Inovations®, Sterngold-ImplaMed®, Interpore IMZ™, Osstem, Zimmer (Paragon, Centerpulse), OIC, IMTEC Corporation®, MIS Implants, Minimatic/Stryker, Bud, Straumann, Biolok International, INNOVA, Implant Direct, Zimmer (Calcitek® Centerpulse), BioHorizons®. See table 1 for platform compatibility.

There are seven (7) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [A], [B], [C], [S], [X], [X], [Z]. Table 1 specifies which dental implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant. The devices are supplied non-sterile, therefore there is no shelf life.

The provided text describes the SFI Bar® Implant Abutments, a medical device for dental use. It outlines the device's characteristics and its equivalence to predicate devices, supported by non-clinical performance data.

Here's an analysis of the acceptance criteria and study information, based only on the provided text, and noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The text only mentions "Test samples torqued above 50 Ncm".
• Data provenance: The studies were non-clinical tests conducted by the manufacturer, Sterngold Dental, LLC. The country of origin is not explicitly stated. It is a retrospective analysis of the device's performance against established standards and predicate devices.

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

• Number of experts: Not applicable for this type of testing. The 'ground truth' for mechanical performance tests like torque is typically defined by engineering specifications and industry standards rather than expert consensus on subjective evaluations.
• Qualifications: Not applicable.

4. Adjudication method for the test set:

• Not applicable. Mechanical tests for medical devices are typically assessed against pre-defined quantitative thresholds and standards, not through adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for diagnostic imaging or similar devices where human readers interpret results. This device is a dental implant abutment, and its performance is evaluated through mechanical testing.

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

• Yes, in essence. The testing described ("Torque tests, application and functional testing") is a standalone assessment of the physical device's performance characteristics. This is a mechanical device, not an algorithm, so the "standalone" concept translates to evaluating the device itself without human intervention affecting its inherent mechanical properties.

7. The type of ground truth used:

• Engineering specifications and regulatory guidance. The ground truth for this device's performance, particularly torque, is based on "implant manufacturer's recommended torque value" and likely general engineering standards for mechanical strength and durability. The evaluation also refers to "FDA guidance 'Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'"

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" here would refer to the design and manufacturing processes, which are guided by established engineering principles and past experience with similar devices (the predicate devices).

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

• Not applicable. As noted above, this is not an AI/ML algorithm. The "ground truth" for the design and manufacturing of such a device is rooted in engineering principles, material science, and regulatory standards for dental implants and abutments. The text states, "The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures," and they conform to "ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy."

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The ERA® Micro 23° and 30° Females are intended to be used as a retention device in conjunction with the Sterngold Acid Etch Dental Implant System in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

The ERA® Micro 23° and 30° Female Abutment is a prosthetic component intended to facilitate functional parallelism of the ERA® Females despite diverging implants during prosthetic rehabilitation. It is intended to be used in conjunction with the Sterngold Acid Etch Dental Implant System in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

It is intended to support single and multiple tooth prostheses in the mandible or maxilla. It is provided in a 3.22mm diameter and two angles (23° and 30°).

These devices have a two piece design configuration; the two-piece assembly consists of a straight base which has a screw post that gets engaged into the internal threading of the dental implant and an angled female, which allows the user to achieve functional parallelism with divergent implants.

The ERA® Micro 23° and 30° Female Abutment is manufactured from the same materials as the predicate devices. The specification for the material used to manufacture the ERA® Micro 23º and 30º Female is 6AL-4V ELI titanium classified as ASTM F136-11. The female receptacle of the ERA® Micro 23° and 30° female abutment, which resides at or above the gingival crest and couples with the Stern ERA System male attachments, is coated with titanium nitride (TiN), which has been cleared under K921010. No coating is applied to snap-in post of the angled female insert or the bases.

These devices are supplied non-sterile in a sealed pouch including instructions for use. Instructions for Use indicate recommended method of sterilization prior to use. These parts are packaged individually.

The provided text describes the K130408 ERA® Micro 23° and 30° Female Abutment, a dental implant component. This submission is a traditional 510(k) for a Class II device. The acceptance criteria and the study that proves the device meets them are outlined in the performance testing section.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions that "Samples were tested with the implants long axis at 40° angle of correction." However, it does not specify the exact number of samples used for the fatigue testing. It also states that testing was "conducted on a 30° angled female abutment and a small diameter (3.75mm) Sterngold Acid Etch Dental Implant finished product. This was determined to be the worst case scenario, largest angle, smallest diameter implant." This implies that a representative sample of the "worst-case" configuration was tested, but the precise sample count is not provided.
• Data Provenance: Not explicitly stated, as this is a laboratory performance test rather than a clinical study with patient data. The testing was conducted by Sterngold Dental, LLC.

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

• This information is not applicable as the study described is an in-vitro mechanical performance test (fatigue testing) and not a clinical study involving human readers or expert-established ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the study described is an in-vitro mechanical performance test and does not involve adjudication of expert readings.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this submission. This is a premarket notification for a dental abutment, focusing on material and mechanical equivalence rather than diagnostic performance assessed by human readers.

6. Standalone Performance Study

• No, a standalone (algorithm only without human-in-the-loop performance) study was not conducted or described. This entire submission is for a medical device (dental abutment), not a software algorithm. The "performance testing" described refers to the mechanical integrity of the device itself.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering and mechanical standards (ISO 14801:2007 and FDA Guidance for Class II Special Controls for Root-form Endosseous Dental Implants). The "truth" is whether the device withstands the specified mechanical forces and fatigue cycles without failure, demonstrating sufficient strength for its intended clinical application.

8. Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is a device and material equivalence submission, not an AI/ML algorithm.

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

• This information is not applicable for the same reason as point 8.

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The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.

The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.

"The provided text does not contain information about studies related to AI/ML device performance or acceptance criteria in the typical sense for such devices. The document is a 510(k) summary for a dental implant system (Stern IC Dental Implant System).

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This document
   focuses on substantial equivalence to predicate devices, not performance criteria
   against a defined benchmark.
2. Sample size used for the test set and the data provenance: Not applicable as
   there is no discussion of a test set for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the
   qualifications of those experts: Not applicable.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was
   done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data,
   etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details the substantial equivalence of the Stern IC Dental Implant
System to predicate devices based on material, design, surface treatment, and intended
use. The study described is a non-clinical testing to demonstrate appropriate
performance for the proposed indications for use, following "Guidance for Industry and
FDA Staff - Class 11 Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments."

Specifically, the non-clinical testing involved:

• SEM photographs: To show removal of all residue of the blasting material from the surface.
• Surface chemical analysis: To confirm no contaminants are left on the surface (conducted on the final device).

It states that fatigue testing was not required because design and technological features are substantially equivalent to predicate devices. The conclusion is based on an analysis of intended use, material, design, and performance being substantially equivalent to the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Straumann ITI Dental Implant System (K012757))."

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