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BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

BIOMET 3i Osseotite and NanoTite dental 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 chewing function.

BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface, both with and without the additional proprietary NanoTite treatment. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Implants are also offered in various diameters and length.

This looks like a 510(k) premarket notification for a dental implant. 510(k)s generally demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria with detailed studies like those of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training data is not applicable to this type of submission.

Instead, the submission focuses on demonstrating that the BIOMET 3i Dental Implants have technological characteristics and intended uses that are substantially equivalent to already legally marketed predicate devices. The "Performance Testing" section mentions:

• Laboratory testing: Conducted to determine device functionality and conformance to design input requirements and FDA's Class II special controls guidance document.
• Risk analysis: Conducted in accordance with ISO 14971.
• Results: Included in the premarket notification submissions for the predicate device.

The FDA's decision letter also confirms that they have determined the device is "substantially equivalent" to legally marketed predicate devices.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i OSSEOTITE® Certain® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for internal hex connections. Additionally, the implants are offered in an expanded platform, lateralized design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. Size appropriate cover screws are offered with each implant.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the 3i OSSEOTITE® Certain® Dental Implants in the format requested.

Instead, the document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance" section explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." However, no specific results, acceptance criteria, or a detailed study design from this laboratory testing are provided.

The text also refers to previous 510(k) clearances for specific performance claims (enhanced performance in poor bone, early loading, use in smokers, immediate loading) based on "OSSEOTITE clinical data in the respective submissions." However, the details of these studies and their acceptance criteria are not included in this document.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert opinions, or MRMC studies because this information is not present in the provided text. The document's purpose is to show substantial equivalence, not to present a detailed performance study against specific acceptance criteria.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i OSSEOTITE® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for external hex connections. Additionally, the implants are offered in a trans-gingival design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. size appropriate cover screws are offered with each implant.

The provided text is related to a 510(k) premarket notification for "3i OSSEOTITE® Dental Implants." However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with numerical results.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the new device is substantially equivalent to previously cleared predicate devices (K874590, K935544, K972444, K980549, K983347, K992334, K014235, K022009, K030164, K033430, K051461).
• Performance Testing: It states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971."
• Previous Clinical Data: It mentions that "Specific performance claims for enhanced performance in poor bone (K980549), early loading (K983347), and use in smokers (K022009), and immediate loading (K030164) have received market clearance based on the OSSEOTITE clinical data in the respective submissions." This indicates that clinical data from previous submissions was used to support specific claims, but no new study details or acceptance criteria for this specific 510(k) submission are presented..

Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The document relies on substantial equivalence to previously cleared devices and refers to prior clinical data from those predicate devices for performance claims, rather than presenting new acceptance criteria and a study to meet them for this specific 510(k).

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3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.

The Conical Angled Abutments are designed to interface with 3i's internal and external connected implants. They will be available in 17° and 25° angles. The seating surface will be 4.1mm and 5.0mm diameters and the transmucosal tissue heights will be 2.0mm and 4.0mm. They will be manufactured out of Titanium Alloy.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental device (Conical Angled Abutments), and it primarily focuses on describing the device, its classification, predicate devices, and an FDA letter confirming substantial equivalence.

It explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act." This indicates that the approval for this device was based on substantial equivalence to a legally marketed predicate device, rather than meeting specific performance criteria demonstrated through a clinical study.

Therefore, I cannot provide the requested table or details about studies, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given text.

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3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The Certain PREVAIL Implants are parallel walled, straight collared internally connected implants with a lateralized seating surface. They will be available in lengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameters will be 4.0 and 5.0mm. The collar diameters will be 4.1mm for the 4.0mm diameter implants and 5.0mm for the 5.0mm implants. The seating surface will lateralize back to 3.4mm for the 4.0mm diameter implants, and 4.1mm for the 5.0mm implants. The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136.

The provided text is a 510(k) premarket notification for a medical device (Certain™ PREVAIL™ Implants). It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one would find in a clinical trial or a standalone AI/software device submission.

Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is not present in the provided document.

However, I can extract the information that is available and highlight what is missing based on the nature of this type of submission.

Here's the breakdown of what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

This submission is a 510(k) for an implantable dental device, not a software or AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device (OSSEOTITE® IOL Dental Implants), rather than meeting specific numerical performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.

The device performance is described in terms of its technological characteristics being similar to the predicate.

Study Details (as applicable for this type of submission)

Given this is a 510(k) for a physical implant, the concept of a "study" with test sets, ground truth, and experts as if it were an AI/software device is not directly applicable. Substantial equivalence for such devices often relies on comparisons of design, materials, manufacturing processes, and potentially non-clinical testing (e.g., mechanical, biocompatibility) rather than clinical studies in the sense of comparing performance characteristics against a ground truth dataset.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of data. The "test" is demonstrating equivalence through a comparison of device characteristics, not patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set of data is established in this summary. The FDA reviewers (experts in regulatory review) assess the submission for substantial equivalence.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in a 510(k) for a physical device is generally the established safety and effectiveness of the predicate device. The new device is compared against this standard.
7. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or mandible and splinted in the anterior region, immediate loading is indicated.

The NanoTite Dental Implants, hereinafter referred to as NanoTite Dental Implants, are the same dental implants referred to as "3i Nano CaP OSSEOTITE" Dental Implants, subject of the predict device submission K051461. The NanoTite Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nanometer scale crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections.

This document is a 510(k) Premarket Notification for the NanoTite™ Dental Implants. It seeks to demonstrate substantial equivalence to previously cleared predicate devices (K051461). The nature of this submission is not for an AI/ML device, therefore the requested information regarding acceptance criteria, study data, and ground truth for an AI/ML device is not applicable.

The document describes a medical device (dental implants) and its intended use, and it relies on established engineering and materials performance testing rather than clinical study of an AI algorithm.

Here's an explanation of why the requested AI/ML specific information cannot be extracted from this document:

• No AI/ML Component: The submission describes a physical medical device (dental implants) that is treated with a specific surface technology (nanometer scale crystals of calcium phosphate). There is no mention of any artificial intelligence, machine learning, or software algorithm that provides diagnostics, prognostics, or treatment recommendations.
• Performance Testing for Physical Device: The "Performance Testing" section states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Results from all of these tests were included in the premarket notification submission for the predicate devices, K051461." This indicates that the performance data refers to physical and biological compatibility testing of the implant itself, not the performance of an AI algorithm.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate substantial equivalence to the predicate device (3i OSSEOTITE Dental Implants, K051461). This involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This is a common regulatory pathway for non-AI/ML devices.

Therefore, the questions regarding acceptance criteria, study details, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for an AI/ML device are not applicable to this 510(k) submission.

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The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance™ Abutment Posts and Temporary Cylinders will be made of the same material (PEEK) as the predicate PreFormance™ Posts and Temporary Cylinders. The posts will be available in both straight and 15° pre-angled configurations while the cylinders will be straight. The cylinders will have either a hexed or non-hexed connection. The hexed connection is for single unit prostheses while the non-hexed is for multi use. The posts and cylinders will connect to 3i's externally connected implants.

This 510(k) summary (K061969) is for a dental device, specifically "PreFormance™ Abutment Posts and Temporary Cylinders." It is a submission seeking clearance for a modified version of an already marketed device, primarily concerning the connection to the implant.

It's important to note that this document does not describe a study proving the device meets acceptance criteria. Instead, it's a 510(k) summary which details the device, its intended use, and argues for its substantial equivalence to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not present in this type of regulatory document. The FDA clearance for this device hinges on its similarity to already approved devices, not on a new, comprehensive performance study with acceptance criteria as typically understood for new major medical devices.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance (Not directly available in this document)

This document does not specify quantitative acceptance criteria or report device performance against such criteria. The submission aims to demonstrate substantial equivalence to previously cleared devices based on similar materials, technological characteristics, and intended use, rather than presenting a de novo performance study with defined acceptance metrics.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Not applicable/Not provided. This 510(k) summary does not describe a performance study with a test set. The argument for substantial equivalence is based on design, materials, and intended use comparison.

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

• Not applicable/Not provided. No specific performance test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

• Not applicable/Not provided. No adjudication method for a test set is described.

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/Not provided. This device is a physical dental implant accessory, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not applicable/Not provided. No performance study with a defined ground truth is presented in this document. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not provided. As above, no training set or ground truth establishment for a training set is relevant for this device.

Summary of what the K061969 document does provide:

• Device Description: PreFormance™ Abutment Posts and Temporary Cylinders made of PEEK, available in straight and 15° pre-angled configurations (posts), and straight with hexed or non-hexed connections (cylinders). They connect to 3i's externally connected implants.
• Intended Use: Accessory to endosseous dental implants to support single and multiple unit prostheses in partially or fully edentulous patients, for up to 180 days during healing, for non-occlusal loading of provisional restorations.
• Technological Characteristics: Similar to predicate devices, with the sole modification being the connection to the implant (external hexed design for the modified device vs. internal connection for the predicate).
• Predicates: PreFormance™ Posts (K053170) and PreFormance™ Temporary Cylinders (K060291).
• Conclusion for Clearance: The device is "substantially equivalent" to the legally marketed predicate devices, based on similar materials, indications for use, and technological characteristics (with the noted connection modification). This "substantial equivalence" is the basis for its regulatory clearance, meaning it is deemed as safe and effective as the existing devices without requiring new extensive clinical trials to prove efficacy from scratch.

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The Provide Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be cement retained to the abutment.

The Provide Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The cylinder is cemented onto an abutment. An acrylic resin provisional restoration can be built onto the cylinder. The height of these cylinders will be 6.5mm and the platform diameters are 4.8 and 6.5mm. Furthermore, they will be used as single use to support a single-unit restoration and multi use where two or more cylinders are splinted together to support a provisional multi-unit restoration

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Provide Temporary Cylinders" device:

Based on the provided K061177 document, the information available does not describe a study involving detailed acceptance criteria and performance metrics typically associated with AI/software devices or clinical effectiveness studies. This submission is for a physical dental implant component, a device modification, and relies on substantial equivalence to a predicate device.

Therefore, many of the requested categories for AI/software device evaluation (like sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's a breakdown of the available information in relation to your request:

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

Study Proving Acceptance Criteria:

The "study" proving the acceptance criteria here is a Substantial Equivalence determination based on comparison with a predicate device (PreFormance Posts, K053170). The submission does not contain explicit details of a clinical study or performance testing with quantitative acceptance criteria for this specific device modification. Instead, it leverages the established safety and effectiveness of the predicate device.

The lack of specific performance standards is explicitly stated: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act."

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

• Not Applicable. This submission does not describe a clinical or performance test set in the way an AI/software device would. The evidence is a comparative analysis to a predicate device based on material, function, and indication for use.

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. There's no "ground truth" to be established by experts in the context of a dataset for this type of physical device's substantial equivalence pathway. The "ground truth" is effectively the regulatory approval and established performance of the predicate device.

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

• Not Applicable. No test set or adjudication method described for a clinical or performance study.

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 a physical dental implant component, not an AI or imaging device. Therefore, no MRMC study would be performed.

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

• Not Applicable. This is a physical dental implant component, not an algorithm or software.

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

• For this type of 510(k) submission, the "ground truth" for demonstrating safety and effectiveness is the established safety and effectiveness of the legally marketed predicate device (PreFormance Posts, K053170), to which the new device is compared for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

• Not Applicable. No training set for an algorithm is involved.

In summary: K061177 describes a submission for a physical medical device modification (dental implant accessory). Its approval is based on demonstrating substantial equivalence to a previously cleared predicate device, rather than a new clinical study with specific acceptance criteria, test sets, or ground truth defined for an AI/software product. The listed "performance" in the document explicitly states that formal performance standards have not been established by the FDA for this class of device under the given section of the Act.

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The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The temporary cylinders have a material retention feature located on the cylinder body area, whereas the posts do not have this feature on the post body.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the "PreFormance™ Temporary Cylinders" device:

This document is a 510(k) Premarket Notification for a device modification, specifically for "PreFormance Temporary Cylinders." The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a PMA (Pre-Market Approval) or some de novo classifications might require.

Therefore, the information for many of your requested points will be "Not Applicable" or "Not Provided" because the nature of a 510(k) submission for a device modification typically focuses on showing that the modified device is as safe and effective as its predicate without the need for extensive new clinical performance studies. The "study" here refers to the comparison against the predicate device rather than a de novo clinical trial with specific performance metrics.

Acceptance Criteria and Device Performance for PreFormance™ Temporary Cylinders

Given that this is a 510(k) submission demonstrating substantial equivalence based on a modification of an existing device, the "acceptance criteria" are primarily related to material, design, and functional similarity to the predicate device, thereby inferring similar performance. Performance standards have not been established by the FDA for this type of device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable / Not provided. This 510(k) does not describe a clinical "test set" in the context of a performance study with human subjects. The evaluation is based on a comparison to the predicate device and potentially engineering analysis or bench testing (which is not detailed in this summary).
• Data Provenance: Not applicable / Not provided for a clinical test set. The submission is a comparison to the company's own predicate device (PreFormance Posts).

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

• Number of Experts: Not applicable / Not provided. Ground truth in the context of a clinical performance study with expert adjudication is not part of this 510(k) submission.
• Qualifications of Experts: Not applicable / Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable / Not provided. No human subject test set or adjudication process is described.

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

• MRMC Study Done?: No. This type of study is not relevant to a device modification 510(k) submission that demonstrates substantial equivalence primarily through material and functional similarity to a predicate.
• Effect Size of AI Improvement: Not applicable. AI is not mentioned or implied in this device or its evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Done

• Standalone Performance Done?: No. This device is a physical dental accessory, not an algorithm or software. Its performance is inherent in its physical properties and interaction with dental implants and prosthetics.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (PreFormance Posts, K053170). The current device is compared against this known performance and characteristics.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/ML device or a device requiring a clinical trial with a training phase.

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

• How Ground Truth Was Established: Not applicable / Not provided. As there's no training set, this is not relevant. The "ground truth" for the substantial equivalence claim relies on the FDA's prior clearance of the predicate device.

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The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance Post will be shaped similar to the currently marketed GingiHue Post. However, the PreFormance Post will be made of PEEK with a titanium insert. The posts will be available in straight and 15° pre-angled configurations. The collar height on the PreFormance Post will be 4mm and 6mm and the post height will be 7mm.

This 510(k) Premarket Notification for the PreFormance™ Post from Implant Innovations, Inc. is for a dental abutment, which is a mechanical device. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through design characteristics and performance testing in a laboratory setting, rather than clinical study data involving human or AI performance.

Therefore, many of the typical elements of an acceptance criteria and study description related to AI or diagnostic device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable here.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy, as it pertains to a mechanical device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to existing predicate devices (GingiHue Abutments and GingiHue Pre-Angled Abutments) and conformance to relevant standards.

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

This is not applicable. The "Performance Testing" described is laboratory testing of the mechanical device, not a study involving patient data or clinical samples. There is no mention of a "test set" in the context of diagnostic performance or AI evaluation.

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

This is not applicable. Ground truth as typically understood for diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission. The "ground truth" here is the engineering specifications, material properties, and functional performance measured against established standards.

4. Adjudication method for the test set

This is not applicable, as there is no "test set" in the context of human or AI assessment requiring adjudication.

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 is not applicable. The device is a dental abutment, not an AI software or a diagnostic tool that involves human readers.

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

This is not applicable. The device is a physical dental abutment, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Engineering specifications and design input requirements: The device is rigorously designed to meet specific dimensions, material properties, and functional characteristics.
• Performance standards: Conformance to relevant national and international standards applicable to dental implants and abutments (e.g., FDA Class II Special Controls Guidance Document, ISO 14971 for risk management).
• Predicate device characteristics: The GingiHue Posts serve as a benchmark for "similar functionality" and "identical...performance characteristics."

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI or machine learning device. The design, manufacturing, and testing processes for mechanical devices do not involve a training set in this context.

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

This is not applicable. (See #8).

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