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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® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar@ consists of an implant adapter (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

Here's a breakdown of the acceptance criteria and study information for the SFI-Bar® based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a separate "test set" and its sample size in the context of clinical data for the SFI-Bar®. The performance evaluation relies on non-clinical test data.

Data Provenance: The testing was conducted as part of a 510(k) submission, originating from Switzerland (Cendres + Métaux SA, Biel/Bienne, Switzerland). The data is retrospective in the sense that it's an evaluation against established performance metrics and comparison to predicate devices, rather than a prospective clinical trial.

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

This information is not provided as the ground truth for this device's performance evaluation was based on engineering and performance testing rather than expert-derived clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human interpretation or adjudication processes like those in clinical image analysis studies. The adjudication for performance was based on meeting technical specifications from engineering tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the SFI-Bar®.

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

This concept is not applicable to the SFI-Bar®. The device is a physical dental abutment, not an algorithm. The performance evaluation was of the physical device's mechanical properties and function.

7. The Type of Ground Truth Used

The ground truth for evaluating the SFI-Bar®'s performance was based on:

• Engineering specifications and standards: Adherence to established mechanical properties (e.g., torque, application, functional requirements).
• Performance characteristics of predicate devices: The SFI-Bar® was compared for substantial equivalence to legally marketed predicate devices, meaning their established safe and effective performance served as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The SFI-Bar® is a physical medical device, not an AI/ML algorithm that requires a "training set."

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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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 SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving compliance for the SFI-Bar® device:

The provided document describes the 510(k) premarket notification for the SFI-Bar® device, a dental implant abutment. It seeks to establish substantial equivalence to predicate devices, rather than proving performance against novel acceptance criteria in a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar® and that acceptance criteria were met. However, the document does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating equivalence to the predicate device.

The "Performance Data" section mentions:

• Validation of Sterilization for metallic components.
• Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G.
• Application and functional testing based on literature research.

The key acceptance criterion seems to be: "The SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®."

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

The document explicitly states: "Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary."

This indicates that a "test set" in the sense of a patient cohort or a large sample for a clinical trial was not used for this submission. The testing performed was non-clinical.

• Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing. The "test samples" mentioned in the context of "analysis of platforms to identify worst-case test samples" would likely refer to physical samples or configurations chosen for non-clinical engineering tests (e.g., sterilization, disinfection). The specific number of these non-clinical worst-case samples is not provided.
• Data Provenance: The submission is from Cendres+Metaux SA, Biel/Bienne, Switzerland. The non-clinical testing was conducted by the manufacturer, but the location where the tests were performed is not specified. The data is retrospective in the sense that it's based on existing designs and literature, and performed prior to this submission for regulatory clearance.

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

Not applicable. As clinical testing was not performed and the submission relies on demonstrating substantial equivalence through non-clinical data and comparison to predicate devices, there was no "ground truth" to be established by experts in a clinical context for a test set. The validation and evaluation mentioned primarily concern manufacturing processes and materials.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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 device is a dental implant abutment, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the nature of the device and the submission, the "ground truth" relied upon is primarily:

• Engineering and material standards (e.g., ASTM F 136 for Titanium alloy).
• Performance characteristics of legally marketed predicate devices (K073628, K083876, K102382) as established through their prior regulatory clearances.
• Scientific literature research supporting application and functional principles.
• Validation of manufacturing processes (sterilization, cleaning).

There isn't "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The submission for the SFI-Bar® focuses on demonstrating substantial equivalence to existing predicate devices, leveraging non-clinical testing, material standards, and literature review. It does not involve new clinical trials, expert consensus, or AI performance metrics.

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The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.

The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

The provided text describes a 510(k) submission for the SFI-Bar® Abutment, a dental device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The acceptance criteria were met" and that the "SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." The performance characteristics evaluated are generally described.

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

• Sample Size: The document does not specify the exact sample sizes used for the torque tests, application testing, or functional testing. It only states that these tests were conducted.
• Data Provenance: The data is non-clinical test data. The country of origin of the data is not explicitly stated, but the applicant (Cendres+Métaux SA) is located in Switzerland. The testing was conducted to support a 510(k) submission to the FDA (USA). The study is retrospective in the sense that it relies on existing testing methodologies and comparisons to a previously cleared predicate device.

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

This information is not applicable (N/A) as the study described is a non-clinical, bench testing study comparing the performance of a new device to a predicate device. There is no "ground truth" derived from expert review of cases or outcomes in a clinical context. The "ground truth" for the testing would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not in bench testing of a dental implant abutment.

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 information is not applicable (N/A). The device described, the SFI-Bar® Abutment, is a physical dental implant component, not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

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

This information is not applicable (N/A). As mentioned in point 5, this is a physical dental device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of non-clinical device testing is engineering specifications, validated test methods, and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the candidate device performs "as well or better than" the predicate device under the same test conditions. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense for this specific evaluation. The "worst-case test samples" were identified through analysis of platforms, indicating an engineering-based approach to defining test parameters.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no concept of a "training set" in the context of this non-clinical bench testing for a physical dental device. Training sets are relevant for machine learning algorithms or similar data-driven models.

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

This information is not applicable (N/A), as there is no training set for this type of device submission.

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The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.

The SFI Bar consists of the following variants:

SFI-Bar® 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region

SFI-Bar® 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region

Not Found

I'm sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental implant abutment (SFI-Bar®), which primarily focuses on its substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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