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ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm
• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular)
• · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP
• · Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm.

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

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

• Test Set Sample Size:
  • The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
• Data Provenance:
  • The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
  • The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

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

• This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
• The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

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

• This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

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, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

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

• For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
• For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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 for Test Set: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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)

• This is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering standards.

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 an endosseous dental implant abutment, not an AI diagnostic tool.

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 component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

Ask a specific question about this device

CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• CEREC Cercon 4D™ Abutment Block
• TiBase
• CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.

The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.

Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.

Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set:
  • For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
  • For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
  • For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.

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

Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).

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 not an AI-assisted diagnostic device; therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.

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

The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not have a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" in the context of machine learning.

Ask a specific question about this device

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant Systems: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Straumann® Bone Level SC Implant System, BioHorizons® Tapered Internal Implant System and MIS® C1 Implant System. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to fabricate one-piece, alltitanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is prescribed by a clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 and used in conjunction with the OEM BioHorizons® Tapered Internal and OEM MIS® C1 multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided text describes a medical device called "Inclusive® Titanium Abutments" and details its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The document is a 510(k) summary for a dental implant abutment, which is a physical component, not a software device or an AI/ML powered device. The "performance data" section focuses on physical and material properties (Biocompatibility Evaluation, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, Use in MR Environment) to demonstrate substantial equivalence to a predicate device, as opposed to functional performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document discusses performance related to physical properties and material compatibility, not AI/ML metrics.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device.
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: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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: Not applicable in the AI/ML sense. "Ground truth" here relates to established standards for material science and dental mechanics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to patientspecific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:

• · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
• · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
• · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
• · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
  All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase Screw for fixation to the implant body.
TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes a 510(k) premarket notification for two dental devices, TruAbutment DS and TruBase. The submission asserts substantial equivalence to a predicate device based on material, intended use, and mechanical testing. The document focuses on regulatory compliance and mechanical performance, rather than clinical efficacy measured by expert assessments or comparative effectiveness studies with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental implants and abutments and ensuring mechanical integrity. The reported performance indicates that the devices met these criteria.

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

• Test Set Sample Size: The document does not explicitly state a sample size for the mechanical fatigue testing beyond "worst-case constructs." For other tests (sterilization, biocompatibility, MRI review), specific sample sizes are not provided, though these are typically laboratory-based tests rather than patient-data-based studies.
• Data Provenance: The document does not specify the country of origin for any data or whether the data is retrospective or prospective. The studies mentioned (e.g., fatigue testing, sterilization) are engineering and laboratory tests, not clinical studies involving patient data.

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

This information is not applicable to the provided document. The studies described are non-clinical (mechanical, sterilization, biocompatibility, MRI safety) and rely on testing against established engineering and safety standards, rather than expert interpretation of a 'ground truth' in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical laboratory tests and material/design assessments, not studies involving human judgment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission relates to dental abutments, which are physical medical devices, and does not involve AI or image-based diagnostics requiring human reader performance studies.

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

This information is not applicable. The device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is based on:

• Established international and national standards (e.g., ISO 14801, ISO 17665, ISO 10993, ASTM F-136, ANSI/AAMI ST79).
• Engineering specifications and design limits (e.g., minimum thickness, maximum angle for abutments).
• Physical measurements and compatibility assessments (e.g., dimensional analysis and reverse engineering of implant-to-abutment connections).
• Scientific rationale and published literature for MRI safety.

8. The Sample Size for the Training Set

This information is not applicable. The devices are physical dental abutments, not AI models that require training data.

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

This information is not applicable as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of physical medical devices through adherence to established engineering and safety standards, rather than clinical performance based on human reader assessments or AI model evaluations.

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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Titanium Coping, Temporary Cap, abutment screws, the Smileloc Activator (or Smileloc Remover) (all cleared under K160786) and Smilekey (cleared under K180609). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable. The Rodo Abutment System eliminates the need for an access hole on the occlusal surface of a screw-retained restoration and also eliminates the possibility of prosthetic screw loosening. The Smilekey is an induction heating device for dental prosthesis removal of the Smileloc Sleeve in the Rodo Abutment System. The Smilekey was cleared as an accessory to the Abutment System in K180609, and there have been no changes to the Smilekey since this clearance.

The Rodo Abutment is provided in five series designs (100 F, 200 P, 300 S, 400 M, 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 300 S series is designed for limited occlusal space and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 3.0 mm to 6.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided text describes a 510(k) premarket notification for the Rodo Abutment System, focusing on adding compatibility with new implant lines. However, it does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

The Rodo Abutment System is a hardware dental device, not an AI/ML software device. The "performance data" section discusses non-clinical testing such as dimensional analysis, reverse engineering, and fatigue testing according to ISO 14801. It does not refer to AI/ML model performance metrics, ground truth establishment, or human reader studies.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or multi-reader multi-case studies, as the provided document pertains to the clearance of a mechanical dental device and not an AI/ML-driven diagnostic tool.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Any sample sizes used for a test set in the context of AI/ML performance.
• Data provenance for AI/ML data (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for an AI/ML model.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance of an AI/ML model.
• Type of ground truth used (pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for a training set in the context of AI/ML.
• How ground truth for a training set was established for an AI/ML model.

The document's "Performance Data" section solely refers to non-clinical bench testing for a mechanical device.

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The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm

• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
  The available range of diameters is summarized below:

Tapered Internal / Laser-Lok 3.0

Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal

Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

(1) For fixing into the endosseous implant

(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The provided document describes the FDA 510(k) clearance for the TruAbutment DS, a patient-specific CAD/CAM abutment. It does not contain information typically found in an AI/ML device approval, such as acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC), sample size for test sets (in the context of AI models), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm (as this is a physical device, not an algorithm), or information about training datasets.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical testing performed for the physical dental abutment device, primarily focusing on its mechanical performance and compatibility with existing implants.

Here's the information parsed from the document based on the device type:

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 for Test Set: The document mentions "finished assembled implant/abutment systems of the worst-case scenario" for fatigue testing. It does not specify a numerical sample size but implies a representative selection for worst-case evaluation. For sterilization and biocompatibility, the tests were "performed for reference device K152559 and leveraged for the subject device," without specifying its sample size.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, performed in a lab setting.

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

• Not applicable. The ground truth for this physical device is based on objective engineering standards (ISO standards, dimensional measurements, material properties), not expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

• Not applicable, as this is not a study requiring adjudication of interpretations.

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. TruAbutment DS is a physical dental implant component, not an AI-assisted diagnostic or prognostic tool.

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

• Not applicable. This is not an algorithm. The device itself is "standalone" in function as it's a physical component.

7. The type of ground truth used:

• Engineering Standards and Measurements: The ground truth for evaluating TruAbutment DS is based on established international (ISO) and national (ANSI/AAMI) engineering standards for medical devices (specifically dental implants and abutments), material specifications (ASTM Standard F-136 for Ti-6A1-4V ELI), and precise dimensional measurements and compatibility assessments.

8. The sample size for the training set:

• Not applicable, as this is not a machine learning model.

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

• Not applicable, as this is not a machine learning model.

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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S. SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase. inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows).

The Sirona Dental CAD/CAM System which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.

Here is the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K111421) rather than explicitly detailing numeric acceptance criteria for each test. However, it lists the types of non-clinical performance data and states that the results support substantial equivalence. The implied acceptance criterion for all tests is "conformity" with the referenced standards or successful validation/analysis, and the reported performance is that these criteria were met.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of abutments for fatigue testing, number of software test cases). It refers generally to "testing" and "analyses."

The data provenance is implied to be internal testing conducted by Dentsply Sirona, as the document details their testing efforts to support the 510(k) submission. No information about country of origin of the data is provided, nor whether it was retrospective or prospective, although typically such a submission would involve prospective testing designed to meet the specified standards.

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

This information is not provided in the document. The document describes compliance with recognized standards and internal validation processes but does not detail the involvement of external experts for establishing ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not provided. The non-clinical testing appears to rely on objective measurements against established engineering and regulatory standards rather than subjective expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. This device is a CAD/CAM system for designing and fabricating dental abutments, not an AI or imaging diagnostic tool that would typically involve human reader performance studies.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study in the form of non-clinical performance data and software verification and validation testing was performed. The document describes:

• Testing to verify conformity with various IEC and ISO standards for medical electrical equipment, electromagnetic compatibility, and dynamic loading.
• Compatibility analyses of new TiBase interface geometries.
• System validation testing for the CAD/CAM software's design and fabrication workflow.
• Software verification and validation testing specifically for the abutment design library to demonstrate design restrictions and locked specifications.

These tests focus on the technical performance and safety of the device components and software, independent of human clinical application for their evaluation.

7. Type of Ground Truth Used:

The ground truth used for non-clinical testing is based on:

• Engineering specifications and design requirements: For confirming the functionality and outputs of the CAD/CAM system and software.
• Recognized international standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14801 which define performance benchmarks and safety criteria.
• Original manufacturer's implant connection geometries: For compatibility analyses of TiBase interfaces.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Sirona Dental CAD/CAM System, as described, is not an AI/ML-based diagnostic device that typically requires a "training set" in the context of machine learning model development. It's a system for computer-aided design and manufacturing within predetermined parameters.

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

This information is not applicable, as there is no mention or indication of a "training set" for an AI/ML model for this device. The software functions based on established CAD/CAM principles and predefined parameters rather than learning from a training dataset.

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The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex). There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part. In case of abutments, 2.5 and 2.1 hexagonal features are usually used. The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6. The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser. The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm. The dimension of each abutment ranges as below: (The tolerance of all products is ±0.03) - Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L) - Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L) - Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20° - . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L) - Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ● - Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L) - Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ● - Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ● - Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L) The implant-abutment connection is internal hex and Morse taper level. Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CSM Submerged3-L Implant System:

This document is a 510(k) Premarket Notification summary for a dental implant system. The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies heavily on bench testing and comparison of technological characteristics rather than extensive clinical efficacy studies in the way you might see for novel pharmaceuticals or advanced AI diagnostics.

Therefore, many of the questions you've asked (e.g., sample size for training/test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, data provenance) are not applicable to this type of medical device submission. These questions are typically relevant for AI/ML-based diagnostic devices or devices where human interpretation of data is a primary function.

This submission focuses on demonstrating safety and effectiveness through:

1. Comparison to predicate devices: Showing that the new device has similar technological characteristics and indications for use as devices already on the market.
2. Non-clinical (bench) testing: Performing specific tests to ensure the device meets established performance standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail manner for the device performance in the way an AI/ML study would (e.g., "accuracy > 90%"). Instead, the acceptance criteria are implicit in the compliance with recognized standards and the demonstration of substantial equivalence to predicate devices. The "reported device performance" is essentially the statement that the device met these standards and is substantially equivalent.

Study Details

As mentioned, many of the requested fields are not applicable to a 510(k) submission for a non-AI/ML dental implant system.

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 device is an implant and its components, not an AI/ML diagnostic system. The "testing" involves bench testing to international standards (e.g., ISO, ASTM) and comparison of physical characteristics to predicate devices. There is no "test set" in the context of imaging or patient data. Data provenance (country of origin, retrospective/prospective) is also not relevant here.

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 is no "ground truth" established by experts in this context. Device performance is assessed against engineering standards and material specifications.

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

• Not Applicable. No expert adjudication is involved.

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 not an AI/ML-assisted device, nor is it a diagnostic tool that involves human "readers."

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

• Not Applicable. There is no algorithm.

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

• Not Applicable. The "ground truth" here is the adherence to engineering specifications, material standards (e.g., ASTM F-136), and performance criteria outlined in international standards (e.g., ISO 17665, ISO 10993, ISO 14801, ASTM F1980-07).

8. The sample size for the training set

• Not Applicable. There is no training set for this type of device.

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

• Not Applicable. There is no training set or associated ground truth.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" consists of a combination of direct non-clinical testing on the subject device and leveraging data from legally marketed predicate devices.

• Direct Testing on Subject Device:

  • End User Steam Sterilization Test: Performed on the abutments according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79.
  • Biocompatibility Tests: Performed on the subject device according to various parts of ISO 10993 (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity).
  • Results: All these tests demonstrated that the subject device met the criteria of the respective standards.

• Leveraged Testing from Predicate Device (K102635):

  • Sterilization Validation Test (ISO 11137-1,2,3): Data from the predicate K102635 was leveraged because the subject product's material, sterilization site, method, SAL, and parameters are identical.
  • Fatigue Test (ISO 14801): Data from the predicate K102635 was leveraged. The applicant specifically states that the worst-case implants from the predicate's testing encompassed the subject device's mechanical properties.
  • Accelerated Aging Test (Shelf Life, ASTM F1980-07): Data from the predicate K102635 was leveraged due to identical product category, material, manufacturing process, facility, packaging material, and packaging procedure.
  • Results: The leveraged predicate data, combined with the direct testing, collectively demonstrate that the CSM Submerged3-L Implant System meets the required performance and safety standards, thus establishing its substantial equivalence.

In essence, the "study" is a comprehensive engineering and material science evaluation, rather than a clinical trial or an AI performance study.

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The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.

This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.

Here's an attempt to address the request based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

• "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
  | - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
  | - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate).
• Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
• Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
  | Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating,"
• "Biocompatibility testing of the PEEK Healing Caps."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Sterilization (ISO 17665-1, -2) | - "Sterilization testing."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p

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