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URIS Long Implant & Abutments are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

URIS Long Implants are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile.

URIS OMNI Long Implants consist of two implant lines, the OMNI Straight and the OMNI Tapered. The OMNI Straight implant features straight walls, with smaller threads at the coronal end and larger threads at the apical end. The OMNI Tapered implant has a tapered wall with a single-thread design.

Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 – Ø 4.5 mm).

Both implant lines share the following diameters and lengths:

URIS OMNI Long Implants are compatible with the following abutments:

• Cover Screw (K172100)
• Healing Abutments (K172100)
• Multi-Unit Straight Abutment (K200817)
• Multi-Unit Angled Abutment (K200817)
• Multi-Unit Healing Cap (K200817)
• Multi-Unit Ti Cylinder (K200817)
• Multi-Unit Temporary Cylinder (K200817)
• Multi-Unit Base (K200817)
• Multi-Unit Cylinder Screw (K200817)
• AOT Base (K231874)
• AOT Temporary (K231874)
• AOT Straight Abutment (K243255)
• AOT Angled Abutment (K243255)
• Multi-Unit Base (K243255)
• Multi-Unit Base Screw (K243255)
• Multi-Unit Temporary Abutment (K243255)
• AOT Direct Screw (K243255)
• AOT Plus Direct Screw (K243255)
• Multi-Unit Direct Screw (K243255)

The abutments are provided non-sterile. All non-sterile products must be sterilized by the end user prior to use.

The AOT Angled Abutment, Multi-Unit Base, and Multi-Unit Temporary Abutment are packaged with their corresponding screw(s).

For convenience, the Multi-Unit Base and Multi-Unit Temporary Abutment are each supplied with two screws included in the package.

The abutments are designed for use with the two implant types submitted in this application. They are also compatible with the implants included in the K172100 URIS OMNI Implant system (Narrow: Ø3.5 mm, lengths 8.5–14.5 mm / Regular: Ø4.0–Ø6.5 mm, lengths 7.0–14.5 mm).

The AOT Straight and AOT Angled Abutments are compatible with the Base and Temporary Abutments included in this submission, as well as those previously cleared under K231874.

The provided FDA 510(k) clearance letter for URIS Long Implant & Abutments does not contain information about acceptance criteria and study proving device performance as typically expected for AI/ML-driven medical devices. This submission is for a traditional dental implant system, and the clearance is based on substantial equivalence to predicate devices through non-clinical testing, primarily focusing on mechanical, material, and biocompatibility properties.

Therefore, many of the requested elements regarding acceptance criteria for device performance (e.g., sensitivity, specificity, AUC), study design (sample size, data provenance, ground truth establishment, expert adjudication), and AI/ML-specific study types (MRMC, standalone performance) are not applicable to this submission.

However, I can extract the information relevant to the type of device and submission, specifically the non-clinical acceptance criteria and the tests performed to meet them.

Acceptance Criteria and Supporting Study for URIS Long Implant & Abutments

As this FDA 510(k) pertains to a traditional dental implant and abutment system (URIS Long Implant & Abutments, K243255), and not an AI/ML device, the acceptance criteria and study details are focused on non-clinical performance, primarily demonstrating mechanical integrity, material compatibility, and safety through established engineering and biological standards, rather than diagnostic accuracy metrics.

The clearance is largely based on demonstrating substantial equivalence to previously cleared predicate devices through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (dental implants), the "performance" is demonstrated through engineering and biocompatibility testing rather than diagnostic accuracy. The acceptance criteria are implicitly meeting the requirements of the cited ISO and USP standards. The document doesn't provide specific quantitative "pass/fail" values for each test, but rather states that the device "met the criteria of the standards."

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

• Sample Size: Not explicitly stated in terms of a "test set" as one would expect for an AI/ML device. The "sample size" would refer to the number of physical dental implants/abutments subjected to each non-clinical test (e.g., number of units for fatigue testing, number of samples for biocompatibility). These numbers are not detailed in the summary but would be standard for regulatory testing required by the ISO/ASTM standards cited (e.g., minimum of 5-10 samples for fatigue per condition).
• Data Provenance: Not applicable in the context of patient data for diagnostic accuracy. The "data" originated from laboratory testing of the manufactured dental implants and abutments.

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

• Not Applicable: This clearance is based on non-clinical engineering and biological safety tests (e.g., fatigue strength, sterility, biocompatibility), not on the interpretation of medical images or patient data requiring expert consensus or ground truth establishment by clinical experts like radiologists.

4. Adjudication Method for the Test Set

• Not Applicable: As there is no human interpretation of data for diagnostic purposes, there's no need for an adjudication process. Test results are objective measurements (e.g., force at failure, sterility present/absent).

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

• Not Performed / Not Applicable: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This device is a physical dental implant, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

• Not Performed / Not Applicable: This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• Engineering/Material Standards and Biological Safety Standards: The "ground truth" for this device's performance is established by the specified ISO and ASTM standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). These standards define acceptable performance limits for mechanical properties and biological responses.

8. Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

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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."

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UniFit Dental Implant System is intended for surgical placement in the maxillary and or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Adin's UniFit Dental Implant System is a new model that provides an additional connection platform to Adin's legally marketed Dental Implant Systems, indicated for use in surgical and restorative applications for placement in the maxillary and/or mandibular arch to provide support for prosthetic devices such as crowns, bridges, or overdentures in order to restore masticatory function.

This new UniFit model is identical to Adin's cleared Touareg™ CloseFit (RP- Regular Platform, and WP- Wide Platform) and Adin's Touareg™-S implant systems (cleared under K112585 and K081751, respectively) except for the "Star" (Torx) connection and new 6mm length for specific diameters.

The UniFit Dental Implant System includes dental implants, screws and prosthetic components for CAD/CAM restorations.

The UniFit dental implants are tapered core implants with a spiral tap, and a dome apex and double lead thread design.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the UniFit Dental Implant System.

Please Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict numerical acceptance criteria against a pre-defined performance target. The studies described are primarily to ensure safety, functionality, and equivalence to already cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission focused on substantial equivalence to predicate devices rather than meeting a specific performance target for AI, the "acceptance criteria" here refer to meeting the established performance standards of the predicate devices and general safety/performance testing for the type of medical device. The document does not provide a traditional table of AI-specific acceptance criteria (e.g., sensitivity, specificity, AUC) or corresponding numerical performance for the device's AI component. Instead, it describes a series of engineering and biocompatibility tests to ensure the new device is as safe and effective as previously cleared devices.

The "device performance" reported is that the device successfully meets the internal protocols and relevant ISO/ASTM standards, indicating it performs comparably to the predicate devices and is safe for its intended use.

No AI is mentioned in the provided text for the UniFit Dental Implant System. The document describes a physical dental implant system and components, not a software or AI-driven medical device. Therefore, the subsequent questions regarding AI-specific criteria (sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable based on this document.

• Pyrogenic Material-Mediated and chemical extractions conducted.
• Biocompatibility tests were conducted in accordance with referenced standards. |
  | Connection Design Effectiveness | Stable connection and all measurements within component's specification, following tolerance analysis. | All tested specimens showed stable connection and all measurements were found to be within each component's specification. |
  | Maximal Applicable Torque Resistance (Implant) | Withstand maximal insertion torque as predefined in implant specification, considering safety margins and device design. | Test conducted in accordance with internal protocol; implies meeting criteria (no explicit numerical value reported as metric). |
  | Tool to Implant Connection Lifetime Performance | Maximal applied torque and deformation test met predefined acceptance criteria; no mechanical or visual damages observed at end of reusable tool's recommended lifetime. | Met predefined acceptance criteria; no mechanical or visual damages observed. |
  | Implant-Abutment Connection Degree of Rotation | Predefined acceptance criterion for degree of free rotation after applying closure torque. | All tested specimens met the predefined acceptance criterion. |
  | Abutment Screw Performance - Maximum Applicable Torque | Torque resistance of connecting screw such that breakage occurs above acceptance criteria and at the desired location (under the screw head/groove). | All tested screws failed in values above the acceptance criteria and at the desired location. |
  | Screw Loosening and Abutment Extraction by Retrieval Tool | Ability to screw and loosen with no deformation or fracture; abutment easily retrieved from implant under lateral pressure; screw retrieval torque withstands predefined torque. | All tested screws and abutments were successfully unscrewed and retrieved; screw retrieval torque withstood predefined torque. |
  | Regular Platform Dynamic Loading (Fatigue) | Meet requirements of ISO 14801:2016 for fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and prosthetic components. | All of the success criteria were met. |
  | Torsion Testing | Meet acceptance criteria for torsional performance as per YY0315:2016 for torsional yield strength and maximum torque of worst-case implant/connecting part joints. | All tested specimens met acceptance criteria for UniFit implant system torsional performance per YY0315:2016. |
  | 6.00mm Implants Pull-Out Test | Axial pull-out strength comparable to or better than predicate devices (MIS short implants K103089), per ASTM F543. | The test met its acceptance criteria (comparison with legally marketed device). |
  | Comparative Surface Area Analysis (before treatment) | UniFit Short Implant's actual surface area (before surface treatment) greater than or equivalent to legally marketed reference item (MIS short implants K103089) at worst-case implant variation. | The total surface area measurements of the tested items were greater than the legally marketed reference item, the acceptance criteria was met. |
  | Comparative Bone to Implant Contact (BIC) Surface Area Analysis | Test article (Adin's UniFit short implant, 6.0 mm) BIC volume and surface area comparable to or exceeding reference item (MIS SEVEN MF7-06420) for Hard Bone (Type I) and Soft Bone (Type IV) conditions. | Test article, at both conditions of the bone, exceeded the MIS reference item in terms of B.I.C. volume and surface area. |
  | Single TMA Fatigue Rationale | Fatigue limit of Single TMA abutments assembled to designated Dental Implants (including compatible screw) conforms to ISO 14801:2016, and does not present new worst-case compared to existing and approved TMA system. | The Single TMA and designated superstructures do not present any new worst-case when compared to the existing and approved TMA system (Rationale provided). |
  | Fatigue testing of TiBase Abutments | Worst-case combination of subject device implants, TiBase abutments, and zirconia superstructure is strong enough for clinical application per ISO 14801. | Tested according to ISO 14801; implies meeting strength requirements (no explicit numerical value reported as metric). |
  | Gamma Irradiation Sterilization | Assurance of SAL (Sterility Assurance Level) of 10^-6 using VDmax 20kGy according to ISO 11137-2:2013 and ISO/TS 13004. | Sterilization validated in accordance with ISO 11137-2:2013, assuring SAL of 10^-6. |
  | Cleaning and Steam Sterilization (End-User) | Assurance of SAL of 10^-6 for steam sterilization (for non-sterile components) using full cycle approach as detailed in Annex D4 of ISO 17665-1:2006, in accordance with ISO 17665-1:2006 and ISO 17665-2:2009. | Steam sterilization validated in accordance with ISO 17665-1:2006 and ISO 17665-2:2009, assuring SAL of 10^-6. |
  | Disinfection (End-User) | Disinfection process validated in accordance with ISO 17664-1:2021 and AAMI TIR12:2020. | Disinfection process validation conducted with accordance with ISO 17664-1:2021 and AAMI TIR12:2020. |
  | Shelf-Life, Packaging and Transportation | Ensure 5 years shelf life under accelerated and real-time aging, and confirmed sterility throughout shelf life and after packaging/transportation per ISO 11607-1. | Shelf-life tests conducted to ensure 5 years shelf life, confirming sterility after packaging and transportation. |

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

As no AI component is described, this question is not directly applicable. The performance data section describes various engineering tests.

• Test Set Description: The "test set" for the engineering evaluations consists of physical samples of the UniFit Dental Implant System.
• Sample Sizes:
  • For most tests (connection design effectiveness, torque resistance, tool life, rotation, screw performance, screw loosening/extraction, torsion testing, fatigue testing of TiBase abutments), the document states "All tested specimens" or "All tested screws," implying all manufactured or a representative sample of components tested met the criteria. It does not provide specific numerical counts for these "specimens" or "screws."
  • For the UniFit 6.00mm Implants Pull-Out test, comparison was made to "proposed predicate devices MIS short implants (K103089)." The sample size for UniFit is not explicitly stated but implies sufficient numbers for comparison.
  • For Comparative Surface Area Analysis and Comparative Bone to Implant Contact Surface Area Analysis, comparison was made against "legally marketed devices (MIS short implants cleared under 510(k) K103089) at worst case implant variation" and "MIS's SEVEN MF7-06420." Again, specific sample sizes for the UniFit components are not given, but "tested items" is used.
• Data Provenance: The data comes from internal testing conducted by Adin Dental Implant Systems Ltd. (implied by "Adin internal protocol") and potentially external accredited labs for biocompatibility and sterilization (e.g., "Tests have been conducted at MDT Medical Device Testing GmbH"). The tests are in accordance with international standards (ISO, ASTM, YY) and FDA guidance. The implants are compared to predicate devices already marketed in the US.

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

This question is not applicable as the document does not describe the use of experts to establish a "ground truth" for an AI algorithm's performance on a test set. The validation is through engineering, materials, and biocompatibility testing against established standards and comparisons to predicate devices, which generally do not involve human "experts" establishing ground truth in the AI sense.

4. Adjudication Method for the Test Set

Not applicable, as there is no AI component or subjective human interpretation of results requiring adjudication for ground truth.

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

Not applicable, as no AI component is described.

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

Not applicable, as no AI component is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established through:

• Compliance with International Standards: Adherence to ISO and ASTM standards for material properties, mechanical performance, fatigue, sterility, and biocompatibility.
• Comparison to Predicate Devices: Performance characteristics (e.g., implant design, connection types, material, dimensions, sterilization methods, clinical indications) are compared against several legally marketed predicate and reference devices (e.g., Adin's Touareg™ CloseFit Dental Implant System, MIS C1 implants, Straumann BLX System, etc.). The "ground truth" implicitly aligns with the documented safety and effectiveness of these predicate devices.
• Internal Protocols: Performance data is generated and evaluated against Adin's internal protocols and specifications.

8. The Sample Size for the Training Set

Not applicable, as no AI component or machine learning model is described that would require a training set.

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

Not applicable, as no AI component or machine learning model is described that would require a training set with established ground truth.

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URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

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

URIS Smart Path Implant System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multipleunit restorations. The surface treated is SLA (Sandblasted, Large grit and Acid etched) and is provided sterile. It consists of two implant lines, the Smart Path OMNI Thread and the Smart Path extra aggressive Thread, with corresponding cover screws, healing abutments. The Smart Path implant has a tapered wall with a single thread design. The Smart Path extra aggressive Thread is straight walled with smaller threading at the coronal end, and bigger threading at the apical end.

URIS SP Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of SP Healing Abutment, SP Temporary Abutment, SP Multi-Unit Straight Abutment, SP Multi-Unit Angled Abutment, SP T-L Straight Abutment, URIS SP Base, URIS SP DS, SP Abutment Screw.

Cover screw and healing abutment are anodized in yellow or green or purple.

Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.

URIS SP Base 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. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is a 510(k) Summary for the URIS Smart Path Implant System & Prosthetic. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, which are typically associated with the questions asked.

The document focuses on non-clinical tests to demonstrate substantial equivalence, as is common for dental implants and prosthetics. These tests are primarily related to material properties, sterilization, packaging, and mechanical fatigue.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance/accuracy studies which were explicitly stated as not included: "No clinical data were included in this submission."

Here's a breakdown of what can be extracted and what information is missing:

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

Missing Information (Not present in the provided document):

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical studies with test sets were performed. Non-clinical tests typically report sample sizes per test standard, but these are not detailed here beyond stating "worst-case scenario" for fatigue testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies requiring ground truth establishment were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies requiring adjudication were performed.
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 system, not an AI-powered diagnostic tool, and no clinical studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed.
8. The sample size for the training set: Not applicable, as no AI/machine learning component requiring a training set is described.
9. How the ground truth for the training set was established: Not applicable, as no AI/machine learning component requiring a training set is described.

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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.

All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.

The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments.

The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm.

The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm.

The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles.

Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration.

The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3.

The provided document describes the K213997 Kontact Dental Implant System. This premarket notification primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and literature review, rather than establishing performance criteria against specific clinical endpoints with a device that provides diagnostic information. Therefore, the typical structure for acceptance criteria and a study proving a device meets these criteria for an AI/ML diagnostic or prognostic device is not directly applicable.

However, I can extract the relevant information from the document to describe how the manufacturer demonstrated that their device met the safety and performance requirements for a dental implant system.

Here's the information organized based on your request, with adaptations for a non-diagnostic medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental implant system), "acceptance criteria" are generally derived from recognized standards for biocompatibility and mechanical performance, and "reported device performance" refers to the results of non-clinical testing against these standards, as well as a review of clinical outcomes from a published study on similar implants.

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

For the non-clinical tests:

• Biocompatibility: The specific sample sizes for cytotoxicity and endotoxin tests are not individually stated but are implied to be sufficient per the referenced ISO and ANSI/AAMI standards.
• Mechanical Performance (ISO 14801): The sample size refers to "worst-case constructs," implying a selection of implant and abutment combinations designed to represent the most challenging scenarios for mechanical failure. The exact number is not explicitly stated.
• Data Provenance: The mechanical performance and sterilization data are from non-clinical bench testing conducted by the manufacturer. The biocompatibility evaluation also involved internal routine monitoring data.

For the leveraged clinical performance:

• Sample Size: 326 implants were evaluated in a published multi-center retrospective study.
• Data Provenance: This was a retrospective study. The country of origin is not specified, but it was a "multi-center" study.

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

This information is not directly applicable as this submission is not for an AI/ML diagnostic device requiring expert-established ground truth for a test set. The "ground truth" for this dental implant system is primarily established by:

• Compliance with recognized international standards (ISO, ANSI/AAMI): These standards define acceptable material properties and mechanical performance.
• Observation of physical outcomes in non-clinical bench tests: Mechanical integrity, sterilization efficacy, and MRI compatibility are directly measured.
• Leveraged Clinical Literature: The multi-center retrospective study (not conducted by the submitter) provides clinical outcome data (bone level changes, survival rate) for similar implants. The experts involved in that study (e.g., dentists, surgeons, researchers) would have established the "ground truth" of patient outcomes, though no specific number or qualifications are provided in this submission for that study.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML diagnostic or prognostic device with human adjudication. The "adjudication" for this device involves applying the results of the non-clinical tests (e.g., pass/fail for mechanical loads, conformity to biocompatibility limits) against the requirements of the referenced standards.

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. This is a dental implant system, not a diagnostic imaging device with AI assistance for human readers.

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

Not applicable. This is a physical medical device (dental implant system), not an algorithm.

7. The Type of Ground Truth Used

• Non-clinical Testing: The ground truth for mechanical performance, sterility, and MRI safety is established by direct measurement and observation against predefined criteria in recognized scientific and engineering standards (e.g., force limits, microbial kill rates, magnetic susceptibility properties).
• Biocompatibility: Established by adherence to ISO 10993 standards for various biological endpoints, alongside review of existing data.
• Clinical Outcomes Data (leveraged): For the indirect clinical performance evaluation, the ground truth was based on clinical outcomes (bone-level changes, implant survival rates) derived from a published multi-center retrospective study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing processes are informed by engineering principles, material science, and prior predicate device data, rather than machine learning on a "training set."

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

Not applicable, as there is no training set for this type of device.

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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:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

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 provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

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 and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific 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 various prosthetic platform diameters. The TruBase screws are composed of titanium alloy per ASTM F136.

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.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.

The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.

Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.

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

The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.

• Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
• Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.

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

This information is not applicable to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.

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

Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.

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. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical dental implant abutment, not an AI algorithm.

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

The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.

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