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MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The subject devices, MIS Implants, are supplied sterile and packaged together with a cover screw which can be connected to the implant during the initial healing period after implant placement.

The implants and cover screws are made of titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The design and material of the implants and cover screws remain unchanged since most recently cleared 510(k).

The implants are also used with a wide range of previously cleared abutments which are sold separately.

This document is a 510(k) clearance letter for dental implants, not an AI/software as a medical device (SaMD) submission. Therefore, it does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/SaMD product.

The document discusses dental implants and their physical and material characteristics, regulatory classifications, predicate devices, and performance testing for mechanical properties, sterility, and packaging. The "Performance Data" section specifically mentions "Hydrophilicity testing" for "wet-packed implants" and other physical tests, but none of these relate to AI/SaMD performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide a table of acceptance criteria, sample sizes for test sets, expert qualifications, or details on MRMC studies, standalone performance, or ground truth establishment relevant to an AI/SaMD product based on the provided text.

The prompt asks for information that this type of medical device submission (dental implants) would not typically include.

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MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS LYNX short implants are indicated for delayed loading only.

The two additional implant size offerings which are being added to the predicate MIS LYNX Conical Connection Dental Implant System (K241692), and are the subject of this submission, consist of a standard platform, 4.20 mm diameter implant and a wide platform, 5.00 mm diameter implant, each available in a 6 mm length.

The proposed implant offerings, as their predicate K241692, are root-form, bone-level, self-tapping, two-piece, screw-type implants which are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.

Each implant offering is provided with a compatible cover screw based on the implant platform (standard and wide). The cover screws are identical to those cleared in K241692 and are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. The cover screw is screwed into the implant's internal thread and the gums are sutured over the cover screw. The cover screw's purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and is then removed and replaced by either a healing cap or an abutment.

The implants and cover screws are manufactured from titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The proposed implants feature an outer profile which has a coronal section which is cylindrical and an apical section which is conical. The outer threads are designed so the implant has a self-drilling property. The implant's geometric design includes a dual thread feature and spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants feature a round (cylindrical) neck.

The proposed MIS LYNX Conical Connection Implants have a conical connection with an anti-rotation index of six positions and an internal thread for cover screws, screw-retained abutments and screwed healing caps. The implant-abutment connection surface of the proposed implants is anodized for color coding purposes to indicate the platform: purple for standard platform implants, and green for wide platform implants. The cover screws are also anodized for platform color coding.

The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in patients.

This 510(k) clearance letter pertains to an Endosseous Dental Implant System, which is a physical medical device, not a software-driven AI device. Therefore, the concepts of acceptance criteria, study data, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI models, and training set sizes are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the context of an AI-driven system. The "acceptance criteria" here are implicitly the standards and performance levels demonstrated by the predicate and reference devices, as well as relevant ISO and ASTM standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the device type:

Device: MIS LYNX Conical Connection Implant System

This device is an endosseous dental implant system, a physical medical device. The FDA clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on the performance of an AI algorithm. Therefore, many of the requested fields related to AI model evaluation are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be compliance with relevant international and national standards for dental implants, and performance comparable to or exceeding established predicate/reference devices.

Table of Acceptance Criteria (Inferred from testing) and Reported Device Performance:

Regarding the other requested information (primarily relevant to AI/Software-as-a-Medical-Device):

2. Sample size used for the test set and the data provenance: Not applicable. The testing done was laboratory-based mechanical and MR safety testing, not evaluation of an AI model with a clinical test set. The implant dimensions analyzed for surface area were "smallest implant length (6 mm) and diameter (4.20 mm)" for proposed and reference devices. Pull-out testing and fatigue testing would have involved a number of physical samples per test, but specific quantities are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., expert labels on medical images) is not relevant here. The "ground truth" for mechanical testing is established by physical measurements and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical dental implant, not an AI assistance system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is derived from established engineering test methods and their performance metrics (e.g., load at failure, cycles to failure). For MR safety, it's compliance with established safety limits for magnetic fields.

8. The sample size for the training set: Not applicable. There is no AI model or training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional physical medical device (dental implant system). The evaluation and clearance process for such devices involve demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, typically through non-clinical (laboratory) testing, materials characterization, and compliance with recognized standards. The concepts and terminology in your request are largely tailored to the evaluation of AI/Machine Learning-driven medical devices, which is not what this document addresses.

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BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue.

The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration.

The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment:

• Scanner: 3Shape Trios 5 intra-oral scanner.
• Design Software: 3Shape Abutment Designer Software, K151455.
• Zirconia Material: sagemax® NexxZr zirconia, K130991.
• CAM software: hyperDENT® Classic
• Milling machine: imes-icore® CORiTEC 150i Pro milling machine
• Cement: 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476.

The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.

The provided document is an FDA 510(k) clearance letter for the Conical Ti Base abutments.

*Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about any clinical studies, sample sizes, expert ground truth establishment, or AI effectiveness studies.

The letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Identical intended use: Both the subject device and the primary predicate (K240187) are "intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations." The subject device adds the "digital dentistry workflow" aspect, which is equivalent to the secondary predicate (K231307).
• Similar or identical design and technological characteristics: This includes material composition (Ti-6Al-4V alloy for the titanium base, sagemax NexxZr zirconia for the superstructure), manufacturing methods, digital design software and hardware (for the zirconia superstructure), design limitations, usage, sterility, and biocompatibility.

The "Performance Data" section discusses:

• Reliance on predicate submission data for non-clinical aspects like mechanical testing, biological safety, steam sterilization, and magnetic resonance testing, as there were no changes since the previous clearance (K240187).
• New testing was conducted to support the CAD/CAM design and use within a digital dentistry workflow, demonstrating controls of this workflow and that the final abutment is equivalent to those produced by the validated milling center cleared in K240187. This involved assessing abutment angulation, diameter, height, wall thickness, tolerances, and part quality.
• Surface characterization (SEM and EDX) was done on the titanium base component to ensure no residual blast media.
• No clinical data were included in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, or AI effectiveness. The clearance is based on non-clinical data and substantial equivalence to existing devices.

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MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function. The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths. The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone. The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients. Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.

The provided document is a 510(k) Summary for the MIS LYNX Conical Connection Implant System. It details the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical testing.

However, the document does not describe a study that proves the device meets specific acceptance criteria based on clinical performance or an AI/algorithm-driven component. Instead, it focuses on non-clinical testing (fatigue, biocompatibility, sterilization, shelf-life, and MRI compatibility) to demonstrate the safety and effectiveness of the dental implant system itself, relative to predicate devices. There is no mention of an AI component, human-in-the-loop study, or any performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI-driven medical device.

The section titled "8. Clinical Tests Summary and Conclusion" explicitly states: "Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Therefore, based solely on the provided text, I cannot generate a response that fulfills the request for acceptance criteria and study details related to an AI/algorithm's performance because such information is not present in the document. The device in question is a dental implant system, not a software device that would typically have acceptance criteria focused on AI performance metrics.

To directly answer your prompt, given the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes non-clinical testing for a dental implant system, not performance metrics for an AI/algorithm. The "acceptance criteria" for the non-clinical tests are implied as meeting the standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 series for biocompatibility) and demonstrating equivalence or superiority to predicate devices. For example, "Fatigue testing... confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices." And "Test results met acceptance criteria" for shelf-life testing. However, specific numerical acceptance criteria and reported performance values for each of these tests are not provided in a table format within this summary.

2. Sample sized used for the test set and the data provenance:
Not applicable for an AI test set. The document refers to samples used for non-clinical tests (e.g., implants for fatigue testing, materials for biocompatibility). Specific sample sizes are not detailed, but the tests are conducted on representative devices. Data provenance is implied as being from the manufacturer's internal testing as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/imaging device requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm providing standalone performance.

7. The type of ground truth used:
Not applicable.

8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable.

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The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Prima Plus™ Conical Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The purpose of this submission is for the marketing clearance for Prima Plus Conical Implants, an endosseous root-form dental implant. The overall system is designed to be used with compatible components and are indicated for single-unit, multi-unit and overdenture restorations. No new prosthetic components were designed as part of this submission, with these implants designed to be compatible with previously cleared prosthetic components.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Prima Plus Conical Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Prima Plus Conical Includes previously marketed abutments with fifteen (1 5) designs: Healing Abutments, Straight (with and without TiPink), Angled (with and without TiPink), Straight Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder (with and without TiPink), Titanium Temporary Immediate (with and without TiPink), Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

lmplants are fabricated from a Titanium 4 Vanadium ELI titanium alloy which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications (UNS R56401). They have a Sandblasted, Large grit and Acid-etched (SLA) surface treatment.

All implants are one-time use devices All Subject device components are provided sterilized by gamma irradiation.

The provided text is a 510(k) summary for a medical device (Keystone Dental Inc.'s Prima Plus Conical Implant System). It describes the device, its intended use, and how it is substantially equivalent to previously marketed devices based on non-clinical performance testing.

However, the document does not contain information typically found in a study proving device performance against acceptance criteria for AI/ML-enabled devices, especially regarding clinical performance, human-in-the-loop studies, or the establishment of ground truth by experts.

The key phrases from your request which are not addressed in the provided text are:

• "Acceptance criteria and the study that proves the device meets the acceptance criteria."
• "Table of acceptance criteria and the reported device performance." (beyond static mechanical testing)
• "Sample sized used for the test set and the data provenance." (There's no clinical test set described)
• "Number of experts used to establish the ground truth for the test set and the qualifications of those experts."
• "Adjudication method for the test set."
• "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."
• "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
• "The type of ground truth used (expert consensus, pathology, outcomes data, etc)."
• "The sample size for the training set."
• "How the ground truth for the training set was established."

The document explicitly states: "No clinical data were included in this submission." This means there are no studies involving human patients or complex data analysis that would require features like AI models, human readers, or ground truth establishment by medical experts.

The "acceptance criteria" and "device performance" mentioned are limited to:

• Non-Clinical Performance Testing:
  • Fatigue testing per ISO 14801:2016 (Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants). This is a mechanical test.
  • Biological Evaluation per ISO 10993-1.
  • Sterilization information leverage (from a reference device, K220200).
  • MRI review (non-clinical, using scientific rationale and published literature).

The "study" that proves the device meets the acceptance criteria is primarily benchtop mechanical performance testing (ISO 14801) on "worst-case constructs" to demonstrate "suitability for intended use."

Therefore, I cannot provide a table or details on the ground truth, expert involvement, or clinical study design as requested for an AI/ML device, because this 510(k) filing for a dental implant does not involve such elements. It is a physical medical device, and its equivalency is based on material properties, design comparisons, and mechanical durability.

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Noris Medical Ltd. Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

The procedure can be accomplished in a one-stage surgical operation. All impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Healing Caps are Titanium devices mounted onto the dental implant before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.

The Subject Abutments (temporary, straight, angular and screw retained) with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions.

Multi-Unit Straight/Angular Screw Retained abutment are intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization.

The abutment screw is intended to fasten the abutment to a dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.

Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.

Based on the provided FDA 510(k) summary for the "Conical Platform Dental Implants System," here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This is different from a PMA (Premarket Approval) application, which requires clinical efficacy and safety studies. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing and comparisons to predicate devices, rather than a full-scale clinical trial with human subjects. The document primarily focuses on physical and material characteristics and demonstrates equivalence through engineering analyses rather than clinical outcomes with an AI component.

The request asks for information that is more typical of a software as a medical device (SaMD) or AI/ML device approval, such as "number of experts," "adjudication method," "MRMC study," and "training set ground truth." However, this document describes a dental implant system, which is a physical device, and does not mention any AI/ML components. Therefore, many of the requested points related to AI/ML device evaluation are not applicable or cannot be found in this submission. I will address the points that are applicable to this type of device and note where information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical device are primarily based on demonstrating substantial equivalence to predicate devices in terms of design, materials, indications for use, and performance testing (specifically fatigue).

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

Since this is a physical device and the primary evidence provided is non-clinical performance data (fatigue testing, material characterization, etc.) rather than a clinical study with a "test set" of patients, the concept of a sample size for a test set and data provenance (country, retrospective/prospective) as it applies to AI/ML or clinical trial data isn't directly applicable here in the same way.

• Sample Size for Testing: The document states that "Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants." ISO 14801 specifies the number of samples for fatigue testing (typically 6-12 samples per group, depending on the desired confidence and methodology), but the exact number used is not explicitly stated in this summary. Other tests (biocompatibility, reprocessing, pyrogen, MRI review) were leveraged or based on scientific rationale, meaning new physical samples were likely not tested for these aspects as equivalence to previously cleared devices was the basis.
• Data Provenance: Not applicable in the context of a clinical test set for a physical device where the primary evaluation is non-clinical. The company is Noris Medical Ltd., located in Nesher, Israel.

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

This question is highly relevant for AI/ML devices where "ground truth" often involves expert annotation or consensus. For this physical dental implant device, ground truth is established through:

• International Standards: e.g., ISO 14801 for fatigue testing, ASTM F136 for material specifications. These standards define the "ground truth" for material properties and mechanical performance.
• Regulatory Guidance: e.g., FDA Guidance for MRI safety, USP for pyrogen limits. These guidances define the acceptable methodology and results.
• Predicate Device Characteristics: The comparison of technological characteristics to predicate devices (K140440, K142260, K130462) establishes the "ground truth" for substantial equivalence.

There is no mention of human experts defining "ground truth" in the way it's done for diagnostic image interpretation by multiple radiologists. The expertise lies within the material science, mechanical engineering, and regulatory compliance teams that designed the device and conducted/evaluated the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment of a test set that would require an adjudication method like 2+1 or 3+1. Performance is measured against objective engineering standards and direct comparison of physical/material characteristics.

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

No. An MRMC study is specific to diagnostic imaging devices, particularly those involving human interpretation of medical images, often assisted by AI. This document pertains to a physical dental implant system and therefore, this type of study was not conducted or required. No AI assistance or human reader improvement is mentioned.

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

Not applicable. This device is a physical dental implant system and does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device application is primarily based on:

• Engineering Standards: Specific material properties, mechanical performance (e.g., fatigue strength as per ISO 14801), and dimensional tolerances.
• Predicate Device Characteristics: The established safety and effectiveness of the chosen predicate devices serve as the benchmark for demonstrating substantial equivalence for the new device's indications for use, materials, and design.
• Leveraged Data: For biocompatibility, reprocessing sterilization, and pyrogen limits, the "ground truth" is that the material, manufacturing, and surface treatments are identical to previously cleared devices (K151909 and K140440), therefore their established safety and performance data (ground truth) is directly applicable.

No pathology reports or patient outcomes data as "ground truth" are mentioned in this 510(k) summary, as it relies on non-clinical data for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described, so there isn't a "training set" in the context of machine learning.

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

Not applicable, as there is no AI/ML component or training set described.

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BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
• · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Restoration Modular 115mm Conical Distal Stem Indications for Use:

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
  · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  · Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty.
The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics' femoral heads, sleeves and acetabular components.
The Insignia Hip Stem is manufactured from Ti6Al4V ELI alloy and the device features hydroxyapatite coating over a commercially pure titanium plasma sprayed surface for cementless fixation.

The subject Restoration Modular 115mm Conical Distal Stem is a part of the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.

The provided text is a 510(k) summary for the Insignia Hip Stem and Restoration Modular 115mm Conical Distal Stem. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing related to Magnetic Resonance (MR) conditional safety. It does not describe a study involving device performance for its primary function (hip replacement) or human reader performance.

Therefore, many of the requested categories (e.g., effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this document.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MR safety testing are implicitly the standards themselves (e.g., ASTM F2052-15). The document states that the components were "evaluated per the following standards" and that "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned in the MR environment." This implies that the devices met the requirements of these standards to be considered MR Conditional. Specific numerical performance results are not provided in this summary.

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

The study involved testing of the Insignia Hip Stem components and the Restoration Modular 115mm Conical Distal Stem. The sample size refers to the number of device components tested for MR compatibility. This information is not explicitly stated in the summary. The tests are non-clinical (laboratory-based), so data provenance like country of origin or retrospective/prospective is not applicable in the human data sense.

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

This category is not applicable. The ground truth for MR safety testing is established by the specifications of the ASTM standards, not by human experts adjudicating medical images or conditions.

4. Adjudication method for the test set

This category is not applicable. The evaluation is based on meeting parameters defined by engineered standards, not on human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This category is not applicable. The device is a hip implant, not an AI-assisted diagnostic tool.

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

This category is not applicable. The device is a hip implant, not an algorithm. The MR safety testing is inherently "standalone" in the sense that it evaluates the physical properties of the device itself.

7. The type of ground truth used

The ground truth for the MR safety testing is defined by the ASTM standards referenced (ASTM F2052-15, ASTM F2213-17, ASTM F2119-07 (Reapproved 2013), ASTM F2182-19). These standards establish protocols and acceptance criteria for classifying medical devices as MR Conditional.

8. The sample size for the training set

This category is not applicable. This is a physical medical device undergoing non-clinical safety testing, not a machine learning algorithm that requires a training set.

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

This category is not applicable. As mentioned above, there is no training set.

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The Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided text describes the 510(k) submission for the "Paltop Conical Implant System." This document is a regulatory filing demonstrating substantial equivalence to previously cleared devices, not a study performing clinical validation against acceptance criteria for a new AI/CADx device.

Therefore, most of the requested information (acceptance criteria for clinical performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in this document, as it pertains to a different type of device and regulatory submission.

The document focuses on non-clinical performance testing (fatigue testing, biocompatibility, endotoxin testing, sterilization validation, and MRI compatibility) to demonstrate the device's mechanical and material properties are equivalent to the predicate devices.

However, I can extract the information that is present and explicitly state what is missing based on the document's content:

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

The document does not specify quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it's a dental implant, not a diagnostic AI device. Instead, it refers to non-clinical performance standards.

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

• Test Set Sample Size: Not applicable. This document refers to non-clinical bench testing (e.g., mechanical fatigue, material properties), not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing appears to be conducted by the manufacturer, Paltop Advanced Dental Solutions, Ltd.

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

• Not applicable. No clinical ground truth was established as this was a 510(k) submission for a physical device, based on non-clinical testing and substantial equivalence to predicate devices.

4. Adjudication method for the test set

• Not applicable. No clinical test set.

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

• No. This type of study is for evaluating medical imaging AI. This document is for a dental implant.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• Not applicable for clinical ground truth. The "ground truth" for this device's performance validation is based on engineering standards, material specifications, and regulatory guidelines (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility).

8. The sample size for the training set

• Not applicable. There is no AI training set.

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

• Not applicable. There is no AI training set.

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Intended Use: The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.

Indications for Use:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.

The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.

The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.

The furnished document is a 510(k) premarket notification from the FDA, specifically concerning a medical device called "Restoration Modular 115mm Conical Distal Stem." This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of a novel device's performance against specific acceptance criteria.

Therefore, the document does not contain any information related to:

• Acceptance criteria directly tied to device performance outcomes (e.g., accuracy, sensitivity, specificity) for a new AI/software device. This notification is for a physical orthopedic implant.
• A study that proves the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document focuses on non-clinical testing (fatigue, biocompatibility, shelf-life, MR safety) to demonstrate equivalence in design and material, not on a clinical performance study.
• Sample sizes for test or training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment. These elements are relevant to the evaluation of AI/software as a medical device (SaMD) where performance is measured against clinical outcomes or expert consensus.

In summary, the provided text does not describe the kind of acceptance criteria or performance study typically associated with AI/software medical devices or diagnostic tools. It is a regulatory submission for an orthopedic implant that demonstrates substantial equivalence through engineering analyses and non-clinical testing.

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