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J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

The document describes the J & P Click Attachments, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to a predicate device, the Zest High Retention Attachment System (K220252), and several reference predicates.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided text is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here are based on comparative attributes for demonstrating substantial equivalence, and "reported device performance" refers to the characteristics of the J & P Click Attachments as compared to the predicate.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests and a comparison to predicate devices, rather than a single "study that proves the device meets acceptance criteria" in the sense of a clinical trial with predefined statistical endpoints. The primary method for demonstrating substantial equivalence is through comparative analysis with predicate devices and non-clinical testing.

Non-Clinical Testing Performed:

• Abutment Steam Sterilization: Done according to ISO 17665-1.
• Cytotoxicity Testing: Conducted according to ISO 10993-5.
• Reverse Engineering Tolerance Analyses: Conducted for all OEM implant systems in the indications for use. These analyses covered OEM implant body models, OEM abutment models, and OEM abutment screw models to ensure compatibility.
• MR Environment Condition (MRI Review): Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to evaluate magnetic compatibility, specifically for magnetically induced displacement force and torque, based on the entire system and material composition (Ti-6AL-4V ELI).

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

• The document does not describe a clinical "test set" with human or animal subjects in the traditional sense of a clinical study.
• The "test set" for the reverse engineering tolerance analyses would be the designs and physical specifications of the OEM implant systems. The number of samples for these analyses is not specified beyond "all OEM implant systems in the indications for use."
• Data provenance: Not explicitly stated, but the submission is for an FDA 510(k), implying compliance with US regulatory standards. Non-clinical tests like cytotoxicity (ISO 10993-5) and sterilization (ISO 17665-1) are international standards.

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 information is not provided in the document. The substantial equivalence determination is based on comparative attributes and non-clinical engineering and biological testing, not on expert-adjudicated ground truth from a clinical data set.

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

• This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication in the context of this 510(k) submission.

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

• This information is not provided and is not applicable to this type of medical device (dental implant attachments). MRMC studies are typically used for imaging diagnostics involving human readers and AI. This device is a mechanical component, not an AI software.

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

• This information is not provided and is not applicable. This device is a physical dental component and does not involve an algorithm or AI.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1.
  • Cytotoxicity: Ground truth is defined by the requirements and endpoints of ISO 10993-5.
  • Reverse Engineering Tolerance Analyses: Ground truth is the design specifications and tolerances of the referenced OEM implant systems.
  • MRI Environment Review: Ground truth is established by scientific rationale and published literature referenced (e.g., relating to magnetic properties of materials).
• For substantial equivalence: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices, as documented in their 510(k) clearances and product specifications.

8. The sample size for the training set

• This information is not provided and is not applicable. The device is a physical medical device, not an AI or software device that undergoes a training phase.

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

• This information is not provided and is not applicable (see point 8).

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MIS Dental Implant Systems are 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 short implants are to be used only with straight abutments.

The proposed MIS Dental Implant System entails a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments.

Lance+ Dental Implants: A modification and line extension to the originally cleared Lance implants (K040807). Manufactured from titanium alloy, Ti- 6Al-4V ELI, compared to the prior CP titanium grade 4. Additional sizes are being added as a line extension.

MIS Internal Hex Cobalt Chrome (CoCr) abutments: Pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. Intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw.

This document is a 510(k) Pre-market Notification for the MIS Dental Implant System. It describes the device, its intended use, and comparative studies to establish substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not applicable or cannot be extracted from this document.

However, I can extract the information related to the device's technical performance and the non-clinical studies conducted.

Here's a breakdown of the relevant information:

1. Table of acceptance criteria and the reported device performance:

Since this is not an AI/software device, there aren't traditional "acceptance criteria" for metrics like sensitivity, specificity, or accuracy. Instead, the acceptance criteria relate to engineering and biocompatibility standards. The reported device performance is demonstrated by meeting these standards.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in the context of an AI/software device. For the non-clinical performance tests like fatigue and corrosion, the sample sizes are determined by the respective ISO/ASTM standards. These details are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI/software device. The non-clinical testing was conducted by MIS Implants Technologies.

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

• Not Applicable. This is a medical device (dental implant and abutments), not an AI/software device that relies on expert interpretation for ground truth.

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

• Not Applicable. See point 3.

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

• No. This is not an AI-assisted device.

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

• Not Applicable. This is a physical medical device.

7. The type of ground truth used:

• Defined by Engineering Standards and Material Properties: The "truth" for this device is its adherence to mechanical performance standards (e.g., fatigue strength), biocompatibility (e.g., non-cytotoxicity, corrosion resistance), and physical characteristics (e.g., dimensions, material composition). This is established through laboratory testing following ISO and ASTM guidelines.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/software device.

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

• Not Applicable. See point 8.

Summary of applicable information from the document:

This 510(k) summary focuses on demonstrating the substantial equivalence of the modified MIS Dental Implant System (Lance+ Internal Hex Implants and Cobalt Chrome Abutments) to existing legally marketed predicate devices. The evidence presented primarily consists of non-clinical performance data:

• Fatigue testing: Conducted according to ISO 14801:2016 for the implants.
• Corrosion testing: For the Cobalt Chrome (CoCr) abutments, indicating low risk of galvanic corrosion when coupled with titanium.
• Biocompatibility testing: Cytotoxicity testing for the CoCr abutments, with implants relying on prior testing for the same materials.
• Surface treatment characterization: Confirmed to be identical to predicate devices.
• Packaging integrity validation: Conducted per ISO 11607-1:2009 and ASTM F1929-12.
• Sterilization validation: For both radiation (implants) and moist heat (abutments), adhering to relevant ANSI/AAMI/ISO standards to achieve an SAL of 10^-6.

The document explicitly states: "No human clinical data were included to support substantial equivalence." This means the device relies entirely on non-clinical engineering and material science data to prove its safety and effectiveness relative to existing, cleared devices.

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MIS dental implant systems are 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 & UNO) 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 long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Regarding the other points of the prompt, as applied to this document:

2. Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

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The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

This submission includes threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12º from orthogonal to the implant). The Straight and Co-Axis implants are each provided in two diameters, 4.0 mm (actual major diameter 4.07 mm tapering to 2.6 mm), and 4.7 mm (actual major diameter 4.70 mm tapering to 3.13 mm), in one prosthetic diameter (3.575 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.

This submission also includes: a Cover Screw (one design/size); Healing Abutments in three diameters (3.7, 4.5, and 5.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Cosmetic Abutments in straight (0°), 12°, and 24° angled engaging designs for single-unit restorations; Passive Abutments with a plastic burn-out component, in one size and two designs (engaging); Compact Conical Abutments in straight (0°), 20°, and 30° angled designs for multi-unit restorations; and abutment screws.

All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar. The remainder of the implant (the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634. The Cover Screw and all abutments (except Compact Conical) are manufactured from unalloyed titanium conforming to ASTM F67. The Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or gold-platinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634 and K163060.

This 510(k) summary is for a dental implant system (Provata Implant System), not a software-driven AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, its performance study details, or ground truth establishment.

Specifically:

• No Acceptance Criteria Table: The document describes the device's design, materials, and comparison to predicate devices, but does not present a table of acceptance criteria and performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC).
• No AI/ML Performance Study: The "Performance Data" section states, "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility... engineering analysis; dimensional analysis; sterilization validation... bacterial endotoxin... sterile barrier shelf life... and static and dynamic compression-bending according to ISO 14801. No clinical data were included in this submission." This explicitly indicates no clinical or reader study was performed for this device as it is physical hardware.
• No Ground Truth Establishment: Since no clinical data or AI/ML model performance is being evaluated, there is no mention of ground truth, expert opinions, or adjudication methods.

Therefore, I cannot provide a response with the requested information based on the provided text.

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The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.

ATLANTIS® products are compatible with the implants shown in the table below.

The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).

The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.

The provided text is a 510(k) Pre-Market Notification for the ATLANTIS® Abutment for MIS Implant. It does not describe an AI/ML powered medical device, but rather a dental implant abutment which is a physical device. Therefore, the questions related to AI/ML device acceptance criteria and study design are not applicable.

However, I can provide the acceptance criteria and the study that proves the physical device meets its acceptance criteria based on the information provided in the document.

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

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

The document does not explicitly state the sample sizes used for the mechanical testing or geometric analyses. It also does not specify the country of origin or whether the data was retrospective or prospective. These details are typically found in the full test reports referenced in the 510(k) submission, not in the summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device, not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be established by engineering specifications, materials science standards, and established regulatory test methodologies.

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

Not applicable. This is a physical device, not an AI/ML device that requires expert adjudication for diagnostic outputs. The performance is assessed through standardized engineering tests.

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

Not applicable. This is a physical device, not an AI/ML device.

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

Not applicable. This is a physical device, not an AI/ML device.

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

The "ground truth" for this medical device would be defined by engineering standards, material properties, and regulatory performance requirements. For example:

• Mechanical Testing: Ground truth is defined by the requirements of ISO 14801, which sets pass/fail criteria for fatigue strength, and by the established strength and durability of the predicate device.
• Dimensional Compatibility: Ground truth is defined by the precise geometric specifications and tolerances of the MIS implant interface, ensuring a proper fit.
• Sterilization: Ground truth is defined by the validation criteria outlined in ISO 17665-1 and ISO 20857, ensuring a sterile product.
• Biocompatibility: Ground truth is established by the accepted biocompatibility of the identical materials used in the predicate device.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a physical device, not an AI/ML device.

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.

The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.

The provided text describes the Chang Gung "ComMed" Series Dental Implant System and its clearance through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing ones, rather than providing extensive de novo clinical trials typical for novel medical devices. Therefore, the information provided focuses on non-clinical testing rather than studies involving human subjects, AI performance, or expert ground truth.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in numerical terms for the non-clinical tests. Instead, it refers to conformity with relevant ISO and ASTM standards. The reported device performance is that it met these standards, supporting substantial equivalence.

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

• Sample Size: Not explicitly stated in the provided text. The non-clinical testing described typically involves specific numbers of samples (e.g., implants, abutments, packaging units) tested in a lab setting, but these quantities are not detailed.
• Data Provenance: The tests are non-clinical, meaning they are lab-based or in-vitro/in-vivo animal studies (for biocompatibility in some cases, though specific animal models are not detailed). The testing was conducted to support the substantial equivalence submission for a device manufactured by Chang Gung Medical Technology Co., Ltd. in Taiwan.

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

This question is not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials subjected to non-clinical tests, not a dataset requiring human expert annotation for ground truth. The evaluation of compliance with standards is done by testing laboratories and regulatory bodies.

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

Not applicable. This concept typically refers to how disagreements among human reviewers (e.g., radiologists) are resolved in clinical studies or AI evaluations. For engineering and biocompatibility testing, the "adjudication" is based on whether the test results meet the specified criteria of the referenced 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

Not applicable. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI performance metrics are not relevant to its evaluation.

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

Not applicable, as this device is not an algorithm or AI system.

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

Not applicable. The "ground truth" for this device's non-clinical testing is adherence to the specified performance characteristics as defined by international standards (ISO, ASTM) for mechanical strength, biocompatibility, sterility, and packaging integrity.

8. The sample size for the training set

Not applicable. Training sets are relevant for machine learning algorithms, which this device is not.

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

Not applicable.

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For immediate or delayed surgical placement of a Dental implant in the anterior region and to allow immediate restoration (for cosmetic purposes).

The Reliadent Dental Implant System includes surgical implants, healing cap, restoration abutments, and surgical instruments.

Implants: Includes one or two step dental implant devices which are designed as conical and cylindrical shapes. They consist of various diameters with a range of 3.6mm-6.0mm and lengths with a range of 8mm-21mm. The internal and external hexagonal shapes are important to maintain the implant stability. One group of the products is HA coated. This surface has been modified to enhance the osseointegration. The dental implants are composed of medical grade 4 pure titanium.

Cover screw and healing cap: The cover screw and healing caps are supplied together with the implants. They cover the internal body of implant to allow gum free space for connection between the implants and restoration abutments.

Abutment: Abutments and accessories are the support part to prosthetic restoration. Screw retained abutments are included in the Reliadent Dental Implant System. The abutments are composed of medical grade 2 titanium.

Surgical Instrument Kit: The surgical instruments include the implants installation set, abutment connections, and drill set. There are hand tools, drill bits of different sizes, and handles in these sets. The instrument kit is designed to be used with a wide range of commercially available implant devices.

This document is a 510(k) summary for the Reliadent Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not present in the provided text.

Here's an analysis of what can be extracted and what is missing:

The provided text does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or technical performance study would for a novel device. Instead, it demonstrates substantial equivalence to an already cleared predicate device (MIS Dental Implant System, K040807). This is a common pathway for device clearance, where the new device is shown to have the same intended use, similar technological characteristics, and equivalent performance to a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, reported device performance metrics (like sensitivity, specificity, accuracy, etc.), sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone performance is not applicable in the context of this 510(k) submission, as these types of studies were not presented or required for this type of submission.

Here's a breakdown based on your request, highlighting what's available and what's explicitly missing/not applicable:

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

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

• Not applicable / Not provided. No specific test set or clinical study data proving performance for the Reliadent Dental Implant System were presented in this 510(k) summary. The submission relies on demonstrating similarity to a predicate device.

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

• Not applicable / Not provided. No test set requiring expert-established ground truth was detailed in this substantial equivalence submission.

4. Adjudication method for the test set

• Not applicable / Not provided. No test set requiring adjudication was detailed.

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

• Not applicable / Not done. This device is a dental implant system, not an AI-powered diagnostic tool. MRMC studies are irrelevant to this product.

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

• Not applicable / Not done. This device is a physical medical device (dental implant), not an algorithm or software. Standalone performance studies in this context typically refer to AI algorithms, which is not relevant here.

7. The type of ground truth used

• Not applicable / Not provided. As no performance study with a test set was detailed, no ground truth was established within this submission. The "truth" here is the prior clearance and presumed safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable / Not provided. No training set was used. This is not an AI/machine learning device.

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

• Not applicable / Not provided. No training set or associated ground truth was established.

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

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence to a predicate device (MIS Dental Implant System, K040807). The argument for meeting the "acceptance criteria" (which is primarily substantial equivalence) is made by:

• Comparing Intended Use: The Reliadent system has the "same intended use" as the MIS Dental Implant System.
• Comparing Materials: Both devices use medical grade titanium. The Reliadent system specifies medical grade 4 pure titanium for implants and medical grade 2 titanium for abutments.
• Comparing Design: The Reliadent system includes "similar" surgical implants, healing caps, restoration abutments, and surgical instruments, with conical and cylindrical shapes, various diameters and lengths, and internal/external hexagonal shapes. A key difference mentioned is the "modified surface" (HA coated) on one group of products in the Reliadent system, intended to "enhance osseointegration." However, this is presented as an enhancement rather than a deviation requiring explicit comparative performance data with the predicate.
• Concluding Equivalence in Performance and Safety: The submission states, "All other technological characteristics are similar and both devices show equivalent performance capabilities," and that the Reliadent system "does not raise any additional concerns regarding safety and effectivity."

The FDA's letter (K061323) confirms their review of the submission and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications for Use" section further clarifies the specific use recognized by the FDA for the RDI Dental Implant System.

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