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Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.

Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).

Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.

Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.

Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.

Abutment Screws: Connects and fixes the abutment and implant body.

This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.

The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.

However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.

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

Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:

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

The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.

• Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.

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 to the type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.

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

This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.

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

This is not applicable. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading.
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  Larger implants are dedicated for the molar region.

The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM). The system offers various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.

The provided document is a 510(k) Premarket Notification from the FDA for the AnyRidge Octa 1 Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a standalone study with acceptance thresholds.

The document discusses non-clinical testing performed to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, AUC values) or corresponding device performance results in the context of clinical effectiveness or diagnostic accuracy, as it is a 510(k) submission focusing on substantial equivalence to predicate devices rather than novel performance claims.

However, it mentions that fatigue tests were performed on the subject devices in accordance with ISO 14801. The acceptance criterion for this would be that the fatigue test results of the subject device are substantially equivalent to the predicate device. The document states:

• "The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device."
  This indicates that the subject device met the implied acceptance criterion of demonstrating comparable mechanical durability to the predicate under the specified test conditions.

Other non-clinical tests mentioned also have implicit acceptance criteria:

• Sterilization validation testing (ISO 11137 and ISO 17665-1, 2): To verify a sterility assurance level (SAL) of 10^-6. The document states this was performed to verify SAL (10^-6), implying it met this standard.
• Shelf life validation testing (ASTM F1980): To validate a 5-year shelf life using accelerated aging. The document states "the test results validated 5 year shelf life," indicating the criterion was met.
• Surface Morphology (EDS), Surface Roughness, GC/LC Analysis, IC Analysis: These tests were done to evaluate SLA treatment. The implicit acceptance would be that the characteristics are consistent with acceptable dental implants and/or comparable to the predicate device's surface treatment.
• Endotoxin testing (USP 39 ): The testing limit is below 0.5 EU/mL. This will be conducted on every batch, implying this is the ongoing acceptance criterion for endotoxin levels.

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

The document does not describe a "test set" in the context of patient data or a clinical study for performance evaluation. The "tests" performed are non-clinical, laboratory-based tests on the device itself. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

Not applicable. This is a non-clinical 510(k) submission, not a clinical study requiring expert ground truth for a test set.

4. Adjudication Method

Not applicable. This is a non-clinical 510(k) submission.

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

Not applicable. This is a non-clinical 510(k) submission for a dental implant system, not a diagnostic device typically evaluated with MRMC studies with human readers and AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" refers to established scientific standards and regulatory guidelines.

• Mechanical Fatigue: ISO 14801, and comparison to the performance of legally marketed predicate devices.
• Sterilization: ISO 11137 and ISO 17665-1, 2.
• Shelf Life: ASTM F1980.
• Biocompatibility: Likely established through previous 510(k) submissions for the predicate devices using similar materials.
• Endotoxin: USP 39 .

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/algorithm-based product that requires a training set.

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

Not applicable.

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This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Intended for delayed loading.

• (1) This Product is designed to be used in dental surgery in mandible or maxilla-arch, where has missing teeth, to have dental crown, fixation-bridge, over-denture installed afterwards, and to support and restore patient's chewing function.
• (2) This implant (Ti-one 101 TS dental implants (Fixture)) is made of grade 4 pure titanium, featuring sandblasting + acid etching surface treatment (SLAffinity).
• (3) Healing screw is one-piece abutment made of grade 4 titanium.
• (4) Abutment is two-piece abutment made of grade 4 titanium. Its surface was anodized.
• (5) Label attached to the surface of outer packaging indicates specification and model number.

The range of diameter for implant (fixture) is provided as below:
Ø Diameter: 3.5, 4.0, 4.5, 5.0 mm
Length: 7.0, 8.0, 9.5, 11.0, 12.5, 14.0 mm

All diameters are available in all lengths, other than the 3.5mm diameter which is not available in the 7.0mm length.

The range of diameters and angulations for each screw model and abutment model are provided as below:
Healing Screw: Ø 4.3 mm, G/H 1.0, 3.0, 4.0 mm, Height (H) 3.5, 5.0, 7.0 mm
Angled Abutment: Ø 4.5, 5.5 mm, G/H 3.5 mm, V/H 11.0 mm, Length (L) 14.13, 14.15, 14.20 mm, Angulation range 12.5°, 20.0°, 27.5°

The provided document is a 510(k) summary for the "Ti-one 101 TS Dental Implant System." It does not describe an AI or software as a medical device (SaMD). Instead, it details a traditional medical device (dental implant system) and its non-clinical testing for substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI/SaMD studies are not applicable.

Here's an analysis of the provided information, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the document. The document refers to "test reports" for each test category but does not include the number of units tested.
• Data Provenance: The biocompatibility tests for the predicate device (K110425) are leveraged from the same manufacturer, Hung Chun Bio-S Co., Ltd. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though performance and biocompatibility testing of medical devices are typically prospective bench or in-vitro tests conducted in a lab setting.

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

• Not Applicable. This device is a physical dental implant, not an AI or SaMD requiring expert interpretation for ground truth establishment. Its performance is evaluated through standardized mechanical, biological, and sterilization tests.

4. Adjudication method for the test set

• Not Applicable. As above, the device is evaluated through objective, standardized tests, not through expert adjudication of data.

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

• Not Applicable. This study is for a physical medical device (dental implant system), not an AI or SaMD. No human readers or AI assistance are involved in its evaluation as described.

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

• Not Applicable. This is not an algorithm or SaMD.

7. The type of ground truth used

• For the non-clinical tests (sterilization, shelf life, biocompatibility, performance), the "ground truth" is defined by the specific requirements and passing criteria of the referenced international/national standards (e.g., ISO, ASTM, USP, AAMI, OECD guidelines). The device's performance is measured against these objective criteria.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/SaMD. There is no concept of a "training set" in the context of this 510(k) summary.

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

• Not Applicable. As above, there is no training set for this device.

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CONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

CONELOG® Implants with 3.3 mm diameter have the following additional specific indications:
These are an alternative in cases where the alveolar ridge width is only 5 - 6 mm. Because of their lower mechanical strength compared with larger diameter implants, they should only be used under the following conditions:

• As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors.
• An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions.
• Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø 3.3 mm must be taken into account.
• Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants.
• The healing time for Ø 3.3 mm implants is at least 12 weeks.

CONELOG® Implants with 7 mm length have the following additional specific indications:
CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

Abutment Indications for Use
CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

Vario SR Indications for Use
CONELOG® Vario SR components for crown and bridge restorations:

• Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandible
  CONELOG® Vario SR components for bar restorations:
• Anchorage of implant-supported full dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulous mandible in conjunction with 2 or 4 or more CONELOG® implants.

The purpose of this submission is to add an alternative to the CAMLOG® Implant System by the introduction of an implant line with a tapered implant abutment interface. The new line of implants and abutments is named the CONELOG® Implant System. The primary features of the current CAMLOG Implant System are a change from the tube-in-tube interface with a square cam design for anti-rotation to the tapered implant/abutment interface connection with three positioning cams and the addition of a 7.0 mm long implant. The three positioning cams of the CONELOG abutments are placed more apically on the abutment shaft but are comparable in design principle to the three positioning cams of the CAMLOG Implant System. All other design features of the system remain the same.

The CONELOG implant system features an implant/abutment interface that includes a 7.5° taper with anti-rotation cams at the base of the connection. Components available with the CONELOG implant/abutment interface include the SCREW-LINE Promote® plus implant and cover screw, healing caps, Universal abutments, Telescope abutments, Esthomic" abutments, the Esthomice abutment inset, temporary abutments, Gold-plastic abutments, Logfit® abutments, ball abutments, bar abutments and Vario SR abutments. All components correspond to previously cleared CAMLOG components with the tube-in-tube interface.

The provided document is a 510(k) summary for a medical device (dental implant system) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document describes the device, its intended use, its equivalence to previously marketed devices, and the administrative information for its 510(k) clearance.

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

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