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QRS Dental Implants 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.

The implants (Ø3.3mm and one-piece) 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.

QRS Dental Implants are self-tapping, root-form, one piece or two piece screw (Red Class, Blue Class and Gold Class) type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.

The QRS' dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The QRS' two piece implant is to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.

QRS dental implants (Red Class, Blue Class and Gold Class) are designed with a standard internal hexagon system and provided in 3.3, 3.75, 4.2, 5.0 and 6.0mm diameter for lengths of 8, 10, 11.5, 13 and 16mm.

QRS dental implant one-piece is provided in 3.3 and 3.5mm diameter for lengths of 10, 11.5, 13 and 16mm.

The ORS' two piece dental implants are to be used in combination with cover screws. healing caps, abutments, smart attachment and straight multi-unit abutment according to commonly used protocol in the dental implantation field.

The QRS Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The implants are grit blasted and acid etched surface.

All QRS' abutments, cover screws, healing caps, Straight ball attachment, smart attachment and strait multi- unit abutments are made of Ti6A14V ELI titanium alloy complying with ASTM F 136-13: Wrought Titanium-6 Aluminum -4Vanadium ELI alloy for surgical implant applications and ISO 5832-3: 2016: Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

Abutments (straight abutments, angulated abutments (15°, 25°), and anatomic angulated abutments (15°, 25°)) are intended to be used in conjunction with endosseous dental implants fixture to aid in prosthetic rehabilitation. The abutments are intended for long term use and are in contact with tissue.

The abutments are available straight or angulated, in different heights and diameters to accommodate the patient's specific needs. They are available in 0, 15 or 25 degrees angulation.

Straight Abutment SP Titanium Abutment is provided in height of 5, 7 and 9mm. Standard shoulder abutment in heights of 1, 2, 3 and 4mm Standard Wide Shoulder Abutment is provided in heights of 1, 2, 3 and 4mm Standard 15° Abutment is provided in heights of 2, 3 and 4mm Standard 25° Abutment is provided in heights of 2, 3 and 4mm The healing caps are intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Healing Caps are provided in 4.5 diameter in heights of 3, 4, 5, 6 and 7mm. Wide Healing Cap is provided in 6 diameter in heights 3, 4, 5 and 6mm.

Straight Ball attachment are designed to increase retention of (partial) overdentures, supported on implants. QRS titanium Ball Attachments provide firm retention and stabilization of the overdenture when used with tissue-supported implant-retained overdentures and are compatible with QRS internal hexagon connection implants.

Straight ball attachments are provided in heights of 2, 3, and 4mm

Smart Attachment - Locator abutments are designed for use with overdentures or partial dentures retained in whole or in part by dental implants in the mandible or maxilla. They offer multiple levels of retention and low vertical profile. The selfaligning design enables patients to easily seat their dentures. Smart attachment are provided with heights of 1, 2, 3 and 4mm.

Straight Multi-unit abutment are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-unit abutments are provided in heights of 2, 3, 4 and 5 mm.

Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit abutment are provided non-sterile to the user and have to be sterilized prior to use by moist heat

All the Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit are intended for single use only.

QRS Implants are especially designed for implantation in a wide range of bone types and bone augmentation procedures.

Each two piece implant is supplied with a cover screw, which is intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process.

Maximum compatibility and accuracy can be achieved when using compatible QRS tools, drills, accessories and prosthetic parts manufactured by QRS.

The QRS Dental Implants System has demonstrated substantial equivalence to predicate devices through a combination of non-clinical performance data.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format with corresponding reported device performance, as might be found in a more detailed test report. Instead, it lists the types of tests performed and generally concludes that the device "showed equivalence to the predicate devices" or "demonstrates at least equivalent performance."

However, we can infer the acceptance criteria from the tests conducted and the stated conclusions of equivalence:

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

The document does not specify the sample sizes used for the test sets for any of the non-clinical tests (e.g., dynamic fatigue, surface analysis).

The data provenance is non-clinical, indicating these are laboratory tests performed on the physical devices. There is no mention of country of origin for the data; typically, such non-clinical tests are performed by the manufacturer or a contracted testing lab. The nature of these tests means they are inherently prospective in execution, as new devices are produced and specifically subjected to these tests to gather performance data.

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 studies described. The studies are non-clinical, laboratory tests evaluating the physical and material properties of a dental implant system. They do not involve interpretation of medical images or patient data requiring expert consensus or ground truth establishment in the traditional sense of clinical studies for diagnostic or treatment effectiveness. The "ground truth" for these tests are the standards themselves (e.g., ISO 14801, ASTM F 136) and the measured physical properties of the device.

4. Adjudication method for the test set

This is not applicable as the studies are non-clinical laboratory tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth establishment.

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 MRMC comparative effectiveness study was done. The submission solely relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, without involving human readers or AI assistance.

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

No standalone algorithm-only performance study was done. This device is a physical dental implant system, not an AI-powered diagnostic or therapeutic algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by:

• International Standards: e.g., ISO 14801 (dynamic fatigue), ISO 11137-1/2 (sterilization), ISO 17665-1/2 (abutment sterilization), ISO 10993-5/10 (biocompatibility), ISO 19227 (cleanliness). The device's performance is compared against the requirements and methodologies outlined in these standards.
• ASTM Standards: e.g., ASTM F136 (material specification), ASTM F1929-12 (package integrity), ASTM F1980-07 (accelerated aging).
• FDA Guidance Documents: For surface analysis and MRI environment testing.
• Scientific Rationale and Published Literature: Used for MRI compatibility assessment.

Essentially, the ground truth is compliance with established engineering and biocompatibility standards and guidelines.

8. The sample size for the training set

This is not applicable. There is no mention of a training set as this is not a machine learning or AI device.

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

This is not applicable as no training set was used.

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MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.

The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.

MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length).

The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field.

The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

The provided document is a 510(k) Premarket Notification for a dental implant system, not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving device meets acceptance criteria for an AI/software device, such as those related to AI performance metrics (sensitivity, specificity, AUROC), expert reader studies, ground truth establishment, training/test set details, and MRMC studies, is not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the "MSDI Dental Implants System" to legally marketed predicate devices. This involves comparing:

• Intended Use/Indications for Use: The devices serve the same purpose.
• Technological Characteristics: Material, design (screw type, internal hex), surface treatment, dimensions, and accessories (abutments, healing caps) are compared.
• Performance Testing: Non-clinical tests like dynamic fatigue testing (ISO 14801), sterilization validation (ISO 11137-1/2, ISO 17665-1/2), biocompatibility (ISO 10993-5), endotoxin testing (USP 161), and cleanliness (ISO 19227) are mentioned to show the device performs comparably and safely.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study data from this document. The document explicitly states: "No clinical performance data is provided in this submission," further indicating the absence of human-in-the-loop or standalone performance studies in a clinical context that would yield the types of performance data you're asking for.

If you have a document related to an AI/software medical device, please provide that, and I will be able to answer your questions.

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The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.

Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.

SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.

Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.

The SpiralTech Dental Implant System's acceptance criteria and studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical performance metrics against a defined standard. Therefore, the device performance is reported in terms of equivalence to established devices and compliance with relevant standards.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is derived from the "Non-Clinical Testing" and "Substantial Equivalence" sections, as well as the comparison tables. The acceptance criteria essentially reflect conformance to established standards and similarity to predicate devices.

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

The document describes non-clinical laboratory testing, not clinical studies involving patient data. Therefore, there isn't a "test set" in the sense of patient data.

• Sample Size for Testing: The specific sample sizes for fatigue testing, sterilization validation, SEM/EDS analysis, and biocompatibility testing are not explicitly stated in the provided text. They are implied to be sufficient for compliance with the referenced ISO and ASTM standards.
• Data Provenance: The studies are non-clinical, laboratory-based tests conducted following international standards (ISO, ASTM, USP). There is no country of origin for "data" in the context of patient information, nor is it retrospective or prospective. The data originates from the manufacturer's testing or contracted laboratories.

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

Not applicable. This device's approval is based on substantial equivalence through non-clinical testing and comparison to predicate devices, not on interpretation of patient data by a panel of human experts.

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

Not applicable, as there is no "test set" requiring expert 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

Not applicable. This document pertains to a dental implant system, which is a physical medical device, not an AI-powered diagnostic or decision support system.

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

Not applicable, as this is not an algorithm-based device.

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

The "ground truth" in this context is the established performance and safety requirements outlined in international standards (ISO, ASTM, USP) for dental implants and materials, as well as the documented characteristics of the predicate and reference devices. For example:

• Sterility: Demonstrated by meeting specified sterility assurance levels (SAL) according to ISO standards.
• Mechanical Strength: Demonstrated by meeting fatigue resistance criteria according to ISO 14801.
• Biocompatibility: Demonstrated by passing cytotoxicity tests (MEM elution) and material characterization (SEM, EDS) in accordance with relevant standards.
• Design & Materials: Comparison to the known, established designs and materials of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

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The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function.

The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The UNIVERSE implants can be used for surgery in two stages or in single stage.

The POWER and SOLUTION implants can be used for surgery in single stage.

All IMMEDIATELOAD dental implants have a double external thread that looks flattened from the proximal area to the distal area. There are three types of implants: UNIVERSE (conical biphasic), POWER (conical monophasic), and SOLUTION (cylindrical monophasic), available in different diameters and length combinations. All the implants are made of Titanium Grade 4. They are provided sterile and are ready to be implanted.

For each measure, the connection between the biphasic implant and the relative prosthetic component is secured by a locking taper connection and a preformed hexagon and by a retained screw.

The abutments are prosthetic accessories made of Titanium Grade 5; they are used to engage, form and create dentures. In particular, the abutment is designed to be applied on the biphasic implant during the surgical reopening, after osseointegration. The straight abutment IMMEDIATE has a straight axis compared to implant's axis. It has a transmucosal collar height ranging from 1 mm to 4 mm.

The inclined abutment IMMEDIATE has axis inclined of 15° compared to the implant's axis. It has a transmucosal collar height ranging from 1 mm to 3 mm. These abutments are fixed to the UNIVERSE implant via a connection screw. The OTK abutment is straight and contains an internal connection screw. It has a transmucosal collar height from 1 mm to 3 mm. The abutments are provided non-sterile and the connection screw for abutments are all provided non-sterile and are intended to be sterilized before use.

This document is a 510(k) summary for a medical device called the "IMMEDIATELOAD Dental Implant System." It describes the device, its intended use, and argues for its substantial equivalence to previously approved predicate devices, primarily based on design, materials, and mechanical performance. It does not describe an AI medical device or a study involving human readers or AI in a clinical setting.

Therefore, I cannot extract the requested information in the format provided because the document does not contain details about:

• Acceptance criteria for an AI device.
• Reported device performance of an AI device.
• Sample sizes for test sets (in the context of AI models).
• Data provenance for AI models.
• Number of experts to establish ground truth for an AI task.
• Adjudication methods for AI performance.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone performance of an AI algorithm.
• Type of ground truth used for AI models.
• Sample size for a training set of an AI model.
• How ground truth for a training set was established for an AI model.

The "studies" mentioned in this document are non-clinical laboratory tests for a dental implant (e.g., sterilization, biocompatibility, fatigue testing) to demonstrate its physical performance and safety, not for an AI algorithm's diagnostic or predictive capabilities.

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Aria Bio's Dental 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of indications for use and technological characteristics with predicate devices.
• Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.

The document states:

• "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
• "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."

This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.

Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.

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The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,

The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10-. This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136.

The provided text is a 510(k) summary for a dental implant device (K082800). It focuses on establishing substantial equivalence to predicate devices based on material composition, implant dimensions, surface treatment, and indications for use.

Crucially, this document does not contain information about acceptance criteria for device performance studies, nor does it detail any studies conducted to prove the device meets specific performance criteria.

A 510(k) summary for a device like a dental implant typically demonstrates substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria. The FDA determined that the device is substantially equivalent based on the provided information, meaning it performs as safely and effectively as previously cleared devices.

Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, ground truth, or sample sizes, as this information is not present in the provided text.

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