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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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