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The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.

The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UF(II) Bar holder abutment:

This document is a 510(k) summary for a medical device (UF(II) Bar holder abutment). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical or standalone studies for a new type of AI/diagnostic device.

Therefore, the requested information elements related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in this context. This is a traditional medical device submission for an implant component, where the focus is on mechanical integrity, materials, and intended use comparison to existing devices.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are derived from established international standards for dental implants and abutments. Since no specific performance metrics like sensitivity/specificity are reported for this type of device, the "reported device performance" is successful completion of the specified tests, thereby demonstrating substantial equivalence.

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

• Sample Size for Fatigue Test: Not explicitly stated as a number of devices, but the test was performed on "finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation)." This implies a representative number of units for the specific configurations tested, as per the ISO standard.
• Data Provenance: The standard (ISO 14801:2007) is international. The testing itself would have been conducted by the manufacturer or a contracted lab. The document does not specify country of origin for the test results, but the submitter (DIO Corporation) is from the Republic of Korea. It is a prospective test, newly performed or leveraged for this submission.

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

• Not Applicable. This is a mechanical/material performance test, not a diagnostic or AI-driven assessment requiring expert ground truth for interpretation. The "ground truth" is determined by the physical outcome of the tests (e.g., whether the device fractured at a certain load, whether the sterilization parameters were met).

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

• Not Applicable. This device is a physical dental implant abutment, not an AI diagnostic tool.

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

• Not Applicable. See point 5.

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

• For the fatigue test: The "ground truth" is the physical failure or non-failure of the device under specific, controlled dynamic loading conditions, as defined by the ISO standard.
• For sterilization: The "ground truth" is the measurable Sterilization Assurance Level (SAL), typically confirmed by biological indicators or other validated methods.
• For biocompatibility: The "ground truth" is the established safety profile of the material based on chemical composition and previous testing (ISO 10993).

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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Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.

Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.

The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.

The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).

The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.

The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.

Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.

Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.

Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.

Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.

Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.

Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.

Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.

Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.

The provided document describes a 510(k) premarket notification for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify explicit "acceptance criteria" in terms of quantitative thresholds for device performance. Instead, it relies on demonstrating that the new models are "the same or similar" to previously cleared predicate and reference devices, and that relevant testing (biocompatibility, sterilization, shelf life, mechanical fatigue) leveraging existing data for the predicate device supports their continued safety and effectiveness.

However, based on the non-clinical testing section, the implicit acceptance criteria are that the device performance should be equivalent to the predicate devices and meet relevant ISO standards for dental implants and abutments.

Study Proving Device Meets Acceptance Criteria:

The document describes a reliance on non-clinical bench testing and leveraging data from previously cleared predicate devices rather than a new standalone clinical study for the current submission.

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

• Test Set Sample Size: The document does not specify a distinct "test set sample size" in terms of cases or patients, as it's a bench study leveraging prior data for substantial equivalence. For the fatigue testing, it states that "fatigue testing... was performed on the worst-case bone level Implant mated with the worst case Implantswiss Dental Abutment." This implies a limited number of physical devices representing the "worst-case" scenario were tested as per ISO 14801. However, the exact number of samples tested for fatigue is not explicitly stated in this summary.
• Data Provenance: The data primarily comes from non-clinical bench testing (biocompatibility, sterilization, shelf life, mechanical fatigue) performed on the predicate device (K181266) and other reference devices (K160221, K150295, K161416, K181037). These studies were presumably conducted by the manufacturer, Novodent SA, or its affiliates and contracted labs. The country of origin of this specific testing data is not explicitly mentioned but is likely from the region where Novodent SA (Switzerland) and its partners operate. The studies are retrospective in the context of this 510(k) submission, as they were conducted for prior device clearances and are now being leveraged.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. This is a non-clinical device submission demonstrating substantial equivalence through bench testing, not a study involving human subjects or expert assessment for ground truth on disease detection.

4. Adjudication method for the test set:
Not applicable, for the same reasons as 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:
Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established scientific and engineering principles, international performance standards (e.g., ISO 10993, ISO 11137-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, USP , ISO 14801, ASTM F1886, ASTM F1929-15, BS EN 868-5:2009), and material specifications (e.g., ASTM F-67, ASTM F-136). Compliance with these standards and material properties, validated by bench testing results, serves as the basis for "ground truth" for device performance.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not a machine learning model.

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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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