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Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).

The provided document is a 510(k) Summary for the Point implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories about acceptance criteria, efficacy studies, and ground truth are not directly addressed in this type of submission.

However, I can extract information related to non-clinical testing and general acceptance of performance based on standards.

Here's a breakdown of the available information:

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

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified. The manufacturer is PointNix Co., Ltd. from REPUBLIC OF KOREA.

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 applicable and not provided in a 510(k) summary for a dental implant system. The document focuses on physical, chemical, and biological performance testing against established standards, not on diagnostic accuracy requiring expert consensus as ground truth.

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

• Not applicable. The tests mentioned are non-clinical, objective tests against engineering and biological standards, not requiring human adjudication of results in the way a clinical imaging study might.

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 dental implant system, not an AI-powered diagnostic device. No MRMC studies were mentioned.

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

• Not applicable. This is a dental implant system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" or reference for acceptance is primarily the criteria defined by international and national standards (e.g., ISO 10993, ISO 14801, ISO 11137, ANSI/AAMI, USP), as well as FDA guidance documents. These standards define methodologies and acceptable limits for properties like biocompatibility, fatigue strength, sterility, and packaging integrity.

8. The sample size for the training set

• Not applicable. This is a medical device (dental implant), not a machine learning model that requires a training set.

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

• Not applicable. (See answer to #8).

Summary of Study Type:

The "studies" described are a series of non-clinical performance tests conducted to demonstrate that the physical, chemical, and biological properties of the Point implant system meet established international standards and FDA guidance for dental implants. These are largely laboratory-based tests comparing the device's performance against predefined thresholds and methodologies specified in the standards. No clinical studies (human trials) were included in this 510(k) submission.

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The IM/ST Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The proposed device, IM/ST Fixture System, is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Implant system contain dental implant and abutment. The dental implant system, IM Implant System and ST Implant System, both of which are divided into mini implant and regular implant. IM Implant and ST Implant have different designs for the external thread section. The external thread part of IM implant is composed of conical shape, double thread and spiral groove, while The external thread part of ST implant is composed of conical shape, single thread, neck micro thread and cutting groove. Both IM implant and ST implant are available in diameters of 3.75, 4.2, 4.6 and 5.05mm and lengths of 7, 8.5, 10, 11.5, 13 and 15mm, and both are bone level. The "mini" and "regular" differ in size, but abutments are cross-compatible with both IM and ST implant types, and the abutment is attached to the implant by abutment screw and fastened to the implant. The material of abutment screw is Titanium Alloy (Ti-6A1-4V, ASTM F136).

The implants are bone level. The implants were made of Pure Titanium Grade 4 and underwent sandblasting and acid etching process. Modified surface testing (SEM/EDS) for blasted/etched surfaces was conducted to demonstrate removal of particles and chemicals from implant surface.

Abutment can be divided into healing abutment, straight abutment, multi-abutment, multi-angled abutment and temporary abutment. And it is divided into mini abutment and regular abutment. In addition, abutment also has three types of cylinder, angled cylinder and temporary cylinder.

The provided document is a 510(k) summary for the Guilin FiTeeth Medical Instrument Co., Ltd. IM/ST Fixture System. It describes the device and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and proving performance against them through a clinical study with detailed metrics like sensitivity, specificity, or AUC.

Therefore, the requested information for acceptance criteria and study details cannot be extracted as the document pertains to a medical device submission for substantial equivalence based on non-clinical tests and technological characteristics comparison, not an AI/Software as a Medical Device (SaMD) performance study with specific acceptance criteria, test sets, ground truth establishment, or human-in-the-loop effect sizes.

The document states:

• "No clinical study is included in this submission." on page 6.

Instead, the submission relies on:

• Non-clinical testing: This included biocompatibility (ISO 10993-1, USP ), dynamic fatigue (ISO 14801), material specifications (ASTM F136, ASTM F67), sterilization validation (ISO 17665-1, ISO 17665-2, ISO 11137-2, ISO 11137-1), accelerated aging (ASTM F1980), and MRI safety review. These tests verify that the device meets design specifications and complies with relevant standards.
• Technological characteristics comparison: The proposed device was compared in detail to a primary predicate device (K121995, OSSTEM IMPLANT CO.,LTD TS FIXTURE SYSTEM) and several reference devices for its abutment components. Differences in structure, body diameter, implant length, shelf life, and dimensions of various abutment types were assessed, and the manufacturer argued these differences do not affect substantial equivalence based on mechanical testing, coverage by predicate/reference ranges, or biocompatibility evaluations.

Since this is a submission for a traditional medical device (dental implant system) and not an AI/SaMD, the typical acceptance criteria and study details related to AI performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, independent test sets, expert ground truth adjudication) are not applicable or provided in this document.

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SuperLine® implants are 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. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose 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. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

AnyOne External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance. AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

Here's a breakdown of the acceptance criteria and study information for the AnyOne External Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details the equivalence to predicate devices rather than explicit, stand-alone acceptance criteria with specific numerical thresholds for each component. However, the core acceptance criteria revolve around demonstrating substantial equivalence to existing, legally marketed devices (predicates and reference devices). The reported performance across all components is that they met the pre-set criteria for the conducted tests.

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

The document does not explicitly state the numerical sample size for the test set used in the performance bench tests (static compression-strength and fatigue tests). It mentions "test was performed on the subject device and predicate device" and "representative specimen".

• Sample Size (Test Set): Not explicitly stated as a numerical value for each test (e.g., how many implants were tested for fatigue). It generally refers to "the subject device and predicate device" and "representative specimen" in singular form, implying at least one of each worst-case scenario. However, for a regulatory submission of this nature, multiple samples would typically be tested to establish statistical confidence, even if not explicitly detailed in this summary.
• Data Provenance: The study is non-clinical bench testing. The country of origin of the data is not specified, but the applicant and correspondent are located in the Republic of Korea. The tests are prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.

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

This is not applicable as the studies are non-clinical bench tests (physical properties, biocompatibility, sterilization, etc.). Ground truth in this context is established by adherence to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts interpreting test results for "ground truth" in the way it might apply to a clinical study involving medical image analysis, for example.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical bench testing. Passing or failing criteria are determined by adherence to established engineering and material science standards (e.g., force applied, number of cycles, endotoxin concentration limits).

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

No. This is a submission for a dental implant system involving physical components. MRMC studies are typically performed for AI/CAD systems that assist human readers in tasks like medical image interpretation.

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

No. As above, this is for a physical medical device. There is no algorithm involved.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to international standards such as ISO 14801 for mechanical testing, ISO 10993-1 for biocompatibility, ISO 11137 and ISO 17665-1, 2 for sterilization, ASTM F1980 for shelf life, and USP 39 for endotoxin testing.
• Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device's performance, materials, and design are comparable to legally marketed predicate and reference devices. The predicate devices themselves serve as a form of "ground truth" for acceptable performance and safety within their intended use.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. See point 8.

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Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.

This document (K210080) describes the Dentis s-Clean s-Line Mini, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device requiring a study to prove meeting acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

The acceptance criteria described in this document are related to the physical, chemical, and mechanical properties, as well as the sterility and biocompatibility of the dental implant components, and their substantial equivalence to already marketed devices. The "study" proving acceptance is a series of non-clinical tests and comparisons to predicate devices.

Therefore, I cannot provide a table with "acceptance criteria and reported device performance" as typically found for AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, I will describe the non-clinical tests and their outcomes as presented in the document to demonstrate the device meets its acceptance criteria for safety and effectiveness as a physical medical device.

1. Table of Acceptance Criteria (for a physical dental implant) and Reported Device Performance

Since this is a physical dental implant, the "acceptance criteria" are based on meeting established standards and demonstrating substantial equivalence to predicate devices in terms of material, design, performance, and biocompatibility.

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

• Sample Size for Test Set: The document doesn't specify a "test set" in the context of an AI/ML diagnostic algorithm. For the physical device, fatigue testing per ISO 14801 would involve a specific number of samples, but the exact count is not provided. Other tests like biocompatibility, sterilization, and shelf-life are typically performed on a limited number of samples representative of the product. The document states a comparative fatigue test was conducted.
• Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the results of non-clinical bench testing and material characterization. The manufacturer is Dentis Co., Ltd. from South Korea. The testing was performed according to international standards (ISO, ASTM, USP) and FDA-recognized guidance. It's a "prospective" assessment in that the tests were done on the manufactured devices to demonstrate their properties.

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

• This is not applicable for a physical medical device submission like this one. "Ground truth" in this context refers to established standards (e.g., ISO for fatigue, ASTM for materials, ISO/AAMI for sterilization), which are derived from broad expert consensus in relevant fields (engineering, microbiology, toxicology, dentistry).

4. Adjudication Method for the Test Set:

• Not applicable as this is not an AI/ML diagnostic study with human readers. Test results are compared against defined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, this type of study is not relevant for a physical dental implant. MRMC studies are typically for evaluating the diagnostic performance of AI/ML systems, often with human readers.

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

• Not applicable. There is no algorithm or AI component in this dental implant.

7. The Type of Ground Truth Used:

• The "ground truth" for proving the device's acceptance is based on:
  • International Standards: Conformance to recognized standards such as ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 series (sterilization), ASTM F67, F136, F1980 (materials, shelf-life), and AAMI/USP guidelines for bacterial endotoxins.
  • Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device has the "same intended use and fundamental scientific technology" as legally marketed predicate devices, and any differences "do not raise different questions of safety and effectiveness."

8. The Sample Size for the Training Set:

• Not applicable. There is no AI/ML training set for this physical device.

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

• Not applicable. There is no AI/ML training set.

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