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IS-III active Short Implants are 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. The IS-III active Short Implants are indicated for the molar region with delayed loading.

IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, 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. Fixture's surface 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 Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.

The provided text describes a 510(k) premarket notification for a medical device (IS-III active Short Implant) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with specific acceptance criteria as you might find for a new diagnostic device or a drug. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to a diagnostic AI/ML device or a drug is not directly applicable in the same way here.

However, we can infer "acceptance criteria" from the performance characteristics and safety evaluations that the FDA requires for substantial equivalence, and "the study" refers to the non-clinical testing performed to meet these requirements.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as the performance and safety benchmarks for substantial equivalence and "study" as the non-clinical testing conducted.

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

Since this is a 510(k) for an endosseous dental implant, the acceptance criteria are primarily focused on mechanical performance, biocompatibility, and sterility, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

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

The document describes non-clinical bench testing. For such tests, the "sample size" refers to the number of physical device samples tested.

• Fatigue Testing: "under the worst-case scenario" implies specific configurations were chosen for testing, but a numerical sample size is not explicitly stated. Typically, multiple samples (e.g., n=5, n=10) would be tested per configuration to ensure statistical robustness.
• Axial Pull-Out Testing: "under the worst-case scenario" implies specific configurations were chosen, but a numerical sample size is not explicitly stated.
• Biocompatibility Testing: The biocompatibility testing was performed on a "reference device, K181138." The sample size for that testing is not specified in this document.
• Sterilization Validation: Tests would involve multiple samples to validate the process to achieve SAL 10^-6, but numerical sample size is not specified.
• Shelf Life Testing: "The worst-case construct was tested," implying specific samples of the device and packaging system were aged and then tested. Numerical sample size is not specified.
• Surface Area Analysis / Comparative Bone to Implant Contact Surface Area Analysis: These are analytical comparisons, likely involving measurements on a set number of devices or designs, but a specific numerical sample size is not given.

Data Provenance: All testing is non-clinical (bench testing), not human data. The data originates from the manufacturer's internal testing and analysis or contracted laboratories, performed to comply with international standards (ISO, ASTM) and FDA guidance documents.

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

This section is not applicable. The evaluations are based on internationally recognized standards (ISO, ASTM) and FDA guidance for medical device performance (mechanical, material, sterility). There isn't a "ground truth" established by human experts in the context of diagnostic interpretation for these types of non-clinical tests. The "truth" is whether the device meets the specified standard (e.g., maximum load before fracture in fatigue testing, or specific material properties).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpreters are evaluating diagnostic images or clinical outcomes, and their interpretations need to be reconciled to establish a consensus ground truth. Here, the "test set" consists of physical devices subjected to mechanical, chemical, and biological tests governed by objective, quantitative standards.

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 section is not applicable. MRMC studies are specific to diagnostic performance evaluations, particularly when assessing the impact of AI on human reader performance for tasks like image interpretation. This submission is for an endosseous dental implant, which is a physical device, not an AI/ML diagnostic tool.

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

This section is not applicable. There is no AI algorithm being evaluated in this submission. The device is a physical dental implant.

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

As mentioned in point 3, the concept of "ground truth" in the context of diagnostic performance (like pathology or expert consensus) is not directly applicable here. The "truth" or reference for evaluating performance of the dental implant consists of:

• International Standards: e.g., ISO 14801 (dental implant fatigue), ASTM F543-17 A3 (mechanical testing), ISO 10993 series (biocompatibility), ISO 11137-1:2006 (radiation sterilization), ASTM F1980 (accelerated aging/shelf life).
• Manufacturer Specifications: Ensuring the device meets its design specifications (e.g., dimensions, material composition).
• Existing Predicate Device Performance: The primary "ground truth" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by matching or exceeding its established performance in relevant tests.

8. The sample size for the training set

This section is not applicable. There is no AI/ML model for which a "training set" would be used.

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

This section is not applicable, as there is no AI/ML model or corresponding training set.

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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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SNUCONE Tissue Level Implant System is inticated 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 terminal or internediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only. The system includes Fixtures and Cover Screw, and Abutment and Component (Solid Abutment, InOcta Closing Screw, InOcta Healing Abutment, InOcta Abutment, InOcta Angled Abutment, InOcta Temporary Abutment, Platform Switching Abutment, and Abutment Screw).

The provided text is a 510(k) premarket notification for a medical device (SNUCONE Tissue Level Implant System). It contains details about the device, its intended use, comparison to predicate devices, and a list of non-clinical tests performed. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria, especially in the context of an FDA clearance for an AI/ML-driven device.

The document explicitly states: "Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It details mechanical performance, sterilization, shelf-life, packaging, MR environment conditions, bacterial endotoxin, and biocompatibility.

THERE IS NO MENTION OF AN AI/ML COMPONENT IN THIS DEVICE.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/ML component. The document describes acceptance criteria for mechanical, material, and sterilization properties, but not AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
2. Sample size for test set and data provenance specific to an AI/ML model. The tests mentioned are laboratory bench tests, not data-driven performance studies on patient cohorts for an AI model.
3. Number of experts and their qualifications for ground truth establishment. This is not relevant to the non-clinical tests described.
4. Adjudication method for the test set. Not relevant.
5. MRMC comparative effectiveness study or human reader improvement. Not relevant.
6. Standalone (algorithm only) performance. Not relevant.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.). Not relevant to the tests performed.
8. Sample size for the training set. Not relevant, as no AI model is described.
9. How ground truth for the training set was established. Not relevant, as no AI model is described.

In summary, the provided document is a 510(k) submission for a physical dental implant system and does not involve any AI/ML components or related performance studies.

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The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The fixtures and abutments in this system are below:

1. Fixture

• Magicore (RBM)
• Magicore (RBM Cutting Edge)
• Magicore II (SLA) .
• Magicore II (SLA Cutting Edge)

2. Abutment

• Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
• Magic Motion
• Magic Motion Housing ●
• Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
• Magic Multiunit Abutment (Cement type Hex, Non-Hex)
• Magic Multiunit Cap .
  An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).

The provided text is a 510(k) summary for the IBS System, an endosseous dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance data against acceptance criteria from a study on the IBS System itself. Therefore, I cannot extract the full details you requested regarding acceptance criteria and the study that proves the device meets them.

The document primarily shows a comparison of technological characteristics between the subject device (IBS System) and various predicate and reference devices. The "SE Discussion" (Substantial Equivalence Discussion) sections explain why the differences are not considered to affect safety and effectiveness, thus supporting the claim of substantial equivalence.

However, I can extract the following information based on the provided text, particularly from the "Non-Clinical Data" section, which outlines the types of tests performed and the standards met:

Inferred Acceptance Criteria and Reported Device Performance (Summary based on tests performed for substantial equivalence):

Further Breakdown of Requested Information (where available):

1. A table of acceptance criteria and the reported device performance: See table above. It's important to note that these are inferred from the standards cited as being met for establishing substantial equivalence, not explicit performance metrics from a comparative study of the new device against specific performance criteria.

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 in the provided text for any of the non-clinical tests (e.g., number of abutments for sterilization, number of implants for fatigue testing, number of participants for human factors).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is InnoBioSurg Co., Ltd. from the 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): Not applicable. This document describes non-clinical engineering and biological tests, not studies involving human expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is for non-clinical testing.

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, not an AI-powered diagnostic or assistive technology.

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

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

   • For Sterilization: Ground truth is defined by the demonstrated sterility assurance level (SAL) of 10^-6, verified by biological indicators and physical parameters outlined in the referenced ISO and AAMI standards.
   • For Biocompatibility: Ground truth is established by the cellular responses and tissue reactions observed in tests, interpreted against the criteria of the ISO 10993 series.
   • For Fatigue Testing: Ground truth is the material's resistance to fracture under cyclic loading, compared to the ISO 14801:2016 standard.
   • For Surface Modification: Ground truth involves microscopic and chemical analysis (e.g., surface roughness, composition analysis, SEM imaging) against established benchmarks or predicate device characteristics.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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ZENEX Implant 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. Wide Fixture System is intended to be used in the molar region

ZENEX Implant System is consisted with ZENEX Fixtures (ZENEX MULTI Fixture and ZENEX PLUS Fixture) and Izenimplant Abutment System. The implant fixtures come in two unique systems, the I-System and the T-System, each with their own abutment compatibilities.

1. ZENEX Fixtures: This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface. As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body. This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone. ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI.

2. Izenimplant Abutment System: Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating. Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

The provided text is a 510(k) Summary for the ZENEX Implant System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical characteristics rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-enabled device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-enabled device. The questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this document describes a traditional medical device (dental implant).

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted on the dental implant system (e.g., sterilization validation, packing validation, biocompatibility, mechanical properties, surface treatment, endotoxin batch test). The acceptance criteria for these tests are typically defined by recognized standards (e.g., ISO, ASTM, FDA guidance documents) rather than specific metrics like sensitivity or specificity for an AI algorithm.

Summary of what is present:

• Acceptance Criteria for Non-Clinical Testing: The document states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the acceptance criteria are adherence to the relevant ISO, ASTM, and FDA guidance documents for each specific non-clinical test (e.g., ISO 11137 for sterilization validation, ISO 10993 for biocompatibility, ISO 14801 for fatigue testing).
• Reported Device Performance: The document confirms that "the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices." It lists various tests performed:
  • Sterilization Validation (Gamma and User Moist Heat)
  • Packing Validation (Shelf-life and Integrity)
  • Biocompatibility Test (ISO 10993-1, 10993-5, FDA Guidance)
  • Performance (Mechanical properties, Fatigue testing per ISO 14801)
  • Surface Treatment Test (SEM, EDS, ICP, IC analysis for SLA; thickness, abrasion, roughness for TiN coating)
  • MR Environment Condition review
  • Endotoxin Batch Test (USP, USP, ANSI/AAMI ST72)
• No ML/AI Component: The device is a dental implant system. There is no mention of any AI or machine learning component, therefore the subsequent questions about AI/ML specific study designs are not relevant.

The requested table and other specific information related to an AI/ML device would be empty or inapplicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):

Inapplicability of AI/ML-specific questions:

2. Sample size for the test set and data provenance: Not applicable. This refers to physical device testing, not data-driven model evaluation.
3. Number of experts and qualifications for ground truth: Not applicable for non-clinical lab testing.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable. Ground truth for a physical device is established by validated measurement techniques and adherence to engineering and material standards.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant. The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment. The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.

The provided text is a 510(k) Summary for the MegaGen Implant Co., Ltd.'s Healing Abutment and Cover Screw. This document is a regulatory submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not a study reporting on specific acceptance criteria and performance data in the traditional sense of a clinical trial or performance study against pre-defined metrics.

Therefore, the information required for topics like acceptance criteria, reported device performance (with quantifiable metrics), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not explicitly present or applicable in the provided regulatory summary.

Here's an analysis of what can be extracted and what is explicitly not available based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new device is as safe and effective as a device already on the market. It does not typically present a table of quantitative acceptance criteria and then report the device's performance against those specific criteria with numerical results.

Instead, the document details physical and material similarities to predicate devices and states that non-clinical testing data "support demonstrating substantial equivalence."

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

• Sample size for test set: Not explicitly stated with numerical values. For the "Precision Fit Test," it mentions that "the test was conducted by selecting randomly among the subject devices in each Implant System." It does not specify the number of devices tested.
• Data provenance: Not specified. The non-clinical tests mention adherence to international standards (ISO, ASTM, USP) but do not detail the origin of the test data (e.g., country where testing was conducted, whether it was retrospective or prospective).

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/not provided. The document is about physical dental devices (healing abutments and cover screws) and their material/mechanical properties, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The non-clinical tests relate to biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, and precision fit, which are typically assessed through laboratory tests against established standards.

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

This information is not applicable/not provided for the same reasons as #3. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 information is not applicable/not provided. This document pertains to physical dental devices, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant.

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

This information is not applicable/not provided. This document pertains to physical dental devices, not an algorithm or AI system.

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

This information is not applicable/not provided in the context of the device's non-clinical testing. The "ground truth" for non-clinical tests (like biocompatibility, sterility, material properties) is typically defined by reference standards (e.g., ISO, ASTM specifications, USP limits for endotoxin) rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as #8.

In summary, the provided document is a regulatory submission (510(k) Summary) demonstrating substantial equivalence for physical dental devices. It focuses on comparing the new device to existing predicate devices based on design, materials, manufacturing processes, and non-clinical performance (biocompatibility, sterility, etc.), rather than reporting on a clinical or performance study with detailed acceptance criteria, quantitative performance metrics, and specific study designs typical for AI or diagnostic devices.

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CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, 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.

CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface 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 device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.

CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.

CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.

The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.

Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.

However, I can extract information related to the device's performance through non-clinical testing.

Here's a breakdown of the relevant information provided:

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

The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.

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

• Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
• Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the 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):

Not applicable. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.

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

Not applicable, as this is non-clinical bench testing against established standards.

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, not an AI/diagnostic device.

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

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no "training set."

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IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.

IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.

All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets them in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a dental implant abutment system (IS Multi Unit Abutment System) and focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for traditional medical devices, not typically AI/ML-driven ones.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily details device descriptions, indications for use, material specifications, and comparisons to predicate devices in terms of physical characteristics and intended use. It also mentions non-clinical testing data related to sterilization and fatigue testing for the physical dental device components.

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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media).

This document describes the Magicore System, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics. The information provided is for regulatory clearance (510(k)) and focuses on comparing the new components of the Magicore System to previously cleared devices.

Therefore, many of the requested categories related to clinical study design, performance metrics, and ground truth establishment are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Magicore System or clinical performance results. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and non-clinical testing.

The acceptance criteria for this 510(k) submission are based on meeting the requirements for substantial equivalence to legally marketed predicate devices. This means showing that the new components of the Magicore System are as safe and effective as the predicate devices and do not raise new questions of safety or effectiveness.

The document states: "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." However, it does not specify what those "criteria" were in terms of quantifiable device performance. It refers to compliance with ISO and ASTM standards for non-clinical aspects.

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

Not applicable. This document is a 510(k) submission for new dental implant components, not a clinical study assessing performance with a test set of data. The testing mentioned is non-clinical (material properties, sterilization, biocompatibility, etc.).

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)

Not applicable. Ground truth establishment by experts for a test set is not relevant to this type of regulatory submission, which relies on engineering and biological testing against established standards and comparison to predicate devices.

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

Not applicable. No test set requiring expert adjudication for ground truth was used in this submission.

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 not a study assessing AI performance or human reader improvement.

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

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

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

Not applicable. The concept of "ground truth" as it applies to diagnostic or treatment efficacy studies is not relevant here. The "truth" in this context is adherence to recognized standards and demonstrated equivalence to already approved devices through non-clinical testing.

8. The sample size for the training set

Not applicable. This product is a physical dental implant system, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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I Do 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 terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

The I Do Fixtures consist of two types of fixtures, Fixture-MT ACTIVE. Both fixtures are a thread type implant made of Ti CP4 according to ASTM F67 which will be placed in the alveola bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixtures' surface 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).

Fixture-S and Fixture MT-Active have same connection but different design.

Fixture S has 2 type of screw bite 0.45mm and 0.35mm in coronal part. Fixture MT-ACTIVE has use only one screw bite of 0.59mm is more tapered.

Tolerance of dimension shall be within ± 1% range. I Do fixtures are provided sterilized.

The provided FDA 510(k) summary (K192294) describes the "I Do" dental implant system. This document is a premarket notification for a new device claiming substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria for performance through clinical trials or extensive standalone algorithm testing.

The document focuses on demonstrating that the "I Do" dental implant system is substantially equivalent to a previously cleared predicate device (IS-III active System, K181138) based on material, design, manufacturing, and non-clinical testing. It does not present a study with performance metrics in the typical sense of accuracy, sensitivity, or specificity for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable as this is not a performance study of an AI/ML diagnostic or therapeutic device.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device through non-clinical testing and comparison of technical characteristics. The "reported device performance" refers to the outcomes of these non-clinical tests meeting the relevant standards.

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

• Test Set Sample Size: Not applicable. This is a technical equivalence review based on non-clinical testing (biocompatibility, sterilization, dimensional analysis, material characterization), not a clinical performance study with a "test set" of patient data in the context of an AI/ML algorithm.
• Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing performed on the device components and comparisons to the predicate device specifications.

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

• Not applicable. There is no "ground truth" established by experts in a clinical context for this type of submission. The evaluation relies on standardized laboratory testing protocols and engineering comparisons.

4. Adjudication method for the test set

• Not applicable.

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 not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• Not applicable for a clinical ground truth. The "ground truth" or reference standards are defined by the accepted international and national standards for materials, biocompatibility, sterilization, and mechanical compatibility of dental implants (e.g., ISO 10993, ISO 11137, ASTM F1980, ANSI/AAMI ST72, ASTM F67, ISO 14801 implicitly for angled abutments but noted as not needed for this device).

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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