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The BLUEDIAMOND IMPLANT 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 in the following situations and with the clinical protocols:

• Delaved loading
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
  It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
  It is specifically recommended for:
• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):

• Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
• Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
  Diameter X Total Length (Thread Length):
• Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
• Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
  Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0
  Gingival (Cuff) Height: Not Found

The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

The provided text is an FDA 510(k) summary for a dental implant device (BLUEDIAMOND IMPLANT). It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, it does NOT contain the specific information required to answer your prompt, such as:

• Acceptance Criteria for AI/ML Performance: The document does not describe performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI/ML models. Instead, it focuses on physical and material properties, and mechanical performance (fatigue, pull-out).
• Study Proving Device Meets Acceptance Criteria for AI/ML: No AI model training, validation, or testing is described. The "performance test" section refers to fatigue tests and pull-out tests, which are engineering tests for the physical implant, not for an AI algorithm.
• Sample Sizes for Test Set (AI/ML): Not applicable, as there's no AI/ML test set.
• Data Provenance (AI/ML): Not applicable.
• Number of Experts/Qualifications (AI/ML Ground Truth): Not applicable.
• Adjudication Method (AI/ML Ground Truth): Not applicable.
• MRMC Study (AI/ML): Not applicable.
• Standalone Performance (AI/ML): Not applicable.
• Type of Ground Truth (AI/ML): Not applicable.
• Sample Size for Training Set (AI/ML): Not applicable.
• How Ground Truth for Training Set was Established (AI/ML): Not applicable.

The document primarily discusses:

• Device Description: Material (CP Ti Grade 4), surface treatment (S.L.A), dimensions, components.
• Indications for Use: Placement in maxillary/mandibular molar areas for prosthetic support, delayed and immediate loading protocols, specific recommendations for 5mm thread length implants.
• Substantial Equivalence: Comparison of the BLUEDIAMOND IMPLANT to a primary predicate device (ARi ExCon Implant System) and several reference devices based on design, dimensions, material, surface treatment, sterilization, shelf life, and features.
• Non-Clinical Testing: Biocompatibility, pyrogen/endotoxin testing, sterilization validation, shelf life, modified surface treatment evaluation, and performance test (fatigue test in accordance with ISO 14801, and pull-out testing), and MR compatibility.

In summary, the provided text describes a physical dental implant device and its regulatory submission to the FDA, not an AI/ML-driven medical device. Therefore, it does not contain the information requested about AI acceptance criteria, performance studies, or ground truth establishment.

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R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.

R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).

The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.

R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.

R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.

The provided text is a 510(k) summary for the R2GATE Lite™ device and does not contain the specific details about acceptance criteria, device performance, and the study methodologies typically found in a comprehensive clinical or performance evaluation report. The document primarily focuses on establishing substantial equivalence to a predicate device (R2GATE Windows).

However, I can extract and infer some information related to software testing and general claims.

Here's an analysis based on the provided text, with a clear indication of what is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the R2GATE Lite™ device. It mentions "Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices." and "Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input."

This implies that the device met its functional and performance requirements as defined internally by the manufacturer, but these specific requirements and their numerical outcomes are not detailed in this summary.

General Software Functionalities (Implied Performance):

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

The 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for either training or testing data. The testing mentioned is "Software verification and validation," which includes unit tests, integration tests, system tests, and acceptance tests. These typically involve synthetic data, simulated scenarios, and potentially real patient data for validation, but the details are not provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a "pre-planning software" for dental implant placement and surgical treatment, and its primary function described is viewing, measuring, and approving plans generated by the predicate device (R2GATE Windows), suggesting a focus on functional equivalency rather than comparative clinical performance with human readers.

6. Standalone Performance Study

While the "Software verification and validation" (V&V) activities listed (Unit test, Peer Code Review, Integration test, Internal release test, Formal system test, Acceptance test) can be considered forms of standalone testing for the algorithm's functionality, the document does not detail a specific standalone performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for any AI or algorithmic component, as the device is presented as an "image viewer" and "pre-planning software" that primarily interfaces with another cleared device (R2GATE Windows).

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function as a pre-planning and viewing tool for dental implants, ground truth would likely relate to the accuracy of measurements, correct rendering of 2D/3D images, proper display of generated nerve canal and implant models, and accurate application of revision/approval functions. This type of ground truth is often established through technical specifications and verification against expected outputs.

8. Sample Size for the Training Set

The document does not provide any information about a training set sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how ground truth for a training set was established.

In summary, the provided FDA 510(k) summary for R2GATE Lite™ focuses on demonstrating substantial equivalence through a comparison of intended use, indications for use, and functional descriptions with a predicate device. It indicates that software verification and validation activities were performed to confirm performance requirements were met, but it does not provide detailed quantitative performance metrics, study designs, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical or performance study report. This level of detail is often not required or included in the public 510(k) summary for certain device types, especially those classified as image management and processing systems.

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The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.

The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:

Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)

This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.

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

The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.

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

This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.

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 where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.

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The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches 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.

The ST Internal Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The abutment is a superstructure of a dental implant system which is attached to the implants made of Ti-6A1-4V ELI with the surface treated by anodizing method(except healing and temporary abutment). The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. The system is consisted of the following components: ST Internal Fixture, EZ Post Abutment, Solid Abutment, Angled Abutment, Milling Abutment, Cover Screw, Healing Abutment, Temporary Abutment, and Abutment Screw.

The provided text is a 510(k) summary for the ST Internal Implant System. It does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined acceptance criteria for accuracy, sensitivity, specificity, etc.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence for a medical device is established by showing that the new device (subject device) is as safe and effective as a legally marketed device (predicate device) that is already cleared by the FDA. This is typically achieved by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The "acceptance criteria" here are not performance metrics like sensitivity or specificity. Rather, the implicit acceptance criteria are that the differences between the subject device and the predicate(s) are minor and do not negatively impact safety or effectiveness, as demonstrated through non-clinical (bench) testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of (implicit) 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)

• Test Set Sample Size: The document does not specify exact sample sizes (number of units tested) for the non-clinical bench tests (static compression-strength and fatigue tests). It mentions that tests were performed "with combination of the fixture and the angled abutment, in consideration of the worst case" and refers to ISO 14801. ISO 14801 typically involves testing a certain number of samples (e.g., n=10 or more) for fatigue and static strength for statistical validity, but the exact count is not provided in this summary.
• Data Provenance: The tests were performed by MegaGen Implant Co., Ltd. which is based in Republic of Korea. The data is non-clinical bench test data, not human subject data, so "retrospective or prospective" doesn't directly apply in the same way it would for a clinical study.

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 as there was no study involving human expert interpretation or establishing ground truth based on expert consensus. The "ground truth" for non-clinical tests like fatigue and strength is based on physical scientific principles and engineering standards (e.g., ISO 14801).

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

• This information is not applicable as there was no study involving human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a dental implant system (physical product), not an AI diagnostic tool that assists human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical 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" is defined by adherence to international standards and guidance documents like ISO 14801 and specific FDA guidance for root-form endosseous dental implants. This involves objective physical measurements (e.g., fatigue limit, static compression strength values) verified against predefined acceptable ranges or performance relative to a predicate.

8. The sample size for the training set

• This information is not applicable. The context is a 510(k) submission for a physical medical device (dental implant), not an AI/ML algorithm that requires training data.

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

• This information is not applicable for the reasons stated above.

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