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The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex). There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part. In case of abutments, 2.5 and 2.1 hexagonal features are usually used. The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6. The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser. The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm. The dimension of each abutment ranges as below: (The tolerance of all products is ±0.03) - Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L) - Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L) - Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20° - . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L) - Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ● - Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L) - Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ● - Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ● - Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L) The implant-abutment connection is internal hex and Morse taper level. Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CSM Submerged3-L Implant System:

This document is a 510(k) Premarket Notification summary for a dental implant system. The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies heavily on bench testing and comparison of technological characteristics rather than extensive clinical efficacy studies in the way you might see for novel pharmaceuticals or advanced AI diagnostics.

Therefore, many of the questions you've asked (e.g., sample size for training/test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, data provenance) are not applicable to this type of medical device submission. These questions are typically relevant for AI/ML-based diagnostic devices or devices where human interpretation of data is a primary function.

This submission focuses on demonstrating safety and effectiveness through:

1. Comparison to predicate devices: Showing that the new device has similar technological characteristics and indications for use as devices already on the market.
2. Non-clinical (bench) testing: Performing specific tests to ensure the device meets established performance standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail manner for the device performance in the way an AI/ML study would (e.g., "accuracy > 90%"). Instead, the acceptance criteria are implicit in the compliance with recognized standards and the demonstration of substantial equivalence to predicate devices. The "reported device performance" is essentially the statement that the device met these standards and is substantially equivalent.

Study Details

As mentioned, many of the requested fields are not applicable to a 510(k) submission for a non-AI/ML dental implant system.

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 device is an implant and its components, not an AI/ML diagnostic system. The "testing" involves bench testing to international standards (e.g., ISO, ASTM) and comparison of physical characteristics to predicate devices. There is no "test set" in the context of imaging or patient data. Data provenance (country of origin, retrospective/prospective) is also not relevant here.

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. There is no "ground truth" established by experts in this context. Device performance is assessed against engineering standards and material specifications.

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

• Not Applicable. No expert adjudication is involved.

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/ML-assisted device, nor is it a diagnostic tool that involves human "readers."

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

• Not Applicable. There is no algorithm.

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

• Not Applicable. The "ground truth" here is the adherence to engineering specifications, material standards (e.g., ASTM F-136), and performance criteria outlined in international standards (e.g., ISO 17665, ISO 10993, ISO 14801, ASTM F1980-07).

8. The sample size for the training set

• Not Applicable. There is no training set for this type of device.

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

• Not Applicable. There is no training set or associated ground truth.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" consists of a combination of direct non-clinical testing on the subject device and leveraging data from legally marketed predicate devices.

• Direct Testing on Subject Device:

  • End User Steam Sterilization Test: Performed on the abutments according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79.
  • Biocompatibility Tests: Performed on the subject device according to various parts of ISO 10993 (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity).
  • Results: All these tests demonstrated that the subject device met the criteria of the respective standards.

• Leveraged Testing from Predicate Device (K102635):

  • Sterilization Validation Test (ISO 11137-1,2,3): Data from the predicate K102635 was leveraged because the subject product's material, sterilization site, method, SAL, and parameters are identical.
  • Fatigue Test (ISO 14801): Data from the predicate K102635 was leveraged. The applicant specifically states that the worst-case implants from the predicate's testing encompassed the subject device's mechanical properties.
  • Accelerated Aging Test (Shelf Life, ASTM F1980-07): Data from the predicate K102635 was leveraged due to identical product category, material, manufacturing process, facility, packaging material, and packaging procedure.
  • Results: The leveraged predicate data, combined with the direct testing, collectively demonstrate that the CSM Submerged3-L Implant System meets the required performance and safety standards, thus establishing its substantial equivalence.

In essence, the "study" is a comprehensive engineering and material science evaluation, rather than a clinical trial or an AI performance study.

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The CSM Internal-R 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 terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

The CSM Internal-R Implant System is intended for use in partial or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The CSM Internal-R Implant system contains two types of fixtures, straight and tapered type based on the shape of the fixture. This system is made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with Resorbable hydroxyapatite Blast Medium.

This document describes CSM Internal-R Implant System, a dental implant device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through diagnostic study. Therefore, most of the requested information regarding diagnostic study elements (like expert panels, adjudication, standalone performance, training sets, etc.) is not applicable or not available in this type of submission.

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

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

The submission does not outline specific, quantified acceptance criteria in the typical sense of a diagnostic performance study (e.g., minimum sensitivity, specificity). Instead, the acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices, particularly in mechanical strength and fatigue resistance.

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

Not Applicable (N/A): This is a 510(k) submission for a physical medical device (dental implant), not an AI/diagnostic software. The "test set" here refers to the physical implants subjected to mechanical and fatigue testing, not a diagnostic dataset of patient cases. The specific number of implants tested is not detailed in the summary, nor is the provenance of such "data" in the sense of patient information. The tests were non-clinical (laboratory-based).

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

N/A: Ground truth in this context would likely be established by engineering standards and validated physical measurements, not clinical expert consensus. There were no clinical experts involved in establishing "ground truth" for mechanical testing in the way they would be for a diagnostic study.

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

N/A: Adjudication methods are relevant for resolving discrepancies in expert interpretations of diagnostic data. This is not applicable to the mechanical testing performed for a dental implant.

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

N/A: This submission is for a physical dental implant, not AI software. No MRMC study was conducted.

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

N/A: This is not an AI algorithm.

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

For the mechanical and fatigue testing, the "ground truth" would be established by:

• Engineering Standards: Compliance with industry standards (e.g., ISO standards for dental implants, ASTM standards for materials).
• Physical Measurements: Objective measurements of mechanical properties (e.g., ultimate tensile strength, fatigue life cycles) against predefined specifications.

8. The sample size for the training set

N/A: There is no "training set" in the context of a physical device's mechanical testing in the way it's used for AI models.

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

N/A: As there's no training set, this question is not applicable.

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CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.

Here's a breakdown of the acceptance criteria and the study information for the "CSM submerged-L Implant System" based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states that the study involved "mechanical testing" and "fatigue testing." However, it does not specify the sample size for the test set (number of implants tested) or the data provenance (e.g., country of origin of the data, retrospective or prospective). This type of information is typically detailed in a full testing report, which is usually not included in the publicly available 510(k) summary.

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

This information is not applicable to this type of device and study. The "CSM submerged-L Implant System" is a physical medical device (dental implant), and its performance is evaluated through mechanical engineering tests (fatigue testing, mechanical strength), not through interpretation of data by human experts to establish "ground truth" in the way it would be for an AI algorithm interpreting medical images.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements, not subject to expert adjudication.

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 is relevant for evaluating the performance of AI algorithms that assist human readers (e.g., in radiology). The "CSM submerged-L Implant System" is a physical implant, and its performance evaluation focuses on its mechanical properties and equivalence to predicate devices.

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

No, a standalone performance study in the context of an AI algorithm was not done. This device is a physical product, not an AI algorithm. Its "standalone performance" refers to its mechanical properties when tested independently.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through physical measurements and engineering standards, specifically:

• Mechanical strength (e.g., yield strength, ultimate tensile strength, fracture toughness)
• Fatigue life
• Dimensional accuracy
• These are compared against established benchmarks or the performance of a predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The "CSM submerged-L Implant System" is a manufactured product, not an AI model that requires a training set. The "training" for such a device involves design, material selection, and manufacturing processes, culminating in a final product that undergoes testing.

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

This information is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the design and manufacturing process are iterative, informed by engineering principles, material science, and previous product data, rather than a specific "training set with ground truth."

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