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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.

Ask a specific question about this device

The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.

The Kerator system is a dental implant system. The provided text describes the device and its equivalence to predicate devices, but it does not contain any information about a study with acceptance criteria and reported device performance in relation to AI or any advanced analytical methods.

Therefore, I cannot provide the requested information in the format of the table or other points, as the document focuses on regulatory approval based on substantial equivalence to existing devices, primarily through material and design comparisons and standard non-clinical testing (sterilization, shelf life, chemical analysis). It does not involve AI or algorithms, nor does it present clinical performance data against specific acceptance criteria in the manner described in your prompt.

The document indicates "Non-Clinical Testing" for sterilization, shelf life, and chemical/SEM analysis, which are standard safety and manufacturing validations, not performance against clinical or analytical acceptance criteria.

If the prompt were referring to a different type of device or study that typically involves such criteria, the answer would differ. However, based solely on the provided text, there is no such study or acceptance criteria information to extract.

Ask a specific question about this device