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HySil Heavy is to be used as heavy-bodied materials for:

• One-step impression technique (simultaneous technique) using single or dual viscosities
• Two-step impression technique using dual viscosities
• Functional impressions

HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:

• Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
• Functional impressions
• Fabricating crown and bridgework or inlays
• Fabricating full or partial dentures
• Reline impressions
• Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
• Transferring root posts when fabricating posts and cores indirectly

HySil Bite is used for impression as below.

• Taking occlusal surfaces
• Confirming occlusal surfaces
• Recording after putting the articulator

HySil Impression materials are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums.

HySil Heavy and HySil Mono are addition-curing, elastomeric materials with hydrophilic property, high tear strength, dimensional accuracy, and a high resistance to permanent deformation. HySil Heavy and HySil Mono are available in an assortment of delivery systems of traditional 1:1 50 ml automix cartridge (predicated, K170736) and 5:1 380 ml automix cartridge version for use in most automatic dispensing and mixing system. HySil Heavy and HySil Mono are classified into Type 1 and Type 2 according to ISO 4823 each.

HySil Bite is an addition-curing silicone bite registration materials in a 50 ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated. HySil Bite is classified into jaw relation recording material according to DIN 13903.

The provided documents are a 510(k) Premarket Notification for a dental impression material named HySil Impression Materals (Heavy, Mono, and Bite). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.

However, I can still extract the acceptance criteria as described in the benchmark standards and the reported performance (which is that it passed these criteria).

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This is a material science and biocompatibility study, not a clinical trial or AI/ML study. Sample sizes for the bench tests are generally defined by the relevant ISO/DIN standards, but specific numbers are not provided in this summary. Data provenance is implied to be from laboratory testing conducted by the manufacturer (OSSTEM IMPLANT Co., Ltd.) for the purpose of this submission. The tests are retrospective as they were conducted prior to the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for material properties testing is based on objective measurements and adherence to international standards (ISO and DIN), not expert consensus in the diagnostic sense. Biocompatibility results are interpreted by qualified toxicologists/biologists according to ISO standards.

4. Adjudication method for the test set
Not applicable. Test results are based on objective measurement against predefined standard criteria, not human 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
Not applicable. This is not an AI/ML device.

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

7. The type of ground truth used
The ground truth for the performance claims (mechanical properties, biocompatibility, shelf life) is based on:
* Objective Measurements: Laboratory measurements of physical and chemical properties of the material.
* International Standards: Adherence to the requirements specified in ISO 4823 (for HySil Heavy and Mono) and DIN 13903 (for HySil Bite).
* Biocompatibility Standards: Compliance with ISO 10993-5, 10993-10, and 10993-11.

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.

The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS SA Implant 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 treatment of MS SA Implant System is SA (Sandblasting and Acid etching).

The provided text describes a 510(k) premarket notification for the "MS SA Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through new clinical trials against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC), and detailed performance metrics derived from such studies is not available in this document.

Here's what can be extracted and inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics to those of the predicate devices. The table below summarizes the comparison presented in the document.

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

• Not applicable / Not provided. The submission states "No clinical studies are submitted." The evaluation relies on comparison to predicate devices and nonclinical testing.
• Data provenance: For mechanical testing ("Fatigue testing"), it is conducted according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This implies a standardized laboratory test, not patient data.

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. No clinical test set requiring expert ground truth assessment was submitted.

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

• Not applicable. No clinical test set requiring adjudication was submitted.

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 a dental implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.

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

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

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

• Not applicable. For the comparative evaluation, the "ground truth" is established by the documented characteristics, materials, and intended uses of the legally marketed predicate devices. For nonclinical testing (fatigue), the ground truth is adherence to established engineering standards and performance requirements for dental implants.

8. The sample size for the training set:

• Not applicable. No machine learning or AI component requiring a training set is involved.

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

• Not applicable. No machine learning or AI component requiring a training set is involved.

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Ziocera & Convertible Systems are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The Ziocera & Convertible Systems are device made of Zirconia and Titanium intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutment, Cylinder and Abutment Screw.

The provided text is a 510(k) summary for a dental device (Ziocera & Convertible System). This document is focused on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of a diagnostic or AI-driven medical device.

The "study" described in this document is a review of material, indication for use, design, and technological characteristics comparing the proposed device to predicate devices, along with safety tests (including biocompatibility). This is typical for a 510(k) submission for a non-AI or non-diagnostic device, where the goal is to show that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because the provided text does not contain this type of information. It's a regulatory submission for a physical dental implant component, not a software or AI-driven diagnostic.

To answer your request, here's a breakdown of what can be extracted or inferred from the document, and where the requested information is absent:

Acceptance Criteria and Study Details for the Ziocera & Convertible System (Based on 510(k) Summary)

This document describes a regulatory submission for a physical dental device (abutments, cylinders, screws), not an AI-driven or diagnostic device. Therefore, many of the requested criteria related to AI performance, reader studies, and ground truth are not applicable or not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a physical medical device like this, "acceptance criteria" are typically met by demonstrating that the device meets recognized standards (e.g., ISO for biocompatibility, ASTM for mechanical properties) and performs comparably to legally marketed predicate devices, rather than through sensitivity/specificity metrics.

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

• Sample Size for Test Set: Not applicable in the context of a diagnostic test or AI performance evaluation. This submission refers to physical device testing. The specific number of physical units tested for safety and performance (e.g., for mechanical testing or biocompatibility) is not detailed in this 510(k) summary.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" refers to test results from physical device evaluations and comparisons to predicate devices. The country of origin for manufacturing and testing would likely be South Korea (Republic of Korea), where the submitting company is based. The nature of the studies would be prospective in the sense that they were conducted specifically for this submission, but not in the clinical trial sense for AI evaluation.

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

• Not applicable. This submission does not involve establishing ground truth for a diagnostic test using expert review. The "truth" for the device's performance relies on engineering specifications, material standards, and comparison to predicate devices, not clinical interpretation of data by experts.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication" in the sense of reconciling expert opinions on diagnostic interpretations. Device testing involves objective measurements 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

• No, not done. This is a physical device, not an AI or diagnostic tool. MRMC studies are irrelevant for this type of submission.

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

• No, not done. This is a physical device, not an algorithm.

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

• Not applicable in the diagnostic sense. The "ground truth" for this device's performance would be derived from:
  • Material specifications: Chemical composition, mechanical properties (e.g., tensile strength, fatigue resistance) as measured in a lab.
  • Biocompatibility standards: Compliance with ISO or ASTM standards for biological safety.
  • Design specifications: Dimensional accuracy, fit with implants.
  • Comparative analysis: Direct comparison of these attributes against the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set exists.

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The US/SS/GS 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. The US/SS/GS Fixture System is for one and two stage surgical procedures. It is not for immediate load.

The US/SS/GS System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

This 510(k) submission (K073247) for the OSSTEM Implant Co., Ltd. US/SS/GS System is for an endosseous dental implant. This document is a summary of the 510(k) submission and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain the details of a study with specific acceptance criteria and performance data in the format requested.

Therefore, I cannot populate the table and answer the specific questions about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies, as this information is not present within the provided text.

The document states:

• "The US/SS/GS System has been subjected to safety, performance, and product validations prior to release."
• "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations."

However, it does not provide the details of these validations or tests, nor does it specify numerical acceptance criteria or the reported performance against them.

In a 510(k) submission for a device like a dental implant, substantial equivalence is often demonstrated through:

• Comparison of materials, design, indications for use, and technological characteristics to predicate devices.
• Results from mechanical testing (e.g., fatigue strength, static strength) to ensure the device meets recognized standards.
• Biocompatibility testing.
• Dimensional and tolerance analysis.

The provided text only asserts that these tests and validations were done and that the device is substantially equivalent to predicate devices (K062030, K062051, K063861). It does not provide the numerical data, study design, or expert review details that would allow me to fill in the requested information.

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Super Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

The Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.

The provided document for K062156, Osstem Implant Co., Ltd.'s "Super Orthodontic Screw," does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission is a "premarket notification" that focuses on demonstrating "substantial equivalence" to predicate devices. It relies on a comparison of characteristics (material, design, use concept) and general safety, performance, and product validations, rather than specific performance metrics and dedicated studies with acceptance criteria as typically found in more recent device submissions or clinical trial reports.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, or ground truth for a performance study from this document.

However, I can extract the general claims made about the device's validation:

General Claims Regarding Validation:

"Super Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature pertaining to the safety and biocompatibility of Super Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Super Orthodontic Screw."

Without further documentation beyond this 510(k) summary, it's impossible to fulfill the request for detailed acceptance criteria and study information. This submission primarily serves to establish substantial equivalence based on general design, materials, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.

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