Search Results

The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.

The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.

The provided document is a 510(k) Summary for the OsteoSync™ Ti Dental Mesh, which is a medical device. This type of document is concerned with demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, many of the specific questions about acceptance criteria, study types, sample sizes, and expert adjudication as they pertain to algorithm performance are not directly applicable to this device submission. The device is a physical dental mesh, and its evaluation focuses on material properties, mechanical performance, biocompatibility, sterilization, and shelf-life, typically compared against standards and known predicate devices.

However, I can extract information related to the device's "acceptance criteria" in the context of its non-clinical testing and the "studies" that support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria and device performance in the format typically used for AI algorithm evaluation (e.g., sensitivity, specificity). Instead, it lists non-clinical tests and their outcomes, indicating that the device "met the predetermined acceptance criteria."

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

• Mechanical Testing: "worst-case devices were evaluated." (Specific sample size not provided, but implies a selection of device configurations).
• Biocompatibility/Preclinical Animal Studies: Not specified, but animal studies (in a canine model) were leveraged from an FDA-authorized master file. Data provenance is implied to be from these leveraged studies.
• Sterilization Validation: Not specified.
• Shelf-Life Validation: Not specified, but "sterile integrity was verified by visual, seal strength and seal integrity evaluations."
• Pyrogenicity (Bacterial Endotoxin Testing): Not specified.

It is important to note that these are not "test sets" in the context of validating an AI algorithm, but rather samples used for physical and biological testing of the device itself.

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

This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI algorithm's diagnostic performance for this physical medical device submission. The "ground truth" for the non-clinical tests is determined by standardized test methods and criteria (e.g., ASTM standards for mechanical testing, ISO standards for sterilization).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There are no "test sets" in the AI sense, and thus no adjudication of expert opinions.

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 question is not applicable. The device is a physical dental mesh, not an AI-powered diagnostic tool used with human readers.

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

This question is not applicable. The device is a physical dental mesh, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical Testing: Ground truth is defined by performance against industry standards (e.g., ASTM F564).
• Biocompatibility: Ground truth is established through biological risk assessment and preclinical animal studies.
• Sterilization: Ground truth is a measured sterility assurance level (S.A.L.) meeting ISO 11137-1 and ISO 11137-2 standards.
• Shelf-Life: Ground truth is the maintenance of sterile integrity and functional properties over time, evaluated against ASTM F1886, ASTM F88, ASTM F1929 and ASTM F2096.
• Pyrogenicity: Ground truth is the measured bacterial endotoxin level against ANSI/AAMI ST72 standards.
• Dimensional/Technological Characteristics: Ground truth is the physical measurements and properties of the device compared to predicate devices, and the established safety and effectiveness of those predicates.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental mesh, not an AI algorithm that requires a "training set."

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

This question is not applicable for the same reason as #8.

Ask a specific question about this device

OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. It is consisted of OssBuilder, Healing Cap, Cover Cap, and OB Anchor. The OssBuilder System is not indicated for permanent implantation.

The provided text is a 510(k) summary for the OssBuilder System, a dental device intended to stabilize and support bone grafts. It does not describe a clinical study in the traditional sense, but rather a set of non-clinical performance tests to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories for clinical studies will not be applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that the mechanical properties of the OssBuilder System were found to be "substantially equivalent" to predicate devices. The acceptance criteria are implied to be that the proposed device performs at least as well as the predicate device in relevant mechanical tests and maintains biocompatibility and sterility.

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

For the non-clinical performance testing (biocompatibility, sterilization, shelf-life, mechanical properties), specific sample sizes are not explicitly mentioned in the provided text. The data provenance is also not detailed beyond stating they are "non-clinical testing data" and "bench tests." It can be inferred that these tests were conducted by the manufacturer, Osstem Implant Co., Ltd., likely in their Korean facilities or outsourced to testing laboratories. The nature of these tests (e.g., material testing, sterilization validation) means they are not retrospective or prospective studies in the sense of clinical trials, but rather laboratory-based evaluations.

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

This question is not applicable as the document describes non-clinical performance testing (material properties, sterilization, etc.), not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable for the same reasons as #3.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The OssBuilder System is a physical dental device, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the OssBuilder System is a physical dental device, not an algorithm.

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

For the non-clinical tests described:

• Biocompatibility: The ground truth is based on the well-established biocompatibility of titanium and Ti-6Al-4V alloys, which are widely used in medical implants, and the equivalence to predicate devices made of the same materials.
• Sterilization Validation: The ground truth for sterility is established by industry standards (ISO 11137).
• Shelf-life: The ground truth for shelf-life is established by internal testing and leveraging data from prior submissions for packaging materials durability.
• Mechanical Properties: The ground truth for mechanical properties (Tensile Strength, Yield Strength, Elongation) is derived from standardized material testing methods and comparison to the known properties of the predicate devices.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical medical device's non-clinical performance testing.

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

This question is not applicable for the same reasons as #8.

Ask a specific question about this device

SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840. The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System. The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995).

This document is a 510(k) premarket notification for a dental device called "SB Anchor." It asserts substantial equivalence to a predicate device, the "SMARTbuilder System." The document does not describe a study involving an AI/CADe device or its performance criteria/results.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device conformance for an AI-based system. The provided text is a regulatory submission for a conventional medical device (an endosseous dental implant abutment).

Specifically, the document states:

• "No clinical studies are submitted" (Page 5, Section 8). This explicitly indicates that no clinical performance data for the device, including any related to AI or a study demonstrating its meeting of acceptance criteria, is present.
• The entire document revolves around demonstrating substantial equivalence to a predicate device based on material, indication for use, and technological characteristics of a physical implant component, not a software algorithm.

Based on the provided text, the following information is not available:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is not an AI/CADe device and no performance study is described.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device