Search Results

ET System: The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System: The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.

The provided document is a 510(k) Premarket Notification from the FDA for a dental prosthetic system. It details the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria in terms of clinical effectiveness or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. Substantial equivalence is established by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Here's an analysis of the information available in the document, keeping in mind that it's a substantial equivalence filing rather than a performance validation study against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily identifies the device's characteristics (materials, dimensions, intended use) and compares them to predicate devices to establish substantial equivalence. It does not list quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or success rates) or specific performance metrics that the device is intended to meet.

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

This information is not applicable in the context of the provided document. The submission explicitly states:

• "No clinical studies are submitted." (Page 22)
• The nonclinical testing primarily involves fatigue testing and biocompatibility evaluations, which are typically performed on samples of the device components rather than a "test set" of patient data. The sample sizes for these engineering tests are not specified in this summary.
• Data provenance for clinical data is not applicable as no clinical data was submitted.

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

This information is not applicable as no clinical studies with a test set requiring ground truth establishment by experts were submitted.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies with a test set requiring adjudication were 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

This information is not applicable. The device described is a physical dental prosthetic system (abutments, screws, caps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

This information is not applicable for the same reason as point 5. The device is a physical prosthetic, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies requiring ground truth were submitted. The basis for safety and effectiveness is substantial equivalence to predicate devices, supported by nonclinical testing (fatigue, biocompatibility, sterilization validation).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning product and no clinical data or algorithms are being trained.

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

This information is not applicable as there is no training set mentioned in relation to this device.

Summary of the Study and "Acceptance Criteria" (as interpreted from the document's context):

The "study" described in the document is primarily focused on nonclinical testing and demonstrating substantial equivalence to predicate devices rather than fulfilling specific performance acceptance criteria for clinical outcomes.

Acceptance Criteria (Implicit from Substantial Equivalence):

From the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is achieved by showing:

• Same Intended Use: The ET US SS Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations (crowns, bridges, over-dentures), which is identical to the indications for use of its identified predicate and reference predicate devices (e.g., K062030, K130662).
• Same Technological Characteristics OR Equivalent Safety/Effectiveness with Different Characteristics:
  • Material: Titanium Alloy, PEEK, Polymer (Polycarbonate, POM) – consistent with predicate devices.
  • Design & Function: Described as similar in various components (e.g., Quick Temporary Abutment, Solid Abutment, ComOcta Abutment, Healing Abutment, Ti Screw, O-ring Abutment, Multi Angled Abutment, Esthetic-low Temporary Cylinder). Where there are differences (e.g., new dimensions, slight shape changes, different connection structures for Multi Angled Abutments), the submission asserts that these differences "do not raise new questions of safety and effectiveness" and that the device maintains "same principles of operation, function, material, characteristic and intended use."
  • Biocompatibility: Stated to be the same as predicates, thus requiring no additional testing.
  • Sterilization: For Cover Screw and Healing Abutment, considered substantially equivalent to a predicate. Other components are non-sterile and require steam sterilization validation according to ISO 17665-1:2006. The results implicitly meet the standard.
  • Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with a worst-case scenario. The implied acceptance is that the device met the fatigue strength requirements comparable to the predicate devices or within safe limits for its intended use, ensuring structural integrity. Specific results or detailed criteria are not laid out, but the successful completion of these tests supports substantial equivalence.

Reported Device Performance (from the perspective of 510(k) substantial equivalence):

The document reports the device's performance by demonstrating its similarities to predicate devices across various characteristics:

• Materials: Predominantly Titanium Alloy (ASTM F 136), Titanium (ASTM F 67), and various polymers (PEEK, Polycarbonate, PolyOxy Methylene). These are well-established materials in dental prosthetics, matching those of the predicate devices.
• Dimensions: Various diameters and heights are listed for each component, often including new dimensions that are added to existing product lines. The claim is that these new dimensions do not alter the fundamental safety or effectiveness and maintain the "same principles of operation, function, material, characteristic and intended use" as the predicate devices.
• Functional Principles: Described for each component (e.g., "Used to make temporary prosthesis," "Used in producing ordinary cement-retained prosthetics," "Connect an abutment with fixture by screw"). These are consistently aligned with the predicate device functions.
• Nonclinical Test Results:
  • Biocompatibility: Implicitly deemed acceptable due to using the same materials, manufacturing processes, surface treatments, and sterilization methods as legally marketed predicate devices.
  • Sterilization Validation: Cover Screw and Healing Abutment results are "considered to be substantial equivalent" to a specific predicate, indicating adequate sterilization protocols. Other non-sterile devices underwent steam sterilization validation to ISO 17665-1:2006, implying successful validation.
  • Fatigue Testing: Performed on a "worst-case scenario" sample, suggesting that the device's mechanical durability was assessed and found satisfactory based on the relevant guidance document, thereby supporting its structural integrity and equivalence.

In conclusion, the document demonstrates that the ET US SS Prosthetic System meets the "acceptance criteria" for a 510(k) submission by establishing its substantial equivalence to predicate devices through a comparison of technological characteristics and successful nonclinical testing for biocompatibility, sterilization, and fatigue. No clinical performance criteria or studies are presented.

Ask a specific question about this device