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HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The HS/HG Prosthetic System is device made of titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.

The provided text describes a 510(k) summary for the HS/HG Prosthetic System, a dental device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new device.

Therefore, the document does not contain information on:

• A table of acceptance criteria and reported device performance for specific thresholds.
• Sample sizes used for a test set or data provenance for a performance study.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, etc.) for performance evaluation.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the submission focuses on:

Study and Evidence Presented:

1. Substantial Equivalence Matrix: The submission directly compares the HS/HG Prosthetic System to two predicate devices:

   • HU/HS/HG Prosthetic System (K081575)
   • Ziocera & Convertible System (K081786)
     The comparison covers manufacturer, 510(k) number, intended use, packaging, sterilization, and shelf life, demonstrating similarity across these characteristics.

2. Safety, Performance, and Product Validations (General Statement): The document states: "The HS/HG Prosthetic 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, specific details of these validations (e.g., acceptance criteria, test results) are not provided in the summary.

3. Fatigue Testing:

   • Test Performed: Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment."
   • Worst-Case Scenario: The testing was done using a "worst case scenario."
   • Result: "The fatigue test result were Similar to previously cleared predicate device." This indicates a comparative approach rather than meeting specific pre-defined numerical acceptance criteria for fatigue.

Conclusion:

The main conclusion presented is that the HS/HG Prosthetic System is substantially equivalent to the predicate devices based on the information provided, including similar material, indication for use, design, technological characteristics, and comparable fatigue test results. This type of submission relies on demonstrating similarity to a previously cleared device, rather than establishing de novo performance against a new set of criteria.

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HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.

The provided text describes a 510(k) premarket notification for the OSSTEM HU/HS/HG Prosthetic System, a dental device. This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/CADe devices.

Instead, the document focuses on:

• Device Description: The HU/HS/HG Prosthetic System is made of titanium, titanium alloy, POM, and PC, intended for prosthetic restoration with dental implants.
• Predicate Devices: The device is compared to several existing OSSTEM Implant Co., Ltd. systems (US System K062030, SS System K062051, GS System K063861, US/SS/GS System K073247).
• Claim of Substantial Equivalence: The manufacturer asserts that the new system is substantially equivalent in design, function, intended use, materials, and performance characteristics to the predicate devices.
• Safety and Performance Validation: It mentions that safety tests, including biocompatibility, were performed to ensure compliance with international and US regulations.

There is no discussion of an AI/CADe device, performance metrics like sensitivity/specificity, or a study to "prove the device meets acceptance criteria" in the way one would for diagnostic software. This is a clearance for a physical dental prosthesis system, not an AI-powered diagnostic tool.

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