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510(k) Data Aggregation
(240 days)
The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
This document describes a 510(k) premarket notification for a medical device called the "ET Abutment System," which is an endosseous dental implant abutment. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical trials.
Therefore, the submission does not contain information about specific "acceptance criteria" for an AI algorithm's performance, nor does it detail a study proving such a device meets these criteria in the typical sense of AI/ML performance evaluation. The "studies" referenced are non-clinical bench tests demonstrating the physical and material properties of the dental abutments are comparable to existing, legally marketed devices.
Based on the provided text, here's an analysis of the "acceptance criteria" and "proof" in the context of this 510(k) submission:
The acceptance criteria and proof fundamentally revolve around demonstrating substantial equivalence to predicate devices, not performance against a specific clinical metric for an AI algorithm.
Missing Information:
The document concerns a physical dental device (abutment system), not an AI/ML powered device. As such, the concept of "acceptance criteria" for AI performance, clinical study design for AI (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this submission. The FDA letter confirms the device type: "Endosseous Dental Implant Abutment."
However, to address the prompt's implied need for "acceptance criteria" and "studies" as they relate to this specific device (dental abutment), I will interpret the request within the context of a 510(k) submission for a non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a Dental Abutment System)
In a 510(k) submission for a dental abutment, "acceptance criteria" are typically defined by demonstrating that the proposed device has the same technological characteristics and similar performance to legally marketed predicate devices, or that differences do not raise new questions of safety and effectiveness. The "reported device performance" comes from non-clinical bench testing.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Intended Use Equivalence: The device has the same intended use as the predicate. | The ET Abutment System is "indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients." This matches the intended use of the primary predicate and reference devices, e.g., "Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." |
| Technological Characteristics Equivalence: The device has comparable design, dimensions, materials, surface, sterilization, and packaging as the predicate. | - Design: "The ET Abutment System has the same design...as the predicate." (Explicitly stated) - Dimensions (Diameter, Length, Height, G/H): Various tables (pages 4, 5, 8, 9, 10, 11, 12, 13) compare proposed device dimensions to predicate/reference devices, showing direct matches or ranges that encompass them. E.g., ET Angled: Diameters 4.0 ~ 6.0 mm (Proposed) vs. 4.0 ~ 6.0 mm (Predicate). Heights 8.0 mm (Proposed) vs. 8.0 mm (Predicate). - Material: Primarily "Titanium alloy Ti-6Al-4V (ASTM F136)" or "Titanium CP Grade 3," and other specified materials (Nylon, Acrylonitrile & Butadiene Polymer (NBR), PolyCarbonate Polymer, Polyoxymethylene (POM), Gold alloy) are identical to those of the predicate devices. (Explicitly stated and documented in tables). - Surface: "Machine surface" across the board, matching predicates. (Explicitly stated and documented in tables). - Sterilization: "Delivered non-sterilized, Steam sterilized by user," matching predicates. "Validation was done following ISO 17665-1 [2006]... not necessary to re-test validation." - Packaging: "Housed in Tyvek-lidded blister tray; Placed in a tamper-evident outer package," matching predicates. Some also "Secured in plastic ampule." |
| Performance Equivalence (Non-Clinical): Device performance is similar, and any differences do not raise new questions of safety or effectiveness. | - Biocompatibility: "Contract manufactured by the predicate device manufacturer using the same manufacturing process and same well known and well-established material as the predicate device; therefore, we reason it was not necessary to re-test biocompatibility." - Shelf Life: "Do not have a stated shelf life" and "use the same exact packaging materials, manufactured from medical grade titanium alloy which are non-mechanical, non-active materials therefore, degradation in performance characteristics is not likely." - Surface Treatment Characterization Testing: "Contractured by the predicate device manufacturer, with surfaces using the same manufacturing process, material and surface finishing as the predicate devices... No additional character testing was necessary." - Mechanical Properties (Fatigue Testing): "Fatique testing of the worst case scenario was conducted per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments." Proposed devices "were fatigue tested in accordance with ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants." This implies the proposed device met the fatigue resistance established for the predicate under this standard. - MRI Compatibility: "K221684 has cleared the contract manufacturer's support for the MRI compatibility of the ET Abutment System." A non-clinical review evaluated components in the MRI environment using scientific rationale and published literature, addressing force and torque per FDA guidance. |
| No New or Increased Risk: The device does not introduce new or increased risks compared to the predicate. | "The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices." This is the ultimate conclusion sought by demonstrating equivalence in all the above categories. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a physical medical device submission and not an AI/ML algorithm:
- Sample Size for Test Set: Not applicable in the context of an AI test set. For physical device testing, the sample sizes would be determined by the relevant ISO standards (e.g., ISO 14801 for fatigue testing). These specific numbers are not detailed in the summary but are typically part of detailed test reports that support the conclusion of substantial equivalence.
- Data Provenance: The data comes from non-clinical testing (bench tests) performed to standard specifications (e.g., ISO 14801). The "ET Abutment System are contract manufactured by the predicate device manufacturer," implying the manufacturing process and potentially some historical performance data are shared or directly comparable.
- Country of Origin: Not specified for the non-clinical test data itself, but the applicant (Hiossen Inc.) is in Fairless Hills, Pennsylvania, USA. The predicate manufacturer (Osstem Implant Co., Ltd.) is generally based in South Korea, suggesting potential international collaboration or shared manufacturing data.
- Retrospective or Prospective: Not applicable in the context of patient data. The non-clinical tests would be conducted prospectively on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This concept is not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert labeling or interpretation for "ground truth." The "ground truth" here is the adherence to material specifications, dimensional tolerances, and performance under specific mechanical and biological test conditions as defined by international standards.
4. Adjudication Method for the Test Set
- This concept is not applicable as there is no "test set" in the sense of clinical cases requiring interpretation or adjudication by multiple readers/experts. Performance is based on mechanical, material, and sterilization testing against predefined standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not applicable. This type of study is for evaluating human performance with or without AI assistance, typically in image interpretation or diagnosis. This submission is for a physical dental implant component. The document explicitly states: "No clinical performance report(s) is being submitted."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This pertains to AI algorithm performance.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on engineering standards, material specifications, and performance data from validated non-clinical bench tests. This includes:
- ASTM (American Society for Testing and Materials) standards for materials (e.g., ASTM F136 for titanium alloy).
- ISO (International Organization for Standardization) standards for testing medical devices (e.g., ISO 14801 for fatigue testing of dental implants, ISO 17665-1 for moist heat sterilization).
- FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
- Direct comparison to the established characteristics and performance of the legally marketed predicate devices.
8. Sample Size for the Training Set
- Not applicable. This concept relates to AI/ML model development. There is no "training set" for a physical dental abutment. The device's design and manufacturing rely on established engineering principles and prior knowledge from the predicate device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. Again, this refers to AI/ML model training. The "ground truth" for developing a physical device is derived from engineering design principles, material science, and the performance history of similar devices.
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(355 days)
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:
- Comparison to predicate devices: Showing that the new device has similar technological characteristics and indications for use as devices already on the market.
- 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.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in submission) |
|---|---|
| Material Composition: Conformance to ASTM Standard F-136 (Ti-6Al-4V ELI) and use of POLYAMIDE 6.6. | "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." (Page 4&5) |
| "Ti-6Al-4V ELI (ASTM-F136)" and "POLYAMIDE 6.6" are listed for individual components, aligning with predicates. (Pages 5-11) | |
| Sterilization Efficacy (Non-sterile components): Ability to be sterilized by end-user according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79. | "The end user sterilization test was performed for the subject abutments." |
| "The results of the above tests have met the criteria of the standards..." (Page 12) | |
| Biocompatibility: Conformance to ISO 10993 series (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity). | "Biocompatibility Test such as cytotoxicity according to ISO 10993-5:2009, irritation according to ISO 10993-10:2010, sensitization according to ISO 10993-10:2010, acute systemic according to ISO 10993-11:2006, and genotoxicity according to ISO 10993-3:2014." |
| "The biocompatibility tests were performed on the subject device and it demonstrated the subject device is biocompatible." | |
| "The results of the above tests have met the criteria of the standards..." (Page 12) | |
| Sterilization Efficacy (Pre-sterilized components): Conformance to ISO 11137-1,2,3 for sterilization validation. | "The sterilization validation test was performed for the predicate, K102635 and leveraged for the subject product because the product material, sterilization site, sterilization method, SAL, sterilization parameters are exactly identical to the predicate, K102635." (Page 12) |
| Fatigue Strength: Conformance to ISO 14801. | "The fatigue testing was performed for the predicate device. K102635 and leveraged for the subject device because we compared the worst-case implants and the test sample from K102635 was the worst. Therefore, it supports mechanical properties." |
| "The results of the above tests have met the criteria of the standards..." (Page 12) | |
| Shelf Life/Aging: Conformance to ASTM F1980-07. | "The accelerated aging testing was performed for predicate device, K102635 and leveraged for the subject device because the product category, material, manufacturing process, facility, packaging material and packaging procedure are the exactly the same as the predicate, K102635." |
| "The results of the above tests have met the criteria of the standards..." (Page 12) | |
| Substantial Equivalence: Similar intended use, fundamental scientific technology, and performance parameters to predicate devices. | The entire submission argues for this, concluding: "The CSM Submerged3-L Implant System... constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, CSM Submerged3-L Implant System, and its predicates are substantially equivalent." (Page 13) |
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.
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(297 days)
URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
URIS OMNI System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:
Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (L).
URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.
The provided text is a 510(k) Summary for the URIS OMNI System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data for mechanical properties and biocompatibility.
Crucially, this document explicitly states: "No clinical data were included in this submission."
Therefore, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance with or without AI, multi-reader multi-case studies, standalone algorithm performance, or ground truth derived from expert consensus, pathology, or outcomes data, cannot be found in this document.
The acceptance criteria mentioned in this 510(k) summary are for non-clinical tests to demonstrate the device's physical and biological properties.
Here's the relevant information that can be extracted, interpreting "acceptance criteria" in the context of this regulatory submission:
Acceptance Criteria and Device Performance (Non-Clinical)
The "acceptance criteria" for this submission are not expressed as performance metrics for an AI/CADe device, but rather as meeting established standards for dental implants and abutments. The "reported device performance" is a statement that the device met these criteria.
| Acceptance Criteria (Stated Purpose) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility: In accordance with ISO 10993 series (e.g., ISO 10993-5:2009 for cytotoxicity, -10:2010 for irritation/sensitization, -11:2006 for systemic toxicity, -3:2014 for genotoxicity, -6:2007 for implantation). | "Biocompatibility testing has been completed." and "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device." (This implies all specified biocompatibility tests were performed and passed.) |
| Sterilization: In accordance with ISO 11137-1,-2,-3 and ISO 11737-1,-2 (for manufacturer sterilization) and ISO 17665-1,-2 (for end-user sterilization). | "Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2" and "End user sterilization Testing according to ISO 17665-1,-2" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful sterilization validation). |
| Shelf Life: In accordance with ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096, and sterility testing. | "Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful shelf life validation, supporting the claimed 5-year shelf life for fixtures). |
| Fatigue Testing: In accordance with ISO 14801:2016 and FDA guidance "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" under worst-case scenario. | "Fatigue testing was conducted according to... ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario." The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating the device passed the specified fatigue tests for mechanical durability). |
| Product Characterization (SEM, EDS): Imaging and elemental analysis to characterize the material and surface. | "SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis" were performed. While not explicitly stated as "passed," these are typically done for characterization to support the material and surface claims, which are deemed "substantially equivalent" to predicates. The overall conclusion supports this: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device." |
Since "No clinical data were included in this submission," the following requested information cannot be provided from this document:
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to device performance in a clinical context.
- The sample size for the training set: Not applicable (refers to AI/machine learning data, not present here).
- How the ground truth for the training set was established: Not applicable.
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(411 days)
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.
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(311 days)
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).
IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.
The provided text describes information for a 510(k) premarket notification for the "IH Implant System" by Sewon Medix Inc. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.
Therefore, many of the requested elements for a study proving device acceptance against specific criteria are not explicitly present in the provided text. The document details bench testing, specifically fatigue testing and biocompatibility, to show equivalence.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in this 510(k) pertains to demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the non-clinical testing performed, the acceptance criteria are generally "in compliance with" or "similar to" established standards and predicate device characteristics, rather than specific performance thresholds.
Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)
| Test | Acceptance Criteria | Reported Device Performance ("IH Implant System") |
|---|---|---|
| Biocompatibility (Fixture) | In compliance with applicable international and US regulations (similar to predicate) | Cytotoxicity (OK), Sensitization (OK), Intracutaneous Reactivity (OK), Acute Systemic (OK), Implantation (OK), Genotoxicity (OK) |
| Biocompatibility (Prosthetic) | In compliance with applicable international and US regulations (similar to predicate) | Cytotoxicity (OK), Sensitization (OK), Irritation (OK), Acute Systemic (OK), Genotoxicity (OK) |
| Roughness of SLA Surface (Ra) | 2.5~3.0 μm (similar to Osstem product catalog) | 2.861 ± 0.262 μm |
| Sterilization Validation | VDmax 25 SAL 10-6 (similar to predicate) | VDmax 25 SAL 10-6 |
| Packaging Validation (Shelf life) | 8 years (predicate device shelf life) | 5 years |
| Fatigue Testing | In compliance with "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2007 (similar to predicate) | Results are in compliance and were similar to previously cleared predicate devices. |
Study Details (as far as available in the text)
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of a clinical study or human performance evaluation.
- For biocompatibility and fatigue testing, the sample sizes are not explicitly stated. These are typically bench tests performed on a representative number of devices.
- Data provenance: For Fatigue Testing, it was "conducted according to... ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario." For Biocompatibility, it states "Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations." The text does not provide country of origin or whether it was retrospective/prospective data, as these are non-clinical lab tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes non-clinical bench testing for substantial equivalence, not a study requiring human expert ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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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-assisted device or an MRMC study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental implant system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of clinical ground truth. For non-clinical tests (biocompatibility, fatigue, surface roughness), the "ground truth" or reference is established by international standards (e.g., ISO 14801, ASTM F67-06), regulatory guidance, and the characteristics of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/machine learning product.
-
How the ground truth for the training set was established:
- Not applicable for the same reason mentioned above.
In summary: The provided 510(k) focuses on demonstrating substantial equivalence of a physical dental implant system through non-clinical laboratory testing. It does not present a clinical study with human subjects, associated acceptance criteria as performance metrics, or the human-involved "ground truth" and reader performance details common in studies for diagnostic devices or AI algorithms. The "acceptance criteria" here refer to meeting established safety and performance standards via bench testing to show similarity to predicate devices.
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(143 days)
The ET/SS Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.
The ET/SS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
This 510(k) premarket notification for the ET/SS Implant System does not contain the level of detail typically found in a study describing acceptance criteria and device performance for AI/ML-based medical devices. The submission focuses on demonstrating substantial equivalence to predicate dental implants through a comparison of physical characteristics, intended use, and a summary of nonclinical testing (fatigue testing).
Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as the document is for a traditional medical device (dental implant) and not an AI/ML device.
However, I can extract the information provided about the nonclinical testing for this device and present it in a similar structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fatigue Testing | Compliance with ISO 14801 and "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst-case scenario. | Results were in compliance and similar to previously cleared predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable as this is a nonclinical, component-level fatigue test, not a performance study on a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for fatigue testing is established by engineering standards and measurement.
4. Adjudication Method
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study was not done. The device is a physical dental implant, not an AI system that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The "device" is a physical implant. The fatigue testing is a standalone test of the implant's physical properties.
7. The Type of Ground Truth Used
Engineering standards and measurements for fatigue life.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for physical fatigue testing of a dental implant in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Information from the Provided Document:
- Device Name: ET/SS Implant System
- Manufacturer: OSSTEM Implant Co., Ltd.
- Device Type: Endosseous Dental Implant
- Classification: Class II
- Key Feature: Made of pure titanium metal, SA (Sandblasting and Acid etching) treated surface.
- Intended Use: For use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations (cemented, screw-retained, or overdenture), and for final or temporary abutment support for fixed bridgework. Intended for delayed loading.
- Nonclinical Testing: Fatigue testing performed according to ISO 14801 and relevant FDA guidance.
- Clinical Testing: No clinical studies were submitted.
- Basis for Equivalence: Substantial equivalence was claimed based on material, indication for use, and similar design and technological characteristics to predicate devices, supported by nonclinical testing results.
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(243 days)
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
The provided document describes a 510(k) submission for a medical device, the "Prosthetic System," which is a dental abutment. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, the requested information elements related to acceptance criteria, diagnostic performance, sample sizes, expert involvement, and ground truth for a study proving device performance are largely not applicable (N/A) in the context of this 510(k) submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. Instead, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices in terms of:
- Material composition
- Intended use
- Design
- Technological characteristics
- Performance characteristics
- Safety (biocompatibility)
- Mechanical fatigue testing according to relevant standards.
- Reported Device Performance:
Performance Aspect Description Substantial Equivalence The device is deemed substantially equivalent to the HU/HS/HG Prosthetic System (K081575) and HS/HG Prosthetic System (K100245) of Osstem Implant Co., Ltd. for the intended use and technological characteristics. Fatigue Testing Conducted for Custom Abutment and Multi Angled Abutment according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. Results are reported to be in compliance. Biocompatibility Performed to ensure compliance with applicable international and US regulations. Results implied compliance. Other Safety/Performance The Prosthetic System has been "subjected to safety, performance, and product validations prior to release," with an overall conclusion that it is "safe and effective."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. No diagnostic performance test set is described as this is not a diagnostic device and the submission focuses on mechanical and material equivalence, not clinical diagnostic accuracy. The fatigue testing would involve a certain number of samples, but the specific sample size is not detailed in this summary. The tests were likely conducted in a lab environment.
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)
- N/A. Not applicable as there is no diagnostic test set or ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the fatigue test would be the standard's pass/fail criteria, derived from engineering principles and industry consensus, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable as there is no diagnostic test set requiring expert 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
- N/A. This is a dental prosthetic system (abutment), not a software or AI-enabled diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical prosthetic device, not an algorithm, so standalone performance in the context of AI/software is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A for diagnostic ground truth. For the fatigue testing, the "ground truth" would be the engineering specifications and pass/fail criteria defined by ISO 14801 and FDA guidance documents. For biocompatibility, it would be the compliance with relevant international and US regulations.
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/machine learning model for this physical medical device.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for an AI/machine learning model.
In summary: The provided 510(k) summary is for a physical medical device (dental abutment) and focuses on demonstrating substantial equivalence to existing predicate devices through material, design, and limited performance (fatigue, biocompatibility) testing, rather than a clinical study evaluating diagnostic accuracy against specific performance criteria. Therefore, most of the requested information regarding AI/diagnostic performance studies is not applicable.
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