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510(k) Data Aggregation
(238 days)
STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.
STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function.
STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.
The provided document is a 510(k) summary for the STERI-OSS Implant System, which is a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets pre-defined acceptance criteria for performance in a clinical setting. For medical devices undergoing 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific novel performance acceptance criteria through clinical studies.
Therefore, the requested information elements such as "acceptance criteria and the reported device performance," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are typically not applicable in the context of a 510(k) substantial equivalence submission for a device like a dental implant. These elements are more commonly associated with clinical trials or performance studies for novel devices or software with AI/ML components requiring new clinical evidence.
The document describes non-clinical testing to demonstrate that the differences between the subject device and predicate devices do not affect substantial equivalence.
Here's a breakdown of the available and non-applicable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not applicable in the format typically used for performance studies with defined acceptance criteria for clinical outcomes. The document instead presents a comparison of technological characteristics with predicate devices and reports on non-clinical engineering and materials testing to support substantial equivalence.
| Item | Acceptance Criteria (Not explicitly defined for clinical performance) | Reported Device Performance (as per non-clinical testing) |
|---|---|---|
| Fixture | - Material: Pure Titanium Grade 4 (ASTM F67) | Matches predicate/reference devices |
| - Connection type: Internal Hex | Matches predicate/reference devices | |
| - Surface Treatment: SLA | Matches predicate/reference devices | |
| - Sterilization: Gamma Sterilization | Matches predicate/reference devices | |
| - Dimensions: Within similar dimensional range of predicates | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Straight Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Solid Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices |
| (Angled Abutment) | - Principle of operation: Cement retained restoration | Matches reference devices |
| - Surface Treatment: None (machined surface) | Matches some reference devices; difference with TiN-coated predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range, supported by mechanical bench testing for differences | |
| Screw | - Material: Ti6Al4V ELI (ASTM F136) | Matches reference devices; difference with cp-Ti predicate deemed minor |
| (Abutment Screw) | - Principle of operation: Connect abutment to fixture | Matches reference devices |
| - Surface Treatment: None | Matches reference devices | |
| - Dimensions: Within reference device dimensions | Demonstrated to be within range | |
| Screw | - Material: Ti6Al4V ELI (ASTM F136) | Matches some reference devices; difference with cp-Ti predicate deemed minor |
| (Cover Screw) | - Principle of operation: Protect internal portion of implant | Matches reference devices |
| - Surface Treatment: None | Matches some reference devices; difference with anodized predicate deemed minor | |
| - Dimensions: Within range of reference device dimensions | Demonstrated to be within range | |
| Abutment | - Material: Ti6Al4V ELI (ASTM F136) | Matches some reference devices; difference with cp-Ti predicate deemed minor |
| (Healing Abutment) | - Principle of operation: Help soft tissue of gum naturally formed | Matches reference devices |
| - Surface Treatment: None | Matches some reference devices; difference with anodized predicate deemed minor | |
| - Dimensions: Similar design and dimension range | Demonstrated to be similar or within range | |
| General Non-Clinical | - ISO 14801:2016 (Fatigue) | Successfully tested for worst-case scenario |
| - ISO 11137-1/2 (Gamma Sterilization) | Validated | |
| - ANSI/AAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1/3 (End User Sterilization) | Validated | |
| - ASTM F88, F1140, F1929, F2096 (Shelf Life) | Tested (5 years) | |
| - ISO 10993-1/5/12 (Biocompatibility) | Evaluated and tested | |
| - USP (Pyrogen and Endotoxin) | Endotoxin testing conducted per batch (limit |
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(221 days)
The LW 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 terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.
The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).
The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.
The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."
Here's an interpretation of the implied acceptance criteria and the summary of reported performance:
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | Compliance with ISO 11137-1, -2, -3 to achieve a Sterility Assurance Level (SAL) of 10-6. | Validated to achieve SAL of 10-6. Results prove equivalence to predicate device. |
| End-User Sterilization Validation | Compliance with ISO 17665-1, -2 and FDA guidance "Reprocessing Medical Devices in Health Care Settings". | Validated. Results showed equivalence to predicate device. |
| Shelf-life Test | Compliance with ASTM F1980; no degradation of device functionality over specified shelf-life. | Devices function adequately for 5 years without degradation. Demonstrated equivalence to predicate devices. |
| Biocompatibility Tests (Cytotoxicity) | Compliance with ISO 10993-1, -5 and FDA Guidance. | Demonstrated biocompatibility of the material used. |
| Fatigue Test (Dynamic Fatigue & Static Compression) | Compliance with ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document". | Expected to function properly for intended use. |
| Bacterial Endotoxin Testing (LAL) | Compliance with USP , USP , and FDA guidance for pyrogen limit specifications. | Met acceptance criteria. Demonstrated substantial equivalence with the predicate device. |
| Surface Treatment Evaluation (SLA) | Compliance with 'Section 11 of Class II Special Controls Guidance Document'; comparable surface roughness, composition, and SEM imaging to predicate. | Demonstrated substantial equivalence through surface roughness, composition analysis, SEM imaging, and ICP analysis. |
| MRI Safety Review | Compliance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" for magnetically induced displacement force and torque. | Performed using scientific rationale and published literature; rationale addressed parameters. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.
Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:
- Sterility: Defined by ISO 11137 with an SAL of 10-6.
- Biocompatibility: Defined by ISO 10993 standards.
- Fatigue: Defined by ISO 14801.
- Bacterial Endotoxin: Defined by USP and .
- Surface Characteristics: Defined by FDA special controls guidance for dental implants.
The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this physical medical device.
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(146 days)
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
- with a temporary prosthesis that is not in functional occlusion,
- when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.
The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.
The document details:
- Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
- Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
- Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
- Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
- Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.
There is no information in this document about:
- Acceptance criteria for an AI/ML device.
- Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
- Sample sizes for test sets in an AI/ML study.
- Data provenance for an AI/ML study.
- Number or qualifications of experts for AI/ML ground truth.
- Adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study results for AI/ML.
- Standalone performance of an AI/ML algorithm.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.
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(156 days)
The NB 1 SA 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 terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.
The document provided is a 510(k) Premarket Notification for the NB 1 SA Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data, rather than reporting on a specific study that evaluates device performance against acceptance criteria in a clinical setting.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not present in this document. The information provided heavily relies on non-clinical tests to support the substantial equivalence claim.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are largely linked to meeting the requirements of specific ISO and ASTM standards for non-clinical testing. The "reported device performance" is that the results of these tests "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| For Devices Delivered Sterile (Fixture & Cover Screw) | ||
| Gamma Sterilization Validation Test | Sterility Assurance Level (SAL) of 10^-6 (according to ISO 11137-1:2006) | Met the criteria of ISO 11137-1:2006; SAL of 10^-6 validated. |
| Shelf-Life Test | Equivalence to predicate devices (according to ASTM F1980) | Met the criteria of ASTM F1980; worst-case construct tested, results demonstrated equivalence to predicate. Shelf life for devices provided sterile is 5 years. |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 (for fixtures) | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| LAL Endotoxin Testing | Compliance with AAMI / ANSI ST72:2011/(R)2016 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. |
| Non-Pyrogenic Claim (NB 1 SA Fixture) | Not applicable | Devices will not be marketed as non-pyrogenic. |
| For TiN Coating Abutments | ||
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -5:2009, -10:2010 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| For Devices Delivered Non-Sterilized (Abutments) | ||
| End User Sterilization Validation Test | Compliance with ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1 and FDA guidance | Recommended sterilization validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Worst-case construct tested, results demonstrated equivalence to predicate device. |
| Biocompatibility Testing (Ti-6Al-4V ELI) | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| Surface Modification Information (Fixtures) | Provided (roughness, composition, SEM with SLA) | Surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. (Results not explicitly detailed as acceptance criteria). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing described is primarily non-clinical (sterilization, shelf-life, biocompatibility, LAL endotoxin, material characteristics).
- Data Provenance: Not explicitly stated as "country of origin for data." The submitter is Arumdentistry Co., Ltd. from Daejeon, Republic of Korea. The testing itself is non-clinical and conducted in vitro or ex vivo (e.g., material testing, microbial inactivation). The document does not describe human subject data.
- Retrospective or Prospective: Not applicable as the described tests are non-clinical hardware tests.
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. The ground truth for the non-clinical tests is established by the specified international standards and guidelines (e.g., ISO, ASTM, AAMI/ANSI). No human expert "ground truth" derived from clinical data is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The described tests are non-clinical and do not involve adjudication by experts in the context of diagnostic interpretation.
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 MRMC comparative effectiveness study is mentioned. The device is an endosseous dental implant system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable to the device described. The NB 1 SA Implant System is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced international standards (e.g., SAL of 10^-6 for sterility, specific material properties, successful validation of sterilization cycles, biocompatibility under ISO guidelines, etc.). No clinical ground truth (like pathology or outcomes data) is discussed for this 510(k).
8. The sample size for the training set
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the device described.
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(366 days)
CORE1 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, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.
CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.
CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.
The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.
Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.
However, I can extract information related to the device's performance through non-clinical testing.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin Test | According to USP and ANSI/AAMI ST72:2011. Testing limit of 20 EU/device for blood contacting and implanted device. | Confirmed that the endotoxin test reagent (PTS cartridge) and laboratory environment were suitable, meeting endotoxin standards and established criteria. Implies performance within the accepted limit. |
| Fatigue Testing | According to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Objective: Confirm permanent restoration of the implant without failure. | Performed on the subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure. The language "to confirm covering permanent restoration of the implant without failure" implies successful completion meeting the standard. |
| Surface Analysis | Not explicitly stated as a separate acceptance criterion but is part of material characterization. | SEM & EDS analysis showed surface roughness leading to a macroroughness and no other impurity on the surface of the final product. This indicates the desired surface characteristics were achieved. |
| Gamma Sterilization | According to ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013, and ISO 11137-3:2006. Objective: Acceptable range of densities of other product in carrier and confirm process stability. | Evaluation showed an acceptable range of densities of other products in the carrier and confirmed process stability. Concluded that the packaging with gamma sterilization of the subject device is equivalent to predicate/reference devices, with a shelf life of 5 years. |
| End User Sterilization | According to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010/A4:2013. | Performed according to the stated standards. The implicit result is that it meets the requirements for end-user sterilization. |
| Biocompatibility Testing | According to ISO 10993-1:2018 and FDA Guidance Document "Use of International Standard ISO 10993-1...", and ISO 10993-5:2009. | Performed for each subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices, which includes assurance of biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
- Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.
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. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is non-clinical bench testing 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:
Not applicable. This is a dental implant, not an AI/diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental implant, not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set."
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(26 days)
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.
The IBS Implant System consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media). This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).
The provided document is a 510(k) Premarket Notification from the U.S. FDA, which focuses on demonstrating substantial equivalence of a new device (IBS Implant System) to existing predicate devices. It does NOT describe a study that proves the device meets predefined acceptance criteria for AI/ML performance.
Instead, the document primarily discusses:
- The Indications for Use for the IBS Implant System (dental implants).
- A detailed comparison of the subject device with predicate devices, highlighting similarities and differences in design, materials, dimensions, and manufacturing processes.
- The non-clinical data leveraged from predicate devices (e.g., sterilization validation, biocompatibility, fatigue testing) to support the substantial equivalence claim for the new components being added.
Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/ML powered medical device. The provided document is for a traditional dental implant system and does not involve AI/ML.
To answer your question meaningfully, I would need a document related to an AI/ML medical device submission.
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