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510(k) Data Aggregation
(98 days)
NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.
NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Temporary prosthetic components have a maximum duration of usage of 180 days.
NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses.
NUVENTUS NV.C™ FINAL PROSTHETIC
NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.
The NUVENTUS NV.C™ Prosthetic Components product portfolio consists of NUVENTUS NV.C™ Healing Components, NUVENTUS NV.C™ Temporary Prosthetic Components, NUVENTUS NV.C™ Multi-unit Abutments, and NUVENTUS NV.C™ Final Prosthetic. NUVENTUS NV.C™ Prosthetic Components product portfolio are intended to be used with the NUVENTUS NV.C™ Dental Implant System (K233081).
NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ Healing Components may come in different designs, either with cap or screw portion machined as one piece or with an integrated occlusal screw. Different shapes, transmucosal heights are available. Healing components are components that cover the implant or abutment platform and prevent tissue overgrowth during the healing phase of the implant. The threaded portion of the healing components fits inside the internal threads of the implant or abutment, while the head of the healing components covers the top surface of the implant (the implant head) or abutment.
NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
The NUVENTUS NV.C™ Temporary Prosthetic Components line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.
NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are premanufactured dental abutments used for restoration of NUVENTUS NV.C™ Dental Implant of different diameters and lengths. The Multi-unit Abutments are available in NP and RP platform sizes; 0°, 17° and 30° angulations; various transmucosal heights and hexagonal index orientations. Multi-unit Abutments are co-packed with abutment carrier and screw. The abutments are delivered sterile for immediate use.
NUVENTUS NV.C™ FINAL PROSTHETIC
The NUVENTUS NV.C™ Final Prosthetic line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.
The provided FDA 510(k) Clearance Letter for NUVENTUS NV.C™ Prosthetic Components does NOT describe a device that uses AI or machine learning. It describes conventional prosthetic components for dental implants.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data, including:
- MRI Safety: Evaluation of components in an MR environment based on scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance.
- Sterilization Validation:
- Gamma irradiation validation (25 kGy dose) for sterile components according to ISO 11137-1 and ISO 11137-2.
- Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 (< 20 EU/device).
- Shelf life testing after accelerated aging (5 years real time) according to ASTM F1980 for sterile barrier integrity.
- Steam sterilization validation for non-sterile components according to ISO 17665.
- Biocompatibility Testing: Cytotoxicity testing according to ISO 10993-5.
- Mechanical Testing: According to ISO 14801:2016 to demonstrate sufficient strength in combination with the NUVENTUS NV.C™ Dental Implant System, referencing FDA Guidance "Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway".
The document explicitly states: "There was no human clinical testing required to support NUVENTUS NV.C™ Prosthetic Components as the indications for use are equivalent to the predicate devices. The non-clinical testing detailed in this submission supports the substantial equivalence."
In summary, none of the requested information regarding AI/ML performance metrics can be extracted from this document, as the device is a conventional medical device and not an AI/ML-driven one.
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(112 days)
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.
This document is a 510(k) summary for the NUVENTUS NV.C™ Surgical Cassette and Tray, a rigid sterilization container. The information provided heavily focuses on non-clinical testing for substantial equivalence, rather than a clinical study involving human readers and AI for diagnostic improvement. Therefore, many of the requested elements for an AI-assisted diagnostic device study (like MRMC, human-in-the-loop, expert consensus for ground truth on a test set, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the device's functional validation as presented in the non-clinical testing summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Validation of the Manual Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards | Evaluate and validate the manual cleaning of the subject devices | Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction.Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL)Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL) | Pass |
| Validation of the Automated Cleaning Process According to the ISO 17664 and the AAMI ST98 Standards | Evaluate and validate the automated cleaning of the subject devices | Extraction Recovery: The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction.Residual marker testing (Protein Assay): less than 6.4 µg/cm² (Assay quantitation limits: 2.5 µg/mL)Residual marker testing (Hemoglobin assay): less than 2.2 µg/cm² (Assay quantitation limits: 10.0 µg/mL) | Pass |
| Sterilization Validation According to the ISO 17664 - ISO 17665 Standards and the AAMI TIR 12 Technical Report | Validate a sterilization cycle and drying time of the subject devices | Sterilization Effectiveness: 3 consecutive half-cycles will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10⁻⁶ is achieved if the Instructions for Use are followed.Drying Time: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed +3% | Pass |
| Use Life Testing (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling and ISO 13402:1995) | Life Cycle (simulated use) testing after 225 cleaning, disinfection and sterilization cycles | Durability/Functionality: Visual inspection, functional verification for 225 use cycles. | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) ISO 10993-5, ISO 10993-12 | Evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay | Cytotoxicity: ≤ 2 reactivity grade after exposure to extract of the device | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of surgical cassettes tested, but rather the number of cycles or repetitions for certain tests.
- Cleaning Validation: Not explicitly stated as a number of devices, but implies multiple tests to meet extraction efficiency and residual marker criteria.
- Sterilization Validation: "3 consecutive half-cycles" implies a specific test setup for validation, not a large sample of devices.
- Use Life Testing: The device was tested for "225 cleaning, disinfection and sterilization cycles." This refers to repeated cycles on a single or limited number of test units to simulate usage over time.
- Biocompatibility: Not specified as a number of devices.
- Data Provenance: Not specified in terms of country of origin. The study appears to be entirely non-clinical bench testing, conducted to demonstrate the device's functional performance and safety (e.g., ability to be cleaned and sterilized, durability, biocompatibility), rather than a clinical study on patient data. It is therefore retrospective in the sense that prototypes were subjected to rigorous testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" here is the objective measurement of chemical residuals, biological indicator inactivation, weight change, and visual/functional inspection against defined engineering and regulatory standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or interpretations involved in establishing ground truth for this type of test, no adjudication method is needed or mentioned.
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-assisted diagnostic device. It's a medical device (surgical cassette and tray) intended for sterilization. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm for diagnostic purposes. The device is a physical object.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is established by objective physical and chemical measurements against pre-defined performance standards based on recognized test methodologies (ISO, AAMI standards). This includes:
- Quantitative measurements of protein and hemoglobin residuals after cleaning.
- Verification of biological indicator inactivation for sterilization efficacy.
- Weight measurements to assess drying.
- Visual inspection and functional verification against product specifications for use life.
- Cytotoxicity assays for biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
In summary, the provided document details the non-clinical performance validation of a reusable surgical cassette and tray to demonstrate its substantial equivalence to a predicate device, focusing on its ability to be cleaned, sterilized, its durability, and biocompatibility. It is not an AI/ML-enabled diagnostic device, so many of the requested elements for such a study are irrelevant to this submission.
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(416 days)
NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NUVENTUS NV.CTM Dental Implants are compatible for use with the following prosthetic interfaces.
| Implant System Prosthetic Compatibility | Platform Size/Designation |
|---|---|
| Nobel Biocare Internal Conical Connection (CC) | NP CC |
| RP CC |
The purpose of this submission is to obtain marketing clearance for NUVENTUS NV.C™ Dental Implant System endosseous dental implants and cover screws. The dental implants are intended to interface with Internal Conical Connection (CC) prosthetic components from Nobel Biocare.
A summary of the subject device implant and the associated compatible OEM prosthetic connection is provided in the table Summary of Subject Device Implant Designs.
| Subject Device ImplantDescription | PlatformDesignation | Length (mm)* | OEM Prosthetic Compatibility(K071370, K161435, K161416) | ||||
|---|---|---|---|---|---|---|---|
| Implant, NV.C, Platform NP, Ø3.5 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform NP, Ø4.3 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform RP, Ø5.0 mm | RP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, RP Platform |
The subject device dental implants have a conical abutment seating surface on the interior of the implants and internal threads so that prosthetic components may be fastened to the implant. The implant lines have two (2) abutment interface connections with internal geometric features to allow for rotational resistance of the mating abutment. All subject device implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
The external surface of all subject device implants is threaded, and the implant body tapers at the apical end. which includes two (2) cutting flutes. At the coronal end. the Ø4.3mm and Ø5.0mm (body diameter) subject device implants have two (2) fluted features on the body of the implant spaced 180° apart. Each fluted feature has horizontal grooves spaced vertically within the flute surface. The number of grooves within each flute ranges from 3 to 5 and the actual number is a function of the implant length. The Ø3.5mm (body diameter) subject device implants do not have fluted features. The endosseous surface of all subject implants is textured by blasting with resorbable media
The subject device implants are compatible with prosthetic components that interface with Nobel Biocare Internal Connection implants. The subject device cover screws are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 and are anodized to identify the prosthetic platform (NP and RP).
The compatible Nobel Biocare Internal Conical Connection prosthetic components (NP and RP platforms) include cover screws, healing abutments, temporary abutments esthetic abutments, straight multi-unit abutment, and angled multi-unit abutments.
All subject device implants and cover screws are individually packaged and are provided sterile.
The FDA document provided pertains to a 510(k) premarket notification for a dental implant system (NUVENTUS NV.C™ Dental Implant System). This document focuses on demonstrating substantial equivalence to predicate devices through engineering analysis, non-clinical performance data (e.g., mechanical testing, biocompatibility), and a review of clinical literature. It does not present a study proving the device meets specific acceptance criteria based on AI/ML performance metrics, expert consensus, or clinical outcomes from a new study specific to an AI device.
Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details because this information is not present in the provided text.
The document discusses performance data related to the dental implant itself (e.g., sterilization, biocompatibility, mechanical testing, surface analysis), and clinical literature data to support the substantial equivalence of the implant's design features with established predicate devices. The "Clinical Testing Literature Table" outlines existing studies on predicate implants, reviewing their clinical outcomes (like bone level changes) to support the subject device's design principles. This is not the same as a study testing an AI device's performance against defined acceptance criteria.
In summary: The provided text is a 510(k) submission for a dental implant system, not an AI/ML-based medical device. Thus, the requested details specific to AI/ML device performance and validation studies are not available in this document.
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