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510(k) Data Aggregation
(163 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:
- include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
- include new OEM platform compatibility for MIS C1 Dental Implant System,
- include attachment components (retention inserts and housing) including reprocessing information in labeling.
The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.
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(342 days)
The Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.
The Esophageal TTS Stents and Niti-S Esophageal Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency. A length of suture is attached to one end of the stent and can be used for stent repositioning during initial placement, in accordance with the instructions for use.
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(150 days)
In Anatomic:
Tornier HRS Max humeral assembly can be used for anatomic arthroplasty when used with a humeral head. It can be used as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total replacement.
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with an intact or reconstructable rotator cuff with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e., osteoarthritis and avascular necrosis)
- Fractures of the humeral head
- Post-Traumatic arthritis
- Oncology applications including bone loss due to tumor resection
- Significant humeral resection where adequate fixation can be achieved
In Reverse:
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Post-Traumatic arthritis
- Massive and non-repairable rotator cuff tear
- Oncology applications including bone loss due to tumor resection.
- Significant humeral resection where adequate fixation can be achieved
The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of a well-fixed humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notice:
- All components are single-use.
- The coated humeral stem is intended for cemented or cementless use
- The all-poly glenoid components are intended for cemented use only.
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
The HRS Max System is designed to address massive proximal humeral bone loss and provide for deltoid wrapping. The modular functionality of the HRS Max Shoulder System allows clinicians to create constructs that can address unique anatomies which include proximal humeral bone loss, while also allowing for use in anatomic hemiarthroplasty or reversed configuration.
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(61 days)
The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
The Navigated Instruments are specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigated Instruments are spine preparation instruments made of surgical grade stainless steel per ASTM F899. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. When used with the appropriate Medtronic single-use sterile spheres the subject devices can be used as navigated surgical instruments with the Medtronic StealthStation™ System (Medtronic computer-assisted surgery system) to track the instruments in the surgical field.
Specialized cases and trays are available for optional use with the Navigated Instruments. They are manufactured from stainless steel per ASTM F899, aluminum per ASTM B209, and silicone. Ancillary non-navigated instrumentation is available for optional use with the Navigated Instruments. These instruments are not specifically intended to be used with the subject device.
The Navigated Instruments are provided non-sterile.
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(269 days)
The TECHFIT Patient-Specific Cranial System is intended to replace bony voids in the cranial skeleton. The devices are indicated for adults and adolescents from 18 years or older.
The TECHFIT Patient-Specific Cranial System is patient specific devices intended to replace bony voids in the cranial/craniofacial skeleton. The TECHFIT Patient-Specific Cranial System includes a cranial implant, cranial model and a software component for digital planning and visualization named Digitally Integrated Surgical Reconstruction Platform DISRP®.
TECHFIT Patient-Specific Cranial Implants are manufactured from Polyether Ether Ketone (PEEK). The TECHFIT Patient-Specific Cranial Implants are attached to the native bone using commercial plates and screws.
The TECHFIT Patient-Specific Cranial System matches the shape and dimensions of the missing skull bone fragments. The implants are manufactured from PEEK according to ASTM F2026 and are manufactured by machining process.
The TECHFIT Patient-Specific Cranial System models are patient specific devices manufactured from clear resin using 3D printing manufacturing process. Those models are a representation of the anatomy of the patient, and they are not indicated to enter to the OR (Operating Room).
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(118 days)
VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.
Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Face Mode:
LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.
The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.
The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.
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(265 days)
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT heart without contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis.
TeraRecon Cardiovascular.Calcification.CT is indicated to generate results from Calcium Score CT scans taken of adult patients, 30 years and older, except patients with pre-existing cardiac devices, electrodes, previous and established ischemic diseases (IMA, bypass grafts, stents, PTCA) and Thoracic metallic devices. The device is not specific to any gender, ethnic group, or clinical condition. The device's use should be limited to CT scans acquired on General Electric (GE) or Siemens Healthcare or their subsidiaries (e.g. GE Healthcare) equipment. Use of the device with CT scans from other manufacturers is not recommended.
The TeraRecon Cardiovascular.Calcification.CT algorithm is an image processing software device that can be deployed as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device provides an automatic 3D segmentation of the coronary calcifications.
When TeraRecon Cardiovascular.Calcification.CT results are used in external viewer devices such as TeraRecon's Intuition or Eureka Clinical AI medical devices, all the standard features offered by the external viewer are employed.
The TeraRecon Cardiovascular.Calcification.CT algorithm is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities, and limitations.
Here's a breakdown of the acceptance criteria and study details for the TeraRecon Cardiovascular.Calcification.CT device, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agatston Classification Accuracy: At least 80% accuracy for the 4 revised Agatston classes (0-10, 11-100, 101-400, >400), with a lower bound 95% confidence interval (CI) of at least 75%. | Passed. Mean accuracies exceeded 94% across Agatston categories, with 95% CI lower bounds above 75%. |
| Vessel Calcification Classification (Dice Similarity Coefficient): At least 80% DICE with a lower bound 95% confidence interval of at least 75% for segmentation of calcifications by vessel (LM, LAD, LCX, RCA). | Passed. Segmentation performance, measured by Dice similarity coefficient against expert annotations, consistently exceeded the predefined acceptance criteria (≥80% Dice with lower 95% CI ≥75%). |
Study Details
1. Sample Size Used for the Test Set:
The test set included 422 adult patients.
2. Data Provenance (Country of Origin, Retrospective/Prospective):
- Retrospective cohort study.
- At least 50% of the ground truth data is from the US, divided between multiple locations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- 3 annotators (experts) were used for each study to segment coronary vessels and apply thresholds to create calcification masks within the vessels.
- Qualifications of experts: Not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- Majority vote (2+1 method): The final calcification ground truth for the calcification segmentation masks was attained if a voxel was part of at least 2 of the masks defined by the three annotators.
- For the ground truth vessel of calcification, it was also attained by majority vote among the 3 annotators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned. The study focused on standalone device performance against expert-established ground truth.
6. Standalone Performance:
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The results reported are directly attributed to the TeraRecon Cardiovascular.Calcification.CT device's performance against ground truth.
7. Type of Ground Truth Used:
- Expert consensus based on annotations from three experts. The experts segmented coronary vessels and applied thresholds to create calcification masks. The final ground truth was established by majority vote among these annotators for both the calcification mask and the vessel classification.
8. Sample Size for the Training Set:
- The document does not explicitly state the sample size used for the training set. It only describes the test set.
9. How the Ground Truth for the Training Set was Established:
- The document does not explicitly state how the ground truth for the training set was established. It only describes the ground truth establishment for the test set.
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(84 days)
DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to add abutments to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K242340 and K240208. The subject device abutment designs include Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), and abutment screws.
Pre-Milled Blank Abutments are designed for custom abutment fabrication by a CAD-CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm and a solid cylindrical design with an engaging or non-engaging implant connection. They are available in versions with a straight screw channel and with an angled screw channel for esthetic considerations. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V).
The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:
- Minimum wall thickness – 0.45 mm
- Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height – 6.0 mm
- Pre-Milled Blanks are for straight abutments only
Multi-Unit Abutments: Straight and Angled are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight (0°), angled 17°, and angled 30°. The designs of the subject Multi-Unit Abutments are similar to the designs of Multi-Unit Abutments cleared in K242340 and K240208. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).
The subject device straight Multi-Unit Abutments have a non-engaging, threaded design that attaches directly to the implant. The subject device straight (0°) Multi-Unit Abutments are included in this submission are similar in design to straight Multi-Unit Abutments cleared in K242340, K230143, and K222288. Subject device straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 1 mm to 5.5 mm.
The subject device angled Multi-Unit Abutments are provided only in an engaging design that requires an abutment screw. The subject device Multi-Unit Abutments angled 17° and 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 2.5 to 4.5 mm.
Select straight and angled Multi-Unit Abutments have an added coating of zirconium nitride (ZrN). This coating is identical to the ZrN coating used on abutments with ZrN cleared in K242340.
DESS® Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of seventeen (17) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K242340 and K240208. Screws are made of titanium alloy (Ti-6Al-4V). Select subject device screws are available with DLC (Diamond-like Carbon) coating and are identical to that used on screws cleared in K240208.
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(269 days)
Immunoglobulin Isotypes (GAM) for the EXENT Analyser:
The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay that is used in conjunction with the Binding Site Optilite IgG, IgA and IgM assays for the semi-quantitative in vitro measurement of monoclonal IgG, IgA, and IgM as a reflex test in serum for patients with a result suggestive of the presence of monoclonal immunoglobulins by serum protein electrophoresis (gel or capillary zone electrophoresis), or with an abnormal serum free light chain concentration and free light chain ratio result.
The assay is intended for use as an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis.
Assay results should be used in conjunction with other laboratory and clinical findings.
EXENT Analyser:
The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. The device is designed for professional in vitro diagnostic use only and it is not a device for self-testing.
The system consisting of the EXENT® Analyser and the EXENT® assays are intended for the in vitro measurements of analytes in human body fluids. It is designed to provide automation and integration of all the analytical steps (including liquid handling and MALDI-ToF mass spectrometry). The EXENT Analyser is designed to be used solely in combination with EXENT assays to measure a variety of analytes depending on the reagents. The device is designed for professional use only and it is not a device for self-testing.
The EXENT Analyser combines automated immunoassay with readout by MALDI-ToF mass spectrometry. It is a modular analyser, and the major components are described in Table 3 and illustrated schematically in Figure 1.
| Component | Description | Function |
|---|---|---|
| EXENT-iP® 500 | Automated liquid handler | Preparation of patient samples by magnetic bead immunoprecipitation assays for subsequent analysis by MALDI-ToF Mass spectrometry |
| EXENT-iX® 500 | MALDI-ToF mass spectrometer | Analysis of prepared patient samples by MALDI-ToF mass spectrometry |
| EXENT-iQ® software | Workflow and data management software | Management of the workflow between the EXENT-iP500 and EXENT-iX500 instruments. Data management including processing and results release. |
The EXENT-iP500 component is an automated liquid handler that prepares human body fluids using the EXENT assay specific reagents. The samples are prepared using magnetic beads that are coated with isotype-specific antibodies. Any unbound material is washed away during the sample preparation process. The EXENT-iP500 also manages the transfer of the prepared patient sample to the MALDI plate.
The EXENT-iX500 component is a MALDI-ToF mass spectrometer. Signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. The EXENT-iX500 is used to read samples prepared by the EXENT-iP500.
The EXENT-iQ software integrates sample preparation and MALDI-ToF mass spectrometry and is used for data storage and processing. It is the primary user interface used by the user to review and release results.
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(59 days)
The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System
The TMINI® Miniature Robotic System (AIM 3.0) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation with the TCM web based plan review, approval and download component, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. This submission introduces modifications to the method of generation, verification and validation of new implant modules for use with the TMINI Miniature Robotic System.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.
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