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• autoSCORE is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. • The spike detection component of autoSCORE is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The spike detection component is intended to be used in patients at least three months old for EEGs <4 hours and at least two years old for EEGs >4 hours. The autoSCORE component has not been assessed for intracranial recordings. • autoSCORE is intended to assess the probability that previously acquired sections of EEG recordings contain abnormalities, and classifies these into pre-defined types of abnormalities, including epileptiform and non-epileptiform abnormalities. autoSCORE does not have a user interface. autoSCORE sends this information to the EEG reviewing software to indicate where markers indicating abnormality are to be placed in the EEG. autoSCORE also provides the probability that EEG recordings include abnormalities and the type of abnormalities. The user is required to review the EEG and exercise their clinical judgement to independently make a conclusion supporting or not supporting brain disease. • This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is not intended to detect or classify seizures.

autoSCORE is a software only device. autoSCORE is an AI model that has been trained with standard deep learning principles using a large training dataset. The model will be locked in the field, so it cannot learn from data to which it is exposed when in use. It can only be used with a compatible electroencephalogram (EEG) reviewing software, which acquires and displays the EEG. The model has no user interface. The form of the visualization of the annotations is determined and provided by the EEG reviewing software. autoSCORE has been trained to identify and then indicate to the user sections of EEG which may include abnormalities and to provide the level of probability of the presence of an abnormality. The algorithm also provides categorization of identified areas of abnormality into the four predefined types of abnormalities, again including a probability of that predefined abnormality type. This is performed by identifying epileptiform abnormalities/spikes (Focal epileptiform and generalised epileptiform) as well identifying non-epileptiform abnormalities (Focal non-epileptiform and Diffuse Non-Epileptiform). This data is then provided by the algorithm to the EEG reviewing software, for it to display as part of the EEG output for the clinician to review. autoSCORE does not provide any diagnostic conclusion about the patient's condition nor treatment options to the user, and does not replace visual assessment of the EEG by the user. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

The SperSort™ Sperm Sorting Chip is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.

1. autoSCORE is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The spike detection component of autoSCORE is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The spike detection component is intended to be used in patients at least three months old. The autoSCORE component has not been assessed for intracranial recordings. 3. autoSCORE is intended to assess the probability that previously acquired sections of EEG recordings contain abnormalities, and classifies these into pre-defined types of abnormalities, including epileptiform abnormalities. autoSCORE does not have a user interface. autoSCORE sends this information to the EEG reviewing software to indicate where markers indicating abnormality are to be placed in the EEG. autoSCORE also provides the probability that EEG recordings include abnormalities and the type of abnormalities. The user is required to review the EEG and exercise their clinical judgendently make a conclusion supporting or not supporting brain disease. 4. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is not intended to detect or classify seizures.

autoSCORE is a software-only decision support product intended to be used with compatible electroencephalography (EEG) review software. It is intended to assist the user when reviewing EEG recordings, by assessing the probability that previously acquired sections of EEG recordings contain abnormalities, and classifying these into pre-defined types of abnormality. autoSCORE sends this information to the EEG software to indicate where markers indicating abnormality are to be placed in the EEG. autoSCORE uses an algorithm that has been trained with standard deep learning principles using a large training dataset. autoSCORE also provides an overview of the probability that EEG recordings and sections of EEG recordings include abnormalities, and which type(s) of abnormality they include. This is performed by identifying spikes of epileptiform abnormalities (Focal epileptiform and Generalized epileptiform) as well identifying non-epileptiform abnormalities (Focal Nonepileptiform and Diffuse Non-epileptiform). The user is required to review the EEG and exercise their clinical judgement to independently make a conclusion supporting or not supporting brain disease. autoSCORE cannot detect or classify seizures. The recorded EEG activity is not altered by the information provided by autoSCORE. autoSCORE is not intended to provide information for diagnosis but to assist clinical workflow when using the EEG software.

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

The Polar Care Wave system is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently. The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device. The device is intended to be used with Breg Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual-bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy. The insulated container is filled with ice and water by the user. The water circulates through the cold-compression pad to deliver cold therapy to the application site. The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR is a textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 from Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free. The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF. DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical thecniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the ziqzag-stripes are in the craniocaudal direction. The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF. DvnaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope. The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler. The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.

DynaMesh®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is indicated for repairing incisional hernias in all current extraperitoneal surgical techniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is a textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber. Polyvinylidene Fluoride (PVDF) has been used for approximately 20 years for long-term implants in cardiac and vascular surgery because of its biocompatibility and durability. PVDF is a high performance polymer material with very high material purity. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a pattern of zig-zag marking stripes as visual aid to the clinician facilitating correct mesh positioning; the mesh is correctly positioned when the zig-zag stripes are in the craniocaudal direction. DynaMesh®-CICAT is supplied as a sterile, flat sheet of material without any coatings or additives. The FEG Textiltechnik's DynaMesh®-CICAT will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

This device is to be used for general relaxation training when used with supported amplifier/encoders.

This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data. The device processes EEG information, separates it into user-specified frequency bands, and displays the results as biofeedback indications to a user.