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The Freeprint® denture flex is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The Freeprint® denture flex is indicated for the fabrication, by additive manufacturing, of dental objects such as flexible partial removable dentures.

Freeprint® denture flex is a light-cured, 3D printed flexible denture resin. The Subject device is used by a dental professional (dentist or dental technician) in the CAD/CAM manufacturing of patient-specific partial dentures. There are two models of the Subject device which are referred to as Freeprint® denture flex clear and Freeprint® denture flex pink-transparent. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment and is provided in an HDPE bottle.

The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.

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The Simplexa COVID-19 / Flu A/B & RSV Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus and respiratory syncytial virus (RSV) in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.

The Simplexa COVID-19 / Flu A/B & RSV Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in nasopharyngeal swab and anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.

Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the Simplexa COVID-19 / Flu A/B & RSV Direct real-time RT-PCR assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B, or RSV infection and should not be used as the sole basis for patient management decisions.

The Simplexa™ COVID-19 & Flu A/B & RSV Direct assay is a qualitative, multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous detection and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swabs (NPS) and anterior nasal swabs (NS) in UTM/UVT and M4RT specimen transport media. The assay is performed on the LIAISON® MDX Instrument using a Direct Amplification Disc (DAD) format, enabling sample-to-answer processing without separate nucleic acid extraction.

The LIAISON® MDX Instrument is a benchtop real-time PCR thermocycler that utilizes a self-contained, single-use direct amplification disc (DAD) to process samples. It performs thermal cycling and real-time fluorescence detection using optical detection modules, each with specific excitation and emission wavelengths. The instrument includes a laser enclosed in a laser product housing, with integrated hardware and software interlocks to ensure user safety. It is operated via a USB connection to a dedicated computer running the LIAISON® MDX Studio software.

The LIAISON® MDX Studio software controls the instrument and provides a user interface for assay setup, execution, and result analysis. The software automatically interprets results for in vitro diagnostic (IVD) assays using pre-defined assay definitions encoded in barcode inserts included with the assay kits. It performs spectral compensation, verifies internal control amplification, and checks for sufficient sample volume prior to amplification. The software also includes user authentication, audit logging, laboratory information system (LIS) connectivity, and cybersecurity features.

The assay kit includes single-use reaction mix vials, a positive control pack with inactivated viral particles in transport media, and the Direct Amplification Disc consumable, which supports up to eight simultaneous reactions.

The assay format is designed for direct amplification, with 24 single-use reaction mix vials per kit. The required sample volume input is 50 µL. The reaction mix is provided in single-use vials and includes DNA polymerase, reverse transcriptase, RNase inhibitor, primers, probes, and encapsulated RNA templates. The buffer component in the reaction mix maintains optimal pH and ionic strength to support enzyme activity and amplification efficiency throughout the RT-PCR process.

The assay includes an encapsulated RNA internal control (RNA IC) in each reaction to monitor for potential RT-PCR inhibition or process failure. The RNA IC is derived from bacteriophage MS2. This non-target RNA is co-amplified with the assay's viral targets and detected independently using post-amplification melting curve analysis. The presence of the RNA IC in a negative specimen confirms that the amplification process functioned as expected, while its absence—along with no target detection—results in an invalid outcome. Detection of the RNA IC is not required in the Positive Control but is expected in the No Template Control (NTC) to verify assay validity.

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Cocoon Solo (DX-7020s) is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients.

Cocoon Solo (DX-7020s) is a handheld, portable X-ray device designed for dental radiographic examination and diagnosis for pediatric and adult patients by exposing a X-ray image receptor to ionizing radiation.

The X-ray tube is located inside the device body to be used with conventional film (F-speed or greater film), PSP (Phosphor plates), or digital X-ray sensors.

The image detectors (an integral part of a fully-functional diagnostic x-ray system) are not part of the submission.

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The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature-controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.

The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort.

The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

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The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.

The L07 Mandibular Advancement Device is an intraoral device that is used to maintain the lower jaw in a forward position to increase pharyngeal space so as to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

The L07 Mandibular Advancement Device include three types: Type A, Type B, Type C. Each type includes one upper tray and one lower tray. The upper tray of these three types are the same, while they are only different in lower tray. By combining upper tray with different lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.

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The LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.

The LithoBlast Single-Use Holmium Laser Fibers are single use surgical fiberoptic laser delivery devices that transmit laser energy in a forward direction. The devices include a SMA 905 connector at the proximal end. The laser fibers are compatible with Ho:YAG laser systems. There are four (4) fiber core diameters: 272 Series (272 µm), 365 Series (365 µm), 550 Series (550 µm), and 940 Series (940 µm).

The laser fibers in the LithoBlast family are 300cm long. All have a 10 mm straight cut flat cleaved distal end. All include a stress booth and an ABS over nut extension sleeve (type A=straight and narrow; type B=indented with finger grips; type C=finger grips protrude) to enable the operator's firm grip. The SMA-905 connector attaches at the proximal end of the device.

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The Latitude-C AM™ Interbody Spacer is indicated for spinal fusion procedures at one or more levels in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Latitude-C AM™ Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Cyclops™ Anterior Cervical Plate System.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C AM™ Interbody Spacer in the cervical spine.

The DeGen Medical Latitude-C AM™ Cervical Interbody Fusion System is an additively manufactured anterior cervical interbody fusion system for anterior cervical fusion procedures. Latitude-C AM™ cervical spacers are comprised of a single component that is additively manufactured. Latitude-C AM™ spacers are available in the following configurations; lordotic, anatomic, and symmetric. The superior and inferior sides of the endplates of the spacer feature porous surfaces to facilitate fusion and mitigate subsidence and expulsion and feature a central aperture to constrain bone graft. Latitude-C AM™ spacers include various depths, widths, heights, and angles of lordosis. Latitude-C AM™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium.

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The Eleganz™ IM Threaded Nail System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

The nails are not intended for interference or soft tissue fixation.

The Eleganz™ IM Threaded Nail System includes nails for bone fixation and a set of instruments used for nail site preparation and delivery. The device is offered in one non-sterile tray that contains the nails, Kirschner wire, bone preparation instrumentation and drivers.

The nails are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

The nails are made from 316L stainless steel. They range from 11-75 mm in length.

The instrumentation includes a reamer, driver handle, driver bit, depth gauge, countersink, and Kirschner wire. The drills and driver components are cannulated. The driver handle is used with the driver bit to insert the screw as well as with the reamer for hand reaming. The countersink has cutting flutes to ease entry of the nails into the intramedullary canal.

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deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

The deepLive device is an update to the previously cleared deepLive device (K240610). The update includes the addition of a hand-held Dermoscope (DMS).

deepLive was designed for an easy integration into clinical practices. The device is composed of:

• A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
• A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
• A first hand-held probe (LC-OCT), integrating the LC-OCT imaging system (interferometric microscope, OCT camera). The probe is connected to the CPU front panel by a sheathed cable bundle, and stored in a dedicated probe-holder fixed on the cart tablet.
• A second hand-held probe (DMS), complementary to the LC-OCT, integrating a dermoscope and providing wide-field surface color images. The probe is connected to the CPU by a USB cable, and stored in a dedicated probe-holder fixed on the cart tablet.
• A central power unit (CPU), mounted on the cart, integrating various imaging and electronic peripherals (laser, computer, electronic cards, drivers, power supplies, etc.), driving and powering the imaging probe.
• A software running on the device's computer, which controls the components of the system, acquires and processes images, and provides user interfaces for performing examinations and managing data.

deepLive hardware interfaces are located on the front-panel of the CPU. Input/output connections include:

• 1 Display port to connect the screen
• 3 USB ports to connect external drives (Wifi key, hard drive disk, etc.)

deepLive software runs on a computer embedded in the CPU of the device. The computer uses Windows Enterprise LTSC operating system. The software executable and all dynamic libraries needed for program execution are deployed at a specific location in the file system.

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The device is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients aged 18 years or older with suspected disease.

Blineslide is a cloud service application that helps qualified users with image-based assessment of lung ultrasound (LUS) cines acquired from the anterior or anterolateral chest regions during a physician-led LUS examination of patients aged 18 years or older. It does not directly interface with ultrasound systems.

Blineslide takes as input user-uploaded B-Mode LUS video clips (cines) in MP4 format and allows users to detect the relevant medical parameters of structures and function (LUS artifacts). Key features of the software are:

• B Line Artifact Module: an AI-assisted tool for detecting the presence or absence of B line artifacts in LUS cines

Blineslide is incompatible with:

• Cines that are acquired from Linear array ultrasound transducers;
• Cines acquired at less than 18 frames per second;
• Cines that require more than 2048 megabytes of memory;
• Cines that are less than 2600 milliseconds in duration; and
• Cines that are greater than 7800 milliseconds in duration

Each of these exclusion criteria are automatically assessed by the software. If detected, an output of Cannot Evaluate is returned to the user to minimize the risk of false LUS artifact detections.

Blineslide does not perform any function that could not be accomplished by a trained user manually. Patient management decisions should not be made solely on the results of Blineslide's analysis.

Here's a breakdown of the acceptance criteria and study details for the BlineSlide device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

Note: The FDA 510(k) summary does not explicitly state pre-defined acceptance criteria for statistical metrics like sensitivity and specificity. Instead, the reported performance is presented to demonstrate substantial equivalence to the predicate device. The "implied" acceptance criteria are derived from the need for the device to be "as safe and as effective as the predicate device."

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Initially 1005 cines. After exclusions for poor image quality, the final dataset comprised 326 positive class examples (B Line Artifacts Present) and 679 negative class examples (B Line Artifacts Absent), totaling 1005 cines.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but mentioned as "various clinical sites in cities with diverse race and ethnicity populations," and "geographically distinct from the data sources used in the development set." This implies a diverse, likely multi-site, geographical origin.
  • Retrospective or Prospective: Not explicitly stated, but typical for these types of studies, the data is likely retrospective, collected from existing archives, then curated into a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: "Two or more experts."
• Qualifications of Experts: Not explicitly stated beyond "experts." However, given the context of identifying B line artifacts in lung ultrasound, it can be inferred that these experts would be physicians credentialed to use lung ultrasound clinically, such as intensivists, emergency physicians, pulmonologists, or other clinicians interpreting LUS cines, as described in the "Intended User" section.

4. Adjudication method for the test set:

• Adjudication Method: Consensus agreement of two or more experts. In rare cases where consensus could not be reached due to poor image quality, clips were excluded.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly reported in this 510(k) summary. The evaluation focused on the standalone performance of the AI algorithm against expert ground truth.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance assessment was done. The summary explicitly states: "The performance of the B Line Artifact Detection Module was successfully evaluated on a test dataset..." and "Performance was assessed by measuring agreement using sensitivity and specificity as co-primary endpoints with Cannot Evaluate outputs scored as false predictions." This directly describes standalone performance.

7. The type of ground truth used:

• Type of Ground Truth: Expert consensus (two or more experts).

8. The sample size for the training set:

• The sample size for the training set is not explicitly stated in the provided 510(k) summary. It only mentions that the "test data was entirely separated from that used for development" and the "data sources used in the test set were entirely different and geographically distinct from the data sources used in the development set."

9. How the ground truth for the training set was established:

• How the ground truth for the training set was established is not explicitly stated in the provided 510(k) summary. It is implied that ground truth was established during the development phase to train the "non-adaptive machine learning algorithms." This would typically involve expert annotations or labels, similar to the test set, but the specific methodology is not detailed.

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