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The RELIEEV HSG Catheter (HSG7FA1) is for the delivery of contrast media or saline into the uterine cavity during hysterosalpingography or sonohysterography for examination of the uterus and fallopian tubes.

The RELIEEV HSG Catheter (HSG7FA1) is a 7 French (Fr) dual lumen polyurethane catheter with a working length of 30 cm. RELIEEV HSG Catheter (HSG7FA1) is available with a closed-end tip with two side ports. The catheter consists of two lumens: an open lumen used to inflate the balloon and an open lumen used to inject diagnostic media into the uterus. The silicone balloon is designed with a balloon volume of 3.5 mL. When the balloon is inflated inside the uterus, the subject device seals the cervix. The catheter features a proximal fitting of a double-lumen polyurethane hub with a polycarbonate stopcock attached. Both the hub and stopcock accept a standard Luer lock. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. An introducing sheath is placed over the tube as a guide and into the endocervix to the level of the internal os (opening of the cervix) with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity.

The RELIEEV HSG Catheter (HSG7FA1) consists of a balloon catheter and a 5 mL syringe. The subject device is supplied sterile and is single-use.

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LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics.

LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.

LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo's Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing.

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The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.

The sizes versions also include indications for the patient population:

Adult: The Adult model is intended for patients over 20 kg (44 lbs).
Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).
Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).

The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.

The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

The BAG is a non-sterile self-inflating manual resuscitator. It is indicated for patients requiring ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG manual resuscitator is intended for short-term use (< 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. It is available in three sizes: adult (for patients > 20 kg (44 lbs.)), pediatric (for patients 2.5-20 kg (5.5-44 lbs.)), and newborn (for patients 2.5-5 kg (5.5-11 lbs.)).

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ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use only with the ArtiSeal Generator in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a sterile, single-use, invasive instrument which is used with electrosurgical generator (ArtiSeal Generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies radiofrequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During surgical procedures, the user operates the grip lever to open and close the jaw. Furthermore, the jaw can be bent up, down, left, and right within a range of up to ±90° or more by adjusting the grip accordingly. The jaw also provides 360° articulation (rotation) by turning the grip.

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The MTS (MIC Test Strip) Aztreonam-Avibactam 0.016/4-256/4 μg/mL is a quantitative method intended for in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL should be interpreted at 16-20 hours of incubation.

Testing with MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL is indicated for Enterobacterales as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter freundii complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens)

MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient aztreonam across 15 two-fold dilutions like those of a conventional MIC method and avibactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the aztreonam-avibactam code (AZA) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.

Aztreonam-avibactam is the combination of aztreonam (a monobactam) that interferes with bacterial cell wall synthesis and avibactam (a β-lactamase inhibitor) that neutralizes β-lactamase enzymes. It is used in combination with metronidazole to treat complicated intra-abdominal infections (cIAI) caused by susceptible E. coli, K. pneumoniae, K. oxytoca, E. cloacae complex, C. freundii complex and S. marcescens.

MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.

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The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.

Portable Oxygen Concentrator, model: JAY-1000P is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The JAY-1000P is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

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The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
• The liver in bariatric procedures
• The prostate and periprostatic tissue in prostatectomy procedures
• The colon, rectum, and pericolorectal tissue in colorectal procedures

The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures

Pediatric use:

The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures

The Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft.

The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible >= 10 mm laparoscopic port to the surgical site and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller.

The Magnetic Controller is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

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Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi).

Ligence Heart is an image post-processing software used for viewing and quantifying adult cardiac ultrasound DICOM studies. The device is intended to generate structured measurement reports for echocardiography analysis and aid qualified sonographers and cardiologists in their decision-making process.

Ligence Heart automatically identifies standard transthoracic echo views with machine-learning–based view classification, cardiac cycle selection, and border detection, then generates reproducible quantitative left-ventricular volumetric and functional measurements. The results are inserted into a PACS-compatible report that the reviewing cardiologist or sonographer can accept, edit, supplement with additional manual measurements, or entirely replace with manual measurements. The software also organizes, displays, and compares each measurement with reference-guideline ranges. Completed reports are exported in PDF, streamlining routine echocardiography workflow while leaving final diagnostic responsibility with the clinician.

Here's a breakdown of the acceptance criteria and the study proving Ligence Heart meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size: 524 echocardiographic studies. (Initially, 600 were acquired, but 76 were excluded).
• Data Provenance: Retrospective, acquired from a U.S.-based independent Echocardiography Core Laboratory.

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

• Number of Experts: Three independent expert sonographers.
• Qualifications of Experts: The document explicitly states "expert sonographers." No further specific details (e.g., years of experience, board certification) are provided in this excerpt.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The document states, "524 echocardiographic studies were assessed by all three human readers..." This implies that all three contributed to the ground truth, but it doesn't explicitly state an adjudication method like 2+1 or 3+1. Given the use of "agreement between Ligence Heart and three independent expert sonographers...quantified using the reference-scaled IEC," it suggests that each expert's measurements were compared against the device, rather than a consensus ground truth being established before comparison with the device.

4. 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, an MRMC comparative effectiveness study was not explicitly done to measure human reader improvement with AI assistance. The study focused on the standalone performance of the Ligence Heart device and its interchangeability with expert human measurements. It did not directly assess how human readers' performance would change when using the AI as an assistant.

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

• Yes, a standalone performance study was done. The primary clinical performance endpoint measured the agreement between "Ligence Heart" (the automated measurements) and "three independent expert sonographers." This evaluates the device's output independently against expert human measurements.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Expert measurements/readings. The ground truth for the comparison was established by the measurements from "three independent expert sonographers."

7. The sample size for the training set:

• The document explicitly states, "Test datasets were strictly segregated from algorithm training datasets, as they are from completely separate cohorts." However, the sample size for the training set is not provided in this excerpt.

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

• The document states that the test datasets were "strictly segregated from algorithm training datasets." However, how the ground truth for the training set was established is not described in this excerpt. It can be inferred that it likely involved expert annotations or measurements, similar to the test set, but the details are not available here.

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Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult, (at least 22 years of age) patients.

The CPRMS is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.

CPRMS measurements are used as an adjunct to other clinical information sources.

The Linshom CPRMS (Continuous Predictive Respiratory Monitoring System) is a portable and reliable system for detection of spontaneous respiration. It's non-invasive and is not corrupted by motion artifacts. The system autonomously adapts to the local thermal environment to deliver a usable signal without complicated hardware and firmware processing.

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