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The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.

The OEC One CFD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.

The subject device is labelled as OEC One CFD.

Here's a summary of the acceptance criteria and the study details for the OEC One CFD device, specifically focusing on the new "Deep learning-based Trajectory Pointer software" feature, as that's where the most detailed study information is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Trajectory Pointer)

2. Sample Size Used for the Test Set and Data Provenance

• Total image dataset: 3078 images
• Test set size: 307 images (approx. 10% of the total dataset)
• Data Provenance (Ethnicity/Country):
  • US: 51.1%
  • China: 35.8%
  • Phantom: 9.8%
  • EU/Australia: 3.3%
• Data type: The document states that sample clinical images were evaluated to demonstrate substantial equivalence, and "all images were collected from GE OEC Mobile C-arm devices," suggesting retrospective collection of clinical images, alongside phantom data. It also notes that the test data covers the "entire range of values for all confounders," implying it's representative of real-world scenarios.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: 3
• Qualifications: U.S. board-certified radiologists. (No specific years of experience are listed).

4. Adjudication Method for the Test Set

• The document states: "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."
• This implies a consensus or verification process by multiple experts to validate the initial manual annotations, but a specific method like "2+1" or "3+1" is not explicitly mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The performance metrics reported are for the algorithm's standalone performance.

6. If a Standalone (Algorithm Only) Performance Study was Done

• Yes, a standalone performance study was done for the Trajectory Pointer feature. The reported success rates of 98.8% for LIH images and 97.1% for Fluoroscopy images (both exceeding the 95% MAAP) are measures of the algorithm's performance.

7. The Type of Ground Truth Used

• For the Trajectory Pointer feature, the ground truth was established by expert consensus/manual annotation. Specifically, "the contours of K-wires were manually outlined by trained annotators," and "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."

8. The Sample Size for the Training Set

• Training set size: 2771 images (3078 total images - 307 test images = 2771 images). The document states: "Total dataset included 3078 images, 307 were used for test dataset and the rest for training/tuning."

9. How the Ground Truth for the Training Set was Established

• While not explicitly detailed for the training set, it is highly probable that the ground truth for the training data was established in a similar manner to the test set: through manual outlining of K-wire contours by trained annotators. The document mentions "comparing ground truth annotations" during deduplication, implying annotations were available for the training data.

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The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life.

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min. The nasal cannula is not sold with the device, users need to purchase accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.

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The OptumSI Implant System is intended for sacroiliac fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The OptumSI Implant System consists of a cannulated diamond-shape, titanium implant (Ti-6Al-4V ELI, ASTM 3001) with a porous surface. The implant is available in varying lengths and are provided sterile and individually packaged. The system utilizes a transverse approach with a lateral or lateral-to-medial trajectory from the ilium to the sacrum. Instruments are provided as a reprocessable set to assist with gaining access and delivering the implant as intended. The principle operation is based on the diamond-shape and porous surface which are designed to prevent and minimize motion of the sacroiliac (SI) joint, thereby stabilizing the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization, and fusion.

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Fisher & Paykel Healthcare OptiPAP Junior is for single-patient use and is intended to deliver noninvasive positive airway pressure (PAP) therapy to spontaneously breathing patients who require respiratory support.

OptiPAP Junior is designed for use in hospital environments where the patient is continually monitored and must be prescribed by a physician. It is intended for use by trained medical professionals on a pediatric subpopulation that includes neonates and infants from birth up to two years of age.

The F&P OptiPAP Junior is intended to deliver heated and humidified Positive Airway Pressure (PAP) therapy to neonates and infants requiring respiratory support.

The F&P OptiPAP Junior is a prescription-only device provided in a non-sterile state and intended to be used in a hospital environment and must be prescribed by a physician. The F&P OptiPAP Junior is for single- patient-use up to 14 days. The F&P OptiPAP Junior will be offered in multiple size variants.

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