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The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities.

The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during MRI or CT scans.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide.

The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device (Goldway UT 4000F Patient Monitor), which determines substantial equivalence to a predicate device. It indicates that the device can be marketed, but does not detail performance studies or explicit acceptance criteria.

The supplied text primarily focuses on:

• The FDA's 510(k) clearance for the Goldway UT 4000F Patient Monitor.
• The regulatory classification (Class II).
• General controls and other regulations the manufacturer must comply with.
• The stated Indications for Use for the device.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a performance study, because this data is not present in the given document.

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The Goldway Digital Video Colposcope Imaging System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in Hospitals and clinics.

The Goldway Digital Video Colposcope Imaging Systems, SLC-2000A and SLC-2000B are intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy.

The SLC-2000A consists of a ¼' Super HAD CCD color camera and image management workstation. Tissue is magnified and viewed directly either via a 5.6" LCD screen attached to the capture device or on the 14'' color monitor attached to the image workstation. The SLC-2000B contains the same capture device but does not include the image workstation. Images can only be viewed via the 5.6'' LCD screen with this model. The images provide recorded documentation for the physician or nurse practitioner to review for diagnostic purposes. The Goldway Colposcopes have a non-patient contact of up to 350mm. Both colposcopes have the option of being equipped with a Dermatology and Venereal Disease application kit and Dynamic White Polarization kit.

The Goldway Colposcopes, SLC-2000A and SLC-2000B are a non-patient contacting CCD color camera with a magnification of x1 ~ x28, working distances supporting 150-350mm, and a green filtered light source mounted on a floor stand. The SLC-2000B also comes with an image workstation which consists of a CCD camera, computer, LCD monitor, a mouse, a keyboard and color printer. The functions of the image management workstation include:

• Storing digital images for viewing during the colposcopy exam, and for printing and/or later review
• Storing textual information about a patient's medical history related to colposcopy
• Storing textual information about observations seen during a colposcopy examination
• Printing a colposcopy report that integrates images and textual information

The provided 510(k) summary for the Goldway SLC-2000 Digital Video Colposcope Imaging System states that no clinical tests were performed for the determination of substantial equivalence.

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states under section "8. Discussion of Clinical Tests Performed:" that it is "Not Applicable." The submission relies on non-clinical tests (meeting standards like IEC60601-1, ISO9001, EN46001) and comparison to predicate devices to demonstrate substantial equivalence, arguing that "any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

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