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Comen Multi-Parameter Patient Monitor models C50, C60, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor.

The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.

The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 obtain and display physiological data of the patient including waveforms and numerical data in real time. COMEN C series can be custom confiqured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), respiration (RESP) or temperature (TEMP). These physiological signals are converted into digital data and displayed.

For each parameter, COMEN C series examine the data for alarm conditions and present them on the display. COMEN C series have audio alarming function that may raise the user's attention of system error or as dictated by the physiological parameter settings.

COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.

Here's an analysis of the provided 510(k) summary regarding the COMEN Multi-Parameter Patient Monitor (K112877) and its acceptance criteria and study information:

Based on the provided document, the device is a multi-parameter patient monitor. The summary emphasizes that the device is deemed "substantially equivalent" to predicate devices, which implies that its performance is expected to be similar or within acceptable ranges of previously cleared devices. However, the document does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages or error margins) for each physiological parameter, nor does it provide a table of reported device performance against such criteria. Instead, it refers to compliance with various international standards as the basis for proving safety and effectiveness.

Here's the breakdown of the requested information:

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

As mentioned above, the document does not explicitly list specific numerical acceptance criteria or a table of device performance. Instead, it relies on compliance with various international standards, which inherently contain their own performance and safety requirements. The document states:

• "COMEN C series meet the following standards: IEC 60601-1-2, IEC 60601-2-30, IEC 60601-2-27, EN1060-1, EN1060-3, EN1060-4, EN60601-2-49, EN 60601-1, AAMI EC13, ISO10993-1, ASTM E1112-00, ISO 9919, ISO 80601-2-56."

Meeting these standards would mean the device implicitly meets the performance and safety criteria outlined within each respective standard for various parameters (ECG, NIBP, SpO2, Respiration, Temperature). For example:
* IEC 60601-2-27: Specific requirements for the safety and essential performance of electrocardiographic monitoring equipment.
* EN1060-1, EN1060-3, EN1060-4: Non-invasive sphygmomanometers (blood pressure monitors).
* ISO 9919 / ISO 80601-2-61 (relevant for SpO2, although ISO 9919 is older): Requirements for pulse oximeter equipment.
* AAMI EC13: Cardiac monitors.
* ASTM E1112-00: Electronic thermometers.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide information on sample sizes for test sets or data provenance. It states: "A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." This implies internal testing but no specific details are given about the subjects or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts or ground truth establishment in the context of a specific test set. The validation is primarily based on compliance with international standards through non-clinical testing.

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

The document does not describe any adjudication method for a test set, as no dedicated clinical test set is elaborated upon.

5. 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 MRMC comparative effectiveness study was done or mentioned. This device is a diagnostic/monitoring tool, not an AI-assisted interpretation system for human readers.

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

The device itself is a standalone monitor. The "testing was conducted to validate the systems overall operation" refers to its standalone performance in accordance with the listed standards. However, the document does not explicitly detail specific "algorithm only" performance data separate from the overall system validation based on standards compliance.

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

For the non-clinical tests performed, the "ground truth" would be the reference values or established methodologies defined within each of the international standards (e.g., standard blood pressure cuffs for NIBP accuracy checks, calibrated temperature probes for TEMP accuracy, defined ECG signals for ECG performance). No clinical ground truth (like pathology or outcomes data) is mentioned as the basis for testing.

8. The sample size for the training set

The document does not mention any training set or associated sample size. This type of device (a multi-parameter patient monitor) typically relies on engineering design, calibration, and validation against established physiological signal processing principles and standard test procedures outlined in the relevant IEC/ISO standards, rather than machine learning training sets.

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

As no training set is mentioned, this information is not applicable and not provided.

Summary of Key Takeaways from the document K112877:

• Acceptance Criteria: Based on adherence to a comprehensive list of international safety and performance standards (e.g., IEC 60601 series, EN1060 series, AAMI EC13, ASTM E1112-00, ISO 9919, ISO 80601-2-56). Specific numerical performance data against these criteria is not detailed in the summary.
• Study Type: Non-clinical bench testing and risk analysis to demonstrate compliance with the listed standards and overall system operation validation.
• No Clinical Studies: The summary explicitly states "Discussion on Clinical Tests Performed: Not Applicable." This means no human subject trials or clinical performance evaluations were conducted or provided in this 510(k) submission to assess the device's accuracy or effectiveness in a patient population.
• Ground Truth: For non-clinical testing, ground truth would be established by the physical or simulated reference values and methods specified within the compliance standards.
• No AI/Machine Learning Aspects: The device is a traditional multi-parameter patient monitor, and there is no indication of AI, machine learning, training sets, or comparative effectiveness studies involving human readers and AI assistance.

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Goldway UT4000A Vital Signs Monitor is intended to monitor basic physiological parameters of patients from adults to neonates within any professional medical environment. The user, responsible to interpret the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data analysis will be made available to the user from the monitor.

Physiological data includes: electrocardiograph, non-invasive blood pressure, and pulse oximetry.

Goldway UT4000A is not intended for use as an apnea monitor. Goldway UT4000A is not intended for use during MRI or CT scans.

The UT4000A is not designed for home use. The device is restricted to be used on one patient at a time.

The Goldway UT4000A monitor interprets and displays physiological data of the patient including waveforms and numerical data in real time. Goldway UT4000A can be custom configured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), or pulse oximetry (SpO2). For each patient vital parameter, Goldway UT4000A will be capable of providing limit alarms and alerts, storing data trends for retrospective review and sending serial port signal to printer for report printing.

This document, a 510(k) Summary for the Goldway UT4000A Vital Signs Monitor, states that no clinical tests were performed to establish its safety and effectiveness. Therefore, it does not contain information on acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as requested.

The device's substantial equivalence to a predicate device (Goldway Model UT4000F Patient Monitor) is based on non-clinical tests (meeting various standards listed in section 7) and a comparison of their intended use and technological characteristics. The document explicitly states:

"8. Discussion on Clinical Tests Performed: Not Applicable."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the provided text.

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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.

Not Found

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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