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The IMEXLAB 9000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use.

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I am sorry, but the provided document does not contain information on acceptance criteria, device performance, details of a study (like sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance), or how ground truth was established for the IMEXLAB 9000.

The document is a 510(k) clearance letter from the FDA, which declares the IMEXLAB 9000 Diagnostic Ultrasound Device as substantially equivalent to devices marketed prior to May 28, 1976, for the stated indications for use. It lists the approved transducers and reminds the manufacturer of regulatory compliance requirements. The "Indications for Use Form" (pages 3 and 4) specifies the clinical applications and modes of operation for which the device is intended, indicating its use in "Peripheral Vascular" applications with "CW" (Continuous Wave Doppler) and "Amplitude Doppler" modes, as well as a "Bidirectional Transducer".

However, it does not provide any performance metrics, study designs, or data related to the device's accuracy, sensitivity, or specificity against any defined acceptance criteria.

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The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician.

It is not indicated for use near non-intact skin or the eyes.

It is not intended for home use.

IMEXLAB 9100 Diagnostic Ultrasound Device

The provided document is a 510(k) premarket notification approval letter for the IMEXLAB 9100 Diagnostic Ultrasound Device, dated April 15, 1998. It primarily focuses on regulatory approval and indications for use, and does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen in modern AI/ML device submissions.

Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance. The details you're looking for (sample sizes, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth types, training set details) are characteristic of recent regulatory submissions for AI-powered medical devices, which involve rigorous performance testing.

The document indicates that the IMEXLAB 9100 was found "substantially equivalent" to legally marketed predicate devices prior to May 28, 1976. This means its regulatory approval relied on demonstrating that it performs as safely and effectively as existing, legally marketed ultrasound devices for its stated indications: "assisting in the detection of peripheral vascular diseases."

Here's a summary of what can be extracted from the provided text, related to the device and its intended use:

• Device Name: IMEXLAB 9100 Diagnostic Ultrasound Device
• Regulatory Class: II (21 CFR 892.1550)
• Procode: 90 IYN
• Indications for Use: "The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use."
• Transducers cleared: 5 MHz CW and 8 MHz CW
• Intended Use Mode of Operation (from Appendix F for both 5MHz and 8MHz transducers): Amplitude Doppler for:
  • Intraoperative (general)
  • Musculo-skeletal Conventional
• Other listed clinical applications for diagnostic ultrasound (but not explicitly marked for IMEXLAB 9100 in the provided forms): Ophthalmic, Fetal, Abdominal, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Musculo-skeletal Superficial.

No study data, performance metrics, or specific acceptance criteria are detailed in this regulatory approval letter. Such information would typically be found in the manufacturer's 510(k) submission itself, not in the FDA's approval letter, especially for devices cleared via substantial equivalence over two decades ago.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

IMEX StethoDop™ (Doppler Ultrasound Device)

This document is a marketing clearance letter from the FDA for the IMEX StethoDop™ (Doppler Ultrasound Device) with a 5 MHz transducer, dated February 5, 1998. It establishes substantial equivalence to a predicate device and allows the manufacturer to market the device.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or how ground truth was established for training sets.

The document primarily focuses on regulatory approval, substantial equivalence, manufacturing practices, labeling regulations, and post-clearance reporting requirements related to acoustic output measurements. The "Indications for Use Form" in Appendix F lists various clinical applications and modes of operation for ultrasound systems but does not provide performance metrics or acceptance criteria for the IMEX StethoDop™.

Therefore, based solely on the provided text, I cannot complete the requested tables and information.

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Ask a specific question about this device