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The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic, Musculo-skeletal (Conventional), Fetal (as enumerated in the IFU Tables), Musculo-skeletal (Superficial), Abdominal, Retroperitoneum, Pediatric, Female reproductive system and foetus, Small Organ (breast, thyroid, testicle), Cardiac (Adult), Invasive diagnostic or therapeutic procedures, Cardiac (Pediatric), Peripheral vessel.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (e.g. testicles, lymph nodes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Invasive diagnostic or therapeutic procedures (e.g. biopsies, punctures, free fluid detection, regional anesthesia, vascular access), Superficial structures & pathologies (incl. Lungs), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (Specify), Peripheral vessel.

eZono 3000

The provided document is a 510(k) premarket notification from the FDA for the eZono 3000 ultrasound system. It primarily focuses on defining the indications for use for various transducers associated with the device and establishing substantial equivalence to previously marketed predicate devices.

Crucially, this document does NOT contain information about acceptance criteria for device performance, the results of a study proving the device meets these criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC).

The "performance" described here is solely in terms of the clinical applications and modes of operation for which the device (with specific transducers) is cleared for use, noting whether these indications are "new" (N) or "previously cleared" (P) based on existing predicate devices. This is a regulatory filing stating what the device can be used for, not a report on its quantitative diagnostic performance.

Therefore, I cannot provide the requested information from this document. The document's purpose is to establish regulatory clearance based on substantial equivalence, not to present a detailed performance study with acceptance criteria and results.

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The interestly and analogs'is vila lions For Ose. The 1977 her in and analgesia vila blockade of peripheral nerves.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Prolong Continuous Nerve Block Set." It indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any other details related to a scientific study proving the device meets acceptance criteria.

The letter is a regulatory document confirming clearance, not a scientific publication detailing a study. Therefore, I cannot extract the requested information from the provided text.

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The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a device called "Echobright" and primarily focuses on the substantial equivalence determination.

It does not contain details about:

• Specific acceptance criteria for device performance.
• Any performance study results, including metrics like sensitivity, specificity, accuracy, or reported performance.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document only states the device's intended use and confirms its substantial equivalence to predicate devices, which implies that the regulatory requirements for safety and effectiveness were met, but it does not describe the specific testing or performance metrics used to demonstrate this.

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The Vesiscan is used to measure bladder volume.

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The StimPro is used to administer peripheral nerve blocks.

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The provided text is an FDA 510(k) clearance letter for the StimPro Anesthesia Conduction Needle. This type of document does not contain the detailed technical study information required to answer the prompt.

FDA 510(k) clearance letters are primarily administrative documents that confirm a device's substantial equivalence to a legally marketed predicate device. They do not typically include:

• Detailed acceptance criteria for performance.
• Results of specific performance studies (like sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies).
• Information about training sets for algorithms.

Therefore, I cannot extract the requested information from the provided text. The document confirms market clearance based on substantial equivalence, but not the specific performance metrics or study details.

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The ARM-1 is interdad to enable the Urolab equipment to measure and record the functioning of a patient's anorectal. function.

Ano-Rectal Manometry Option (ARM-1)

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. The document is an FDA 510(k) clearance letter for a medical device called "Ano-Rectal Manometry Option (ARM-1)", indicating that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not delve into the technical validation studies.

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The intended use of the Prolong is for local anesthesia and analgesia via blockade of peripheral nerves.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any details related to the evaluation of an AI/ML powered device.

This document is a standard regulatory communication confirming that the device, "ProLong Continuous Nerve Block Set", is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It does not delve into the specific technical performance or clinical study results in the manner requested by your prompt.

Therefore, I cannot extract the requested information from this text.

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The intended use of the ProLong Centinuous Nerve Block set is for prolonged regional anesthesia and analgesia via blockade of peripheral nerves.

Not Found

The provided document is an FDA 510(k) clearance letter for the "ProLong Continuous Nerve Block Set." This type of document declares a device substantially equivalent to a predicate device and permits its marketing. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical study report or a 510(k) summary, which is a separate document.

Therefore,Based on the provided FDA 510(k) clearance letter:

• 1. A table of acceptance criteria and the reported device performance: This information is not available in the provided document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on the predicate's established safety and effectiveness. However, specific acceptance criteria and performance metrics are not detailed here.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided document.

• 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): This information is not available in the provided document.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided document.

• 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: This information is not available in the provided document. The device is a medical instrument (nerve block set), not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance would not be applicable.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided document. As noted above, the device is an instrument, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided document. Given the nature of a nerve block set, ground truth would likely relate to the device's ability to deliver nerve blocks successfully and safely, assessed through clinical outcomes or direct observation, but specifics are not provided.

• 8. The sample size for the training set: This information is not available in the provided document. If a training set were relevant (e.g., for an AI device), its details would typically be in a separate technical study summary.

• 9. How the ground truth for the training set was established: This information is not available in the provided document.

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