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The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

The probes are sterile and are for single patient use only.

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The provided text is a 510(k) clearance letter from the FDA to Excel-Tech Ltd for their XLTEK Stimulator Probes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The document is a regulatory approval letter based on the claim of substantial equivalence, not a detailed report of a performance study. Therefore, I cannot extract the information you are looking for from this text.

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XLTEK Clear Signal Adhesive Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are for single patient use only.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "XLTEK Clear Signal Adhesive Electrodes". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details about training sets.

The document primarily states the device's intended use and confirms its regulatory clearance by the FDA.

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The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.

The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

This document is a 510(k) clearance letter from the FDA for a medical device called the "XLTEK EMU40 EEG Headbox". It doesn't contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it's primarily a regulatory approval document.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding based on comparison to existing devices, rather than a detailed performance study with specific acceptance criteria.
2. Sample Size and Data Provenance: This information would be found in a study report, which is not part of this 510(k) letter.
3. Number and Qualifications of Experts: Again, this would be part of a study design and not typically included in a 510(k) clearance letter.
4. Adjudication Method: Not applicable or present in this regulatory document.
5. MRMC Comparative Effectiveness Study: The letter does not mention a comparative effectiveness study.
6. Standalone Performance Study: The letter does not describe a standalone performance study.
7. Type of Ground Truth: Not applicable or present.
8. Training Set Sample Size: Not applicable as this is not a study report.
9. Ground Truth for Training Set: Not applicable.

In summary, this document is a regulatory approval for market clearance, not a technical report detailing performance criteria or study results. Therefore, it does not contain the information required to answer your request.

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The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

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The provided text is a 510(k) clearance letter from the FDA for the XLTEK NeuroPath device. This type of document primarily confirms that a new medical device is "substantially equivalent" to an already legally marketed predicate device.

Crucially, a 510(k) clearance letter itself does NOT typically contain detailed information about specific acceptance criteria or the comprehensive results of performance studies that prove a device meets those criteria.

Instead, the manufacturer (Excel-Tech Ltd. in this case) would have submitted detailed performance data, acceptance criteria, and study protocols to the FDA as part of their 510(k) submission. The FDA reviews this information to make their substantial equivalence determination.

Therefore, based solely on the provided text, I cannot provide the requested information. The text confirms the device name, K-number, regulation number, regulatory class, and its intended use, but it does not delve into the specifics of performance studies or acceptance criteria.

To answer your questions, one would need access to the actual 510(k) submission (traditional or special, which contain more detailed information), which is often publicly available through the FDA's Dockets Management Staff or a Freedom of Information Act (FOIA) request, though summaries are typically available on the FDA's 510(k) database.

In summary, the provided document is an FDA clearance letter, not the study report itself.

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XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.

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Here's an analysis of the provided text regarding the XLTEK Clear Signal Sub-dermal Needle, focusing on acceptance criteria and study information.

It's important to note that this document is a 510(k) clearance letter from the FDA. While it confirms the device's substantial equivalence to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary. The provided text primarily focuses on the regulatory aspects of the clearance.

Therefore, many of the requested details about specific acceptance criteria and the studies proving them are not available in the provided document. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trial data for every new device. This means that the "proof" often points to the predicate device's established safety and effectiveness.

Here's what can be extracted based on the provided text, and where information is missing:

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

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

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this 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)

• Number of Experts: Not specified in this document.
• Qualifications of Experts: Not specified in this document.

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

• Not specified in this 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

• Not applicable. This device is an electrode for recording biopotential signals (EMG, EEG, Nerve potential signals), not an AI-assisted diagnostic tool. Therefore, a MRMC study concerning human readers with/without AI assistance would not be relevant.

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

• Not applicable. This device is a physical medical device (sub-dermal needle electrode), not an algorithm or AI system.

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

• Not applicable in the context of an algorithm's ground truth. For a physical device like this, "ground truth" would relate to its physical properties, biocompatibility, electrical performance, sterility, and mechanical integrity, which are typically assessed through bench testing and, if necessary, animal or human studies to demonstrate safety and effectiveness. The specifics of these tests are not in this clearance letter.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" and corresponding ground truth.

Summary regarding the XLTEK Clear Signal Sub-dermal Needle 510(k) Clearance:

The provided document is an FDA 510(k) clearance letter. This type of clearance indicates that the device (XLTEK Clear Signal Sub-dermal Needle) has been found substantially equivalent to a legally marketed predicate device. This means the FDA believes it is as safe and effective as the predicate device for its stated indications for use: "recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals."

The letter itself does not provide the detailed scientific or clinical study reports, specific acceptance criteria, or performance data that would be found in the 510(k) summary or the underlying submission. The "proof" of meeting acceptance criteria for a 510(k) device often relies on:

• Demonstration of substantial equivalence to a predicate device.
• Bench testing (electrical performance, mechanical strength, biocompatibility).
• Sterilization validation.
• Biocompatibility testing.
• Performance data from the predicate device.

To obtain the specific study details for this device, one would typically need to review the 510(k) summary document filed by the manufacturer, which is usually publicly available through the FDA's 510(k) database.

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The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:

• Digital recording of high-level output signals (such as EEG, respiratory and oximetry . signals) from conventional polygraphic recorders, signal transducers or amplifiers.
• Selection of recorded signal sections for on-screen review, annotation and marking of . sleen stages.
• Computer-assisted event marking and quantitative analysis of EEG, respiratory and . oximetry signals.
• Computer-assisted reporting of simple measures obtained from the recorded signals (such . as magnitude, time and frequency and simple statistical measures of marked events)

The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.

The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

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I apologize, but the provided text is a legally focused document (an FDA 510(k) clearance letter) and does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific details about standalone or MRMC studies.

The document primarily focuses on:

• Granting substantial equivalency for the XLTEK Connex device.
• Listing the regulatory classification and product codes.
• Outlining general regulatory compliance requirements for the manufacturer.
• Stating the intended use (Indications for Use) of the device, which is for acquiring and reviewing sleep recordings (polysomnography) in research or clinical environments. It also specifies its limitations (e.g., not for critical care or intraoperative settings).

Therefore, I cannot extract the table of acceptance criteria, study details, or other specific performance metrics as they are simply not present in this document.

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The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.

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The provided text is a 510(k) premarket notification approval letter for the XLTEK Trex, an electroencephalograph device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot fulfill your request for this specific document.

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The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

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This document is a 510(k) clearance letter from the FDA for the XLTEK Protektor Stimulator. It does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets those criteria.

The letter explicitly states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device meets the safety and effectiveness profile of an existing device, rather than providing new performance data against specific acceptance criteria in this document.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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 present. The device is an electrical stimulator, not an AI algorithm for image reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily covers the administrative details of the 510(k) clearance, including:

• The device name: XLTEK Protektor Stimulator
• The 510(k) number: K040358
• The date of clearance: August 6, 2004
• The product code: GWF (Evoked response electrical stimulator)
• The regulatory class: Class II
• Indications for Use: "The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

To obtain the information you requested (acceptance criteria, study details, etc.), one would typically need to review the full 510(k) submission document or related clinical study reports, which are not included here. This letter is the final decision from the FDA, not the detailed submission itself.

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The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.

The EMU128S is a digital electroencephalograph.

This document describes a Special 510(k) Notification for the EMU128S device. A Special 510(k) is submitted when there are minor modifications to a legally marketed device that do not affect its fundamental intended use or alter its fundamental scientific technology. Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than requiring extensive new clinical studies or detailed performance criteria beyond what was established for the predicate.

Given this context, the document outlines the substantial equivalence claim.

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. For a Special 510(k) based on substantial equivalence to a predicate device for minor modifications, a new test set and clinical study proving safety and effectiveness are typically not required if the fundamental technology and intended use remain unchanged. The comparison is primarily based on engineering and design control documentation, and potentially bench testing to confirm the new component (the switch matrix) does not negatively impact performance.

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

Not applicable. Ground truth establishment for a test set is not typically part of a Special 510(k) for this type of modification. The assessment relies on the established safety and effectiveness of the existing predicate device.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or required. The modification (addition of a switch matrix) is an engineering change to facilitate external device attachments and does not directly involve diagnostic interpretation by human readers that would necessitate such a study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was conducted or required. The EMU128S is a hardware device for acquiring EEG signals, not an AI or algorithmic diagnostic tool.

7. Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (XLTEK 128 Channel EEG Headbox) which was previously cleared by the FDA. The current submission argues that the EMU128S, despite its modification, performs equivalently to this predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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