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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transcranial (Adult Cephalic) and Peripheral Vascular Diagnostic Device

The Pioneer TC8080 applies ultrasound probes of 1.6 MHz Pulsed Wave (PW), 2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz, PW/CW, 16 MHz PW and 20 MHz PW to support Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation.

This document is primarily a 510(k) cleared device notification letter, which indicates the device, Pioneer TC8080, is substantially equivalent to legally marketed predicate devices. It also lists the intended uses and associated transducers.

Crucially, this document does NOT describe specific acceptance criteria or an analytical study with performance metrics. The tables provided are "Diagnostic Ultrasound Indications for Use Forms," which specify the clinical applications and modes of operation for various transducers. They do not contain any quantitative performance data, sample sizes, expert qualifications, or details about ground truth establishment.

Therefore, many of the requested items cannot be answered from the provided text.

Here's an attempt to answer what can be gleaned from the document, with explicit indications of missing information:

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

This information is not provided in the document. The tables are "Indications for Use" forms, not performance results.

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

This information is not provided in the 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 provided in the document.

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

This information is not provided in the 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 provided in the document. The device is an ultrasound system with transducers, not an AI software.

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

This information is not provided in the document. The device is a hardware ultrasound system with transducers.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of what the document does provide:

The document is a 510(k) clearance letter from the FDA for the Pioneer TC8080 Ultrasonic pulsed doppler imaging system and associated diagnostic ultrasonic transducers.

• Device Name: Pioneer TC8080

• Device Type: Ultrasonic pulsed doppler imaging system and diagnostic ultrasonic transducers

• Intended Uses (as per the "Diagnostic Ultrasound Indications for Use Form"):

  • Diagnostic ultrasound imaging or fluid flow analysis of the human body.
  • Specific clinical applications and modes of operation (PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler) are indicated by 'N' (new indication), 'P' (previously cleared by FDA), or 'E' (added under Appendix E).

  Here's a summary of the indicated uses for various transducers:

  For the Pioneer TC8080 system generally (implied for various transducers due to overall statement):

  • Adult Cephalic: PWD (N)
  • Peripheral Vascular: PWD (N), CWD (N)

  Specific Transducer Applications:

  • 1.6 MHz Pulsed Wave (PW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Indicated as "E" for Adult Cephalic PWD in one form).
  • 2 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Not explicitly shown as an 'N', 'P', or 'E' in the provided tables for specific clinical applications, but mentioned in the general comments).
  • 4 MHz PW and Continuous Wave (CW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Adult Cephalic PWD, referring to previous clearance K993939).
  • 8 MHz PW/CW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Peripheral Vascular PWD and CWD, referring to previous clearance K993939).
  • 16 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).
  • 20 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).

• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This typically means the device has the same intended use and technological characteristics as a predicate, or if there are differences, they do not raise different questions of safety and effectiveness. The specifics of the comparison to predicate devices are not in this document.

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The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.

The provided text is a 510(k) premarket notification for the Nicolet BraiNet device. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The document concludes that the "intended use and technology...is substantially equivalent to the predicate device" and that "No new questions of safety or effectiveness are raised," but it does not provide specific performance metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 mentioned. This type of study is typically for evaluating AI-assisted diagnostic tools, which the BraiNet (an electrode cap) is not.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Similarly, this is not relevant for the type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on:

• Description of the Device: BraiNet, an electrode cap for EEG electrode placement.
• Intended Use: Supports EEG electrode placement.
• Technological Characteristics: Made from elastic and Velcro commercial garment grade materials.
• Predicate Device: Electro-Cap (K780045).
• Conclusion: Substantial equivalence to the predicate device.

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The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording. The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices. The electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898. These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.

This document describes a 510(k) premarket notification for a medical device, the Nicolet Subdural Strip Electrodes. Much of the typical information found in an AI/algorithm-based device study is not present because this is a hardware device, not a software algorithm. Therefore, many of the requested fields cannot be answered from the provided text.

Here is the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a hardware device submission, not a performance study for an AI/algorithm. The submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance

Not applicable. No "test set" in the context of an algorithm's performance is mentioned as this is a hardware device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment for an algorithm's test set.

4. Adjudication method for the test set

Not applicable. No test set adjudication detailed for an algorithm.

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 is a hardware device. No AI component or human reader study is discussed.

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

Not applicable. This is a hardware device. No algorithm is involved.

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

Not applicable. For a hardware device being cleared via 510(k), the "ground truth" for clearance is typically demonstration of substantial equivalence to a legally marketed predicate device, often through material comparisons, manufacturing process reviews, and functional testing to ensure it meets its intended use safely and effectively, rather than a diagnostic ground truth like pathology for an AI.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No training set for an algorithm is mentioned.

Summary of Device and 510(k) Submission:

The Nicolet Subdural Strip Electrodes are a hardware medical device intended for temporary placement on the surface of the brain or subdural space to support stimulating the brain or recording its electrical activity.

The 510(k) submission, K021144, asserts substantial equivalence to predicate devices (K970587, K923803, K850342 manufactured by Ad-Tech Medical Instrument Corp.). The basis for this claim is:

• Identical intended use: "The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity."
• Similar technology: "The Subdural Strip Electrodes are made from the same materials as the predicate devices."
• Safety compliance: The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
• Absence of active electronics or software: The device is passive and connects to existing medical equipment.

The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness. This clearance allows Nicolet Biomedical to market the device.

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The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is used under the guidance and interpretation of a licensed medical professional.

The SNAP device records and displays a processed EEG parameter called the SNAP Index, records and displays a time based trend of the SNAP Index and displays a real time EEG signal. The SNAP system has four significant components:

1. A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer.
2. A disposable, single patient use SNAP Electrode for acquiring the EEG signal.
3. A patient cable which connects the Visor SNAP module to the patient electrode.
4. SNAP personal computer application software, which is provided for use on personal computers operating with Microsoft Windows® operating systems.

The provided document is a 510(k) premarket notification for the Nicolet Biomedical SNAP EEG Monitor. This type of regulatory filing is focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and statistical performance measures.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance for a specific study proving it meets acceptance criteria.
• Type of ground truth used for such a study.
• Training set sample size or how its ground truth was established.

Instead, the document states:

• Intended Use: The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is a prescription device used under the guidance and interpretation of a licensed medical professional. This is consistent with the classification 21 CFR 882.1400, Electroencephalograph.
• Technological Equivalence: "The technology of the SNAP device is equivalent to other EEG monitoring devices. The EEG signal is acquired in analog format, digitized and presented to the user for interpretation. The SNAP device includes an EEG trended parameter of the power spectrum of the EEG signal, SNAP Index."
• Conclusion of Substantial Equivalence: "The indications, intended use and technology of the SNAP device is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." The predicate devices listed are the ASPECT Medical Inc. A-1050 EEG Monitor (K952347) and the Nicolet Biomedical Bravo Endeavor Multi-Modality System (K991054).

The FDA's letter explicitly confirms "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In summary, the provided text does not describe a study to prove acceptance criteria for device performance, but rather lays out the basis for substantial equivalence to predicates, which is the regulatory pathway taken.

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The VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test].

Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or how ground truth for training sets was established.

The document is a 510(k) premarket notification letter from the FDA regarding the VersaLab APM device. It primarily discusses the substantial equivalence determination and the device's indications for use. It does not contain technical performance data or study details.

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The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.

The Nicolet Electrocautery Detector is an accessory device designed to mute external audible outputs from a nerve monitor when electrocautery interference is detected. The device's performance is compared to a predicate device, the XOMED NIM-2 XL.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not contain information regarding a specific "test set" in the context of clinical trials or performance testing with human subjects. The comparison is based on device specifications and features, not a study involving a particular sample size of cases or patients. The data provenance is derived from the technical specifications and design of the Nicolet Electrocautery Detector and its predicate device. This is a comparison of product specifications, not a clinical study.

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

Since there is no mention of a "test set" for a clinical study or performance evaluation with human data, there is no information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a "test set" involving expert review of cases, there is no information on an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study. This device is an accessory for a nerve monitor, designed to automatically mute auditory signals, not an AI-based diagnostic tool requiring human reader interpretation or improvement. Therefore, there is no information on an effect size for human reader improvement with or without AI assistance.

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

The document does not describe a standalone algorithm performance study. The device functions as an accessory that performs an automated action (muting) based on detecting electrocautery interference. The "performance" is implicitly evaluated by comparing its technical specifications (like recovery time and detection method) to those of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the technical specifications and functional design of the device and its predicate. The assessment is made by comparing these attributes, particularly the method of electrocautery detection and muting, and key performance parameters like recovery time. There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set

The provided document does not mention a "training set". This type of device, an electro-mechanical accessory, is not typically developed using machine learning or AI models that require a training set of data. Its functionality is based on detecting physical RF energy.

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

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

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The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set.

Nicolet Biomedical Electromagnetic Navigation System

This is a regulatory letter from the FDA regarding the 510(k) premarket notification for the "Nicolet Biomedical Electromagnetic Navigation System." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, the letter does not contain the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is a marketing authorization letter, not a study report or a summary of performance data.

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The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.

The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups.

This document is a 510(k) premarket notification for the Nicolet Biomedical BioRehab System, a biofeedback device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study with defined performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove it is not typically found or required in a 510(k) submission like this one.

Here's why and what information can be extracted/inferred:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not usually involve extensive clinical trials or performance studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) application would.
• "Summary of Safety and Effectiveness" vs. "Performance Study": The document explicitly states "Summary of Safety and Effectiveness". This summarization points towards a comparison with predicate devices, not a de novo study with acceptance criteria.

Therefore, I cannot populate the table or answer most of your numbered questions directly from the provided text because this type of study was not performed or reported in this 510(k) submission.

However, I can extract information related to the device and its intended use:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here implicitly is that the device is as safe and effective as the predicate devices.
• Reported Device Performance: The document states:
  • "The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy."
  • "The EMG signal output of the BioRehab system is qualitative not quantitative."
  • "Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor."
  • "The control of the computer cursor supports patient game playing on the computer."
  • Conclusion: "The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

The following numbered items cannot be answered from the provided text for the reasons explained above:

2. Sample sizes used for the test set and the data provenance: Not applicable to a 510(k) predicated on substantial equivalence without specific performance studies described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 a biofeedback system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is used "Under the care and guidance of a physician or therapist" and involves "patient game playing under EMG control," indicating a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for substantial equivalence.
8. The sample size for the training set: Not applicable, as this is not a machine learning device or a study describing a training set.
9. How the ground truth for the training set was established: Not applicable.

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Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue.

The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet.

The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.

The EMG electrodes consist of a needle with a connector or lead wire attached. The connector or lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The EMG Electrodes are provided sterile and for single patient use.

This document is a 510(k) summary for Sterile EMG Electrodes by Nicolet Biomedical Incorporated. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that typically does not involve new clinical performance studies or specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

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