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These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach.
These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Axon Systems' Stimulus Dissection Instruments are disposable (for "Single Use Only"), sterile devices used for tissue dissection and stimulation of spinal nerve roots for location and identification during surgery.
These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The probes are a protected pin design and meet the requirements of IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12
The instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively.
The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.

The provided text is a 510(k) summary for a medical device (Axon Systems' Stimulus Dissection Instruments), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be found in a clinical study report.

Therefore, many of the requested sections cannot be filled from the provided text because this type of information is generally not included in a 510(k) summary. A 510(k) emphasizes comparison to legally marketed predicate devices and addresses safety and effectiveness through that comparison, rather than through de novo performance studies with specific statistical endpoints.

Here's how much of your request can be answered based on the provided document:

Acceptance Criteria and Device Performance

The 510(k) summary does not define specific acceptance criteria (e.g., target specificity, sensitivity, or accuracy thresholds) for the device's performance in stimulating spinal nerve roots or for tissue dissection. Instead, it relies on demonstrating substantial equivalence to predicate devices whose safety and effectiveness are already established.

The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use of tissue dissection and stimulation of spinal nerve roots. The document states: "Axon Systems' Stimulus Dissection Instruments are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident."

Table of Acceptance Criteria and Reported Device Performance:

Study Details Not Available in 510(k) Summary:

The following information cannot be extracted from the provided 510(k) summary because it typically pertains to clinical performance studies, which are not usually detailed in a 510(k) submission focused on substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available. A 510(k) of this type typically relies on bench testing, materials testing, and comparison of technological characteristics rather than a clinical "test set" in the context of diagnostic accuracy.
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): Not available/Applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available/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 surgical instrument, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available/Applicable.
8. The sample size for the training set: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

Information Available from 510(k) Summary (Relevant to Device Description and Comparison):

• Device Type: Stimulus Dissection Instruments (needles, probes, dilators)
• Intended Use: Tissue dissection and stimulation of spinal nerve roots for location and identification during surgery. Specifically, for pedicle preparation or access to the vertebral body for screw placement in open and minimally invasive procedures to reduce nerve root injury.
• Technological Characteristics: Disposable, sterile, biocompatible electrical insulation, non-insulated stainless steel distal surfaces, proximal connectors, protected pin design meeting IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12. Materials are the same as in predicate devices.
• Predicate Devices:
  • Medtronic Xomed, "Stimulus Dissection Instruments" (K031003)
  • Axon Systems, Inc., "Disposable Stimulator Probes" (K062996)
  • Nuvasive, "Surgical Nerve Stimulator/Locator" (K002677)

The clearance is based on the argument that the device's technological characteristics, materials, and intended use are similar to those of previously cleared predicate devices, thus demonstrating substantial equivalence.

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To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.

This submission pertains to Axon Systems' Disposable Stimulator Probes, which are devices used to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results. As such, the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in the provided text.

The 510(k) summary only states the following:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The summary focuses on technological characteristics and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on test set sample sizes or data provenance is available.

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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as there is no test set or ground truth establishment process described.

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 is not applicable. The device described is a medical instrument (stimulator probe), not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there isn't a diagnostic algorithm undergoing validation against a ground truth.

8. The sample size for the training set: Not applicable and not mentioned.

9. How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of the 510(k) Conclusion:

The document concludes that "Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This equivalence is based on the description of technological characteristics, such as:

• Identical materials: "Materials used are the same as in the predicate devices."
• Similar design: Insulated probe shaft of various lengths mounted to a plastic handle, electrically connected to a "touch-proof" safety connector.
• Intended Use: "To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery," which is presumably consistent with the predicate devices.

The predicate devices mentioned are:

• Technomed Europe - Disposable Probes (K050325)
• Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)

In essence, the "study" proving the device meets acceptance criteria in a 510(k) submission like this is primarily a demonstration of substantial equivalence to already cleared devices, rather than a de novo clinical trial with defined acceptance criteria and performance outcomes.

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Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipment and the patient. Electrodes are used in electro-diagnostic clinical studies or during intraoperative monitoring for electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. The electrodes used to detect electro-physiological signals or provide electrical stimulation cutaneously. The electrodes are non-sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier.

1. Table of Acceptance Criteria and Reported Device Performance:

   The submission primarily focuses on establishing substantial equivalence to predicate devices through functional testing rather than defining specific numerical acceptance criteria. The acceptance criteria can be inferred as meeting the functional performance of the identified predicate devices, as no novel technology or basic materials were used, and "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures."

   Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
   Functional Performance	Equivalent to predicate devices (Nicolet Biomedical Pre-gelled Surface Electrodes, Medicotest, Inc. Surface Electrodes, Tyco Health Kendall ECG Pellet Electrodes) based on "accepted laboratory test procedures."	"The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures. Based on the technical information provided and the safety and effectiveness criteria of the design and development process, we claim the Pre-gelled Surface Electrodes to be safe, effective and substantially equivalent to the predicate device(s) noted." (This indicates the device met the functional performance, though no specific numerical results are provided in the summary.)
   Materials	Identical or substantially equivalent to predicate devices.	"No new technology or basic materials are used in these designs."
   Intended Use	Same as predicate devices.	"Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only." (This matches the general intended use of surface electrodes.)
   Physical Dimensions	May vary from predicate devices.	"The exceptions are in physical dimensions only."

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

   The document does not specify a distinct "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. Instead, it refers to "functional testing using accepted laboratory test procedures." It's likely that a sample of the manufactured electrodes was subjected to these functional tests.

   The data provenance is not specified beyond "accepted laboratory test procedures." There is no mention of country of origin or whether the testing was retrospective or prospective in a clinical sense.

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

   This information is not applicable. The submission is for a medical device (surface electrodes) and does not involve AI or ground truth established by experts in the context of diagnostic interpretation. The "ground truth" for this device would be its physical and electrical properties meeting specifications through engineering and quality control testing.

4. Adjudication Method:

   This is not applicable as there is no diagnostic test or AI algorithm requiring adjudication of results.

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

   This is not applicable. The submission is for a physical medical device (surface electrodes), not an AI algorithm. Therefore, there's no comparison of human readers with vs. without AI assistance.

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

   This is not applicable. The device is a physical surface electrode, not an algorithm.

7. The Type of Ground Truth Used:

   For a physical medical device like a surface electrode, the "ground truth" is established through engineering specifications, material properties, and functional performance tests (e.g., impedance, adhesion, signal integrity). The document states "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures." This implies that the 'ground truth' was based on meeting the established performance characteristics for surface electrodes.

8. Sample Size for the Training Set:

   This is not applicable. The submission is for a physical medical device, not an AI algorithm requiring a training set.

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

   This is not applicable for the reasons stated above.

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The systems are intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status.

Doppler analysis is not to be used for Obstetrics.

The Eclipse Neurological Workstation with TCD and vascular Doppler, Eclipse TCD Neurovascular Workstation and CardioMon (The Systems) provide continuous monitoring of brain and neural pathways and intracranial and extracranial vascular blood flow intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas.

The Systems can be used to monitor neurological and vascular data using either individual or multimodality EEG, EMG, evoked potential and Doppler test protocols.

The Systems main components include: computer, internal or external Doppler, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Systems also provide support for the Nonin XPod pulse oximeter module and a high impedance preamplifier module to allow recording from micro electrodes.

Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. Electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators.

The computer controls the user interface for setting parameters and the display of processed data. The computer also provides the hardware and software Doppler interface.

The TCD and vascular Doppler provide blood flow information using a spectral display and audible Doppler signal.

A built-in pulse oximeter provides pulse rate and oxygen saturation measures.

Data from external devices, such as vital signs or other physiological monitors, can be imported to the systems display screen, allowing the operator to correlate changes in neurological function with systemic changes.

In addition, a display window may be opened to observe the surgeon's microscope view or other video inputs. The systems are network compatible for data review within the hospital and permits secure information access over the Internet.

The Systems were tested functionally using accepted laboratory test procedures.

Technologically, The Systems are similar to the predicate devices.

This submission for K061639 does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary for the Axon Systems Eclipse TCD Neurovascular Workstation, Eclipse Neurological Workstation with TCD and Vascular Doppler, and CardioMon. It describes the device, its intended use, and lists multiple predicate devices. The majority of the provided text is the FDA's letter granting substantial equivalence.

Key information absent from the submission includes:

• Acceptance Criteria Table: There is no table outlining specific performance metrics (e.g., sensitivity, specificity, accuracy) and their corresponding acceptance thresholds.
• Reported Device Performance: The document does not present any quantitative performance data for the device.
• Study Details: There's no description of a study conducted to evaluate the device's performance against any set criteria. This means information regarding sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods is not provided.
• MRMC Study: There is no mention of a multi-reader multi-case comparative effectiveness study or any effect size related to human reader improvement with AI assistance.
• Standalone Performance: The document does not describe any standalone performance evaluation of the algorithm.
• Training Set Details: There is no information regarding a training set, its size, or how its ground truth was established, as this device does not appear to involve AI/ML.

The submission states, "The Systems were tested functionally using accepted laboratory test procedures." However, it does not elaborate on what these procedures entailed, what the results were, or what the acceptance criteria for these functional tests were. For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove specific performance against numerical acceptance criteria in the way an AI/ML device might.

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The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.

The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four.

The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode.

A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe directs stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results.

The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.

The system is network compatible for data review within the hospital and permits secure information access over the Internet.

Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes.

OrthoMon was tested functionally using accepted laboratory test procedures.

This 510(k) summary does not contain the detailed study results and acceptance criteria typically found in a clinical study report. The document is primarily a premarket notification for a medical device, focusing on substantial equivalence to predicate devices rather than direct performance metrics against predefined acceptance criteria from a standalone study.

However, based on the provided text, we can infer some information about the device's functional testing and claims of effectiveness.

Here's an attempt to answer your questions based solely on the provided text, with many fields explicitly stating that the information is "Not provided in the text" as a detailed study was not presented:

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

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

• Sample Size for Test Set: Not provided in the text. The document refers to "accepted laboratory test procedures" for functional testing but does not detail a specific clinical test set or its size.
• Data Provenance: Not provided in the text. There is no mention of country of origin or whether any data was retrospective or prospective.

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)

• Not provided in the text. The document does not describe the establishment of a ground truth for a test set by external experts. The claims of safety and effectiveness are based on "the design and development process, validated and verified" by the manufacturer.

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

• Not provided in the text. No adjudication method is mentioned as there's no detailed study describing expert review or consensus for a test set.

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. The OrthoMon system is an intraoperative neural monitoring system, not an AI-assisted diagnostic imaging device that involves "human readers" in the sense of interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is outside the scope of this device's function as described.

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

• The device itself is a standalone system for monitoring and stimulating, though it is used by surgeons and OR teams and provides "feedback to the surgeon and OR team." The document states it "performs these functions automatically or manually." While it can operate automatically, the "performance" described isn't an algorithm that independently makes diagnoses or decisions without human interaction on a case. No specific "standalone algorithm performance" study, distinct from its integrated use, is mentioned.

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

• Not provided in the text. For the functional testing, ground truth would likely refer to established physiological responses and electrical measurements, but the method for establishing this "ground truth" (e.g., against a gold standard instrument) is not detailed.
  • For the claims of assisting in nerve localization and avoiding injury, the "ground truth" in efficacy would ultimately be the actual state of nerve integrity and accurate placement, but no specific method for validating this using pathology or outcomes data is described in this summary.

8. The sample size for the training set

• Not applicable/Not provided. The OrthoMon system is described as using neurophysiological techniques for monitoring and stimulation, not as a machine learning or AI algorithm that requires a "training set" in the conventional sense for model development. The "design and development process" implied internal testing and validation.

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

• Not applicable/Not provided. As no training set for an AI model is described, there's no mention of how its ground truth would be established.

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The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.

The Eclipse Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas.

The Eclipse Neurological Workstation can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols.

The main Eclipse system components include: computer, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Eclipse also provides support for the Nonin XPod pulse oximeter module and high impedance preamplifier module to allow recording from high impedance electrodes.

Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. The electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators. The computer controls the user interface for setting parameters and the display of processed data.

A built-in pulse oximeter provides pulse rate and oxygen saturation measures. Data from external devices, such as vital signs or other physiological monitors, can be imported to the Eclipse display screen, allowing the operator to correlate changes in neurological function with the patient's systemic measurements. In addition, a display window may be opened to observe the surgeon's microscope view or other video input. The Eclipse is network compatible for data review within the hospital and permits secure information access over the Internet.

The provided text is a 510(k) summary for the Eclipse Neurological Workstation. It outlines the device's intended use, classification, and substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text.

The information given primarily focuses on:

• Identifiant: K050798
• Device Name: Eclipse Neurological Workstation / Eclipse Lite Neurological Workstation
• Applicant: Axon Systems, Inc.
• Contact: Howard Bailin
• Common Name: Electroencephalograph (EEG Monitor), Evoked Potential (SEP, BAEP, AEP, VEP, MEP) System, EMG Monitor
• Classification Name: Electroencephalograph, Evoked Response, Electromyograph
• Regulation Numbers: 21 CFR 882.1400, 21 CFR 882.1420, 21 CFR 882.1870, 21 CFR 882.1570, 21 CFR 882.1620, 21 CFR 882.1900
• Product Codes: GWQ, GWS, GWF, GWE, GWJ, CAB
• Predicate Devices: Axon Systems - EpochXP (K032741), Digitimer - D185 (K020400), NuVasive - Neurovision JJB (K032083), Grass Telefactor - AS40 Amplifier (K021807)
• Device Description: Provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit using EEG, EMG, and evoked potential test protocols. It includes a computer, controller, digital preamplifiers, various stimulators, and support for pulse oximetry and external device data import.
• Indications for Use: Intended for use to monitor sensory and motor pathways in the operating room and critical care areas. It uses EEG, EMG, motor and sensory evoked potentials, and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.
• Conclusion: The device is claimed to be safe, effective, and substantially equivalent to the predicate device(s).

To answer your full request, you would need access to the full 510(k) submission, which typically includes detailed performance data, verification, and validation studies.

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Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment. The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet. Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The provided text describes a 510(k) premarket notification for Axon Systems' Subdermal Needle Electrodes. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.

Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) are not applicable to this type of submission as the core of a 510(k) is about demonstrating similarity to existing, legally marketed devices.

However, I can provide information based on what is available in the document:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states: "Axon Systems' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This is the core performance claim in the context of a 510(k). Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as they are typically not required for this type of submission unless a significant new technological feature is being introduced that affects performance beyond that of the predicate.

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

• Not Applicable: This was a 510(k) submission focused on substantial equivalence to predicate devices. There is no mention of a "test set" in the context of a performance study with human subjects or a dataset. The evaluation likely involved technical comparisons and analysis of the device's design, materials, and intended use against the predicate devices.

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

• Not Applicable: See point 2.

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

• Not Applicable: See point 2.

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 Subdermal Needle Electrode, which is an invasive medical device for recording and stimulating biopotential signals. It is not an AI-powered diagnostic imaging device or software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable: This device is hardware and is used by a licensed physician or technologist. It does not operate as a standalone algorithm in the way AI software would.

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

• Not Applicable: The concept of "ground truth" as used in performance studies (e.g., for diagnostic accuracy) is not relevant here. The "truth" in a 510(k) is established by successfully demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it shares their fundamental safety and effectiveness profile.

8. The sample size for the training set:

• Not Applicable: See point 2. There is no mention of a "training set" as this is not an AI/machine learning device requiring such a component.

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

• Not Applicable: See point 8.

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The EpochXP Neurological Monitor is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status and guide treatment during surgery or long term monitoring in the ICU

The EpochXP Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environments.

The EpochXP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols. The main EpochXP system components include: CPU, interface enclosure, data acquisition module, sensory and motor electrical stimulator, stimulator extension boxes, LED goggles and insert earphones.

Recording electrodes, placed on the patient, are connected the digital preamplifier (data acquisition module) The signal is amplified, filtered, optically isolated and converted to a digital signal. The digitized data is then routed to the digital signal processing (DSP) board located in the interface enclosure. The DSP processes the data and controls timing for the stimulators. The CPU acts as the user interface for setting parameters and controls and for display of the processed data.

Data from external devices, such as vital signs monitors, can be imported to the EpochXP display screen, allowing the operator to correlate changes in neurologic function with the patient's systemic vital signs. In addition, a display window may be opened to observe the surgeon's microscope view on screen. The EpochXP is network compatible for data review within the hospital and permits secure information access over the Internet.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the administrative details of a 510(k) submission for the EpochXP Neurological Workstation, including its description, intended use, and substantial equivalence to predicate devices. It does not provide any specific quantitative acceptance criteria or report on any studies (clinical or non-clinical) that demonstrate the device's performance against such criteria.

Therefore, I cannot extract information for the following points as they are not present in the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Epoch XP is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status during surgery or long term monitoring in the ICU.

The Epoch XP Neurological Workstation provides continuous monitoring of brain and neurologic electrical activity for applications intraoperatively or in the intensive care unit. The system has been designed to meet the demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environments. The Epoch XP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked components include: CPU, interface enclosure, data acquisition module, electrical stimulator extension boxes, LED goggles and insert earphones. Recording electrodes, placed on the patient, are connected the digital preamplifier (data acquisition module) The signal is amplified, filtered, optically isolated and converted to a digital signal. The digitized data is then routed to the digital signal processing (DSP) board located in the interface enclosure. The DSP processes the data and controls timing for the stimulators. The CPU acts as the user interface for setting parameters and controls and for display of the processed data. Data from external devices, such as vital signs monitors, can be imported to the Epoch XP display screen, allowing the operator to correlate changes in neurologic function with the patient's systemic vital signs. In addition, a display window may be opened to observe the surgeon's microscope view on screen. The Epoch XP is network compatible for data review within the hospital and permits secure information access over the Internet.

Based on the provided text, the submission is an FDA 510(k) summary for the Epoch XP Neurological Workstation. This document primarily focuses on establishing substantial equivalence to a predicate device (Epoch 2000 K971819) rather than detailing a specific clinical study with acceptance criteria and device performance as typically seen for novel AI/ML devices.

Here's an breakdown of the information that can be extracted, and what is not present:

Information Present in the Document:

• Device Name: Epoch XP Neurological Workstation (and Epoch XP Lite Neurological Workstation)
• Intended Use/Indications for Use: The Epoch XP is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials, and EMG techniques to provide healthcare professionals with information to help assess a patient's neurological status during surgery or long-term monitoring in the ICU.
• Predicate Device: Epoch 2000 (K971819)
• Classification: Class II
• Description: The Epoch XP provides continuous monitoring of brain and neurologic electrical activity. It's designed for comprehensive neurological monitoring in electrically hostile operating room and critical care environments. It can monitor neurological data using individual or multimodality EEG, EMG, and evoked potentials.

Information NOT Present in the Document (and why):

This document is a 510(k) summary for an electrophysiological monitoring device (EEG, evoked potentials, EMG monitor), which is a conventional medical device, not an AI/ML device. Therefore, the detailed performance metrics, study design, and ground truth establishment typically required for AI/ML device submissions (especially those involving image analysis or diagnostic support) are not included. The focus of a 510(k) for such a device is on demonstrating that it is as safe and effective as a legally marketed predicate device, often through engineering and comparative testing, rather than a clinical trial proving a specific diagnostic accuracy against a ground truth.

Specifically, the following requested information is not available in the provided text:

• 1. A table of acceptance criteria and the reported device performance: This type of quantitative performance data is not presented. The document asserts substantial equivalence based on concept, function, and meeting design and development criteria, validated and verified.
• 2. Sample size used for the test set and the data provenance: No test set or data provenance details are provided.
• 3. Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth for a test set is not discussed as no such test is detailed.
• 4. Adjudication method for the test set: Not applicable as no test set is described.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this type of study is for diagnostic performance of AI, not for a physiological monitor.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physiological monitoring system that provides data to healthcare professionals.
• 7. The type of ground truth used: Not applicable as the device is a data acquisition and display system for physiological signals, not a diagnostic algorithm generating its own "ground truth."
• 8. The sample size for the training set: Not applicable; this device is not an AI/ML model trained on data in the usual sense.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document describes a conventional neurological monitoring workstation and seeks substantial equivalence to a predicate device. It does not contain the specific performance metrics, study designs, or ground truth methodologies relevant to AI/ML device evaluations. The "acceptance criteria" for this device would have primarily revolved around engineering specifications, safety standards (e.g., electrical safety, EMC), and functional equivalence to the predicate device in terms of signal acquisition, processing, and display, rather than diagnostic accuracy against a clinical ground truth dataset.

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Ask a specific question about this device