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The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

The DS7AP Constant Current Stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Peña, "Pull-through" or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique.

The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

Here's a breakdown of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance and Performance:

The primary acceptance criteria for the DS7AP were related to demonstrating substantial equivalence to the predicate device (Radionics Pena Muscle Stimulator PS-1 - K980448) in terms of intended use, indications for use, and technological characteristics.

While there are differences in specific electrical output values (e.g., maximum output voltage and current, pulse width, pulse frequency), power source, and some safety features (automatic overload trip, compliance with 21 CFR 898), the manufacturer argued and the FDA determined that these differences do not raise different questions of safety or effectiveness. For instance, regarding the power source difference, the subject device's power supply is "identical to that of the Digitimer DS7A/AH Constant Current Stimulators, which are approved for marketing under number K051357."

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

• Sample Size: Not applicable. The submission states that no clinical tests were required for this submission. The evaluation was based on non-clinical testing and comparison of technological characteristics to a predicate device.
• Data Provenance: Not applicable for a test set as no clinical tests were performed.

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

• Not applicable as no clinical tests were conducted and thus no expert-established ground truth for a test set was established.

4. Adjudication method for the test set:

• Not applicable as no clinical tests were conducted.

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 constant current stimulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

• Not applicable. This is a medical device (constant current stimulator), not an algorithm. Its function is to directly stimulate muscles, not to provide an output that requires standalone evaluation against a ground truth in the way an algorithm would.

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

• Not applicable. The substantial equivalence determination was based on non-clinical testing to national and international standards (e.g., EN 60601-1, IEC 60601-1-2, IEC 62366-1, ISO 14971, EN 60601-2-10) and a comparison of technological characteristics to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable as this is a medical device, not an AI/machine learning model that requires a training set.

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

• Not applicable as no training set was used.

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The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited stimuli. The acquired data are necessary to perform somatosensory. auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures.

Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the nervous system in response to the stimulation.

EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head.

Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions.

TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis.

SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room.

IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

• . Evoked potential (EP) in the form of:
  • Brainstem auditory (BAEP): O
  • Visual (VEP); and O
  • Somatosensory (SSEP). O
• Transcranial electrical motor evoked potential (TcMEP).
• Electromyography (EMG). ●
• Triggered EMG.
• Electroencephalogram (EEG). ●
• Nerve conduction studies.
• Train of four (TOF). ●
• SpO2 and heart rate values. ●
• Threshold mode. ●
• Cortical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cadwell IOMAX Intraoperative Monitor:

Acceptance Criteria and Reported Device Performance

The provided document describes the Cadwell IOMAX Intraoperative Monitor, an electroneurodiagnostic device. The acceptance criteria are broadly focused on the device's technical performance, safety, and compliance with various medical device standards. The document does not present specific quantitative acceptance criteria or reported performance values in a distinct table format. Instead, it states that "Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards." and "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard."

However, we can infer the categories of acceptance criteria based on the performance testing summary. The reported device performance is generally a statement of compliance.

Study Details:

The provided document summarizes various tests rather than detailing a single "study" as one might expect for a clinical trial. However, it does outline the testing performed to demonstrate compliance.

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

   • Biocompatibility: Not explicitly stated as a "sample size" for a test set in the clinical sense. The verification was on "component materials" of accessories. Data provenance is implied to be laboratory testing of materials.
   • Software, Electrical Safety, EMC, Bench Performance: Not applicable in terms of patient sample size. These involve engineering and laboratory testing of the device itself.
   • Clinical Performance (SpO2): The document states "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard [ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment]". This standard defines requirements for pulse oximeters, which would necessitate testing on human subjects. However, the specific sample size for this clinical testing is not provided in the given text. The data provenance is clinical testing against a standard. The country of origin is not specified.

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

   • This information is not provided in the document. The testing described is primarily technical compliance with standards, and clinical performance for SpO2 which refers to a standard directly. There is no mention of independent expert review or ground truth establishment in the traditional sense for diagnostic accuracy.

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

   • This information is not provided and is unlikely to be applicable for the types of compliance testing described here. Adjudication methods are typically used for medical image interpretation or diagnostic accuracy studies involving human readers.

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:

   • No MRMC comparative effectiveness study was done or mentioned. This device is an intraoperative monitor and stimulator; it is not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases with or without AI assistance. Therefore, no effect size of human improvement with AI assistance is applicable or provided.

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

   • The IOMAX is an electroneurodiagnostic device that acquires and displays physiological data. Its "performance" is based on the accuracy and reliability of its measurements and stimulation. The testing described (electrical safety, EMC, bench, and clinical for SpO2) assesses the device's inherent function, which is essentially "standalone performance" in the sense that the device directly performs the measurement or stimulation. It doesn't involve an "algorithm" in the AI sense, but rather the hardware and software's ability to accurately capture and present physiological signals or deliver specific stimuli.
   • The clinical performance for SpO2 (compliance to ISO 80601-2-61) is a test of the device's standalone accuracy in measuring oxygen saturation and heart rate.

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

   • For the technical compliance tests (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" is defined by the requirements of the specified industry standards (e.g., ISO 10993-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60068, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366). The device's output is compared against the expected performance defined by these standards.
   • For the clinical performance testing for SpO2, the ground truth would be established by a reference method or device as required by ISO 80601-2-61, which typically involves comparing the pulse oximeter's readings against arterial blood gas analysis results.

8. The sample size for the training set:

   • This information is not applicable as the device is not described as an AI/machine learning device that requires a training set in the conventional sense. The "training set" for software development would be the requirements and specifications used during its creation, rather than a dataset for statistical model training.

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

   • As the concept of a "training set" for an AI model is not applicable here, the establishment of ground truth for such a set is also not applicable. The software's "ground truth" during development would be its specified functional requirements.

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The devices are intended to be used for stimulation of peripheral nerves for diagnostic purposes.

MagPro R30 incl. MagOption, MagPro X100 and MagPro X100 incl. MagOption are Magnetic stimulators used for Magnetic stimulation. These three devices are, together with the predicate device MagPro R30, called "MagPro Family". Hereafter we name the three devices in this submission "the new devices". Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The new devices are connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. All Standard coils as well as the Fluid and Cool coils can be used with the MagPro devices, (K926516, K061645, K071821). The new devices are magnetic stimulators, featuring Biphasic, Monophasic, Halfsine, Biphasic Burst waveform, stimulation rates up to 100 pulses per second (pps), stimulus sequences and protocols controlled via a built-in computer and 8,4" display.

This 510(k) premarket notification is for magnetic stimulators (MagPro R30, X100, and variants) and does not contain information typically associated with AI/ML device studies. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and compliance with existing medical device standards rather than clinical performance metrics in the context of an algorithmic decision.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this specific 510(k) submission.

The document indicates that the devices are for "stimulation of peripheral nerves for diagnostic purposes" and that "The difference in performance between the new devices and the predicate devices are thoroughly compared and discussed in the 'Substantial Equivalence' section." However, this section (not fully provided in the input) would likely focus on electrical and magnetic output characteristics, safety, and functional equivalence, not diagnostic accuracy in the way an AI/ML device would be assessed.

The submission concludes that "The new devices do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate devices." This is the primary "acceptance criterion" for a 510(k) of this nature.

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The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application for use with the Navigator Pro hardware platform for the recording of evoked responses (i.e., electrical potentials) upon the presentation of sensory stimuli.

The ENoG Protocol works on the basis of a repeating stimulus-response cycle. It is a convenience feature developed for the user to quickly set up testing for Electroneuronography evaluation of the facial nerves. The protocol utilizes the existing technology of the evoked response somatosensory function of the software. The evoked response from the patient is recorded through the use stimulus electrodes positioned near the mastoid, a cathode behind the earlobe, and an anode in front of the earlobe with the forehead as the ground.

The provided document describes a 510(k) summary for the Navigator Pro, AEP Software Modification - ENoG, which is an evoked response somatosensory stimulator. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on substantial equivalence to predicate devices by comparing technological characteristics and ensuring safety and effectiveness through adherence to design control specifications and risk analysis. The "study" mentioned below refers to the safety and effectiveness summary provided in the document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria (e.g., minimum sensitivity, specificity, or quantifiable performance metrics) for the ENoG Protocol, nor does it report numerical device performance against such criteria. The "acceptance" discussed is primarily in the context of substantial equivalence to predicate devices and adherence to quality systems and risk management.

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

Not applicable. The document does not describe a clinical performance study using a test set of patient data with a specified sample size.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There's no mention of a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no test set for which an adjudication method would be required.

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

No. The document does not describe an MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The device is not presented as an AI-assisted diagnostic tool in this context, but rather as a software modification to an existing evoked response system.

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

No. The document explicitly states: "The ENoG protocol feature does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." This indicates that the device is intended for use with a human-in-the-loop, and no standalone performance study without human intervention is mentioned.

7. Type of Ground Truth Used

Not applicable. Since no performance study comparing device output to a known truth is described, there's no mention of the type of ground truth used.

8. Sample Size for the Training Set

No. The document does not describe a machine learning algorithm that requires a training set. The ENoG Protocol is described as a "convenience feature" and a "Windows® based software application" that utilizes "existing technology of the evoked response somatosensory function of the software."

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

Not applicable, as there is no training set for a machine learning algorithm.

Summary of the "Study" (Safety and Effectiveness Summary):

The "study" or assessment demonstrating safety and effectiveness relied on:

• Internal Product Development Procedures: The device was developed in accordance with Bio-logic's internal product development procedures, which are stated to meet ISO-9001, ISO 13485:2003, and FDA QSR Design Control specifications.
• Hazard/Risk Analysis: A detailed Fault Tree Analysis (FTA) was performed for the Evoked Potential family of products.
• Risk Assessment: A detailed Risk Assessment for the AEP Software was written in accordance with ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices.
• Human-in-the-Loop: A key aspect of safety is that "All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." The program also allows users to review raw data and perform other analyses.
• Substantial Equivalence: The primary argument for market clearance is that the ENoG Protocol is substantially equivalent to legally marketed predicate devices, with differences in technological characteristics not raising new issues of safety or effectiveness.

In conclusion, the given document describes a regulatory submission centered on substantial equivalence and a risk management approach to safety, rather than a clinical performance study with specific quantitative acceptance criteria and reported device performance.

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