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LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic(EEG) studies. It is to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation.

The LED PHOTIC Systemis managed by the EEG system software for setting some parameters, IC, and the power supply called LED PHOTIC IC POWER is an integral part of the LED PHOTIC System.

The provided text describes the regulatory clearance for a medical device called "LED PHOTIC System" and its comparison to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification summary for a Class II medical device, which is an accessory for EEG studies to provide photic stimulation. The performance testing mentioned focuses on safety standards (electrical safety, usability, EMC compliance, photobiological safety), not on accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML device evaluations.

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

• A table of acceptance criteria and the reported device performance: The document only lists safety standard compliance, not performance criteria for diagnostic accuracy or similar AI/ML metrics.
• Sample size used for the test set and the data provenance: No such testing is described for diagnostic performance. The safety tests would have their own sample sizes (e.g., number of units tested) but these are not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study described.
• Adjudication method for the test set: Not applicable.
• 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, as the device is a photic stimulator, not an AI/ML diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable (no AI/ML algorithm mentioned).
• How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section only states:

• The LED PHOTIC System was tested and found compliant to the following safety standards:
  • IEC 60601-1:2005+A1:2012: Medical Electrical safety
  • IEC 60601-1-6:2010+A1:2013: Usability
  • IEC 60601-2:2014: EMC Compliance
  • IEC 62471:2006: Photobiological Safety

This submission is about establishing substantial equivalence to a predicate device (Lifelines Photic Stimulator K101691) primarily based on shared intended use, similar operational principles, and compliance with general medical device safety standards. It is not an evaluation of an AI-driven system.

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The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected and with the SystemPlus EVOLUTION software; it cannot serve as a stand-alone cortical stimulator.

The SD LTM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intraccanial electrodes) and the resulting cortical or deep brain potentials third-party cortical or intracranial electrodes. The use of these types of recordings can be related to the diagnosis/study of nervous system diseases.

Here's an analysis of the acceptance criteria and study information for the SD LTM STIM Cortical Stimulator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K180761) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria through a de novo clinical trial. Therefore, explicit "acceptance criteria" related to a new clinical performance study, in terms of specific sensitivity, specificity, or other outcome measures, are not defined in the document.

Instead, the acceptance is based on demonstrating that the new device (SD LTM STIM) is as safe and effective as a legally marketed predicate device (Cervello Stim K151354). The "performance" reported is primarily a comparison of its technological characteristics to the predicate.

Here's a table summarizing the comparative technical performance, which serves as the basis for acceptance in this 510(k) submission:

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

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

Therefore, there was no test set of clinical data used in this submission. The evaluation was based on a comparison of technological characteristics and compliance with recognized voluntary consensus standards.

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

Since no clinical test set was used, no experts were involved in establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As there was no clinical test set, no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done as the submission did not rely on clinical performance data. The device is a stimulator, not an diagnostic imaging AI, so this type of study would not typically be applicable for a 510(k) of this nature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a hardware cortical stimulator that works as an accessory to an EEG system and software. It is explicitly stated that "it cannot serve as a stand-alone cortical stimulator." Therefore, there was no standalone performance evaluation in the context of an algorithm. Its performance is always in conjunction with the controlling system.

7. The Type of Ground Truth Used

Given that no clinical performance data was used, no traditional "ground truth" (like pathology, expert consensus, or outcomes data) was established or utilized for comparison in this submission. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety profile of the predicate device and compliance with relevant safety standards.

8. The Sample Size for the Training Set

There was no training set in the context of a machine learning or AI algorithm, as this is a hardware device submission.

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

Since there was no training set, this question is not applicable.

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The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software.

The system includes:

-hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and

-software which is used for the signal acquisition, display, storage, process and measure of biologic signals.

The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers.

The device is intended to be used by physicians, technicians, and other medical professions that are trained in EEG and/or PSG.

The Micromed BRAIN QUICK System is a multi-modal physiological recording system, for use in research institutions, clinics, hospitals, operating rooms, epilepsy monitoring unit environments and/or sleep laboratories. The Micromed BRAIN OUICK System is a modular system which can be configured in different versions; however, the intended use, operating principle and technology remain the same for the different configurations of the Micromed BRAIN QUICK system. The basic unit consists of one or more acquisition amplifiers, a communication interface for transferring data to a PC, a PC with monitor and user interface devices and software for the processing, storage and display of the acquired traces. The power supply is provided through an isolation transformer allowing the connection of several devices to the transformer secondary winding.

The Micromed BRAIN QUICK system acquires EEG signals (bio-potential derived from the brain activity) from third-party commercial electrodes connected to the patient. The Micromed BRAIN QUICK system processes the signal (amplification and filtering), converts it from analogical to digital representation and transmits the result to the software which controls the display of the resulting signal on a monitor, the storage of the signal on a digital storage media (e.g. hard disk or DVD), the analysis for deriving signal measures. The clinical meaning of the displayed trace is determined by the physician only, based upon the signal morphology.

The device is not intended to directly come in contact with any part of the patient body. The device uses and is compatible with EEG commercial electrodes. The device is neither sterile nor sterilizable. It is reusable. The expected lifetime is ten years.

The provided text is related to a 510(k) premarket notification for the Micromed BRAIN QUICK System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing new performance criteria or conducting studies to prove a specific level of diagnostic accuracy against a ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in terms of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the performance testing described is primarily focused on safety and electrical compatibility to show equivalence.

Specifically, the document states:

• "No specific guidance document on performance is required for EEG/PSG devices."
• "The device capability is equivalent to the features specified for predicate devices."
• "Safety Tests have been performed to verify compliance with IEC 60601-1 and IEC 60601-2-26..."
• "Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed..."

Given this, I cannot construct the table or provide details for the requested study components because the provided text does not describe such a study for the device. The focus is on technical and functional equivalence to already-marketed devices, not on proving a specific clinical performance threshold for a new diagnostic capability.

If you have a document that describes a clinical performance study for an AI/diagnostic device, I would be happy to analyze it against these criteria.

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The devices are intended to acquire and store physiological signals for EEG and Sleep Studies, and to transfer the data to separate polysomnographic analysis software.

The devices are intended for use by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

The device function is the acquisition of bloelectric signals, as is typical for EEG amplifiers and holter recorders. The device receives and amplifies patient input signals, converts them to digital format, packs them by a programmable logic and sends them to an internal microcontroller. The microcontroller stores them in a RAM buffer, from where they are written at defined time to the Compact Flash memory. The data can be viewed directly on the display or downloaded by using elther specific interface modules (BQUSB towards the USB port of the PC or BQNET towards an Ethernet link) or the built-in Bluetooth® link. Data can also be read directly from the Compact Flash card via a memory card reader. In PC a typical polysomnographic analysis software application manages the storage and the on-line or off-line display of the data. In the main version, the device is provided with 32 input channels:

• 24 channels for EEG (BW: 0.15-220 Hz) .
• DC channels (0-330 Hz) .
• 2 channels for the built-in flow sensors .
• 2 channels for external inductive belts (respiratory effort sensors) .
• 1 channel for a built-in body position sensor .
• 1 channel for digital data from the oximeter (SpO2, heart rate and plethysmographic signal)

The device is enclosed in a (2.5 -> 3.5) h x 7.5 x 11.4 cm plastic case and weighs 200g. It is powered by 2 AA 1,5V alkaline batteries, by the BQUSB interface (via the connected PC) or the BQNET module (via separate AC mains adapter).

The device has a LCD allowing the menu to be display gives information on the recording mode, acquisition time, remaining memory, impedance measure and allows the rough display of the acquired traces both on-line and after the recording. The user interface includes 4 membrane keys enclosed in the label below the display.

The device has no patient contacting parts. Input signals are collected by commercially available accessories like EEG electrodes, oximeter sensors, cannulae and respiratory effort sensors (elastic band). The patient and operator can eventually touch the plastic external enclosure but the device is usually worn above the clothes in a synthetic fabric bag.

The manufacturer does not intend to limit the utility of this device by listing a finite set of commercially available sensors. The device is only a recorder that receives and records input form sensors and subsequently downloads those recordings to a PC resident polysomnological application software for clinical analysis: it is very versatile in the range of input sensors that can be used in various sleep study dinical settings. The sensors, kits and application software are not intended in this application for dearance.

For connection with the sensors and the PC, the devices are provided with:

• touch proof connectors for patient electrodes (EEG channels)
• touch proof (BRAIN SPY PLUS) or 3-pin connector (MORPHEUS/TITANIUM) connectors for DC channels
• 1 screw-lock and 2 hose barb connectors for flow sensor cannulae (MORPHEUS/TTTANIUM version)
• 2 connector for the resplratory effort elastic band (MORPHEUS/TTTANIUM version)
• 3-pin (MORPHEUS/TITANIUM) or 4-pin (BRAIN SPY PLUS) connectors for the oximeter
• 4 pin push-pull connector for the connection to the BQUSB or BQNET module.

The communication lines with the BQUSB or BQNET module are optically isolated.

In the PC data coming from either USB, Ethernet or Bluetooth® ports are then acquired by an acquisition software. The submitted device is supported by PC based application software such as Embla's Somnologica Studio (version 5.1), or Micromed's System Plus (version 1.03). The application software is not intended to be included in this application for clearance.

Battery power is provided to make the device safer, ergonomic and able to acquire good signals even in electromagnetically nolsy environment. Low power consumption allows 24 hours of consecutive recording with a pair of standard alkaline battery. Maximum power consumption is 80-100 mA, plus 30 mA in wireless transmission mode. In stand-by, the power consumption is less than 100µA.

When voltage and communication signals are present on the cable connection, the device is powered by the USB interface modules through a DC/DC converter.

The device can also be connected to the PC through a radio (Bluetooth®) link using the RADIOEEG. built-in module. The microcontroller communicates with the radio module through Its serial port and transmits the data to a Bluetooth® receiver on the PC.

The Compact Flash storage memory capacty determines the duration of the recording to the number of the channels used. The commercially available (1 GB) allow more than 24 hours recording of 32 channels at 128 Hz sampling rate, without data compression. If data compression algorithm Is used, recording time can be increased by 25-30%.

The device family is composed of two basic models all sharing the same case, internal hardware and firmware. The BRAIN SPY PLUS model is obtained by a MORPHEJS model without the internal sensors and with a different input panel (less and different connectors). The Embla TITANIUM model Is identical to MORPHEUS, differing only in labeling (distributor brand and device name).

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Micromed devices:

This 510(k) summary does not include detailed acceptance criteria or a study proving the device meets them in the way typically expected for performance claims. Instead, it focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and compliance with safety and EMC standards.

The document does not report numerical performance metrics or statistical results from a comparative effectiveness study or a standalone algorithm performance study. It emphasizes that the device functions as an acquisition and storage unit, and does not perform analysis or make judgments on the displayed signals. The analysis software is explicitly stated as separate and not included in the clearance application.

Therefore, the following information is extracted based on the provided text, and where information is not present, it is explicitly stated as such.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the document. The document refers to "Safety Tests," "Electromagnetic Compatibility tests," "Immunity tests," "Verification of firmware," and "Functional testing" but does not specify the number of devices or data sets used for these tests.
• Data Provenance: Not explicitly stated. The document refers to compliance with international standards (IEC, UL) and internal verification/functional testing, implying laboratory testing, but does not specify if patient data (retrospective or prospective) was used for these tests.

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

• This information is not provided in the document. The document describes compliance with technical standards and functional verification, which typically do not involve expert-established ground truth in the context of clinical performance, as the device is an acquisition and storage unit, not an analytical one.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Given the nature of the tests mentioned (safety, EMC, functional verification), an adjudication method for a "test set" as understood in clinical performance evaluation is not relevant or 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

• No, an MRMC comparative effectiveness study was not done and is not described in this document.
  • The device is an acquisition and storage system, not an AI-assisted diagnostic tool.
  • The document explicitly states that the "separate polysomnographic analysis software" (which would include any AI part) is "not intended to be included in this application for clearance."
  • The device "does not make any judgment of normality of the displayed signals."

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

• No, a standalone algorithm performance study was not done and is not described. As mentioned above, the device itself is an acquisition and storage unit and does not contain analytical algorithms for which standalone performance would be measured.

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

• The document focuses on engineering and regulatory compliance rather than clinical performance (e.g., diagnostic accuracy). Therefore, "ground truth" in the sense of clinical reference standards (like pathology, expert consensus on disease presence) is not applicable and not mentioned for the tests described. The "ground truth" for the tests performed would be compliance with electrical, safety, and functional specifications.

8. The sample size for the training set

• Not applicable / Not provided. Since this device is an acquisition and storage unit, and not an AI/ML system performing analysis or diagnosis, there is no "training set" in the context of machine learning.

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant.

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